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.

Objective To explore the effects of pharmaceutical services through enterprise WeChat for outpatients with cancer pain.　Methods A retrospective study was conducted on patients who were first diagnosed and/or previously treated for cancer pain and visited Outpatient Department of the First Affiliated Hospital of Soochow University from January 1, 2020 to January 30, 2023. The outpatients were divided into conventional pharmaceutical services management group (conventional group) and pharmaceutical services management group through enterprise WeChat (enterprise WeChat group) based on whether they received pharmaceutical services for cancer pain through enterprise WeChat. Prescription appropriateness, changes in cancer pain and life quality evaluation indicators after treatment in patients between the 2 groups were recorded and compared.　Results A total of 174 patients were included, with 87 patients in each group. There were no significant differences in age and gender between the 2 groups (all P>0.05). Before the pharmaceutical services management for cancer pain through enterprise WeChat, the differences in the proportion of patients with pain free, mild, moderate, and severe pain after pain relief treatments between the 2 groups were not significant (all P>0.05). In the conventional group, 13 out of 87 patients (14.9%) had inappropriate prescriptions, and 2 out of 87 (2.3%) in the enterprise WeChat group, with statistically significant difference (χ2=8.828, P<0.05). After management with enterprise WeChat, the patients of pain-free increa- sed from 19 to 55 (63.2%) in the enterprise WeChat group, and from 18 to 41 (47.1%) in the conventional group. The difference in the proportion of pain-free patients between the 2 groups was statistically significant (χ2=4.555, P=0.033). The differences in the scores of various indicators of life quality between the 2 groups before management with enterprise WeChat were not significant (all P>0.05). After the management with enterprise WeChat, life quality scores in all the 8 dimensions were significantly higher than those in the conventional group (all P<0.05).　Conclusion The utilization of enterprise WeChat could improve the treatment effect of cancer pain, enhance their life quality, help improve the quality of pharmaceutical services, and have certain promotion and utilization value.

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.

A 31-year-old woman received semaglutide injection subcutaneously for weight loss. Three months later, the electrocardiogram showed sinus tachycardia, and the laboratory tests showed triiodothyronine (T3) 2.75-nmol/L, thyroxine (T4) 199.86-nmol/L, free triiodothyronine (FT3) 11.31-pmol/L, free thyroxine (FT4) 46.63-pmol/L, thyroid-stimulating hormone (TSH)<0.005 mU/L. Considering the sinus tachycardia and hyperthyroidism caused by semaglutide injection, the drug was discontinued, and methimazole 10-mg orally, twice daily and metoprolol 25-mg orally twice daily were given. After treatment for more than 1 month, the electrocardiogram of the patient was normal, and the thyroid function examination showed T3-1.79-nmol/L, T4-127.33-nmol/L, FT3-4.94-pmol/L, FT4-15.87-pmol/L, and TSH<0.005 mU/L. However, there were elevated liver enzymes, showing alanine aminotransferase 327-U/L, aspartate aminotransferase 148-U/L, and γ-glutamyl transpeptidase 123.4-U/L. Then, methimazole and metoprolol were stopped, and silibinin 140-mg orally thrice daily combined with bicyclol 50-mg thrice daily were given. More than 1 month after treatments, the patient′s thyroid function and liver function were normal, and silibinin and bicyclol were stopped. After that, the thyroid function, liver function and electrocardiogram were all normal in repeated examinations.

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.

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.

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.

