Iron deficiency is the most common cause of anemia. Intravenous iron is a common therapeutic drug for iron deficiency and iron deficiency anemia, which is commonly used in the treatment of anemia patients with chronic kidney disease, heart failure, inflammatory bowel disease, and cancer, as well as anemia patients in perioperative period and during pregnancy and lactation. In order to strengthen the rational use of intravenous iron and improve the pharmaceutical care level, the Chinese Pharmacological Society Professional Committee of Drug-induced Diseases and the Guangdong Pharmaceutical Association organized experts majoring in medicine, pharmacy, nursing, hospital mana- gement and other specialties to develop this consensus through discussing, retrieving domestic and foreign literature, and collecting evidence-based medical evidence. The differences among intravenous iron agents, clinical situations of applica- tion, and the safety issues are considered in the consensus, in order to provide the basis for the rational application and pharmaceutical care in clinic.

Anticancer drugs are important causes of kidney injury in cancer patients. Once kidney injury occurs, it will affect anticancer therapy and patient prognosis. Thus, the Japanese Society of Nephro- logy, Japan Society of Clinical Oncology, Japanese Society of Medical Oncology, and Japanese Society of Nephrology and Pharmacotherapy have jointly formulated the Clinical Practice Guidelines for Management of Kidney Injury During Anticancer Drug Therapy 2022 and made a particular discussion on the prevention and management of anticancer drug-induced kidney injury. This article focuses on interpreting the management of kidney injury related to cytotoxic anticancer drugs, targeted therapies, and immune checkpoint inhibi-tors to more effectively guide clinical practice.

In 2023, a total of 27 742 cases of medication error (ME) from 439 hospitals in 27 pro‑vincial administrative regions were collected in the National Monitoring Network for Clinical Safe Medica‑tion. Among them, 282 (1.02%) were classified as grade A, 22 452 (80.93%) as grade B, 4 239 (15.28%) asgrade C, 499 (1.80%) as grade D, 141 (0.51%) as grade E, 127 (0.46%) as grade F, 1 (<0.01%) as grade G,and 1 (<0.01%) as grade I; no MEs of grade H occurred. Among the 27 460 patients involved in MEs ofgrade B to I, 15 131 (55.10%) were male and 12 329 (44.23%) were female; their ages were from 1 day to103 years; 3 198 (11.65%) were children (<18 years old), 12 576 (45.80%) were young and middle‑agedadults (≥18 to <60 years old), and 11 686 (42.56%) were elderly (≥60 years old). The top 3 contents of MEwere wrong drug class (5 880 cases, 20.97%), wrong dosage (4 668 cases, 16.65%), and wrong administration·390·药物不良反应杂志 2024 年7月第 26 卷第7期 ADRJ，July 2024, Vol. 26, No. 7frequency (3 184 cases, 11.35%). A total of 270 patients were involved in severe MEs (grade E‑I), including140 (51.85%) males and 130 (48.15%) females, aged from 52 days to 94 years, of which 31 (11.48%) werechildren, 91 (33.70%) were young and middle‑aged adults, and 148 (54.82%) were elderly. The top 3 drugsinvolved were cefoperazone sodium and sulbactam sodium, metformin, and estazolam. One fatal ME wascaused by mistakenly orally taking Fufang Jingjie for fumigation and washing. Among the 27 460 gradeB‑I MEs, 19 655 (71.58%) were triggered by physicians, 5 688 (20.71%) by pharmacists, and few by nurses,patients and their family members, etc. These MEs mainly occurred in clinics (10 537 cases, 38.37%), inhospital wards (8 187 cases, 29.81%), and in pharmacies (6 470 cases, 23.56%). But among the 270 severeMEs, 121 (44.81%) occurred in the patient′s home. The top 3 persons who discovered the ME were phar‑macists (20 693 cases, 74.46%), patients and their family members (3 240 cases, 11.66%), and physicians(2 214 cases, 7.97%). The top 3 factors causing ME were lack of related pharmacologic knowledge (9 382cases, 28.3%), tiredness (5 974 cases, 18.05%), and insufficient training of medical workers (3 831 cases,11.58%). In view of MEs with high incidence or more severe in 2023, relevant risks should be paid attentionto, including misusing external drugs for internal use, ingestion of drug packaging by mistake, wrong doseconversion in children, ME in special dosing frequency, too fast infusion speed of enteral nutrition prepara‑tions and irritant intravenous preparations, interaction between montmorillonite powder and other drugs,hypernatremia caused by fosfomycin sodium, etc. In addition, strengthening the management of drug varietieswith frequent severe MEs and fatal MEs, as well as the popular science and safe drug use education forpatients, can help ensure the medication safety of patients.

Objective To explore the occurrence and risk factors of piperacillin sodium and tazobactam sodium (TZP)-related hypokalemia.　Methods The clinical data of adult inpatients treated with TZP in Linyi Central Hospital from January 2022 to January 2023 were collected through the hospital′s electronic medical record system, including patient demographic information, infection sites, major underlying diseases, laboratory tests, TZP use information and concomitant drugs, and patients with TZP-related hypokalemia were screened. The occurrence of TZP-related hypokalemia was analyzed by descriptive statistics. According to whether or not having TZP-related hypokalemia, the patients were divided into hypokalemia group and non-hypokalemia group, and the clinical characteristics were compared. The clinical characteristics with statistically significant differences between 2 groups were included in the multivariate logistic regression, and the risk factors of TZP-related hypokalemia were analyzed.　Results A total of 363 patients were included in the analysis, of which 86 (23.7%) were with hypokalemia and were judged to be associated with TZP, 46 (53.5%) were male and 40 (46.5%) were female; the age was 76 (68, 83) years. Of the 86 patients, 76 (88.4%) had mild hypokalemia, 10 (11.6%) had moderate hypokalemia, and none had severe hypokalemia. Through clinical characteristic comparison between the hypokalemia group and the non-hypokalemia group, statistically significant differences were found in patient gender, age, body mass index, the proportion of patients with pulmonary infection, abdominal/gastrointestinal infection, and urinary tract infection, the proportion of patients with coronary atherosclerotic heart disease and without major underlying diseases, baseline hemoglobin, serum total protein, serum albumin, blood calcium, blood magnesium, and the proportion of patients using potassium preserving diuretics and other diuretics during TZP treatment (all P<0.05). The above variables were included in the multivariate logistic regression, and the results showed that only the baseline level of blood magnesium was an independent influencing factor of TZP-related hypokalemia, and the lower the level, the higher the risk (odds ratio=0.105，95% confidence interval: 0.012-0.956，P=0.045).　Conclusions Hypokalemia is a common adverse reaction of TZP, which should be paid attention to in clinic. The lower level of blood magnesium at baseline may be related to the increased risk of hypokalemia during TZP treatment.

A 78-year-old female patient with type 2 diabetes for 30 years, hypertension for more than 10 years, diabetes nephropathy for 4 years, and renal anemia for several years additionally received roxadustat (70 mg thrice per week orally) for anemia. After 5 days, the patient developed sudden chest tightness, asthma, acute left heart failure, and depressed edema of both lower limbs. The electrocardiogram showed sinus arrest, escape rhythm, and a heart rate of 40 beats per minute. Laboratory test results showed   blood  pH 7.31， blood potassium 5.3 mmol/L, blood creatinine 304 μmol/L, B-type natriuretic peptide 1 280.0 ng/L, high sensitivity troponin T 0.042 μg/L, and creatine kinase MB 0.83 μg/L. Acute left heart failure, hyperkalemia, and metabolic acidosis caused by roxadustat were considered. Roxadustat and other long-term oral medication such as hypoglycemic and antihypertensive drugs were discontinued. Symptomatic treatments such as sodium bicarbonate, insulin, furosemide, calcium gluconate, and blood filtration were given. Two days later,the patient′s heart rate and blood potassium returned to normal; 7 days later, the patient′s B-type natriuretic peptide was 168.0 ng/L, blood creatinine was 170 μmol/L, and blood potassium was 4.13 mmol/L. The patient had no chest tightness or asthma, and no edema in both lower limbs. Long-term oral medication such as hypoglycemic and antihypertensive drugs were given again. At a 1 month follow-up, the patient did not experience chest tightness or asthma, and the electrolyte levels were normal.

