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.

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 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.

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.

Objective To analyze and compare the reporting data of adverse events following immunization (AEFI) of influenza vaccines in Fujian Province from 2019 to 2023.　Methods Using the National Immunization Program Information Management System, the AEFI reports and vaccination data of influenza vaccines in Fujian Province from 2019 to 2023 were collected, and the reporting rates and clinical characteristics of AEFI of 6 types of influenza vaccines were compared. The 6 types of vaccines in the analysis were as follows: trivalent inactivated influenza vaccines (IIV3) for 6-35 months old people, IIV3 for ≥3 years old people, trivalent live attenuated nasal spray vaccine (LAIV3) for 3-17 years old people, quadrivalent inactivated influenza vaccines (IIV4) for 6-35 months old people, IIV4 for ≥6 months old people, and IIV4 for ≥3 years old people.　Results From 2019 to 2023, a total of 87 687.21 million doses of influenza vaccine were vaccinated in Fujian Province, and 510 cases of AEFI were reported, with a reporting rates of 5.82 per 100 000 doses. Among the 510 cases, 443 (86.86%) were general reactions, 56 (10.98%) were abnormal reactions, 1 (0.20%) was psychogenic reactions, and 10 (1.96%) were coincidence. There were no reports of vaccination accidents and vaccine quality accidents. The reporting rates of AEFI were relatively higher in 2019 and 2020 (18.38 and 18.00 per 100 000 doses, respectively), and lower in 2021, 2022 and 2023 (8.91, 10.68 and 2.30 per 100 000 doses, respectively); the differences were statistically significant (all P<0.05). The differences of reporting rates of AEFI between  IIV3 for 6 35 months old people and IIV4 for 6-35 months old people, the injectable vaccines and nasal spray vaccines were not statistically significant. However, the reporting rates of overall AEFI, general reactions and abnormal reactions of IIV3 for ≥3 years old people were all higher than those of IIV4 for ≥3 years old people (7.77 per 100 000 doses vs. 3.88 per 100 000 doses, 6.18 per 100 000 doses vs. 3.59 per 100 000 doses, 1.41 per 100 000 doses vs. 0.19 per 100 000 doses). The reporting rates of overall AEFI and general reaction of IIV3 for 6-35 months old people were both higher than those of IIV3 for ≥3 years old (16.47 per 100 000 doses vs. 7.77 per 100 000 doses, 13.05 per 100 000 doses vs. 6.18 per 100 000 doses), and the differences were statistially significant (all P<0.05). The reporting rates of general abnormal reactions of IIV4 for 6-35 months old and ≥ 6 months old people were both higher than those of IIV4 for ≥3 years old people (14.73 per 100 000 doses and 9.52 per 100 000 doses vs. 3.88 per 100 000 doses); the reporting rates of general reactions and abnormal reactions of IIV4 for ≥6 months old people were both higher than those of IIV4 for ≥3 years old people (12.94 per 100 000 doses vs. 3.59 per 100 000 doses, 1.34 per 100 000 doses vs. 0.19 per 100 000 doses), the dif- ferences were statistcially significant (all P<0.05). In terms of clinical features, the reporting rates of fever (37.6-38.5 ℃ and ≥ 38.5 ℃), local redness and swelling (diameter 2.6-5.0 cm), and local induration (diameter  ≤2.5 cm and 2.6-5.0 cm) after vaccination of IIV3 for ≥3 years old people were higher than those of IIV4  for ≥ 3 years old people (1.41 per 100 000 doses vs. 0.64 per 100 000 doses, 3.00 per 100 000 doses vs. 1.16 per 100 000 doses); the reporting rates of allergic rash and angioedema of IIV3 for ≥ 3 years old people were higher than those of IIV4 for ≥3 years old people (0.53 per 100 000 doses vs. 0.12 per 100 000 doses, 0.35 per 100 000 doses vs. 0); the differences were statistically significant (all P<0.016 7).　Conclusions The reporting rates of AEFI for influenza vaccines in Fujian Province from 2019 to 2023 was showing a downward trend. The AEFI was mainly general reactions. The reporting rates of AEFI were different among dif- ferent influenza vaccines, but the overall safety was good.

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.

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.

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.

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 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 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.

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.

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.

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.

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.

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 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 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.

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.

