In 2024, a total of 27 309 cases of medication error (ME) from 484 hospitals in 27 provincial administrative regions were collected in the National Monitoring Network for Clinical Safe Medication. Among them, 279 (1.02%) were classified as grade A, 22 081 (80.86%) as grade B, 4 268 (15.63%) as grade C, 472 (1.73%) as grade D, 96 (0.35%) as grade E, 105 (0.38%) as grade F, 6 (0.02%) as grade H, and 2 (<0.01%) as grade I; no MEs of grade G occurred. Among the 27 030 patients involved in MEs of grade B to I, 15 124 (55.95%) were male and 11 906 (44.05%) were female; their ages were from 1 day to 104 years; 3 369 (12.46%) were children (<18 years old), 12 113 (44.81%) were young and middle-aged adults (≥18 to <60 years old), and 11 548 (42.72%) were elderly (≥60 years old). The top 3 contents of ME were wrong drug class (5 347 cases, 19.13%), wrong dosage (4 913 cases, 17.58%), and wrong administration frequency (3 429 cases, 12.27%). Among the 27 030 grade B-I MEs, the main person who triggered the event were physicians (18 703 cases, 69.19%) and pharmacists (6 343 cases, 23.47%). These MEs mainly occurred in clinics (11 009 cases, 40.73%), in hospital wards (7 393 cases, 27.35%), and in pharmacies (6 219 cases, 23.27%). The main persons who discovered the MEs were pharmacists (21 021 cases, 74.14%). The top 3 factors causing ME were lack of related pharmacologic knowledge (8 716 cases, 26.49%), tiredness (5 755 cases, 17.49%), and inexperienced skills (4 505 cases, 13.69%). A total of 209 patients were involved in severe MEs (grade E-I), including 133 (63.64%) males and 76 (36.36%) females, aged from 21 months to 94 years, of which 42 (20.10%) were children, 75 (35.88%) were young and middle-aged adults, and 92 (44.02%) were elderly. The top 3 diseases diagnosed in severe MEs were drug poisoning (41 cases, 19.62%), diabetes (34 cases, 16.27%), and hypertension (14 cases, 6.70%); the main person who triggered the MEs were patients and their families (135 cases, 64.59%); the MEs occurred mainly in patients′ houses (116 cases, 55.50%). Drug poisoning was mainly related to accidental ingestion by children, and MEs in patients with diabetes and hypertension were often related to issues on patient compliance. Based on the data of MEs in 2024, it was proposed to establish a better medication safety culture and improve the ME reporting situation in China, pay attention to the risks of misusing external drugs for internal use, children′s accidental ingestion and insulin-related MEs, strengthen the prevention of MEs related to look-alike sound-alike drugs, pay attention to the post administration management and the compliance education of home care for patients with chronic diseases, so as to improve the medication safety of patients in China.

Objective To construct a recommended list of high-alert medication (HAM) based on big data from medication error (ME) reports in China, providing reference for preventing and reducing HAM-related risks.　Methods The drugs involved in the serious ME reports of the National Monitoring Network for Clinical Safe Medication (Monitoring Network) were collected (as of December 31, 2023), and the candidate drugs were preliminarily determined referring to the HAM list of China 2023 (Chinese list) and the latest three lists of American Institute for Safe Medication Practices (ISMP). Candidate drugs that were included in both the Chinese list and ISMP lists, as well as those existed in the Chinese list but had never been included in the ISMP lists were included in the current list, and their risk levels followed the original risks in the Chinese list. Candidate drugs that existed in the Chinese list but had been excluded from the ISMP lists, and those existed in the ISMP lists but had not been included in the Chinese list were listed as suspected drugs. For the other candidate drugs, those did not meet the definition of HAM were excluded firstly, and those related to ME that had caused serious harm were listed as suspected drugs, according to the judicial cases on ME of China Judgements Online and PKULAW database. Two methods, including Delphi expert consultation and questionnaire survey, were used to determine whether the above suspected drugs were included in the HAM list and their risk levels.　Results A total of 138 drugs were obtained through the initial screening, 106 of which were directly included in the current list, and 32 of which were listed as drugs requiring further assessment. After 2 rounds of Delphi expert consultation by 18 experts and surveys with 136 valid questionnaires, 32 suspected drugs did not meet the inclusion criteria. Finally, a total of 106 drugs were included in the current list, including 51 A-class drugs in 9 categories, 33 B-class drugs in 9 categories, and 22 C-class drugs in 5 categories.　Conclusion Based on the big data of the ME reports in China, a HAM list is constructed, which is accurate and concise and better fits the actual clinical drug risks in China, helping to improve the drug safety management.

External preparations have advantages including direct therapeutic action, high local drug concentrations, and minimal systemic adverse reactions, representing an important therapeutic modality for various diseases. However, current clinical application standards for external preparations remain substantially suboptimal, posing considerable medication safety risks. To establish dosage specifications and combination therapy strategies for external preparations and promote their safe and rational use, the Beijing Pharmaceutical Association Primary Care Pharmacy Committee and Beijing Pharmacy Center for Quality Control and Improvement convened clinical and pharmaceutical experts from 27 medical institutions in Beijing and developed the "Expert consensus on standardized prescribing and rational use of external preparations in medical institutions (2026 edition)", based on current evidence-based medical data, experience of multidisciplinary experts in frontline clinical practice, and the patients′ rational use requirements for topical preparations. The expert consensus addresses 7 clinical questions across 3 medication scenarios and provides specific recommendations and the recommendation strengths for each scenario, including monotherapy of one external preparation, combination therapy of external preparation with its systemic preparation, and combination therapy with 2 or more external preparations. It is published with the aim to promote rational drug use of external preparations and reduce the occurrence of adverse drug reactions.

Objective To investigate the occurrence and characteristics of adverse reactions of Xuesaitong preparations, mine its coagulation disorders/bleeding risk signals, and provide references for its safe and rational use in clinic.　Methods The reports of adverse drug reactions (ADR) caused by Xuesaitong preparations from August 2003 to August 2023 in the database of Shandong Provincial Center of Adverse Drug Reaction Monitoring were collected. ADR were counted and classified using the system organ class (SOC) and preferred term (PT) of Medical Dictionary for Regulatory Activities 26.1. Three methods, namely the reporting odds ratio (ROR), the proportional reporting ratio (PRR), and the comprehensive standard method of the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom, were used to detect the risk signals of coagulation disorders/bleeding in using Xuesaitong preparations.　Results A total of 17 015 reports of ADR related to Xuesaitong preparations were collected, involving 9 dosage forms, in which injection dosage form accounted for 95.50% (16 250/17 015). The median age of the patients was 62 years, 44.87% of the cases were 45-64 years and 42.90% of them were 65 years and above. There were 2 217 cases of severe ADR reports, accounting for 13.03% (2 217/17 015). A total of 18 SOCs were involved, the top 3 were skin and subcutaneous tissue diseases, systemic diseases and drug administration site reactions, and neurological diseases. A total of 54 PTs were not recorded in the instructions, among which 34 were severe. Ninety-three cases about coagulation disorders/bleeding (98 times) were reported, the top 3 PTs were hematuria ［24.49% (24/98)］, purpura ［11.22% (11/98)］, and epistaxis ［10.20% (10/98)］. Seven dosage forms of Xuesaitong preparations were involved, the top 3 were Xuesaitong for injection (freeze-dried) (48 cases, accounting for 51.61%), Xuesaitong injection (29 cases, accounting for 31.18%), and Xuesaitong tablets (8 cases, accounting for 8.60%). Among 93 reports of coagulation disorders/bleeding, there were 23 severe cases, accounting for 24.73%, which was significantly higher than that in other reports (12.97%), and the difference was statistically significant (P<0.001). Sixteen PTs about coagulation disorders/bleeding were not recorded in the instructions, among which 9 were severe. The proportion of cases with onset time longer than 7 days in ADRs about coagulation disorders/bleeding was higher than that in other ADRs [22.58%(21/93) vs. 7.43%(1 258/16 922), P<0.001]. The risk signals of coagulation disorders/bleeding were mined for Xuesaitong for injection (freeze-dried), Xuesaitong injection, Xuesaitong tablets, and Xuesaitong capsules, and the risk signal density of Xuesaitong tablets was the strongest.　Conclusions The ADRs of Xuesaitong preparations involve multiple systems and organs. Among them, Xuesaitong for injection (freeze-dried), Xuesaitong injection, Xuesaitong tablets, and Xuesaitong capsules have a strong association with coagulation disorders/bleeding risks, and the proportion of severe cases is relatively high. However, the relevant risk warning information is not included in the drug instructions of some manufacturers. Medication monitoring needs to be strengthened and timely intervention should be carried out in clinic.