Intravitreal injection (IVI) is an administration technique that uses a syringe to deliver drugs into the vitreous cavity. Currently, multiple IVI drugs have been successively approved for the treatment of various fundus diseases, including antivascular endothelial growth factor drugs, intravitreal sustained- release glucocorticoid drugs, and so on. Meanwhile, there are many injection drugs off label used by IVI. At present, there is a lack of pharmaceutical care guidance documents for the clinical application of IVI drugs. To promote the development of pharmaceutical care for IVI drugs, Ophthalmic Pharmacy Professional Committee of Peking Safety Medicine Foundation, Medicine Therapy Management Working Committee of Chinese Pharmacists Association, and Clinical Pharmacy Branch of China International Exchange and Promotive Association for Medical and Health Care organized experts to formulate this consensus based on clinical practice experience and with reference to relevant domestic and foreign research data, guidelines, and literature. This consensus combs the characteristics of clinical application of IVI drugs, relevant pharmaceutical services before, during and after injection, and forms 26 recommendations for 5 clinical issues, which can be used by medical institutions at all levels to carry out pharmaceutical services of IVI drugs. The users are medical staff in medical institutions at all levels (including pharmacists, physicians, nurses, and other relevant staff), and the target population for application is mainly patients using IVI drugs.

Objective To mine the adverse events (AE) risk signal of azithromycin in children, establish the corresponding pharmaceutical care process, and provide reference for the safe use of azithromycin in clinic.　Methods AE caused by azithromycin in children (<18 years) were searched from the US FDA Adverse Event Reporting System (FAERS) database from the 1st quarter of 2004 to the 4th quarter of 2023. The AE was standardized and classified using the preferred term (PT) and system organ class (SOC) in the Medical Dictionary for Regulatory Activities 26.1 version. Reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods were used for detection of AE signal of azithromycin. AE that simultaneously met the following conditions was considered as a risk signal: the number of reports≥3, lower limit of the 95% confidence interval of ROR≥1, PRR>2, and χ2>4. Descriptive analysis on the signals was performed. The pharmaceutical care process of azithromycin for children was established based on the results of signal mining and satisfaction survey was conducted.　Results A total of 1 457 AE reports related to azithromycin in children were collected, involving 127 PTs and 18 SOCs. The top 5 PTs in the number of reports were rash, pruritus, urticaria, drug hypersensitivity and diarrhea. The top 5 PTs in signal intensity were infantile diarrhea, myasthenia gravis crisis, intermittent explosive disorder, diarrhea neonatal, and infantile vomiting. A total of 16 risk signals that were not recorded in the label were mined out, and the top 5 PTs according to signal intensity were intermittent explosive disorder, conversion disorder, bronchiectasis, tooth discoloration, and choreoathetosis. The analysis of 79 AE reports with death outcomes showed that drug-induced liver injury, Stevens-Johnson syndrome, rash, vomiting, nausea, cyanosis, and diarrhea were related risk signals. Based on the signal mining results mentioned above, the medication safety officer team in our hospital established a pharmaceutical care process of azithromycin application for children, including pre-medication assessment (indications, medical history, heart and liver function, etc.), speed and mode of administration monitoring during the medication, and intervention measures after the occurrence of adverse reactions, and 178 hospitalized children who received azithromycin treatment were monitored. The satisfaction survey results showed the degree of satisfaction was 100%.　Conclusions The main AEs related to azithromycin in children are rash, pruritus, urticaria, drug hypersensitivity, and diarrhea, all of which are recorded in the label. In addition, we should also be vigilant against the risk signals such as intermittent explosive disorder, conversion disorder, bronchiectasis, tooth discoloration, and choreoathetosis, which are not recorded in the label. The pharmaceutical care process for azithromycin use in children based on the risk signal mining results is feasible and effective.

A 66-year-old female patient with multiple chronic diseases was on long-term treat- ment with digoxin, spironolactone, metoprolol, atorvastatin, dapagliflozin, and entecavir, with no abnormality platelet count (PLT). Due to hypertrophic obstructive cardiomyopathy and atrial fibrillation, digoxin was discontinued, and rivaroxaban 15 mg once daily orally was added to prevent thrombosis. Concurrently, furosemide, sacubitril valsartan, meglumine adenosine cyclophosphate, and silibinin was given for cardiac load reducement, blood pressure control and heart failure improvement, myocardial nutrition, and liver function improvement, respectively. After the initiation of this regimen, the patient′s PLT gradually decreased and was 51×10⁹/L on day 13. Drug-induced thrombocytopenia was considered, with rivaroxaban being the likely causative agent. Rivaroxaban was then switched to warfarin, methylprednisolone 40 mg was administered intravenously once, and the remaining medications were continued. The patient′s PLT gra- dually increased. On day 11 after discontinuing rivaroxaban, the PLT was 155×10⁹/L. At a 2-week follow- up, PLT of the patient was 169×10⁹/L.

Accumulation of drugs and its metabolites in the body occurs and risks of adverse drugreactions increase in renal insufficiency patients due to the renal function decline or delay of renal excretionand the pharmacokinetic changes related to the decline of renal function. Therefore, the dose of anticancerdrugs should be adjusted in tumor patients with renal dysfunction. The Japanese Society of Nephrology,JapanSociety of Clinical Oncology,Japanese Society ofMedical Oncology,and Japanese Society of Nephrologyand Pharmacotherapy have jointly formulated Clinical Practice Guidelines for Management of Kidney Injury During Anticancer Drug Therapy 2022, and specifically discusses the dose adjustment of anticancer drug forpatients with renal injury in the second chapter. This article focuses on the interpretation of the principle ofdrug dose adjustment for patients with renal insufficiency and suggestions for dose adjustment of platinumdrugs and fluorouracil drugs in this chapter.

Due to the characteristics of cytotoxicity, vascular toxicity, and immunotoxicity, anticancer drugs may be more likely to cause kidney injury than other drugs. It is an important content in anti  tumor treatment to fully understand the clinical manifestations and risk factors of anticancer drug related renal injury, and evaluate the disease severity reasonably, so as to better adjust the anticancer schedule. Thus, the Japanese Society of Nephrology, Japan Society of Clinical Oncology, Japanese Society of Medical Oncology, and Japanese Society of Nephrology and Pharmacotherapy have jointly formulated the Clinical Practice Guidelines for Management of Kidney Injury During Anticancer Drug Therapy 2022 and made special discussions and suggestions on the definition, evaluation methods, main clinical manifestations, and risk factors of drug induced kidney injury in cancer patients after receiving anticancer drug treatments. This article interprets this part of the content in order to make more effective guidance in clinical practice.

With the aging of the population and the increasing number of patients with throm- boembolic diseases, oral anticoagulants are more and more widely used. Anticoagulant-related nephropathy (ARN) is a significant adverse reaction in the treatment with oral anticoagulants, generally considered to be a form of acute kidney injury caused by excessive anticoagulation. The mechanisms involved may include glomerular hemorrhage, obstruction of renal tubules by red cell casts, and damage to tubular epithelial cells. Abnormalities in coagulation function and renal function are the main risk factors for ARN; older age, diabetes mellitus, and cardiovascular diseases such as hypertension and heart failure also increase the  risk of ARN occurrence. ARN should be managed based on individual patient characteristics. Benefits and risks of treatment should be carefully considered when choosing oral anticoagulants; renal function should be closely monitored during treatments to detect potential risks early. In case of ARN, it is advised to promptly adjust the anticoagulant therapy and provide symptomatic supportive treatments. In severe cases, treatments with methylprednisolone combined with hemodialysis can be employed.