Glucagon-like peptide-1 receptor agonists (GLP-1RA) are used to treat type 2 diabetes mellitus (T2DM) by enhancing insulin secretion and inhibiting glucagon secretion. GLP-1RA has good efficacy and safety, but it may have the risk of pancreatic injury. Its incidence is low, but it is more harmful. At present, the research conclusions of GLP-1RA-related pancreatic injury are not consistent. This article reviews the research progress of GLP-1RA-related pancreatic injury from the aspects of occurrence, possible mechanism, related clinical research, clinical manifestations, and management measures. The possible mecha- nisms include activation of stellate cells, induction of proliferation and metaplasia of pancreatic ductal epithelial cells, presence of immune rejection, and influence on the expression of pancreatic injury related genes. Pancreatitis is more common in GLP-1RA-related pancreatic injury, and its clinical manifestations are abdominal pain, nausea, vomiting, and the elevation of lipase and amylase. It is suggested that patients should be given necessary medication education before medication. Once relevant symptoms occur, acute pancreatitis should be considered and the medication should be stopped immediately. If pancreatitis is confirmed, GLP‐1RA treatment is not recommended.

With the increasing prevalence of chronic kidney disease (CKD) and the progress of renal replacement therapy, there were more and more patients with long-term hemodialysis (hemodialysis). Cardiovascular diseases were the leading cause of death among hemodialysis patients, and a lot of these patients needed to be treated with percutaneous coronary intervention (PCI). However, hemodialysis patients had higher risks of both bleeding and thrombotic events, which made it difficulty to select drugs and their dosages for post-PCI dual antiplatelet therapy in clinical practice, and the impacts of hemodialysis on dual antiplatelet therapy were still unclear. We reported a 65-year-old male patient with CKD, who was on long-term hemodialysis treatment and underwent PCI for acute non-ST segment elevation myocardial infarction. The patient was given dual antiplatelet therapy with aspirin and clopidogrel after the procedure, and on the fourth day after PCI (14 hours after restarting hemodialysis), he developed subacute stent thrombosis due to clopidogrel resistance, which was resolved after revascularization. Based on the treatment experience in this patient and review of relevant literature, we proposed recommendations on management of dual antiplatelet 

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 explore the occurrence and clinical characteristics of infusion-related reactions (IRRs) caused by lecanemab in Chinese patients with Alzheimer disease, and summarize the nursing management experience of IRRs.　Methods This study was a single center retrospective study and the subjects were Alzheimer′s disease patients who received lecanemab (10 mg/kg, once every 2 weeks) in the Department of Neurology, Xuanwu Hospital, Capital Medical University from June 26 to August 18, 2024. The occurrence, clinical characteristics, severity, and outcome of IRRs that occurred during the treatment of lecanemab in these patients were descriptively analyzed.　Results A total of 45 patients were included in the study, including 15 males (33.3%) and 30 females (66.7%); the age ranged from 52 to 82 years, with a median age of 62 years. Among the 45 patients, 15 (33.3%) developed IRRs, including 6 males and 9 females, and 2 of them had a previous history of allergy. In the 15 patients, there were 3, 8, 1 and 3 patients with 1, 2, 3 and 4 treatment cycles, respectively; 13 patients were pretreated with diphenhyd-ramine 30 minutes before lecanemab treatment; 14 patients had IRRs in the first cycle of lecanemab treatment, and 1 in the second cycle; IRRs occurred within 5 hours after finishing the intravenous infusion of lecanemab in 13 patients and on the second day after the administration in 2 patients. The main manifestations of IRRs were fever and chills; some patients had headache, nausea, and vomiting symptoms, and only 1 patient developed rash and itching. After symptomatic treatments, these symptoms in the 13 patients were relieved soon, and IRRs did not recur after the continued treatment of lecanemab according to the regime. The severity of IRRs was grade 1, 2, and 3 in 5, 9, and 1 patient, respectively. The incidence of severe IRRs was 2.2% (1/45).　Conclusions IRRs are common adverse reactions of lecanemab, mainly characterized by fever and chills, with mild severity. Generally, lecanemab-related IRRs occurs after the first administration, and may not occur again in the continued treatments. Vital signs should be routinely monitored in lecanemab treatment. Once IRRs occur, timely treatments should be given according to the severity, and the prognosis is usually good.