Objective To evaluate the clinical safety of Fufang E‘jiao syrup and provide reference for its rational and safe clinical use.　Methods The literature involving Fufang E'jiao syrup in domestic and international databases, as well as the relevant clinical trials on ClinicalTrials.gov and the Chinese Clinical Trial Registry website were searched up to June 1, 2024. Those literature and clinical trials reporting drug adverse events were included, and the basic information about literature/clinical trials (title, publication year, study design, etc.), patients (age, gender, primary diseases, and dosage of Fufang E'jiao syrup), and adverse events (time of occurrence, clinical manifestations, and outcomes) was extracted. The adverse events were standardized and classified using the Medical Dictionary for Regulatory Activities version 25.0, and were also analyzed based on traditional Chinese medicine theory.　Results A total of 19 literature were included in the analysis, including 16 observational/experimental clinical studies, and 3 case reports. The 19 literature reported a total of 430 adverse events involving 398 patients, and the patients were mainly with malignant tumors and anemia. The 430 adverse events involved 11 system organ classes, which mainly included gastrointestinal disorders (260 events, 60.47%, with the most common symptom being dry mouth), respiratory, thoracic, and mediastinal disorders (119 events, 27.67%, with the most common symptom being dry throat), and skin and subcutaneous tissue disorders (16 events, 3.72%, with the most common symptom being mucosal ulcers). Based on traditional Chinese medicine theory, the 430 adverse events were mainly manifested as symptoms of indigestion (nausea, epigastric discomfort, and decreased appetite) and symptoms of “heat” (dry mouth and dry throat).　Conclusions Fufang E'jiao syrup has a relatively good overall safety profile, with the most common adverse events being symptoms of “heat” and gastrointestinal reactions. Patients should not use it blindly, and it should be used with syndrome differentiation in clinical practice.

Neutropenia is the most common hematological toxicity in chemotherapy for cancer patients. Granulocyte colony-stimulating factors (G-CSF) are currently the most commonly used symptomatic therapeutic drugs in clinical practice, playing a key role in ensuring adequate doses and on schedule in chemotherapy. As of December 2024, more than 80 specifications of G-CSF have been approved for market in China, which provides diverse options in clinical practice while also poses higher demands on standardized management of pharmaceutical services. Therefore, the Oncology Specialty Pharmacists Branch of the Chinese Pharmacists Association, in collaboration with the National Cancer Center and multidisciplinary experts nationwide, jointly formulated this guideline by integrating clinical evidence, relevant regulations on pharmaceutical affairs management, and pharmaceutical service practices. The development process involves systematic literature search, Delphi method, expert interviews, and discussions. The key pharmacological service points of G-CSF in cancer patients were systematically elaborated in this guideline, covering aspects such as indication management, dosage and administration, medication for special populations, combined medication strategies, economic evaluation, and adverse reaction monitoring, resulting in 22 recommendations. This guideline aims to provide a systematic and scientific reference for the rational use of G-CSF and related pharmaceutical services for cancer patients.

Objective To investigate the implementation of boxed warning of drug labels in US Food and Drug Administration (FDA) from 2019 to 2024, and compared it with the relevant situations in China, in order to provide reference for the revision of drug labels and safe drug use.　Methods Data on boxed warning revisions in the US FDA "Drugs Safety Related Labeling Changes" Database from January 1, 2019 to December 31, 2024 were retrieved, and the revised contents were classified. The drug labels for newly marketed drugs in the United States during the same period were collected, the boxed warnings were recorded and summarized, and compared with the warning statements in drug labels of relevant drugs approved in China.　Results From 2019 to 2024, FDA revised boxed warnings in 209 drug labels. Among them, 22 items (10.53%) were newly added, 63 items (30.14%) were major updates, 115 items (55.02%) were minor updates, and 9 items (4.31%) were removed. A total of 293 new drugs were approved in the United States from 2019 to 2024, of which 69 (23.55%) had boxed warnings when they were approved, and 4 (1.37%) were added boxed warnings when they were revised in the labels. Up to December 31, 2024, 92 of the 293 new drugs had been approved in China. Compared with the labeling in the United States, some drugs lacked warning statements section in China, including zolpidem tartrate, dexzopiclone, zaleplon, montelukast sodium, denosumab, terlipressin, etc.　Conclusions The warning statements in some Chinese drug labels are inconsistent with the boxed warnings in the American drug labels. It is suggested that the revision of the boxed warning by US FDA should be regarded as one of the new sources of safety information to assess the risks of related drugs and determine whether it is necessary to revise the relevant drug labels in China.

Hyperthyroidism combined with abnormal liver function is a tricky problem in clinical diagnosis and treatment, which mainly includes hyperthyroidism-related liver injury, liver injury caused by antithyroid drugs (ATD), and other liver diseases associated with hyperthyroidism. Chinese Pharmacological Society Professional Committee of Drug-induced Diseases, Section of Clinical Toxicology of Chinese Society of Toxicology, and the Editorial Committee of Adverse Drug Reactions Journal organized relevant experts majoring in endocrinology, hepatology, and clinical pharmacy to jointly discuss and formulate this consensus based on a systematic review of relevant research progress at home and abroad, combined with the actual clinical situation in China. This consensus systematically expounds the epidemiology, pathogenesis, clinical characteristics, diagnosis and differential diagnosis, monitoring and treatment of hyperthyroidism with liver dysfunction, and puts forward recommendations for diagnosis and treatment, aiming to help clinicians make reasonable decisions in the prevention, diagnosis and treatment of hyperthyroidism combined with abnormal liver function, and improve the level of clinical diagnosis and treatment.

Objective To detect adverse reaction risk signals of triazole antifungal agents and provide evidences for their safe use in clinic.　Methods Adverse reaction/event reports with fluconazole, itraconazole, voriconazole, posaconazole, or isavuconazonium as the primary suspect drug were collected from the data in National Adverse Drug Reaction Monitoring System of China reported by Shandong Province from January 2004 to June 2024 and the US Food and Drug Administration Adverse Event Reporting System (FAERS) database from the first quarter of 2004 to the second quarter of 2023. Adverse reaction/event terms were standardized using the preferred term (PT) and system organ class in Medical Dictionary for Regulatory Activities 24.0. Risk signals were detected using the reporting odds ratio (ROR) method and the Bayesian confidence propagation neural network (BCPNN) algorithm. A PT was defined as an adverse reaction risk signal if the number of reports was ≥3, the lower limit of the 95% confidence interval (CI) for ROR was >2, and the lower limit of the 95%CI for the information component (IC) was >0. Descriptive statistical analysis was performed.　Results A total of 3 988 reports with the above 5 antifungal drugs as the primary suspect drug were collected from data in National Adverse Drug Reaction Monitoring System of China reported by Shandong Province, 822 (20.6%) of which were serious cases. Voriconazole, fluconazole, itraconazole, posaconazole, and isavuconazonium was the primary suspect drug in 1 852, 1 395, 703, 27, and 11 cases among the 3 988 reports, and in 591 (31.9%), 149 (10.7%), 59 (8.4%), 18 (66.7%), and 5 (5/11) serious cases among the 822 serious case reports, respectively. A total of 20 066 reports with the above 5 drugs as the primary suspect drug were collected in FAERS database, 9 635 (48.0%) of which were serious cases. Voriconazole, fluconazole, itraconazole, posaconazole, and isavuconazonium was the primary suspect drug in 7 758, 6 180, 2 869, 1 796, and 1 463 cases among the 20 066 reports, and in 4 295 (55.4%), 2 806 (45.4%), 1 191 (41.5%), 828 (46.1%), and 515 (35.2%) serious cases among the 9 635 serious case reports, respectively. Based on the data reported by Shandong Province and in FAERS database, 18 and 207 risk signals of  adverse reaction not mentioned in the labels were identified, respectively, and 5 of them were identified in both databases, including fluconazole-induced renal impairment and voriconazole-induced oliguria, delirium, psychiatric disorders, and rhabdomyolysis. In the data reported by Shandong Province and in FAERS database, 13 and 189 reports of muscle-related disorders (rhabdomyolysis, myopathy, and myositis) were identified respectively, involving voriconazole (in 8 and 62 cases), itraconazole (in 4 and 74 cases), and flucona- zole (in 1 and 53 cases).　Conclusions Renal impairment induced by fluconazole and oliguria, delirium, psychiatric disorders, and rhabdomyolysis induced by voriconazole are risk signals of adverse reaction not mentioned in the labels for triazole antifungal agents. Voriconazole, itraconazole, and fluconazole may also cause muscle-related disorders, warranting vigilance in clinical practice.

To enhance the understanding of shared issues related to hospital intelligent pharmacy (HIP), experts from various fields at home and abroad collaboratively developed the International Expert Consensus on Hospital Intelligent Pharmacy through questionnaire-based surveys and the Delphi consensus method. To facilitate a better understanding of this consensus by pharmaceutical professionals in domestic medical institutions, this article summarized and elucidated the key points of the consensus. On the one hand, the consensus clarified the definition and connotation of HIP and emphasized its significance in intelligent hospital. On the other hand, a system covering important functional modules was constructed, including intel- ligent drug supply chain management, drug dispensing, prescription review, pharmacovigilance, medication therapy management, therapeutic drug monitoring, telepharmacy services, pharmacy administration, science popularization, and clinical trials. In addition, the consensus emphasized the importance of professional talent cultivation and academic carrier construction, and proposed to provide support for continuous innovation and practical promotion in this field through specialized talent cultivation and high-quality academic platforms.