Objective To analyze the occurrence and clinical features of liver injury induced by dandelion, a food-medicine homologous traditional Chinese medicine.　Methods The patients with liver injury caused by taking dandelion, who were admitted to the Department of Infectious Diseases, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School from January 1, 2017 to December 31, 2023, were enrolled in this study. The electronic medical records of the patients were retrieved, and the patients′ general information, using of dandelion, combined medication, clinical manifestations, and liver biochemical test results were recorded. The causal relationship between dandelion and the liver injury were evaluated, and the clinical manifestations, classification, severity, treatment and prognosis of liver injury were analyzed.　Results A total of 13 patients were enrolled in the study, including 8 females and 5 males. The age ranged from 29 to 78 years. Nine patients took dandelion by themselves, and 4 accor- ding to the doctor′s advice. The administration methods included dandelion root tea drink, whole herb tea drink, and powder drink mixed in water. Most patients′ liver injury occurred within 90 days after taking dandelion. The main clinical manifestations were yellowish staining of skin and sclera, dark urine, abdominal distension, abdominal pain, loss of appetite, etc. The laboratory tests showed that serum aminotransferase and bilirubin increased in 13 patients, alkaline phosphatase increased in 12 patients, and plasma ammonia increased in 5 patients. The causality evaluation results showed "probable related" in 8 cases and "highly probable related" in 5 cases. The clinical classification showed that 11 patients were of hepatocellular type and 2 of mixed type. The severity was mainly grade 2 (8 of 13 patients). Two patients with grade 3 and 2 patients with grade 4 developed liver failure. After symptomatic treatments, 11 patients′ liver function returned to normal or were improved; 2 patients′ condition progressed, of which 1 patient survived after liver transplantation and 1 patient died.　Conclusions Dandelion can cause liver injury, mostly occurring within 90 days after administration, with moderate severity. After stopping dandelion and giving symptomatic treatments, most patients have a good prognosis, but there is a risk of liver failure and death.

The safety of traditional Chinese Medicine (TCM) has garnered widespread attention and has become a major obstacle to its further development and internationalization. The complexity of TCM and the unpredictability of its interactions with the human body pose significant challenges to safety research. The causes of TCM safety issues are multifaceted, including intrinsic and extrinsic toxicity, confusion of herbal sources and misuse in clinical practice, inadequate patient awareness of safe medication use, and insufficient regulatory oversight of TCM quality and safety. To strengthen the risk managements, it is essential to employ scientific technologies to investigate the fundamental nature of TCM safety, leverage artificial intelligence for big data analysis and early risk warning, promote the scientific concept of safe TCM use, and establish a comprehensive lifecycle pharmacovigilance system for TCM. These will facilitate TCM safety research in China, ensure patient medication safety, and promote the healthy and sustainable development of the TCM industry and its internationalization.

Intravenous infusion has played an important role in emergency treatments in China, but there is also the phenomenon that emergency infusion is overused. The high burden of emergency infusion may cause more medication safety problems, such as adverse drug reactions, medication errors, drug interactions, and so on. The risks in emergency infusion should be paid high attention to. We should actively construct a comprehensive management model for the prevention and control of emergency infusion safety risks by strengthening multidisciplinary cooperation, avoid unnecessary intravenous infusion, and develop diagnostic criteria and treatment guidelines for adverse events in intravenous infusion, so as to better ensure the medication safety in emergency patients treated with intravenous infusion.

Pre-marketing clinical trials may fail to detect rare or delayed adverse drug reactions (ADRs) due to insufficient sample size and short follow-up periods. Therefore, continuous post-marketing safety evaluation is necessary. Evidence generation relies on discovering ADR signals and conducting studies to verify specific risks. Integrating evidence from multiple sources through methods like meta-analysis can further enhance the comprehensiveness and reliability of drug safety evaluations. Additionally, risk management in clinical practice should be emphasized by developing standardized clinical guidelines and establishing decision support systems to facilitate the dissemination and application of evidence, ensuring its practical use. Constructing an evidence ecosystem not only helps identify and understand potential medication safety issues, but also enhance the scientific and practical aspects of risk management, ultimately reducing patient harm from ADRs.

Objective To understand the occurrence of drug?drug interaction (DDI) in medical orders and the relevant common medications of hospitalized patients treated with voriconazole.　Methods The treatment information of hospitalized patients treated with voriconazole and had blood trough concentration (Cmin) results in Quanzhou First Hospital, Fujian Province from May 2018 to August 2023 was collected through the hospital information system. Descriptive statistical analysis was conducted on the incidence of DDI medical orders, the drugs involved in DDI, the types and risk levels of DDI, the departments where DDI occurred, and the Cmin changes of voriconazole in patients with 1 or 2 type of voriconazole?related DDI medical orders (including drugs not recommended in combination with voriconazole or voriconazole dose needs to be adjusted when combined) during voriconazole treatment.　Results A total of 752 patients were included, of which 592 (78.7%) had 1?344 medical orders with voriconazole?related DDI, involving 28 drugs. Among them, 67.7% (401/592) of patients used 2 or more DDI drugs. Glucocorticoids ［91.6% (542/592)］, followed by proton pump inhibitors ［87.8% (520/592)］, were most frequently involved in the medical orders of DDI with voriconazole. Among the 28 voriconazole?related DDI drugs, 5 were involved in type 1 or 2 DDI, including rifampicin, nirmatrelvir/ritonavir, phenobarbital, phenytoin sodium, and rifabutin. The 5 drugs involved 33 patients, of whom 51.5% (17 patients) had voriconazole Cmin<1.0?mg/L; rifampicin involved the most patients (17 patients), followed by nirmatrelvir/ritonavir (10 patients). When voriconazole was combined with rifampicin, rifabutin, phenobarbital and phenytoin sodium, its Cmin in most patients decreased significantly. The incidence of medical orders with voriconazole?related DDI was highest in the Intensive Care Unit, followed by the Department of Respiratory and Critical Care Medicine.　Conclusions Medical orders with DDI are very common in the clinical application of voricona- zole, and most patients have used two or more DDI drugs, in which glucocorticoids and proton pump inhibitors appeared more common. It is necessary to be alert to the occurrence of DDI between voriconazole and rifampicin, rifabutin, phenobarbital and phenytoin  sodium in clinic.

Objective To analyze the clinical characteristics and treatments of adverse reactions and anaphylaxis induced by cisatracurium besylate, and provide reference for medication safety in clinic.　Methods Adverse reaction reports of cisatracurium besylate in database of Shandong Provincial Center for Adverse Drug Reaction Monitoring between January 1， 2008 and April 18， 2023 were collected and analyzed retrospectively. The adverse reaction terminology was standardized using the preferred terms and system organ class (SOC) in the Medical Dictionary for Regulatory Activities 25.1. The cases of anaphylaxis were selected and graded. The characteristics of all anaphylaxis and treatments of anaphylaxis of grade Ⅱ-Ⅳ were analyzed.　Results A total of 163 adverse reaction reports were included for analysis, involving 201 preferred terms. The top 3 SOCs involved were mainly skin and subcutaneous tissue disorders (133 cases， 66.17%), vascular disorders (14 cases, 6.96%), and immune system disorders(14 cases, 6.96%). One hundred and forty-five patients (89.0%) experienced anaphylaxis, mainly within 10 minutes after medication (115 cases, 79.3%). Of them, 37 (25.5%) patients had anaphylaxis of grade Ⅱ-Ⅳ. The most common initial symptom was circulation system symptoms (19 cases， 51.4%), followed by skin or mucosal signs (12 cases, 32.4%). The main therapeutic drugs included glucocorticoids (27 cases, 73.0%), adrenaline (17 cases, 45.9%), and other vasopressors other than adrenaline (19 cases, 51.4%). All patients showed improvement or recovery in symptoms after treatments.　Conclusions The anaphylaxis caused by cisatracurium besylate mainly occurred within 10 minutes after medication and have a good prognosis. For anaphylaxis classified as grade Ⅱ-Ⅳ, the acute phase treatment drugs mainly include glucocorticoids, adrenaline, and other vasopressors other than adrenaline.