A 35-year-old male patient with type 2 diabetes mellitus was treated with metformin and dapagliflozin orally for a long time. Due to poor glycemic control and overweight, the treatment was adjusted to subcutaneous injection of semaglutide 0.25 mg once a week plus 1 metformin and empagliflozin tablet orally twice daily. The patient experienced abdominal bloating and significant satiety after the first dose, which did not attract attention, and metformin and empagliflozin tablets were not discontinued. Three days later, he developed persistent epigastric pain, and laboratory tests indicated blood ketone body (β-hydroxybutyrate) 4.70 mmol/L. Despite treatments with lansoprazole, anisodamine, metoclopramide, and dezocine, the symptoms was not alleviated. Gastrointestinal decompression was perfor- med, which led to a slight improvement in abdominal pain. An immediate abdominal CT scan revealed gastric retention. The patient′s gastric retention was considered to be associated with the administration of semaglutide. The following day′s laboratory tests indicated carbon dioxide combining power 2.36 mmol/L, suggesting the occurrence of diabetic ketoacidosis, which was hypothesized to be related to empagliflozin. The original hypoglycemic regimen was discontinued, insulin pump therapy was given with blood glucose level monitoring, and fasting, gastrointestinal decompression, fluid resuscitation, and acid suppression was applied. The patient′s symptoms were significantly improved, and the ketone body levels gradually decreased. After 3 days of treatments, the patient began to eat, and after 6 days, he returned to a normal diet without further abdominal pain or bloating. The ketone body levels and carbon dioxide combining power returned to normal, and the hypoglycemic regimen was adjusted to lispro insulin plus acarbose.

Objective To explore the adverse effects of maternal exposure to angiotensin receptor blockers (ARBs) during the second and third trimesters of pregnancy on the fetus/neonate.　Methods Rele- vant databases at home and abroad were searched (up to April 2024), and case reports of ARB exposure during the second and third trimesters of pregnancy were collected. Data such as patient age, ARB drugs exposed to and the gestational age, concomitant drugs, maternal amniotic fluid examination, and fetal/neonatal outcomes were extracted from the literature. Descriptive statistical analysis was conducted on the information of ARB exposure during pregnancy.　Results A total of 37 case reports were included, describing the outcomes of 55 fetuses/neonates (including a pair of twins) exposed to ARBs in utero during the second and third trimesters of pregnancy of 54 pregnant women. Six kinds of ARBs were involved in the 54 pregnant women, including valsartan (31.5%, in 17 women), candesartan (25.9%, in 14 women), losartan (22.2%, in 12 women), olmesartan (11.1%, in 6 women), telmisartan (5.6%, in 3 women), and irbesartan (3.7%, in 2 women); 49 women (90.7%) took above ARBs continuously form pre-pregnancy or the first trimester of pregnancy to the second and third trimesters of pregnancy, which were mostly prescribed by non-obstetricians (internal medicine or general practice). In the 54 pregnant women, 46 had amniotic fluid examination during pregnancy, of which 45 (97.8%) had oligohydramnios or absence of amniotic fluid; 4 voluntarily induced labor to terminate pregnancy, and 50 reported the natural outcome of pregnancy and had 51 fetuses/newborns, 15 (29.4%) of which died in utero or within 1 week after birth, and 36 (70.6%) of which were discharged alive. Among the newborns, 81.3% (39/48) were premature infants, and 74.4% (32/43) were low birth weight infants. In the 55 fetuses/newborns, 48 (87.3%) had varying degrees of disease and developmental defects. The most commonly involved organ or system was kidney ［72.7% (40/55)］, and the major pathological change was renal tubular dysplasia; the following injury was lung/respiratory diseases and dysplasia with an incidence of ［41.8% (23/55)］, which was the main cause of fetal/neonatal death. Subsequently, abnormal development of skull/brain and limbs/hands and feet, abnormal circulatory system, abnormal coagulation, retinopathy, etc. have also been reported.　Conclusion ARBs exposure during the second and third trimesters of pregnancy poses significant risks to the fetus/neonate, often leading to developmental defects of renal tubular, lung, skull/brain, and limbs, and even death.

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 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.

A 46-year-old female patient received Tongtian oral solution 10 ml thrice daily combined with Yangxue Qingnao pills 2.5 g thrice daily for migraine. After 10 days of treatments, the patient developed yellow urine. After 12 days of treatments, the patient stopped using Tongtian oral solution by herself. After continuing to take Yangxue Qingnao pills for 5 days, the patient developed symptoms of yellowish skin and sclera, and 10 days later, Yangxue Qingnao pills were discontinued by herself. The next day of discontinuing the Yangxue Qingnao pills, the patient experienced abdominal distension. The laboratory tests showed alanine aminotransferase (ALT) 1 454 U/L, aspartate aminotransferase (AST) 1 429 U/L, gamma glutamyltransferase (GGT) 290 U/L, alkaline phosphatase (ALP) 176 U/L, total bilirubin (TBil) 94.2 μmol/L, and total bile acid (TBA) 365.9 μmol/L. Based on the patient′s medical history, laboratory test results, and auxiliary examinations, drug-induced liver injury was diagnosed, which might be related to Tongtian oral solution and Yangxue Qingnao pills. After one week of Yangxue Qingnao pills withdrawal, the patient′s symptoms of yellowish skin and sclera were improved and urine color became lighter, with ALT 495 U/L, AST 202 U/L, GGT 181 U/L, ALP 120 U/L, TBil 24.6 μmol/L, and TBA 15.6 μmol/L. After 7 days of treatments such as magnesium isoglycyrrhizinate, hepatocyte growth-promoting factor, and ademetionine, the patient′s condition was significantly improved. The above-mentioned drugs were discontinued and switched to bicyclol 25 mg thrice daily orally. Eight days later, the patient′s liver function indicators had basically returned to normal.