Objective To develop an agent integrating a large language model (LLM) with population pharmacokinetic (PPK) models for personalized medication recommendation via natural language interaction.　Methods Using the Dify workflow as the framework and employing DeepSeek-R1 as the LLM, an intelligent agent system was constructed by integrating functional modules including retrievalaugmented generation (RAG), question classification, parameter extraction, and result integration and output. The system was connected to a local knowledge base integrating clinical guidelines and pharmacokinetic research literature, as well as a PPK model application developed in Python. RAG technology was utilized to enhance response accuracy and knowledge timeliness. A structured process enabled full automation from user natural language queries to parameter extraction, model selection, PPK calculation, and result output.　Results A personalized medication recommendation agent integrating a local knowledge base and PPK models was successfully developed. This agent could respond correctly to clinical medication-related queries via natural language interaction. Its core functionalities included the following: answering pharmaceutical consultation questions based on the local knowledge base and providing reference sources; completing individualized dose recommendations, simulation calculation of drug concentration, and plotting of drug concentration-time curves based on PPK models and individual patient characteristics (e.g., age, body weight, pathological status); accurately estimating individual patient pharmacokinetic parameters using Bayesian feedback with sparse measured drug concentration data. Validated in clinical scenarios such as treatment of neonatal Candida albicans infection and individualized tacrolimus therapy in pediatric post-liver transplantation patients, the agent generated precise medication recommendations, parameter results, and drug concentration-time curves, effectively supporting clinical individualized medication decision-making.　Conclusion The intelligent agent constructed in this study effectively integrates LLM with PPK models and achieves personalized medication recommendation through natural language interaction. Dose recommendations based on the PPK model provide quantitative evidence for clinical medication, helping to reduce unnecessary drug exposure and lower the risk of adverse drug reactions and harmful drug interactions. Additionally, this study demonstrates the feasibility of a cooperative framework combining a front-end LLM application with a back-end professional model in the field of pharmaceutical services.

Objective To analyze the clinical characteristics of tigecycline-related adverse reactions and provide the basis for the safe and rational use of the drug.　Methods Adverse reaction reports with suspected drug as tigecycline from Beijing Adverse Drug Reaction Monitoring Center from January 1st, 2019 to June 30th, 2024 were collected. The adverse reaction reports were standardized using the preferred term (PT) and system organ class (SOC) in the Chinese updated edition (2015 version) of the World Health Organization Adverse Reaction Terminology. The patients′ general condition, tigecycline use, and adverse reaction occurrence (including latency, severity, treatment, outcome, and correlation evaluation) were descri- ptively and statistically analyzed.　Results A total of 408 tigecycline-related adverse reaction reports were entered, including 153 females (37.5%) and 255 males (62.5%). The age was (68±21) years, ranging from 2 to 99. The main reasons for tigecycline use were infections of lung, blood flow, skin and skin soft tissue, etc. The pathogens were mainly Klebsiella pneumoniae, Acinetobacter baumanii, Escherichia coli, etc. The usage and dosage of tigecycline in most patients were in line with the instructions. Four hundred and eight adverse event reports involved 11 SOCs and 580 PTs. The top 3 SOCs were gastrointestinal diseases (195 case times, 33.62%), vascular, bleeding and coagulation diseases (183 case times, 31.55%), and hepatobiliary diseases (142 case times, 24.48%). The main clinical manifestations were nausea, vomiting, diarrhea, etc. The main laboratory abnormalities were decreased plasma fibrinogen, decreased platelet count, increased alanine aminotransferase, increased aspartate aminotransferase, and increased bilirubin. There were 27 case times of adverse reactions that were not recorded in the instructions, mainly including leukopenia, abdominal distension, fever, dysbacteriosis, etc. The latency of adverse reactions ranged from 5 min to 65 days, with a median time of 5 days. The grade of adverse reactions was general in 379 patients (92.89%) and severe in 29 patients (7.11%). The top 3 SOCs involved in 53 case times of severe adverse reactions were hepatobiliary diseases (30 case times, 56.60%), vascular, bleeding and coagulation diseases (8 case times, 15.09%), and urinary tract diseases (4 case times, 7.55%), the main clinical manifestations were elevated liver enzymes, coagulation disorders, pancreatitis, etc. After the occurrence of adverse reactions, all patients stopped tigecycline, and received symptomatic treatments such as liver protection, intravenous infusion of human fibrinogen, intravenous infusion of platelets, and antidiarrheal therapy. Among 408 patients, 66 (16.18%) were cured, 297 (72.79%) were improved, 20 (4.90%) were not improved, and 25 cases′ outcome (6.13%) were unknown. The shortest time for recovery or improvement was 0.5 hour, the longest was 44 days, with a median time of 5 days. The correlation between tigecycline and adverse reactions was probable in 132 patients (32.35%), and possible in 276 patients (67.65%).　Conclusions Tigecycline-related adverse reactions involve multiple organ systems, mainly including gastrointestinal diseases, vascular, bleeding and coagu- lation diseases, and hepatobiliary diseases, etc. which can lead to severe adverse reactions such as acute pancreatitis and coagulation disorders. After drug withdrawal and symptomatic treatments, most patients had a good prognosis.

Bruton's tyrosine kinase inhibitors (BTKi) are a class of novel small-molecule targeted antitumor drugs used to treat B-cell malignancies. However, safety issues associated with BTKi may lead to treatment interruption, compromising their efficacy. To promote the standardized management of safety in BTKi treatment, Evidence-Based Pharmacy Professional Committee of the Chinese Pharmaceutical Association, Hospital Pharmacy Professional Committee of the Chinese Pharmaceutical Association, Division of Therapeutic Drug Monitoring of Chinese Pharmacological Society, Expert Committee on Lymphoma of Chinese Society of Clinical Oncology, Expert Committee on Leukemia of Chinese Society of Clinical Oncology, Integrated Cancer Cardiology Branch of China Anti-Cancer Association, Hematology Branch of the Chinese Medical Association, and Hospital Pharmacy Professional Committee of the Cross-Straits Medicine Exchange Association formulated the Evidence-based Expert Consensus on the Clinical Management of Safety of Bruton′s Tyrosine Kinase Inhibitors (2024), which was published in the Chinese Journal of Cancer Research in June 2024. It covered 9 clinical issues in the following 3 domains: (1) the management of common adverse reactions of BTKi such as bleeding, cardiovascular events, hematological toxicity, infections, rashes, diarrhea, and arthralgia; (2) the management of drug-drug interactions; (3) management guidance for special populations. This consensus provides evidence-based recommendations for the safety management of BTKi medication in clinical practice. This article provides an interpretation and evidence summary of the consensus in Chinese, aiming to facilitate its implementation in China, enhance the safety management of BTKi treatment, and improve patient outcomes.

Objective To explore the differences on contraindication information for children in domestic and foreign drug instructions, and provide reference for improving the relevant information in Chinese drug insert sheets.　Methods Chinese drug insert sheets of chemicals and biological products contained in the China Pharmacopoeia 2020 and those of the western medicines in the 2023 China′s Basic Medical Insurance, Work-related Injury Insurance and Childbirth Insurance Drug Catalog were collected; drugs that were marked as contraindication for children were selected and relevant contraindication information in the Chinese drug insert sheets was collected. Instructions of the above-mentioned drugs approved by the U.S. Food and Drug Administration (English labels) were also collected, and the information on pediatric medication was reviewed and compared with the Chinese drug insert sheets.　Results A total of 222 drugs were labeled as contraindication for children in the Chinese drug insert sheets, of which 149 were available for their English labels; 123 drugs (17.5%) were not labeled as contraindication for children in English labels, and 26 (82.5%) were labeled. The 123 drugs that were not labeled as contraindication for children in the English labels included the following conditions: 58 were labeled as contraindication for children of some age in the Chinese drug insert sheets but not in the English labels, and relevant medication information was provided; 40 were labeled as contraindication for children of some age group in the Chinese drug insert sheets but was described as the effectiveness and safety of the use for children have not yet been determined for this age group in the English labels; 13 were labeled as contraindication for children in the Chinese drug insert sheets, but the medication information on children in the English labels was not clear or missing; 12 were labeled as contraindicated for children in Chinese drug insert sheets but not in the English labels, only expressed as not yet determined or not recommended for use, etc., with inconsistent age group. Among the 26 drugs labeled as contraindication for children in both Chinese and English instructions, the contraindication age group were the same in above 2 instructions for 20 drugs, and were inconsistent for the other 6 drugs; reasons for contraindication were described in both the 2 instructions for 17 drugs (13 were consistent, 4 were inconsistent), only in English labels for 8 drugs, and only in Chinese drug insert sheets for 1 drug.　Conclusions Many drugs are labeled as contraindication for children in Chinese drug insert sheets, but reasons for contraindication are rarely explained. Differences in children′s age in contraindications exist for some drugs between the Chinese drug insert sheets and English labels. The information on contraindications for children in Chinese drug insert sheets still needs to be further improved.