Objective To mine the risk signal of acute kidney injury (AKI) induced by different oral anticoagulant drugs (OACs) in various populations and provide a reference for clinical use of OACs.　　Methods Reports of AKI induced by OACs and non-OACs in the US Food and Drug Administration Adverse Event Reporting System database from the 1st quarter of 2004 to the 3rd quarter of 2023 were collected. The relationship between the drugs mentioned above and the AKI in patients were analyzed by methods of reporting odds ratio (ROR) and Bayesian confidence propagation neural network (BCPNN). When the number of reports of the target adverse event (AE) for the target drug was ≥3, and the lower limit of the 95% confidence interval (CI) of ROR was >1 or the lower limit of the 95%CI of the information component (IC025) was >0, it indicated a statistically significant association between the target drug and the target AE.　Results A total of 12 402 AKI reports related to OACs were collected, including 1 313 for warfarin, 3 086 for dabigatran, 4 730 for rivaroxaban, 2 918 for apixaban, and 365 for edoxaban; 454 378 AKI reports were related to non-OACs. The overall analysis of OACs showed an ROR (lower limit of 95%CI) of 1.791 (1.759) and an IC (IC025) of 0.813 (0.787) for AKI caused by OACs. Analysis of individual OACs showed that warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban all posed risks for AKI, with ROR (lower limit of 95%CI) of 1.220（1.156）, 2.386（2.302）, 2.044（1.986）, 1.375（1.326）, 3.003（2.706）, respectively, and IC (IC025) of 0.284（0.204）, 1.231（1.178）, 1.010（0.968）, 0.452（0.399）, 1.560（1.407）, respectively. Edoxaban had the highest ROR and IC values, while warfarin had the lowest. Subgroup analysis showed that in the <18 years subgroup, neither warfarin nor rivaroxaban showed a risk of AKI; the ROR method did not show dabigatran to have a risk of AKI, but the BCPNN method did. In the 18-45 years subgroup, both methods showed that apixaban did not have a risk of AKI, while all other OACs did. In the 45-64 years subgroup, all OACs showed a risk of AKI. In the ≥65 years subgroup, warfarin and apixaban posed risks for AKI. Gender subgroup analysis showed that both methods indicated a risk of AKI with warfarin in males; all OACs showed a risk of AKI in females.　Conclusions OAC has a statistically significant risk of AKI, among which edoxaban has the highest risk intensity and warfarin has the lowest. Different OACs have different risks of AKI in patients with different ages.

Objective To mine the adverse event (AE) risk signals of semaglutide and liraglutide in weight management populations, and provide references for the safe use of these drugs in relevant patients.　Methods The reporting odds ratio (ROR) method, proportional reporting ratio (PRR) method, Bayesian confidence propagation neural network (BCPNN) method, and empirical Bayesian geometric mean (EBGM) method were used to mine the AE risk signals of semaglutide and liraglutide in weight management populations from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database from the 1st quarter of 2010 to the 4th quarter of 2023. Adverse events that met the criteria of all 4 mining methods were considered as risk signals. The adverse events were classified and statistically analyzed using the system organ class (SOC) and preferred term (PT) of the 26.1 version of the Medical Dictionary for Regulatory Activities 26.1 version, and the identified risk signals were analyzed.　Results During the set period, 2 292 AE reports for semaglutide for weight management (excluding diabetes) and 2 973 for liraglutide were retrieved. The semaglutide-related AE reports involved 83 PTs, among which 57 were already recorded in the instructions and 26 were not. Among the 26 PTs not recorded in the labels, the top 5 PTs in terms of AE report numbers were increased appetite, hunger, panic attack, binge eating, and feeling cold; the top 5 PTs in terms of ROR values were lack of satiety, hunger-induced ketoacidosis, myoglobinuria, binge eating, and bulimia. The liraglutide-related AE reports involved 74 PTs, among which 60 were already recorded in the instructions and 14 were not. Among the 14 PTs not recorded in the labels, the top 5 PTs in terms of AE report numbers were weight gain, increased appetite, binge eating, weight fluctuation, and pancreatic cyst; the top 5 PTs in terms of ROR values were lack of satiety, binge eating, hepatic adenoma, increased appetite, and pancreatic cyst. Three PTs of severe AEs that were not recorded in the labels for semaglutide were identified, namely, olfactory abnormality, ketoacidosis, and panic attack. One PT of severe AE that was not recorded in the labels for liraglutide was identified, namely, metastatic pancreatic cancer.　Conclusion The AE risk signals of semaglutide and liraglutide in weight management include AEs not recorded in the labels, and some are even serious AEs, which need to be identified and prevented in clinical practice.

Objective To analyze the influencing factors on the occurrence of acute kidney injury(AKI) in hospitalized patients treated with esomeprazole and to construct a risk prediction model to predictthe occurrence of esomeprazole‑associated AKI. Methods The study was designed as a retrospectivestudy. The subjects were selected from patients who were hospitalized in the First Affiliated Hospital of·405·药物不良反应杂志 2024 年7月第 26 卷第7期 ADRJ，July 2024, Vol. 26, No. 7Shandong First Medical University from January 2018 to December 2020 and received treatment withesomeprazole. The clinical data of patients, including basic information, operations, intervention measures,medication, and laboratory test results, was collected through the hospital′s electronic medical recordsystem. Patients were divided into AKI and non‑AKI groups according to the occurrence of esomeprazole‑associated AKI, and the clinical characteristics between the 2 groups were compared. The least absoluteshrinkage and selection operator (LASSO regression) was used to analyze the influencing factors ofesomeprazole‑associated AKI. Patients were randomly divided into the training set and the test set at a 8∶2ratio. Based on data in the training set, 5 machine learning algorithms were used to build esomeprazole‑asso‑ciated AKI prediction models, including logistic regression, random forest, gradient boosting machine(GBM), extreme gradient boosting, and light gradient boosting machine. Based on data in the test set, the per‑formance of 5 models was validated through the area under the receiver operating characteristic curve (AUC),sensitivity, specificity, and accuracy. Results A total of 5 436 patients were enrolled in the study, including 3 231 males and 2 205 females, with an age of 61(51, 70) years. Esomeprazole‑associated AKI occurredin 393 patients, with an incidence of 7.23%. The results of LASSO regression analysis identified 24 variablesclosely related to esomeprazole‑associated, such as hepatic insufficiency, chronic renal insufficiency, hypo‑proteinemia. Based on data in the training set (4 349 patients), the esomeprazole‑associated AKI risk predic‑tion models were constructed and their predictive performance was good (all AUC>0.900). The predictiveperformance validation was conducted using the data in the test set (1 087 patients), and the results showedthat the GBM model has the highest AUC (0.922) and relatively stable performance, with small differences invarious indicators between the training and the test sets. Conclusions The use of esomeprazole is signifi‑cantly associated with AKI, and the risk is influenced by factors such as baseline renal function, comorbidi‑ties, and combined medications. The risk prediction model based on GBM algorithm is helpful for earlyassessment of the risk of esomeprazole‑related AKI in clinical practice.