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.

Objective To analyze the occurrence and influencing factors of adverse reactions in patients with inflammatory bowel disease (IBD) during the long-term treatment with vedolizumab （VDZ）.　Methods The study was a retrospective observational design. The study subjects were selected from patients who long-termly used VDZ to treat moderate-to-severe active IBD in Tianjin Medical University General Hospital from February 1, 2021 to December 31, 2023. Clinical data of patients were collected through the hospital system of clinical pharmacy management, including general information, IBD condition, VDZ maintenance treatment plan, combination of drugs, laboratory test results, etc. The adverse reactions of VDZ were screened and their clinical manifestations, severity, intervention and outcomes were analyzed descriptively. The patients were divided into 2 groups according to whether VDZ adverse reactions occurred, and the differences in clinical data between them were compared; the influencing factors of adverse reactions were analyzed by multivariate logistic regression method.　Results A total of 142 patients were included in the study, including 81 males and 61 females, aged (37.6±6.4) years with a range from 18 to 57 years. There were 103 patients (72.5%) developed VDZ adverse reactions, which mainly involved skin (52 patients, account for 50.5%), digestive system (33 patients, account for 32.0%) and respiratory system (18 patients, account for 17.5%). All 103 patients did not stop VDZ treatment, and the adverse reaction symptoms disappeared or were relieved after symptomatic treatments. Compared with patients without VDZ adverse reactions, the age of patients with VDZ adverse reactions were higher [(39.5±5.4) years vs. (32.4±6.7) years], and the proportions of patients with chronic relapsing clinical type [65.0%(67/103） vs. 41.0%(16/39)], severe disease activity [60.2%(62/103） vs. 33.3%(13/39)], combined drug use [67.0%(69/103） vs. 46.2%(18/39)], and injecting VDZ once every 4 weeks during maintenance treatment [27.2%(28/103） vs. 10.3%(4/39)] in the group were larger, with statistical significance (all P<0.05). Multivariate logistic regression analysis showed that the chronic relapsing clinical type ［odds ratio (OR)=1.012, 95% confidence interval (CI): 1.001-1.028, P=0.002］, severe disease activity (OR=1.096, 95%CI: 1.010-1.158, P=0.040), combination drugs (OR=1.035, 95%CI: 1.003-1.122, P=0.041), VDZ maintenance therapy injection interval of 4 weeks (OR=1.014, 95%CI: 1.002-1.113, P=0.005) were the risk factors for VDZ adverse reactions.　Conclusions Among IBD patients receiving long-term treatment of VDZ, the incidence of adverse reactions of VDZ was 72.5%, mainly involving skin, digestive system and respiratory system. Symptomatic treatments could be given, and the prognosis was good. Patients with chronic relapsing clinical type, severe disease activity, com- bination therapy, and shorter VDZ maintenance injection interval were at higher risk of adverse reactions.

Objective To mine the risk signals of adverse events (AEs) in mavacamten treatment for hypertrophic cardiomyopathy, and provide reference for safe use of the drug in clinic.　Methods AE reports on mavacamten from June 2022 to June 2024 were collected by searching US Food and Drug Adminis- tration Adverse Event Reporting System (FAERS) database. AEs were classified and standardized according to the system organ class (SOC) and preferred term (PT) of Medical Dictionary for Regulatory Activities version 26.1. Reporting odds ratio (ROR) method and comprehensive standard method of the UK Medicines and Healthcare Products Regulatory Agency (MHRA) were used to mine the AE risk signals. An AE that simultaneously met the criteria of ≥3 reports, lower limit of the 95% confidence interval (CI) of ROR >1, PRR ≥2, and χ2 ≥4 was defined as a risk signal. Descriptive statistical analysis on signals was performed.　Results A total of 1 041 AE reports were collected, involving 47 PTs and 12 SOCs. The top 10 risk signals based on the number of AE reports were dyspnea, dizziness, fatigue, atrial fibrillation, cardiac failure, palpitation, nasopharyngitis, chest pain, COVID-19, and weight increased. Except dizziness and heart failure, above AEs were not recorded in the label. The top 10 risks in signal intensity were acquired left ventricle outflow tract obstruction, transvalvular pressure gradient increased, cardiovascular symptom, echocardiogram abnormal, hypervolaemia, left ventricular failure, ejection fraction decreased, coronavirus infection, brain fog, and atrial fibrillation. Except cardiovascular symptom, left ventricular failure, and ejection fraction decreased, above AEs were not recorded in the label.　Conclusions The AE risk signals of mavacamten in the treatment for hypertrophic cardiomyopathy recorded in the label are mainly heart failure and ejection fraction decreased. Clinicians and pharmacists should also be vigilant against risk signals not recorded in the lakel, such as atrial fibrillation, fatigue, nasopharyngitis, coronavirus infection, and brain fog, etc.