Objective To preliminarily develop a medication educational agent based on multi- modal interactive and solve the problem of information understanding obstacles in medication education for tuberculosis patients.　Methods Based on the Dify 1.4.1 platform, an agent workflow was constructed using large language model (LLM) and retrieval-augmented generation. A total of 50 tuberculosis patients, who discharged from Beijing Chest Hospital, Capital Medical University from March to September 2025, were selected. The structured information was collected and input into the agent to evaluate its intrinsic performance, including structured information extraction capability (precision, recall, and micro-averaged F1-value), text generation quality ［bilingual evaluation understudy (BLEU) 4 and series of indicators of recall-oriented understudy for gisting evaluation (ROUGE)］, as well as stability (interaction success rate), efficiency (response time and average material generation time), compliance (compliance rate), and user experience (satisfaction scores). A total of 38 medical professionals (physicians and pharmacists), who worked in the hospital from February to March 2025, were selected as survey subjects. Using the Wenjuanxing platform, the accuracy, comprehensiveness, readability, humanistic care, and personalization of medication education materials from 3 sources were evaluated, including the hospital′s current standardized medication guidance template (material 1), medication education materials directly generated by a generalpurpose LLM (material 2) and materials generated by the agent developed in this study (material 3). And the application effectiveness of the agent was assessed via the survey results.　Results The evaluation result of the agent using structured information of 50 tuberculosis patients showed that the precision was 95%, the recall was 92%, and micro-averaged F1-value was 0.93. The agent was scored (18.61±4.06), (38.60±5.93), (22.40±5.13), and (29.42±6.81) points in BLEU-4, ROUGE-1, ROUGE-2, and ROUGE-L, respectively. The interaction success rate was 96% (48/50), with an average response time of  (3.1±0.6) s and a material generation time of (27.4±1.5) s, the compliance rate was 100% (50/50), and the patient satisfaction score for the agent generated text was (84.5±5.5) points. The survey results of 38 medical professionals showed in dimensions of readability, humanistic care and personalization, the scores of material 3 were better than materials 1 and 2, and the differences were statistically significant (all P<0.016 7). The score of material 3 in the comprehensiveness dimension was better than the material 1 (P=0.003). In these medical professionals, 71.1% (27/38) were satisfied with material 3.　Conclusions A multi-modal interactive agent for medication education in tuberculosis patients is successfully developed. The multiple performance indicators of this agent have good feasibility and reliability, and have certain advantages in readability, humanistic care, and personalization. By providing multi-modal and layered outputs, this agent offers a novel paradigm for medication education in tuberculosis patients.

Objective To mine the drugs that may cause capillary leak syndrome (CLS), and evaluate the risk of CLS, and provide reference for safe and rational use of drugs in clinic.　Methods Adverse event (AE) reports with the preferred term "capillary leak syndrome" from the 1st quarter of 2004 to the 4th quarter of 2023 were collected by searching US Food and Drug Administration Adverse Event Reporting System (FEARS) database. Reporting odds radio (ROR) method and proportional reporting ratio (PRR) method were used to mine the AE risk signals. Drugs with report number ≥3, lower limit of the 95% confidence interval (CI) of ROR value >1, PRR ≥2, χ² ≥4 were grouped and classified according to the Anatomical Therapeutic Chemical Classification (ATC) system. The top 20 drugs in ROR values were selected, and a risk assessment for drugs potentially causing CLS was performed by reviewing drug labels, adverse reaction datasets, and relevant literature.　Results A total of 1 033 AE reports related to CLS were collected, involving 558 primary suspected drugs associated with CLS. The top 5 types of drugs that the most commonly causing CLS were antineoplastic and immunomodulating agents, systemic hormonal preparations, anti-infectives for systemic uses, cardiovascular system, and alimentary tract and metabolism. The risk assessment results showed that 13 drugs of the top 20 drugs in signal intensity (clofarabine, gemcitabine, interleukin-3, denileukin diftitox, dinutuximab, filgrastim, trabectedin, cytarabine, busulfan, docetaxel, trastuzumab, vildagliptin and melphalan) were high-risk drugs causing CLS, among which cytarabine, docetaxel, busulfan, trastuzumab, vildagliptin, and melphalan were not recorded to cause CLS in the labels. The other 7 drugs (asparaginase, fludarabine, amphotericin B, bosutinib, daunorubicin, ponatinib, and bleomycin) were low-risk drugs causing CLS.　Conclusions Thirteen drugs are high-risk drugs that may cause CLS, among which cytarabine, docetaxel, busulfan, trastuzumab, vildagliptin and melphalan are not recorded causing CLS in the labels. It is suggested that clinicians and pharmacists should be vigilant against high-risk drugs, especially those not recorded causing CLS in the labels.

Adverse drug reaction (ADR) is an important problem in clinical diagnosis and treatment, and basic research related to ADR is essential. Exploring the mechanism of ADR through basic research can provide a theoretical basis for formulating effective prevention strategies and targeted treatment programs for ADR; many safety problems found in the process of clinical medication can be effectively verified and solved through basic research, such as the dose?response (toxicity) relationship of drugs and drug interactions; basic research related to drug toxicity is an indispensable key link in the process of drug research and development, and its research results are directly related to the safety of candidate compounds and the feasibility of clinical application. At present, there is a limited amount of literature on the basic research related to the mechanism of ADR in China. It is hoped that more researchers will pay attention to basic research related to ADR and drug safety, and promote the development of this field to a higher level.

Objective To establish a predictive model for the efficacy of the antiemetic regimen with neurokinin-1 receptor antagonist, 5-hydroxytryptamine 3 receptor antagonist, and dexamethasone (abbreviated as triple antiemetic regimen) in preventing chemotherapy-induced nausea and vomiting (CINV) in tumor patients undergoing cisplatin chemotherapy based on machine learning, and to provide a basis for the selection of antiemetic regimens in clinic.　Methods Tumor patients who received cisplatin chemotherapy and used the triple antiemetic regimen at the Department of Oncology, Tianjin Medical University General Hospital from January 2018 to December 2022 were entered. Clinical information was collected via the hospital information system, including patient age, gender, tumor type, history of pregnancy-related nausea, and laboratory tests results before chemotherapy, etc. After pre-processing, the data were stratified and randomly divided into the training set and the validation set at a ratio of 8∶2. The predictive model was constructed based on the training set, using five algorithms of categorical boosting, deep forest (gcForest), support vector machine, random forest and decision tree. The model′s performance was evaluated based on the validation set. The Shapley Additive exPlanation (SHAP) value was used to analyze the features from the global and local levels.　Results A total of 379 patients were entered, including 261 males (68.9%), with a median age of 63 years. These patients received 731 cycles of chemotherapy in total, and CINV occurred after 114 cycles (15.6%) of chemotherapy. Twenty-four variables were identified using the least absolute shrinkage and selection operator regression analysis. The constructed five models all had good predictive performance in the training set, and the gcForest model had the best in the validation set, showing area under the receiver operating characteristic curve 0.872, accuracy 0.850, precision 0.739, recall 0.840, F1 score 0.770, and Brier score 0.090. The difference between the indicators of gcForest model in the training set and the validation set was minor, and the prediction performance was stable. The SHAP analysis revealed that creatinine clearance (Ccr), gender, age, expected nausea and vomiting, and globulin level were the main features for model prediction. Effectiveness of the triple antiemetic regimen increased with higher Ccr, and age and decreased with higher globulin level; its effectiveness reduced in female patients and patients with expectation of nausea and vomiting .　Conclusions The model based on the gcForest algorithm and incorporating metabolism-related features such as Ccr had shown good performance in predicting the effectiveness of triple antiemetic regimens for prevention of cisplatin-induced CINV. It could provide auxiliary support for individualized risk stratification and antiemetic regimen selection in patients.

A 66-year-old male patient received abrocitinib 100 mg once daily orally for atopic dermatitis. After 3 and a half months, the patient′s condition was significantly improved and the dose of abrocitinib was reduced to 100 mg once every 2 days orally. After 35 days of continuous medication, the patient developed a sense of stuffiness in both ears, occasional tinnitus, and hearing loss. According to specialized examinations in otolaryngology, the sudden deafness was diagnosed, which was considered to be related to abrocitinib. Abrocitinib was stopped. After 38 days of treatments with nurturing nerves, improving circulation, his hearing basically returned to normal. After that, dermatitis recurred in the patient, and he received abrocitinib 100 mg once daily orally again. One month later, the patient developed hearing loss again. After 9 days of drug withdrawal, the patient′s tinnitus and other symptoms were basically relieved. Subsequently, abrocitinib was placed by dupilumab to treat atopic dermatitis in the patient. At a six-month of follow-up, symptoms such as tinnitus and hearing loss did not recur.

Prescription sequence symmetry analysis (PSSA) is one of the important methods for post-marketing pharmacovigilance based on the real-world medical prescription databases. It can be used to detect prescription cascades and mine adverse drug reaction (ADR) signals, which has been verified by many studies. PSSA shows high specificity and medium sensitivity in identifying ADR. It can quantify the correlation or risks of ADR. It is easy to use and simple in algorithm, and it has good robustness to some non time-dependent confounding factors. However, the results may be affected by some human confounding factors and data quality. This paper reviews the principle, calculation method, application scope, and precaution of PSSA by reviewing related literature on PSSA domestically and abroad, in order to provide reference for pharmacovigilance in China.