Objective To investigate the differences in the incidence of QT interval prolongationbetween moxifloxacin and levofloxacin in anti‑infective therapy among cardiology intensive care unit (CCU)patients, and to analyze the risk factors for QT interval prolongation. Methods The data of patients whoreceived anti‑infective treatments with moxifloxacin and levofloxacin in CCU of Xiaogan Central Hospitalfrom January 2020 to December 2022 were collected and analyzed retrospectively. The clinical characteris‑tics in the 2 groups were compared. Potential influencing factors of QT interval prolongation were analyzedusing univariate regression analysis. Variables with P<0.2 were included in a logistic regression model formultivariate analysis. The effect values were expressed as odds ratio (OR) and its 95% confidence interval(CI). Results A total of 146 patients were included in the study, with 76 patients in the moxifloxacingroup and 70 patients in the levofloxacin group. In the moxifloxacin group, 18 out of 76 patients (23.68%)experienced QT interval prolongation, while in the levofloxacin group, 6 out of 70 patients (8.57%) experi‑enced QT interval prolongation; the difference between the 2 groups was statistically significant (P=0.025).There were no statistically significant differences in other factors between the 2 groups. Univariate regression·412·药物不良反应杂志 2024 年7月第 26 卷第7期 ADRJ，July 2024, Vol. 26, No. 7analysis showed that female (OR=2.958, 95%CI: 1.144-7.647, P=0.025), myocardial infarction (OR=2.958,95%CI: 1.144-7.647, P=0.025), concomitant use of amiodarone (OR=2.569, 95%CI: 1.042-6.337, P=0.040)and escitalopram were influencing factors of QT interval prolongation. Factors with P<0.2 were entered inthe multivariate logistic regression analysis, and the results showed that female (OR=3.616, 95%CI:1.240-10.538, P=0.019), hypokalemia (OR=2.953, 95%CI: 1.263-6.905, P=0.012), and myocardial infarc‑tion (OR=3.026, 95%CI: 1.057-8.666, P=0.039) were independent risk factors for QT interval prolongation.Conclusions Moxifloxacin is associated with a higher incidence of QT interval prolongation compared tolevofloxacin. Female and patients with hypokalemia and myocardial infarction have high risks for QT intervalprolongation.

With the spread of hemodialysis therapy and the continuous breakthrough of kidney transplantation technology, the survival period of patients with end stage renal disease is prolonged, and malignant tumor has become one of the main causes for hospitalization and death of patients on hemodialysis and undergoing kidney transplantation. Due to the particularity of pharmacokinetics in patients on dialysis and the long term maintenance immunosuppressive therapy in kidney transplant patients, many aspects need to be considered and balanced in these patients when they need anti tumor drug treatments. The Japanese Society of Nephrology, Japan Society of Clinical Oncology, Japanese Society of Medical Oncology, and Japanese Society of Nephrology and Pharmacotherapy have jointly formulated Clinical Practice Guidelines for Management of Kidney Injury During Anticancer Drug Therapy 2022, and systematically answers many clinical questions about anticancer drug therapy in patients on hemodialysis and underwent kidney transplantation in the second chapter. This article interprets this part to provide references for the anti-tumor drug treatments of patients on dialysis and after kidney transplantation in China.

Objective To explore the risk factors of severe medication errors (ME) of tranexamic acid injection (TXAI), and put forward prevention suggestions.　Methods TXAI-related ME reports in the National Monitoring Network for Clinical Safe Medication (Monitoring Network) and medical literature databases at home and abroad were searched, and case reports of TXAI-related ME were collected; China Judgements Online and PKULAW database were searched, and TXAI-related judicial cases judged to be responsible by the hospital were collected. The retrieval time of all data was up to May 1, 2024. The severity grade, occurrence link and place, and the trigger person of TXAI-related ME reported in the Monitoring Network were retrospectively analyzed. The year of report, country of occurrence, clinical application, error content, and occurrence place of the collected severe ME cases, and the clinical characteristics of patient injury, patient outcome and the ME grading were retrospectively analyzed.　Results From September 22, 2012 to May 1, 2024, the Monitoring Network received a total of 138 TXAI-related ME reports, and there was an increasing trend in the number of reports year by year. Among 138 cases of ME, 79 (57.3%) occurred in the drug dispensing and distribution link; 58 (42.0%) occurred in the prescription/doctor′s order prescribing and delivery link and mainly involved easily mixed drugs and drug overdose, of which 1 (1.7%) was a severe ME (grade E); 1 (0.7%) occurred in the drug administration link, and iodohexol was mistakenly injected as TXAI into the patient′s joint cavity. A total of 29 severe ME reports related to TXAI were collected. Of them, 24 (82.8%) were due to incorrect administration routes (22 were confused with anesthetics and 2 were confused with injection catheters, all resulting in incorrect intrathecal injections) and 5 (17.2%) were due to prescription errors (3 were overdosed, 1 was used for high-risk thrombosis patient, and 1 was treated with combination use of hemocoagulase for high-risk thrombosis patient); 23 (79.3%) occurred in the operating rooms, and 6 (20.7%) occurred in the wards. The 24 patients involved in incorrect intrathecal injections of TXAI mainly developed severe pain, neurotoxicity (status epilepticus) and/or cardiotoxicity (arrhythmia and ventricular fibrillation), of which 11 (45.8%) died and 2 (8.3%) had sequelae of limb muscle weakness. Among the 5 patients with prescription errors, 4 developed severe thrombotic disease, resulting in 2 deaths and 2 cerebrovascular-related sequelae, and the other one developed palpitation, shortness of breath, nausea and vomiting. Among the 29-severe ME cases, 2 (6.9%) were grade E, 3 (10.3%) were grade F, 4 (13.8%) were grade G, 7 (24.2%) were grade H, and 13 (44.8%) were grade I.　Conclusions TXAI-related ME mainly involved easily mixed drugs and prescription errors. The severe ME main occurred in the operating room and mainly due to incorrect intrathecal injection, leading to fatal neurological and cardiac toxicity in patients.

Objective To explore the status and problems of safety recommendations in clinical practice guidelines and expert consensuses (guidelines/consensuses) on Chinese patent medicine (CPM) in China.　Methods Wanfang Med Online, CNKI, VIP, China Biology Medicine Database, Chinese Medical Journal Full Text Database, and the websites of Medlive, and China Association of Chinese Medicine were searched, and the guidelines/consensuses related to CPM were collected. The basic information, types, subject areas, evidence rating methods, safety reporting items, safety recommendation levels, and evidence sources of these guidelines/consensuses were extracted and analyzed by descriptive statistics.　Results A total of 138 guidelines/consensuses were included in the analysis, including 19 guidelines and 119 consensuses. The first guideline/consensus on CPM was published in 2004. Five, 3, 9, 15, 29, 32, 29, and 11 guidelines/consensuses were published respectively from 2016 to 2023. From 2020 to 2023, 101 guidelines/consensuses were published, which was 2.73 times the total number of those published in the past 16 years.(101/37). Among the 138 guidelines/consensuses, 59 (42.75%) were "disease?based" and 79 (57.25%) were "drug?based". The top 5 institutions in terms of the number of publications were National Administration of Traditional Chinese Medicine, China Association of Chinese Medicine, Institute of Basic Research in Clinical Medicine of China Academy of Chinese Medical Sciences, Chinese Association of Integrative Medicine, and Chinese Medical Association, of which National Administration of Traditional Chinese Medicine issued 19 guidelines. However, the issuing units of 26 guidelines/consensuses were medical colleges/medical institutions and the issuing units of 8 guildlines/consensuses were not clearly stated. Among the 138 guidelines/consensuses, 18 (13.04%) did not describe the safety of drugs and 120 (86.96%) described. Among the 120 guidelines/consensuses, none of the safety recommendations were graded according to The Grading of Recommendations Assessment, Development and Evaluation, and only 32.50% (39/120) of the evidence sources contained randomized controlled trials. A proportion of 50.72% (70/138) in 138 guidelines/consensuses did not report the funding situation, and 37.68% (52/138) did not disclose the conflict of interest.　Conclusions In recent years, the number of guidelines/consensuses on CPM has increased significantly in China, but the issuing agencies of some of them had poor authority. Most of the guidelines/consensuses are "drug-based", the descriptions of safety are insufficient, the evidence level is low, and there may be some bias.