Objective To explore the clinical features of nivolumab-induced Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN).　Methods Relevant databases at home and abroad (as of December 31, 2023) were searched to collect case reports of nivolumab-induced SJS/TEN, and the demographic characteristics, nivolumab application, combination drugs, clinical manifestations, intervention measures, and outcomes were extracted and analyzed descriptively and statistically.　Results A total of 27 case reports were included and 29 patients were enrolled in the study, including 18 males and 11 females. The age ranged from 45 to 86 years, with an average age of 67 years. The primary diseases were mainly melanoma, stomach cancer, and lung cancer. Twelve patients had records of nivolumab administration, and the dosage was within the recommended range in the labels; 13 patients had records of combination drugs, mainly other antineoplastic drugs, hypoglycemic drugs, antihypertensive drugs, lipid-regulating drugs, etc. The time from using nivolumab to the diagnosis of SJS/TEN was 7 d to 3 years, and 20 patients were <8 weeks. The clinical manifestations were mainly diffuse erythema, flaky skin peeling and erosion, mucosal involvement, etc. Sixteen patients had skin biopsy records, all of which met the histopathological characteristics of SJS/TEN. After the diagnosis of SJS/TEN, 17 patients discontinued nivolumab and received symptomatic treatments, of which 15 patients had improved skin symptoms, one patient had worsened skin symptoms, and one patient had no record of skin outcome; 12 patients had no record of whether or not discontinuing nivolumab, of which 8 patients had improved skin symptoms, 2 patients had worsened skin symptoms, one patient had no record of skin outcome, and one had no record of prognosis. One patient rechallenged nivolumab, severe SJS/TEN recurred. Thirteen of 29 patients died. Of them, 1 died due to cardiac arrest, 4 due to worsened skin rash, and 8 due to primary disease progression.　Conclusions SJS/TEN caused by nivolumab mostly occurs within 8 weeks of treatment, and the clinical manifestations were similar to those caused by other drugs. The mortality rate of nivolumab-induced SJS/TEN is high, and skin rash could be improved after withdrawal of nivolumab and symptomatic treatments.

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 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.

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.

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.

A 70-year-old female patient with tumor in the neck and body of the pancreas received 11 cycles of chemotherapy with paclitaxel and gemcitabine. Due to disease progression, she subsequently underwent chemotherapy of fluorouracil, calcium folinate, and irinotecan, combined with immunotherapy of serplulimab. After 28 days (only one session of immunotherapy), the patient developed drooping of the right upper eyelid and chest tightness, followed by pain in the middle and lower segments of the sternum and radiating pain to the throat, accompanied by speech difficulties, dysphagia, and chest tightness and wheezing. Laboratory tests indicated hypersensitive troponin T 0.551 μg/L, creatine kinase (CK) 3 426 U/L, CK-MB 176 μg/L, and myoglobin 1 702 μg/L. The imaging examination of head and neck ruled out intracranial lesions, while the electrocardiogram suggested myocardial damage. Immune-related myocarditis with myositis and/or myasthenia gravis overlap syndrome (IM3OS) induced by serplulimab was considered. Immunotherapy was temporarily halted, and treatments with methyprednisolone and human immunoglobulin were administered. Sixteen days later, clinical symptoms of IM3OS in the patient were improved, with laboratory tests showing hypersensitive troponin I 0.075 μg/L, CK 216 U/L, CK-MB 58 μg/L, and myoglobin 273 μg/L. Upon follow-up, the patient switched to monotherapy with irinotecan alone or combined with raltitrexed for cancer treatment, clinical symptoms of IM3OS did not recur, and no abnormalities were observed in myocardial injury markers or muscle enzymes.

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.