Pharmacovigilance is the core component of ensuring the safety of drugs throughout their entire lifecycle, undertaking the important mission of monitoring, identifying, evaluating and controlling adverse drug events, and safeguarding public health. In 2019, the newly revised Drug Administration Law of the People′s Republic of China officially established the pharmacovigilance system as one of the basic systems for drug management in China. In 2021, Good Pharmacovigilance Practice further clarifies regulatory requirements. However, existing information system of pharmacovigilance still faces bottlenecks such as a surge in adverse reaction reports, difficulties in integrating multisource data, and passive and lagging monitoring modes. The breakthrough development of artificial intelligence (AI) technology provides an important opportunity to overcome these transformation challenges in pharmacovigilance. In this paper, the technological innovation pathways of AI-empowered pharmacovigilance, including multisource and multimodal data integration, avoidance of violation risks, and reduction of technical application thresholds are elaborated; the application value of AI in pharmacovigilance scenarios such as automated report generation, signal screening, audit verification, and risk assessment is analyzed; the practical challenges that AI faces in terms of data quality, model efficiency, human-machine collaboration, cost control, and ethical standards are explored, and at last, a vision for the future development direction of the integration of AI technology and pharmacovigilance from 5 dimensions are proposed, including data governance, technological optimization, capacity building, cost control, and ethical norms.

Objective To understand the application situation and role of prescription sequence symmetry analysis (PSSA) in pharmacovigilance.　Methods The relevant databases at home and abroad were searched (up to April 30, 2024), and the original articles using PSSA as the research method were collected. The basic information of the literature (first author, publication year, country, etc.), the purpose and main content of the study, the index drugs as well as the marker drugs or medical diagnoses involved in the adverse drug reactions (ADRs) were extracted. Descriptive statistical analysis was carried out.　Results A total of 66 articles were included in the analysis. The first article was published in 1996, the number of articles published in recent years has increased significantly, and those published after 2016 accounted for 68.2% (45/66). The top 3 countries in terms of published literature quantity were the United States, Denmark, and Japan. The index drugs most commonly studied were those for the cardiovascular system and the neuropsychiatric system, in 18 and 14 articles respectively. The drugs studied in 3 or more papers were hypolipidemic drugs, antihypertensive drugs, antipsychotics, antiepileptics, proton pump inhibitors, hypoglycemic drugs and anticoagulants. The targeted ADRs/diseases most studied were those about the neuropsy- chiatric system (in 13 studies), followed by those about the endocrine and metabolic system (in 12 studies). The research objective in 47 articles was to explore the association between index drugs and ADRs/diseases through PSSA. Finally, the associations between 21 ADRs and index drugs were identified in 24 articles, of which 9 were new ADRs not recorded in drug instructions; benefits or potential preventive and therapeutic effects of index drugs on certain diseases were found in 7 studies. Ten studies were conducted to explore ADR information of specific drugs or detect suspicious drugs that cause specific ADRs, and some correlation signals between drugs and ADRs that previously unknown were detected. Nine studies evaluated the prescribing cascades, including the use of antitussive drugs after ACEI, the prescribing cascades related to drug-induced lower urinary tract symptoms and edema, the prescription cascades of statins, and the prescribing cascade relic.　Conclusion PSSA is a useful method for identifying potential prescribing cascades and mining ADR signals using medical prescription databases, especially suitable for the safety monitoring of long-term medication for chronic diseases and the signal detection of ADR that causal relationships are difficult to determine.

Objective To mine the potential risk drugs associated with fingerprint loss and provide reference for clinical safe drug use.　Methods Adverse event (AE) reports with the preferred term  “fingerprint loss” were collected by searching US Food and Drug Administration Adverse Event Reporting System (FAERS) database from the first quarter of 2004 to the first quarter of 2025. Reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods were used to mine the AE risk signals. Drugs meeting the criteria of ≥3 reports, 95% confidence interval lower limit of ROR>1, PRR≥2, and χ²≥4 were consi- dered to have a potential risk signal for fingerprint loss. The identified drugs were classified according to the Anatomical Therapeutic Chemical (ATC) classification system. In addition, relevant literature databases were searched to collect case reports of drug-induced fingerprint loss, and descriptive analysis were conducted on the reported clinical characteristics and medications involved.　Results A total of 134 AE reports of drug-induced fingerprint loss were collected within the limited time period, and 87 reports were detected as risk signals by ROR and PRR methods; it involved 7 drugs, all of which were classified as antineoplastic agents according to the ATC system. Ranked in descending order of signal strength, the 7 drugs were capecitabine (ROR=267.47), tucatinib (ROR=146.54), ribociclib (ROR=24.61), fluorouracil (ROR=21.41), pal- bociclib (ROR=16.99), trastuzumab (ROR=12.52), and bevacizumab (ROR=10.47). Among them, only the label of capecitabine had records of fingerprint loss. A total of 13 case reports of drug-induced fingerprint loss were retrieved, involving 14 patients; related drugs included capecitabine in 9 cases, fluorouracil, osimertinib/anlotinib, doxorubicin, paclitaxel, and venlafaxine in 1 case each.　Conclusions The main risk drugs for fingerprint loss are antineoplastic drugs, among which capecitabine has the strongest risk signal. Other risk drugs include osimertinib/anlotinib, doxorubicin, paclitaxel, and venlafaxine.

Objective To analyze the characteristics of adverse reactions of sodium-glucose cotransporter 2 inhibitors (SGLT2i), and provide a basis for the rational clinical application.　Methods The adverse drug reaction (ADR) cases of SGLT2i reported by Beijing from January 1, 2019 to June 30, 2024 were collected through searching the National Adverse Drug Reaction Monitoring System of China. The Medical Dictionary for Regulatory Activities (MedDRA) terminology set was used to standardize the description of ADR, and the involving system organ class (SOC) and preferred term （PT） was extracted. Data of ADR were analyzed descriptively and statistically.　Results A total of 409 SGLT2i-related adverse reaction reports involving 409 patients were included. Among these patients, there were 232 females and 177 males; the median age was 62(52, 70) years, and 231 cases (56.48%) were under the age of 65 years; 5 types of SGLT2i (dapagliflozin, empagliflozin, canagliflozin, ertugliflozin, and henagliflozin proline) were involved, and reports of dapagliflozin was the most (279 cases， 68.22%). The primary indication for medication was diabetes (404 cases, 98.78%). The majority of ADRs did not reach the severe level (395 cases, 96.58%). The 14 cases (3.42%) of severe ADR were primarily about diabetic ketoacidosis (11 cases, 11/14), of which 7 cases presented with normal blood glucose levels and 5 cases occurred after medical stress events. The outcomes of patients were improvement in 241 cases (58.92%) and recovery in 127 cases (31.05%). In total, 476 ADR occurrences were recorded among the 409 patients, involving 82 PTs, 24 of which were not listed in the drug labels. The top 2 SOCs were the infections and infestations ［26.26% (125/476)］ and renal and urinary disorders ［13.87% (66/476)］; the top 3 PTs were urinary tract infection ［23.32% (111/476)］, urinary ketone detection ［6.51% (31/476)］, and vulvovaginal pruritus ［5.88% (28/476)］; the top 3 newly identified possible ADRs (PTs) were dizziness ［2.31% (11/476)］, palpitations ［1.89% (9/476)］, and decreased appetite ［1.05% (5/476)］.　Conclusions Based on the ADR monitoring data in Beijing in the past 5 and a half years, SGLT2i-associated adverse reactions primarily involved the infections and infestations, and renal and urinary disorders. ADRs identified in the study such as dizziness and palpitations are not documented in the drug labels,  euglycaemic ketoacidosis accounts for a high proportion of severe reactions, and most of them occur after acute stress events. 

Large language models have developed rapidly in the field of healthcare in recent years, particularly in clinical pharmacy, where they demonstrated broad application prospects for knowledge retrieval, information integration, risk assessment, and decision support. The prompt engineering played an important role in ensuring the accuracy, interpretability, and clinical applicability of output content. Drawing upon the current practical experience in clinical pharmacy, this article systematically expounds the fundamental concepts, working principles, and main types of prompt engineering, explores its major application scenarios, optimization strategies, and common challenges, and further discusses future development directions, aiming to provide pharmacists and relevant researchers with systematic references and practical guidance.

Objective To analyze the clinical characteristics of dissociative symptoms induced by esketamine hydrochloride nasal spray in patients with treatment-resistant depression (TRD).　Methods The medical records of patients in phase Ⅲ clinical trials for the treatment of TRD who received esketamine hydrochloride nasal spray in Beijing Anding Hospital, Capital Medical University from June 2018 to February 2021 were collected. The general situation of patients (age, gender, comorbid diseases, etc.), the medication of esketamine hydrochloride nasal spray, the combined use of antidepressants, the time from medication to the occurrence of dissociative symptoms each time, duration, severity, evaluation results of causal relationship with esketamine application, intervention and prognosis were recorded, and a retrospective descriptive statistical analysis was performed.　Results A total of 21 patients with TRD were enrolled in the study, including 17 (81.0%) with dissociative symptoms, 10 males and 7 females; the age ranged from 20 to 53 years, with a median age of 36 years. All patients were treated with esketamine hydrochloride by nasal spray. The first dose was 56 mg, and the other seven doses were 56 mg or 84 mg, twice a week, lasting for 4 weeks. The 17 patients were all given combination treatment with oral antidepressants. A total of 88 times of dissociative symptoms occurred in the 17 patients. The time from medication to the onset of dissociative symptoms ranged from 4 to 128 min, with a median time of 15 min. The duration of dissociative symptoms ranged from 12 to 326 minutes, with a median time of 70 minutes. The dissociative symptoms were mostly mild. The causal relationship analysis between the esketamine hydrochloride nasal spray and the dissociative symptoms showed that it was definitely related in 6 cases, probably in 1 case, and possibly in 10 cases. The dissociative symptoms in all patients were subsided without intervention.　Conclusions Esketamine hydrochloride nasal spray can cause dissociative symptoms in patients with TRD, most of which occur within 30 minutes after the treatment. The duration of symptoms in most patients is less than 120 minutes, most of which are mild and can subside on their own, and the prognosis is good.