Sodium-glucose transporter 2 inhibitors (SGLT2i) are currently widely used as a class of hypoglycemic drugs. Due to their unique hypoglycemic mechanism and significant cardio-renal protective effect, SGLT2i have become one of the core drugs in the treatment of type 2 diabetes mellitus. However, in recent years, it has been found that SGLT2i can lead to increased serum creatinine and urea nitrogen in some patients, and the risk of kidney injury has gradually attracted clinical attention. How to effectively prevent and supervise the potential renal injury risk while giving full play to its therapeutic advantages has become an important topic in current clinical practice and drug safety management. Multi-dimensional prevention and supervision strategies should be adopted in clinical practice such as identifying high-risk populations based on the latest evidence, strictly screening patients, dynamically monitoring renal function, optimizing combination medication regimens, and achieving risk warning using biomarkers and artificial intelligence tools.

Objective To mine the risk signals of adverse events (AE) of satralizumab for treatment of neuromyelitis optica spectrum disorder (NMOSD) and provide reference for safe use of the drug in clinic.　Methods AE reports on satralizumab from the 1st quarter of 2020 to the 4th quarter of 2023 were collected by searching US Food and Drug Administration Adverse Event Reporting System (FAERS) database. AEs were classified and standardized according to the preferred term (PT) and system organ class (SOC) of Medical Dictionary for Regulatory Activities version 26.1. Reporting odds radio (ROR) method and Bayesian confidence progressive neural network (BCPNN) method were used to mine the AE risk signals. An AE with ≥3 reports, lower limit of the 95% confidence interval (CI) of ROR >1, and the information component (IC) of BCPNN method minus 2 times of standard deviation (IC-2SD) >0 were defined as a risk signal. Descriptive analysis on the signals was performed.　Results A total of 526 AE reports were collected, 39 risk signals (PT) were mined by ROR and BCPNN methods, involving 13 SOCs. Among the 39 PTs, 11 were adverse reactions recorded in the label, including blood triglycerides increased, hepatic function abnormal, cellulitis, and etc. Twenty-eight PTs were not recorded in the label, 11 of which involved infections and infestations. The top 5 PTs in signal intensity were atypical mycobacterium infection, pyelonephritis, compression fracture, spinal compression fractures, and lymphocyte count decreased. The top 5 PTs in number of reports were urinary tract infection, pneumonia, corona virus disease 2019, sepsis, and herpes zoster.　Conclusion In addition to the blood triglycerides increased, hepatic function abnormal, cellulitis, and other AEs recorded in the label, NMOSD treatment with satralizumab may also cause atypical mycobacterial infection, pyelonephri- tis, compression fracture and other AEs not recorded in the label, which clinical physicians should be vigilant.

Objective To mine the adverse events (AE) of nervous system caused by epidermal growth factor receptor (EGFR) inhibitors, and provide reference for the safe use of EGFR inhibitors in clinics.　Methods AE of nervous system caused by gefitinib, erlotinib, afatinib and osimertinib were searched from FDA Adverse Drug Event Reporting System (FAERS) database using OpenVigil data platform from 2004, 2004, 2013, and 2015 to the 2nd quarter of 2023, respectively. The AE was standardized using the preferred term (PT) in the Medical Dictionary for Regulatory Activities 23.0 version. Data such as patient general condition and AE of nervous system was extracted from AE reports and was analyzed descriptively. Reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods were used for detection of AE signal of nervous system. AE that simultaneously met the following conditions was considered as a risk signal: the number of report cases ≥3, lower limit of the 95% confidence interval of ROR≥1, PRR≥2, and χ2≥4.　Results A total of 422 nervous system AE cases related to gifitinib were collected, involving 297 patients and 42 preferred terms (PT); 10 risk signals were detected, including dementia, brain oedema, demyelina- tion, leukoencephalopathy, hemiplegia, vocal cord paralysis, neurological symptom, cerebral atrophy, intracranial pressure increase and neuropathy, with 64 AE cases involved. One thousand seven hundred and fifty?five nervous system AE cases related to erlotinib were collected, involving 1?477 patients and 69 PT; 7 risk signals were detected, including ageusia, hyperaesthesia, facial pain, demyelination, motion sickness, vocal cord paralysis, peripheral paralysis, with 142 AE cases involved. Two hundred and forty?seven nervous system AE cases related to afatinib were collected, involving 212 patients and 32 PT; 7 risk signals were detected, including ageusia, cerebral infarction, brain oedema, epilepsy, central nervous system lesion, leukoencephalopathy, cerebral disorder, with 49 AE cases involved. Six hundred and fifty?two nervous system AE cases related to osimertinib were collected, involving 582 patients and 46 PT; 3 risk signals were detected, including cerebral infarction, vocal cord paralysis, facial paralysis, with 54 AE cases involved. Ageusia was an AE already included in the label of afatinib, while other AE were not included.　Conclusion Most of the EGFR inhibitor?related AE signals found in the FAERS database are not included in the labels, and should be monitored during the clinical use.

A 67-year-old male patient with intrahepatic bile duct carcinoma was treated with oxaliplatin (hepatic artery perfusion)+gemcitabine (hepatic artery perfusion)+camrelizumab (intravenous infusion)+apatinib (oral). Platelet count (PLT) decline (49×109/L) was observed after 2 months (apatinib had been discontinued by himself), which was improved after platelet elevating therapy. Due to multiple tumor metastases, bevacizumab (hepatic arterial perfusion, once per 30 days) was added. Before bevacizumab treatment, PLT and coagulation function of the patient were basically no abnormalities. After 2 cycles of treatments, the PLT was 101×109/L and prothrombin time was 14.1 s. Considering the high risk of bleeding in interventional therapy, oxaliplatin and gemcitabine were discontinued, and bevacizumab administration was changed to intravenous infusion. PLT and coagulation function were not improved. Six days after the 5th dose of bevacizumab, the patient had intermittent hematemesis twice (about 300 ml). Laboratory tests showed PLT 75×109/L and prothrombin time 15.8 s. The patient was diagnosed with digestive tract hemorrhage. Fasting and water restriction was performed, and gastric acid suppression, hemostasis, parenteral nutrition, etc. were given. The patient had no hematemesis but intermittent black stool. Gastroscopy indicated duodenal ulcer accompanied by bleeding. Rabeprazole and sucralfate were added. Fasting was stopped and liquid diet was given. The next day, the patient had blood in the stool, and the bleeding of the lower digestive tract was judged to be related to camrelizumab and bevacizumab. The bleeding symptoms were slightly improved after treatments with arterial embolization hemostasis and type A cryopprecipitation coagulation factor, etc. Later， the patient had repeated bleeding condition, and finally died despite of rescue efforts.

In order to promote rational drug use in perioperative period, a perioperative clinical medication pathway system was constructed in the Affiliated Hospital of Qingdao University using the project management method of work breakdown structure (WBS). To establish this system, the following 7 tasks should be completed: requirement investigation of the pathway, formulation of drug usage standards, formulation of clinical medicine pathways, clinical communication and training, effect evaluation and supervision, informazation of medication supervision, and therapeutic drug monitoring, which were implemented by pharmacists of different specialties, respectively. After 4 years of effort, 6 general clinical medicine pathways were completed for antibiotics, analgesics, drugs in venous thromboembolism prophylaxis, nutritional support agents, airway management drugs, and proton pump inhibitors, respectively. These pathways had positive effects in improving the rational use of antibiotics, optimizing the postoperative pain management, and strengthening the risk assessment of thrombosis for patients in the surgical department. The personalized pathway constructed for the Cardiac Surgery Department and the multidimensional pharmaceutical intervention in the Anesthesiology Department also had remarkable effects. In conclusion, the construction of perio- perative medication pathway system through WBS was helpful to refine the division of work tasks, reflect the value of pharmacists, and improve the quality of perioperative pharmaceutical services.