Objective To understand the clinical application of magnesium sulfate injection in inpatients of the obstetrical department, and analyze retrospectively its rationality and existing problems.　　Methods The clinical data of obstetric inpatients who used magnesium sulfate injection in the hospital information system of our hospital from September 2022 to January 2023 were collected. Based on the drug instructions, guidelines for the diagnosis and treatment of hypertensive disorders in pregnancy, domestic and foreign guidelines, and literature reports, the rationality of magnesium sulfate injection in terms of obstetric medication indications, dosage and administration, and treatment course was evaluated.　Results A total of 303 obstetric patients were included in the use of magnesium sulfate injection, with an age of 32 (ranging from 18 to 44) years and a gestational age of 14 to 40 weeks. Among them, 33 cases were used for threatened abortion, 141 cases for threatened preterm birth, and 129 cases for the prevention of eclampsia attacks. Among the 303 patients, 134 cases (44.22%) had no indications for medication. Among them, 13 patients with threatened abortion were treated for fetal brain protection, and 20 patients with threatened abortion and 101 patients with threatened preterm birth were treated for preventing miscarriage by uterine contraction inhibition. There were 118 cases (38.94%) with inappropriate administration methods, mainly due to inappropriate usage and dosage, as well as overly long treatment courses. Of them, 26 cases (22.03%, 26/118) used for brain protectors of premature fetuses were not given loading doses, 15 (12.71%, 15/118) cases had a total medication duration of more than 48 hours, 76 cases (64.41%, 76/118) used for the prevention of eclampsia were not given loading dose, and 1 case （0.85%，1/118） received rapid infusion time of the loading dose more than 30 minutes. Among the 303 patients, 3 patients presented nausea and vomiting, constipation, and skin flushing, respectively.　Conclusions Nearly half of the magnesium sulfate injection used in obstetrics department in our hospital has inappropriate indications and over one-third has non-standard usage, dosage, and treatment courses. Clinicians should comprehensively assess the patient′s condition and strictly follow recommended methods in the guidelines and drug instructions for standardized use.

Objective To explore the methods and effects of management to allergy risk assessment and de-labeling for patients with β-lactam (BL) allergy labels during the perioperative period led by clinical pharmacists.　Methods Perioperative patients with a history of BL allergy recorded in their medical records and hospitalized at Department of Colorectal Surgery in Sun Yat-sen University Cancer Center from January 2020 to February 2025 were included in the study. Patients who gave informed consent underwent bedside consultations by clinical pharmacists and the relevant allergy history was collected. The Penicillin Allergy Risk Tool (PEN-FAST) and Antibiotics Allergy Assessment Tool (AAAT) were used to stratify the risk of allergic reactions in patients. Pharmacists provided personalized de-labeling or medication recommendations based on the patient′s allergy risk (extremely low, low, and moderate/high) and the characteristics of allergic reactions. The physician′s adoption of pharmacist advices and the safety of medication in de-labeling patients were followed up.　Results A total of 93 patients with a history of BL allergy in the medical records were collected, of which 66 (70.97%) received pharmacists′ evaluation and were included in the analysis. Risk assessment results showed that 25 patients (37.88%) were stratified as having extremely low risk (PEN-FAST evaluation score 0), 8 patients (12.12%) as having low risk, and 33 patients (50.00%) as having medium/high risk (AAAT evaluation). Based on these results, pharmacists suggested that 28 patients (42.42%) could be directly de-labeled, 5 (7.58%) could be treated with BL antibiotics under informed consent and close monitoring, and 33 (50.00%) could be treated with BL antibiotics under close monitoring after negative skin test. After that, 80.30% (53/66) of the pharmacists′ suggestions were adopted by doctors, and BL treatments were given during the perioperative period. Neither allergic reactions nor other adverse reactions related to the use of BL antibiotics occurred.　Conclusions For patients with BL allergy labels, the de-labeling method based on allergy risk stratification led by clinical pharmacists is feasible and safe for patients. Most recommendations could be adopted by clinical physicians.

Objective To systematically evaluate the incidence and risk factors of acute kidney injury (AKI) induced by vancomycin in pediatric patients.　Methods Databases of PubMed, Embase, The Cochrane Library, Web of Science, CNKI, Wanfang, VIP, Chinese Biomedical Database (CBM) were searched and articles about the risk factors of AKI induced by vancomycin in pediatric patients from inception to June 2024 were collected. Quality assessment was performed using the Newcastle-Ottawa Scale (NOS) for the included studies. Meta-analysis of the data for relevant exposure factors extracted from the included literature was conducted using Rev Man 5.4. The strength of association between the exposure factors and AKI was expressed using the odds ratio (OR) and its 95% confidence interval (CI).　Results A total of 13  studies were entered, involving 11 073 patients. Of them, 1 388 patients were in AKI group and 9 685 patients in non-AKI group. The incidence of AKI was 12.53%, ranging from 4.62% to 27.07%. The quality evaluation results showed that the 13 documents were all of high-quality (NOS score ≥7 points). Meta-analysis showed that admission to intensive care unit (ICU) （OR=2.39, 95%CI: 1.59-3.59, P<0.001）, vancomycin using time ≥7 d (OR=2.19, 95%CI: 1.44-3.34，P=0.003), vancomycin steady-state trough concentration ≥15 mg/L (OR=2.98, 95%CI: 2.22-4.01, P<0.001), combined with nephrotoxic drugs ≥2 kinds (OR=2.92, 95%CI=1.84-4.64, P<0.001), combined with piperacillin sodium and tazobactam sodium (OR=2.71, 95%CI: 1.72- 4.27, P<0.001), combined with carbapenem (OR=2.36, 95%CI: 1.36-4.10, P=0.002), combined with aminoglycosides (OR=1.78, 95%CI: 1.35-2.35, P<0.001), combined with loop diuretics (OR=3.16, 95%CI: 2.36- 4.23, P<0.001), combined with amphotericin B (OR=2.26, 95%CI: 1.35-3.79, P=0.002), combined with contrast medium (OR=2.34, 95%CI: 1.04-5.25, P=0.040), and combined with aciclovir (OR=1.74, 95%CI: 1.04-2.84, P=0.030) were all risk factors of AKI induced by vancomycin in pediatric patients.　Conclusions The incidence of vancomycin-related AKI in pediatric patients was 12.53%. Admission to ICU, vancomycin trough concentration ≥15 mg/L, medication time ≥7 d, and concomitant use of ≥2 nephrotoxic drugs and etc.were risk factors of vancomycin-related AKI.

The stronger the knowledge complementarity between pharmacists and doctors, the more effectively pharmacists can function, particularly in the Surgical Department. There is no unified system for surgical pharmacy services abroad, and it mostly refers to the work of pharmacists in medication- related tasks in the Surgical Department, emphasizing their role in surgical treatment. In recent years, practice standards for surgical pharmacy services and surgical patient care quality control measures involving clinical pharmacist practice have advanced in several developed countries, among which the United States and Australia have established specific standards for pharmacy services in surgery. The pharmacist is an indispensable member of the surgical treatment team. Guangdong Pharmaceutical Association advocates for a new surgical treatment model of “surgeons are responsible for surgery, anesthetists for anesthesia, and pharmacists for medication therapy”, and propose the construction of a special knowledge system “surgical pharmacy” for surgical pharmacists. Surgical pharmacy care is critical measures to ensure safe and rational drug use in surgery, aiming to maximize treatment benefits while reduce risks, which is also the real needs of modern surgical practices like microtraumatic operation and enhanced recovery after surgery.

Objective To understand the knowledge structure of artificial intelligence (AI) technology applications in the field of drug-induced diseases (DID), and to reveal the research hotspots and development trends.　Methods Relevant literature on drug safety research with AI technologies was systematically retrieved from PubMed, Embase, Web of Science, SinoMed, CNKI, and Wanfang databases (up to December 2024). The bibliometric online analysis platform, VOSviewer 1.6.18 and CiteSpace 6.4.R2 were used to analyze and visualize the indicators such as publication volume, author countries/institutions, publishing journals, highly cited literature, and keywords.　Results A total of 1 857 articles were included, comprising 1 433 English and 424 Chinese publications. Annual publication volumes for both English and Chinese literature showed continuous growth. Authors from China contributed the most English publications (462 articles), followed by those from the United States (401 articles); also, collaboration between the 2 countries was the most frequent. About the author institutions, Harvard University had the largest volume of publications (243 articles), followed by Central South University (112 articles). The English journal with the most publications in this field was Frontiers in Pharmacology (94 articles), while the primary Chinese journal was China Pharmacy (22 articles). The top 10 articles ranked by total cited frequency were all in English, focusing on the use of machine learning algorithms and deep learning models for early warning and data mining for DID. Keyword clustering revealed 11 clusters for English literature and 10 clusters for Chinese literature. In the English clusters, chemical and drug induced liver injury was the largest cluster (started in 2015 and included 87 keywords), Bayes theorem was the earliest cluster (started in 2009 and included 34 keywords), and random forest was the latest cluster (started in 2019 and included 42 keywords). In the Chinese clusters, data mining was the largest cluster (started in 2016 and included 38 keywords), and signal mining was the latest cluster (started in 2023 and included 18 keywords).　Conclusions The application of AI technologies in DID researches is rapidly expanding. Research hotspots have evolved from machine learning to deep learning and large language models, with the liver injury, kidney injury, and cardiac injury induced by drugs as the key diseases. Future researches in this field will primarily focus on 2 aspects, further integration of advanced technologies and tools for the first, and expansion of data scale and diversification of data sources for the second, to promote the development of this field towards proactivity, precision, and intelligence.

Objective To investigate the awareness of medical staff on pharmacovigilance and the current situation of the construction of pharmacovigilance system in medical institutions.　Methods A self-designed questionnaire was sent to medical institutions in China through Professional Committee on Pharmacovigilance Research, China Society for Drug Regulation in the form of Wechat, and medical staff participated voluntarily. The contents of the questionnaire included 23 questions in 4 dimensions, including the basic information of the respondents, their understanding of the concept and regulations of pharmacovigilance, the management of pharmacovigilance, and the reporting and feedback of adverse drug reactions(ADRs)/events in their medical institutions. The survey time was from August 18, 2023 to October 18, 2023. The data from the questionnaire were analyzed descriptively.　Results The collected questionnaires were from medical institutions in 31 provinces, autonomous regions, and municipalities directly under the central government, with a total of over 100 questionnaires collected in each region. A total of 10 991 medical staff participated in the survey, including 5 504 pharmacists, 2 120 doctors, and 3 367 nurses. Among them, 10 131 (92.18%) respondents had heard of pharmacovigilance, 4 511 (41.04%) had participated in pharmacovigilance-related works, 9 368 respondents (86.41%) answered that the ADRs monitoring and management system had been established in medical institutions where they worked, 8 186 respondents (75.51%) answered that leading group for pharmacovigilance (including ADRs monitoring) had been set up in the medical institutions where they worked, 8 605 respondents (79.37%) answered that the pharmacovigilance works was managed by special personnel in the institutions where they worked, 7 859 (72.49%) answered that there were liaison officers in the clinical departments where they worked, 6 043 (55.74%) answered that the individuals would be rewarded for reporting ADRs, 4 809 （44.36%） answered that pharmacovigilance had been included in the daily works and assessment indicators of the departments, and 5 351 （49.36%） answered that reports of ADRs were reviewed by special personnel. Active reporting by medical staff was the main collection channel of ADRs, 3 391 (31.28%) answered they had actively captured ADRs from the hospital information system, and 7 728 (71.28%) answered they had reported ADRs through the hospital information system, 10 061 (92.81%) answered that the monitoring results of ADRs would be regularly fed back in the hospitals where they worked, and 6 239 (57.55%) answered that regular training on pharmacovigilance for all medical staff would be provided in the institutions where they worked.　Conclusions Medical staff have generally heard of pharmacovigilance and are aware of the national pharmacovigilance system, but they still have insufficient understanding of the concept and regulations of pharmacovigilance. The degree of participating in pharmacovigilance works of medical staff in different regions are different. The monitoring and management of ADRs could be paid attention to in the most medical institutions, but the degree of improvement of pharmacovigilance system in different levels of medical institutions is different.

An 82-year-old male patient with chronic obstructive pulmonary disease was treated with doxofylline injection (0.3 g intravenous infusion, once daily) due to worsened condition of recurrent cough and dyspnea. After 3 days of treatment, the patient′s dyspnea was significantly improved, but he suddenly developed urgent and frequent micturition, and dysuria. Color Doppler ultrasound examination of urgent urinary system and residual urine volume measurement revealed prostate enlargement and a residual urine volume of 281 ml. Acute urinary retention was considered and suspected to be caused by doxofylline. The drug was immediately discontinued, and catheterization was performed, along with oral administration of tamsulosin and finasteride. After 3 days of comprehensive treatments, the patient′s symptoms of urgent and frequent micturition and dysuria were improved, tamsulosin and finasteride were discontinued. At one-month of follow-up, the patient′s urination returned to normal, with no recurrence of urinary retention.

Objective To evaluate the consistency of steady-state blood trough concentration of vancomycin and minimum inhibitory concentration to the area under the serum concentration-time curve (AUC/MIC) and promote the rational use of vancomycin.　Methods It was a single center retrospective study. The clinical data of patients admitted to Xuanwu Hospital, Capital Medical University from January 1, 2019 to December 31, 2020, who were treated with vancomycin and met the inclusion criteria, were collected. Vancomycin calculator was used to calculate AUC/MIC. According to the steady-state blood trough concentration and AUC/MIC standards, the patients were divided into not meeting standard group, meeting standard group, and exceeding standard group, respectively. The standard-reaching status of steady-state blood trough concentration and AUC/MIC in each group was evaluated, as well as the consistency in patients under the 2 different grouping methods. The patients who met the AUC/MIC standard were divided into not meeting standard group, meeting standard group, and exceeding standard group based on steady-state blood trough concentration. The anti-infection efficacy and incidence of vancomycin-associated acute kidney injury (VA-AKI) were evaluated between the different groups to assess clinical effectiveness and safety.　Results A total of 153 patients were included in the study. Among them, 98 (64.1%) patients were male, with age of 61.0 (53.0, 73.0) years, body mass index of 23.9 (21.5, 27.0) kg/m2, creatinine clearance rate of 107.2 (84.1, 147.0) ml/min, and acute physiology and chronic health evaluationⅡscore of 9.0 (6.0, 14.0) points. Among the 153 patients, the AUC/MIC and steady-state blood trough concentration did not meet standards in 86 cases, met the standards in 17 cases, and exceeded the upper limit of the standards in 14 cases; the results were consistent in 117 cases for both methods, and the consistency rate was 76.5%; the results were inconsistent in 36 patients (23.5%). Among the 36 patients, the steady-state blood trough concentration did not meet the standard in 34 cases ［with initial steady-state blood trough concentration of 13.9 (12.8, 14.4) mg/L］, while the AUC/MIC met the standard ［437 (420, 471)］. AUC/MIC met the standard in 51 patients (33.3%), of which 34 had the steady-state blood trough concentration of less than 15.0 mg/L, and 17 had the concentration of 15.0-20.0 mg/L; the efficacy of anti-infection was 88.2% and 13/17, respectively, the incidence of VA-AKI was 2.9% and 1/17, respectively; the difference was not significant (all P>0.05). No patients had the steady-state blood trough concentration over than 20.0 mg/L.　Conclusions The consistence between steady-state trough concentration of vancomycin and AUC/MIC is 76.5%, which is acceptable. For those who meet the AUC/MIC standard for vancomycin, even if the steady-state blood trough concentration is less than 15.0 mg/L, as long as the AUC/MIC meets the standard, the efficacy and safety can be guaranteed.

A 60-year-old male patient with penile squamous cell carcinoma received postopera- tive treatment with serplulimab (200 mg intravenous infusion on day 1, every 21 days as one cycle). Pre- treatment fasting blood glucose was 5.6 mmol/L. Four days after administration of the 6th cycle, the patient developed symptoms of dry mouth, polydipsia, and polyuria, followed by nausea and vomiting 3 days later. Laboratory tests showed random blood glucose 31.9 mmol/L, β-hydroxybutyrate 6.9 mmol/L, blood pH 7.21, base excess -15.4 mmol/L, bicarbonate concentration 10.9 mmol/L, serum potassium 4.59 mmol/L, blood lactate 1.7 mmol/L, urine glucose (++++), and urine ketones (++). Diabetic ketoacidosis was diagnosed and considered to be induced by serplulimab. The drug was therefore discontinued, and supportive treatments including fluid replacement, potassium supplementation, and continuous insulin infusion for glycemic control were initiated. The next day, fasting blood glucose was 15.1 mmol/L and glycated hemoglobin 8.1%. One day later, the insulin pump was stopped and replaced with a regimen of insulin lispro, insulin glargine, and acarbose. The following day, both fasting and 1 hour/2 hour postprandial C-peptide levels were<0.01 nmol/L, and diabetes-related autoantibodies were all negative. Two days later, the fasting blood glucose still elevated at 12.7 mmol/L, which was considered as fulminant type 1 diabetes with poor glycemic control, and metformin was added. Two days afterwards, urine ketones negatire, the fasting blood glucose decreased to 6.0 mmol/L. At a 40 day follow-up, the glycated hemoglobin was 7.7%.