A 60‑year‑old male patient with lumbar disc herniation and sciatica received SanqiShangyao 3 tablets thrice daily orally by himself. After 6 days of administration, the patient developed upperabdominal stuffy pain, nausea, vomiting, and yellowish skin. Laboratory tests showed total bilirubin (TBil)155.2 μmol/L, direct bilirubin (DBil) 87.1 μmol/L, alanine aminotransferase (ALT) 817 U/L, aspartateaminotransferase (AST) 367 U/L, and alkaline phosphatase (ALP) 136 U/L. The concentration of γ‑glutamyltransferase (GGT) was 455 U/L. The drug was stopped, liver protective treatments were given for 8 days, andthe above symptoms in the patient were improved; after 38 days of treatments, laboratory tests showed TBil27.3 μmol/L, DBil 9.3 μmol/L, ALT 46 U/L, AST 28 U/L, ALP 83 U/L, and GGT 55 U/L. The patient′s liverinjury was possibly related to the aconitine contained in the Radix Aconiti Kusnezoffii and Aconitumracemulosum Franch of Sanqi Shangyao tablets.

Drugs or their metabolites may accumulate in the body due to the decline of renal excretion function in cancer patients with renal insufficiency. Therefore, adjusting the treatment scheme and drug dose according to the patient′s renal function is an important part of anticancer treatment for these patients. The Japanese Society of Nephrology, Japan Society of Clinical Oncology, Japanese Society of Medical Oncology, and Japanese Society of Nephrology and Pharmacotherapy have jointly formulated Clinical Practice Guidelines for Management of Kidney Injury During Anticancer Drug Therapy 2022, and specifically discusses the dose adjustment of anticancer drug treatment for patients with renal injury in the second chapter.
This article focuses on the interpretation of the application and dose adjustment of antifolate agents, BCRABL1 tyrosine kinase inhibitors, epithelial growth factor receptor tyrosine kinase inhibitors, antibody molecularly targeted agents and tumor adjuvant therapy drugs such as bone‑modifying agents in patients with renal injury in this chapter. 

Objective To investigate the reasons for contraindication of chemical drugs and biological products that were marked as contraindication for children in drug labels in China.　Methods The drugs labeled as contraindication for children in drug labels of chemicals and biological products covered by the China Pharmacopoeia 2020 and the 2023 China′s Basic Medical Insurance, Work?related Injury Insurance and Childbirth Insurance (western medicine) were searched. The reasons of contraindication for children were collected through searching the drug labels, Clinical Medication Instructions of the China Pharmacopoeia 2020, the website of the National Medical Products Administration, and drug labels from the Unite States, and analyzed descriptively.　Results There were 222 drugs were labeled as contraindication for children in the drug labels, involving 20 categories and mainly antibiotics and digestive system drugs. Among 222 drugs, 137(61.7%) had the reasons for contraindication in pediatric patients, and the main reasons were adverse drug reactions (65.7%, 90/137) and lack of effectiveness and safety information yet in children (30.7%, 42/137), followed by the unsafe auxiliary materials (1.5%, 2/137), unsuitable pres- cription design or ingredients for children (1.5%, 2/137) and unsuitable dosage form for children (0.7%, 1/137). The above reasons were collected from domestic drug instructions (100 drugs), U.S. drug labels (17 drugs), NMPA website instructions revision announcements and popular science knowledge (15 drugs), and Clinical Medication Instructions of the China Pharmacopoeia 2020 (5 drugs).　Conclusions It is relatively common in China to label drugs that are contraindicated for children without specifying the reasons for contraindication or with non?standard explanations in the instructions. Therefore, it is necessary to further standardize the contraindication information for children and apply continuous updates and improvement in order to provide timely and up?to?date drug use information for clinical practice.

Objective To understand the influencing factors for cardio-cerebrovascular complications in patients with T2DM and construct a nomogram risk prediction.　Methods The study design was a prospective observational study, and the subjects were selected from hospitalized patients with T2DM admitted to Huangshan City People′s Hospital from May 2022 to April 2023. Data on patients' gender, age, body mass index, alcohol consumption, smoking status, family history of cardio-cerebrovascular diseases, insulin use, duration of diabetes, blood pressure, and routine laboratory test results were collected using the hospital electronic medical record system. At discharge, patients were assessed using the T2DM-Specific Medication Belief Scale (total score range: 10-50), Medication Literacy Assessment Scale (total score range: 0-7), and Morisky Medication Adherence Scale (total score range: 0-8). Patients were followed up by telephone for 6 months after discharge and divided into 2 groups based on the occurrence of cardio-cerebrovascular complications. Logistic regression analysis was performed using SPSS 26.0 software to identify influencing factors for cardio-cerebrovascular complications in T2DM patients. A nomogram prediction model was constructed using R 4.1.0 software, and internal validation of the model was conducted using the Bootstrap method.　Results A total of 294 T2DM patients were included in the analysis. The medication belief score was (32.6±5.6) score, the medication literacy score was (4.2±0.5) score, and the medication adherence score was (6.1±0.8) score. During the 6 month follow-up, a total of 43 patients (14.6%) experienced cardio- cerebrovascular complications, including of coronary heart disease (23 cases), heart failure (12 cases), and stroke (8 cases). Compared to patients without cardio-cerebrovascular complications, patients with complications had higher body mass index, glycosylated hemoglobin A1c (HbA1c), D-dimer, and uric acid levels, as well as lower medi- cation belief scores, medication literacy scores, and medication adherence scores (all P<0.05). Binary logistic regression analysis showed that HbA1c, D-dimer, uric acid, medication belief, medication literacy, and medication adherence were influencing factors for cardio-cerebrovascular complications in T2DM patients. Accordingly, a nomogram prediction model was established. Internal validation results of the model showed that the concordance index was 0.958, the area under the receiver operating characteristic curve was 0.824, and the calibration curve was close to the ideal curve.　Conclusions The current status of medication belief, medication literacy, and medication adherence in T2DM patients was not ideal. High levels of HbA1c, D-dimer, and uric acid, as well as poor medication belief, medication literacy, and medication adherence were risk factors for cardio-cerebrovascular complications in T2DM patients. The nomogram model, which integrated multiple influencing factors, had high value in predicting the risks.

Drug-induced neurological disorders (DINDs) refer to the central or peripheral nervous system disease caused by drugs. DINDs account for a large proportion of adverse drug reactions/events in China, and its onset is complex to some extent. Common DINDs include epilepsy, movement disorders, stroke, peripheral neuropathy, spinal cord injury, cognitive impairment and so on. Usually, DINDs have characters of gradual development and late-onset reactions, and it is difficult to associate their clinical manifestations with drugs, leading to misdiagnosis and poor prognosis in clinic. To reduce the neurotoxicity of drugs, multidisciplinary cooperation should be strengthened, and individualized treatment plans for high-risk people and closer monitoring should be implemented for timely identification and diagnose. At the same time, relevant researches on DINDs should be strengthened in the clinic to cope with the complexity and long-term prognosis challenges of the diseases.

Objective To explore the role of using laboratory critical values for active monitoring of serious adverse drug reactions (SADRs) in pharmacovigilance.　Methods Xingtai Central Hospital was used as a sentinel hospital. The reports containing critical value in blood routine, blood biochemistry, blood gas analysis, and coagulation function from July 2022 to December 2022 were collected by the laboratory information system in the hospital. The electronic medical records of patients involved in the reports were reviewed, and the correlation between therapeutic drugs and the critical values was evaluated. The critical values related to adverse drug reactions (ADRs) and SADRs, and the suspicious drugs were analyzed by descriptive statistics. The occurrence of ADRs and SADRs in outpatients/emergency patients and hospita- lized patients were compared.　Results A total of 1 597 reports containing critical values were included in the analysis. In these reports, 174 (10.90%) were judged to be related to ADRs, of which 68 (39.1%) were related to SADRs. The proportion of reports containing critical values in the Inpatient Department was signi- ficantly higher than that in the Outpatient/Emergency Department ［0.39% (1 114/288 541) vs. 0.16% (483/307 176), P<0.001］; the proportion of reports related to ADR in all laboratory reports of the Outpatient/Emergency Department was significantly higher than that of the Inpatient Department ［14.29% (69/483) vs. 9.43% (105/1 114), P=0.004］; the proportion of reports involving SADRs in those involving ADRs ［31.88% (22/69) vs. 43.81% (46/105)］ and that in all reports ［4.55% (22/483) vs. 4.13% (46/1 114)］ both were similar between Outpatient/Emergency Department and Inpatient Department, and the differences were not statistically significant (all P>0.05). Six-eight reports of SADR involved 80 critical values, and the top 3 were leukopenia (mainly involving anticancer drugs), coagulation dysfunction (mainly involving anticoagulants) and electrolyte disorder (mainly involving antihypertensive drugs), some of which were induced by medication errors or improper drug use.　Conclusions Reporting laboratory critical values can effectively do some help in implement of active monitoring of SADRs in blood cells, blood biochemistry and coagulation function caused by drugs, which is conducive to the timely detection of SADRs in outpatient/emergency and hospita- lized patients, as well as serious adverse events caused by medication errors and inappropriate treatments.

A 45-year-old male patient with type 2 diabetes mellitus was additionally treated with henagliflozin (10 mg, once daily), enalapril, fenofibrate, finerenone, celecoxib, eperisone and mecobalamin due to poor glycemic control, hypertension, hyperlipidemia and other conditions at previous therapy of insulin aspart 30 and acarbose. Before the additional medication, the patient′s serum creatinine (Scr) and blood urea nitrogen (BUN) were normal., Later, the patient discontinued celecoxib, finerenone, and fenofibrate by himself as relevant symptoms were improved successively. On the 36th day of medication, the patient experienced paroxysmal pain in the lumbar region, which gradually worsened. Then the patient stopped using henagliflozin by himself 2 days later while the other medications remained. The next day, laboratory tests indicated Scr 180 μmol/L and BUN 9.6 mmol/L, and acute kidney failure was diagnosed. Analgesic, antispasmodic and glucocorticoid pulse therapy was administered, and the patient′s lumbar pain was gradually improved. On the 6th day of discontinuing henagliflozin, Scr was 142 μmol/L and BUN was 9.4 mmol/L; on the 9th day, Scr was 113 μmol/L and BUN was 9.1 mmol/L; approximately 3 months after drug discontinuation, Scr was 66 μmol/L and BUN was 6.0 mmol/L.

Objective To investigate the clinical characteristics and interventions associated with drug-induced anaphylaxis in the emergency infusion room.　Methods Bases on the adverse drug reaction database from the emergency medicine center of the First Affiliated Hospital of Nanjing Medical University, clinical data of patients who experienced drug-induced anaphylaxis in the emergency infusion room between November 2019 and November 2023 were collected, including gender, age, history of previous adverse drug reactions, allergy history, Charlson comorbidity index, medication details, information related to drug-induced anaphylaxis (onset time, clinical manifestations), interventions, outcomes, and follow-up. The clinical characteristics and interventions in these patients were analyzed.　Results During the study period, a total of 398 772 patients in the emergency infusion room in our hospital received intravenous infusion of drugs. Of them, 625 cases developed adverse drug reactions (ADRs) and 75 cases developed drug- induced anaphylaxis, accounting for 0.02% (75/398 772) of the total infusion patients and 12.0% (75/625) of all ADR cases. Of the 75 patients with anaphylaxis, 30 cases (40%) were classified as grade Ⅱ, and 45 cases (60%) as grade Ⅲ, with no grade Ⅳ cases. The most common drugs involved in 75 cases of anaphylaxis were anti-infective drugs (41 cases, 54.7%). Drug-induced anaphylaxis exhibited diverse clinical manifestations, with cardiovascular symptoms being the most common, primarily varying degrees of transient hypotension (67 cases, 89.3%), followed by systemic and neurological symptoms, including profuse sweating (31 cases, 41.3%) and dizziness (28 cases, 37.3%). All 75 patients with anaphylaxis were treated with measures such as discontinuation of medication, replacement of infusion sets, rapid assessment of circulation and respiration, and monitoring of vital signs, of which 65 (86.7%) received rapid intravenous infusion for volume expansion, 6 (8.0%) received intravenous injection of glucocorticoids, 3 (4.0%) received intramuscular injection of 0.5 mg epinephrine, and 2 (2.7%) received antihistamines. All 75 patients showed improvement in symptoms, and no sequelae or deaths were found.　Conclusions In the emergency infusion room, the severity of anaphylaxis is mainly grade Ⅱ and Ⅲ with a good prognosis after timely intervention. The treatment measures mainly focus on rapid intravenous infusion for volume expansion, and the use of epinephrine is relatively low.

A 66-year-old male patient administered diclofenac sodium 10 mg once daily for arthralgia by himself. After 3 days of medication, he developed oral bleeding and a platelet count (PLT) of 1×109/L. Considering that the patient had normal PLT previously and diclofenac sodium was used only for a short time, he was diagnosed with immune thrombocytopenia after a series of examinations including bone marrow aspiration and biopsy. Diclofenac sodium was discontinued, and the patient was treated with glucocorticoids, platelet transfusion, and hemostasis therapy. On the 7th day of treatments, the PLT increased to 164×109/L, and subsequent PLT re-examinations remained normal. Approximately 2 months later, the patient took diclofenac sodium for arthralgia again. After 2 days of medication, the PLT dropped to 8×109/L. Diclofenac sodium was discontinued, and the patient was treated with the previous therapeutic regimen, supplemented with recombinant human thrombopoietin and leucogen tablets. After 4 days of treatments, the PLT increased to 117×109/L. The patient′s reduction in PLT was considered to be caused by diclofenac sodium.

Objective Based on the adverse drug event active surveillance and assessment system-Ⅱ (ADE-ASAS-Ⅱ) and the information of inpatients in the hospital information system (HIS), the automatic monitoring module of movement disorders was constructed and its application effect in the real- world study of drug-induced movement disorders (DIMDs) was explored.　Methods Literature reviews, case reports, spontaneous reports and medical records were collected, the keyword set was screened based on ADE-ASAS-Ⅱ system and text classification technology, and an automatic monitoring module was constructed. The information of hospitalized patients in Chinese PLA General Hospital （our hospital） was selected from October 10 to 16, 2022. The results of manual evaluation and the system alarm by the automatic monitoring module were compared, and the performance of the automatic monitoring module was evaluated and optimized through repeated machine learning. The medical record information of hospitalized patients who used sodium valproate throughout the year in our hospital in 2022 were collected, and the occurrence of movement disorders related to sodium valproate was analyzed using the automatic monitoring module.　Results A total of 4 918 hospitalized patients (146 with movement disorders) were collected, and the final setting conditions of the automatic monitoring module were determined, including inclusion criteria (43 text keywords, 3 diagnosis) and exclusion criteria (11 text and 20 document titles were omitted). Among the 1 138 hospitalized patients using sodium valproate in 2022, the incidence of DIMDs with tic and tremor as main clinical manifestations detected by automatic monitoring module was 1.67% (19/1 138).　Conclusion The automatic monitoring module of druginduced movement disorders based on machine learning and manual evaluation can be applied to explore the occurrence characteristics of DIMDs in the real world, and provide information for pharmacovigilance in clinic.