Objective To systematically evaluate the efficacy and safety of ensifentrine in the treatment of chronic obstructive pulmonary disease (COPD).　Methods Randomized controlled trials (RCTs) of ensifentrine in the treatment of COPD were collected by searching related databases at home and abroad (up to February 11, 2025). On the basis of conventional treatment for COPD, patients in in the trial group were given ensifentrine, while those were given placebo additionally in the control group. The efficacy outcomes included forced expiratory volume in 1 second (FEV1), sores of Evaluating Respiratory Symptoms in COPD (E-RS-COPD) and St.George′s Respiratory Questionnaire (SGRQ), transition dyspnea index (TDI), and daily rescue medication use (RMU). The safety outcomes included the incidences of adverse events (AEs) and acute exacerbation of COPD during treatment. Quality of methodology was evaluated using bias risk assessment tool of Cochrane collaboration networks. Meta-analysis was performed using RevMan 5.3 software. The effect sizes of measurement data were mean difference (MD) and its 95% confidence interval (CI), while the effect sizes of counting data were odds ratio (OR) or relative risk (RR) and its 95%CI.　Results A total of 4 RCTs and 2 367 patients were entered in the analysis, including 1 629 patients in the trial group (divided into 5 dose groups of 0.357, 0.75, 1.5, 3, and 6 mg) and 738 in the control group. The meta-analysis results showed that compared with the control group, the peak FEV1(MD=139.03 ml, 95%CI: 121.54-156.52 ml), area under the curve of FEV1 from 0 to 12 h (MD=91.59 ml, 95%CI: 67.39- 115.79 ml), and FEV1 morning trough values (MD=43.44 ml, 95%CI: 18.88-68.00 ml) in the trial group were significantly increased at the end of the observation compared to baseline, while the scores of E-RS-COPD (MD=-1.25 points, 95%CI: -1.60- -0.91 points) and SGRQ (MD=-2.45 points， 95%CI: -3.42- -1.47 points) were significantly decreased compared to baseline, and the differences were statistically (all P<0.001). In addition, the TDI of the 1.5 mg, 3 mg, and 6 mg subgroups in the trial group was improved more significantly respectively compared to those in the control group, the average daily RMU in the 6 mg subgroup was significantly reduced compared to that in the control group, and the differences were statistically significant (all P<0.05). There was no significant difference in the incidence of AEs ［5.6% (91/1 629) vs. 5.0% (37/738), RR= 1.00, 95%CI: 0.69 1.45］, incidence of serious AEs ［4.2% (69/1 629) vs. 5.0% (37/738), RR=1.01, 95%CI: 0.69 1.49］, or incidence of AEs leading to drug discontinuation ［5.9% (96/1 629) vs. 7.2% (53/738), RR=0.92, 95%CI: 0.67-1.28］ during the study period between the trial group and the control group (all P>0.05).　The acute exacerbation rate of COPD in the trial group was significantly lower than that in the control group［7.1%(115/1 629) vs. 13.4%(99/738), RR=0.61, 95%CI: 0.48-0.79, P<0.001］. Conclusion Ensifentrine can significantly improve the lung function and dyspnea in COPD patients, and reduce the risk of acute exacer- bation, with a good safety profile.

Objective To analyze the current status and existing issues in assessment of the severity of adverse drug reactions (ADRs) and explore the feasibility of applying Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (CTCAE 5.0) as a grading basis for ADR severity.　Methods A single-center retrospective study was conducted in this study. The severity of ADRs submitted by the First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital) (our hospital) to the National Adverse Drug Reaction Monitoring Center (National Center) from January 1, 2023 to September 30, 2024 was re-evaluated based on CTCAE 5.0 (grades 1-2 were judged as “mild” and grades 3-5 as “severe”）. The collection of ADR reports, patients′ basic information, etc. were analyzed descriptively and statistically. The Kappa coefficients among the evaluation results of initial reports, pharmacist review reports, re-evaluation results based on CTCAE 5.0, and the evaluation results of National Center were calculated (Kappa≤0.4 indicating low consistency, >0.4-0.6 moderate consistency, >0.6-0.8 high consistency, and >0.8 excellent consistency). According to clinical outcome of patients, reports were divided into 3 subgroups, namely cured, improved, and not improved groups, and the Kappa coefficients for subgroups were calculated, respectively.　Results A total of 1 175 ADR reports were submitted during the study period (invoving 1 175 patients), with 968 reports (82.38%) from clinical physicians, 152 reports (12.94%) from pharmacists, and 55 reports (4.68%) from nurses. Among the 1 175 patients, 675 were female, 499 were male, and one patient was with unknown gender information; their ages were from 1 to 95 years, with a median age of 56 years. The Kappa coefficients in ADR severity classification among the initial reports, pharmacist review reports, CTCAE 5.0 re-evaluation results, and the National Center′s assessments were 0.20 (lower), 0.56 (moderate), and 0.74 (higher), respectively. Subgroup analysis showed the consistency between the initial reports and the National Center′s assessment results was lower (Kappa values were 0.05, 0.23 and 0.43, respectively); there were differences in the consistency between the pharmacist review and the National Center assessment results (Kappa values were 0.39 in the cured group, 0.53 in the improved group, and 0.74 in the not improved group), and the consistency between the CTCAE 5.0 re-evaluation results and the National Center assessment results was higher (Kappa values were 0.74, 0.74 and 0.66, respectively).　Conclusions Discrepancies exist in severity assessments of ADRs reported by our hospital between the initial reports, pharmacist review reports, CTCAE 5.0 re-evaluation, and the National Center assessment. Different reporting personnel may have different understandings of the ADR severity assessment standards. It is suggested that CTCAE 5.0 could be used as an auxiliary reference standard for ADR severity grading in order to improve the consistency between the reporter's assessment results and the National Center's assessment results.

Objective To explore the causes of medication errors (ME) associated with deslanoside injection and put forward targeted preventive recommendations.　Methods ME reports related to deslanoside injection in the National Monitoring Network for Clinical Safe Medication (Monitoring Network) as of August 31, 2024 were collected, and sever ME cases of deslanoside injection were also collected though searching medical literature databases at home and abroad, China Judgements Online, and PKULAW database at the same period. The level of severity, occurrence link, error content, occurrence place, trigger personnel and patient outcomes of the MEs were retrospectively analyzed.　Results The Monitoring Network received a total of 41 ME reports of deslanoside injection from September 2012 to August 2024, and the number of reports showed an upward trend year by year. These MEs were classified as grade A in 1 case (2.4%), grade B in 18 cases (43.9%), grade C in 17 cases (41.5%), grade D in 4 cases (9.8%), and grade F in 1 case (2.4%). There were 63.4% (26/41) of MEs occurring in the prescription/doctor′s order prescribing and delivery links, mainly caused by physicians, and the common error contents included solvent errors, medication under contraindications, and having drug-drug interactions. In addition, 26.8% (11/41) of MEs occurred in the drug dispensing and distribution link, and 9.8% (4/41) occurred in the administration and monitoring links. A total of 4 severe MEs of deslanoside injection were collected from the Monitoring Network, medical literature and judicial cases, all of which occurred in the prescription/doctor′s order prescribing and delivery links. Among the 4 severe MEs, 2 ME cases of grade I occurred due to incorrect usage and dosage, resulting in patient death; 1 ME case of grade F was caused by interaction with traditional Chinese medicine, resulting in digitalis poisoning, and another case of grade F was that deslanoside injection was administered to a patient with digitalis poisoning (medication under contraindications).　Conclusions MEs of deslanoside injection often occurs in the prescription/doctor′s order prescribing and delivery links, mainly because of insufficient knowledge of doctors to the drug instructions. It is suggested to strengthen learning and training of medical staff centered around drug instructions, and improve the system interception and process management, so as to improve the medication safety.

A 56-year-old male patient received an intravenous infusion of 720 mg belimumab once every 2 weeks for systemic lupus erythematosus. On the second day of medication, the patient developed small red papules on the skin of the chest and abdomen, which gradually spread to the head, face, behind the ears, earlobes, neck, back, and groin, manifesting as extensively and symmetrically distributed edematous papules. The lesions on the back skin merged into large patches, with target-like lesions visible locally. The pathological results of the patient′s chest skin biopsy showed a large number of pustules in and below the stratum corneum, dilated and congested blood vessels in the superficial and middle layers of the dermis, and infiltration of surrounding lymphocytes and neutrophils, which was consistent with the diagnosis of acute generalized exanthematous pustulosis. It was considered to be induced by belimumab. Belimumab was discontinued immediately and antiallergic treatments with methylprednisolone and loratadine, combined with topical application of fluticasone propionate cream and fusidic acid cream. After 1 week of treatments, the rash was improved significantly, and after 1 month, the rash basically disappeared, leaving behind pigmentation and desquamation.

 A 66-year-old female patient self-administered Jingyaokang capsules (a compound preparation of traditional Chinese medicines， 3 capsules thrice daily orally) due to lumbar pain. The patient developed oliguria and edema of bilateral lower limbs after 3 doses of medication on the same day. The laboratory tests showed WBC 7.3×109/L, neutrophil percentage 0.70, blood urea 12.7 mmol/L, blood crea- tinine 179 μmol/L, and blood uric acid 461 μmol/L. The kidney function tests 15 days ago showed no abnormalities in the patient. Acute kidney injury caused by Jingyaokang capsules was considered. The drug was stopped and symptomatic treatments including torasemide and maintenance of fluid balance were given. The patient′s urine output gradually increased. Five days later, the patient′s edema of bilateral lower limbs disappeared, and her blood urea and creatinine decreased to normal range. The acute kidney injury in the patient may be related to strychni semen component in the Jingyaokang capsules.