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 investigate the risk of adverse event (AE) associated with inclisiran and to provide reference for the safe use in clinical practice.　Methods The AE reports in the US FDA Adverse Event Reporting System (FAERS) database from the 4th quarter of 2004 to the 2nd quarter of 2023 with inclisiran as the primary suspect drug were collected. AE was standardized and classified using the preferred terminology (PT) and the system organ class (SOC) of the Medical Dictionary for Regulatory Activities 26.0. AE risk signal mining was performed using the report odds ratio (ROR) method and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) comprehensive standard method. PT that was considered as an AE risk signal in both methods were defined as AE risk signals ［ROR method: ≥3 reports  and the lower limit of the 95% confidence interval (CI) of the ROR>1; MHRA comprehensive standard method: ≥3 reports、PRR ≥2 and χ2≥4]. A descriptive statistical analysis was performed.　Results A total of 1 888 AE reports were collected with inclisiran as the primary suspect drug, involving 1-888 patients and 835 PTs. The AE was predominantly reported in the United States (88.7%, 1 675/1 888), and predominantly by the consumer (62.1%, 1 171/1 886); there were a total of 484 reports (25.6%) about serious AE. Excluding non-drug and indication-related PTs, 85 PTs (involving 15 SOCs) met the criteria in both the ROR method and the MHRA comprehensive standard method, and defined as AE risk signals. The top 5 PTs ranked by the number of reports were arthralgia (248 cases), injection site pain (237 cases), limb pain (170 cases), myalgia (158 cases), and diarrhea (132 cases); the top 5 PTs ranked by the signal intensity included bladder discomfort (ROR=28.87, PRR=28.85), injection site discomfort (ROR=24.48, PRR=24.40), sinus pain (ROR=23.20, PRR=23.19), injection site vesicles (ROR=17.63, PRR=17.61), and injection site rash (ROR=12.51, PRR=12.45). Among the top 20 PTs ranked according to the number of reports and signal intensity respectively, 8 and 13 PTs were not documented in domestic and international specifications, of which myalgia and hypoacusis had more reports and stronger signal intensity.　Conclusion The main AE  of inclisiran in the US FAERS database were injection site reactions, followed by musculoskeletal-related AEs (arthralgia, myalgia, and myospasm, etc.) and infection-related AEs (such as urinary tract infections and bronchitis), which require clinical attention.

Objective To explore the clinical characteristics of mirtazapine-related thrombocytopenia.　Methods The diagnosis and treatment of a patient with mirtazapine-related thrombocytopenia who was admitted to the Aerospace Center Hospital was reported, and the main clinical data (gender, age, indications of mirtazapine use, dosage of mirtazapine, combined medication, platelet count before and after medication, time from application of mirtazapine to thrombocytopenia occurrence, clinical treatment and prognosis, etc.) of the case and similar cases collected by searching relevant databases (up to August 31, 2023) were analyzed by descriptive statistic method.　Results A total of 9 patients were enrolled in the analysis, including 4 males and 5 females; the age ranged from 28 to 74 years, with a median age of 52 years. The indication of medication was depression in 8 patients, and 1 had no record. The daily dose of mirtazapine was 15-mg in 4 patients, 30-mg in 3 patients, and no record in 2 patients. Two patients were treated with mirtazapine alone, 6 patients were treated with mirtazapine combined with other drugs, and it was not recorded in 1 patient. The time from the application of mirtazapine to occurrence of thrombocytopenia in the 9 patients ranged from 2 to 28 days, with a median time of 8 days. The severity of thrombocytopenia was grade 1, 3, and 4 in 3, 3, and 2 patients, respectively; 1 patient had no relevant record. Of the 5 patients with severe thrombocytopenia, 3 developed bleeding, and 1 had skin ecchymosis. The results of drug-dependent antiplatelet antibody test in 2 patients were positive. Nine patients stopped mirtazapine treatment after diagnosis of thrombocytopenia, 6 patients did not receive special intervention, and 3 patients were given symptomatic treatments. After drug withdrawal for 2-43 days with the median time of 9 days, platelet counts returned to the reference range in 7 patients, platelet count increased in 1 patient, and platelet count was unknown but skin symptom was improved in 1 patient.　Conclusions Mirtazapine-related thrombocytopenia usually occurs within 10 days of treatments, which can be improved after drug withdrawal. It is suggested to monitor the blood routine before and after the application of mirtazapine.

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.

Anti-microbial agents are one of the most widely used drugs in clinical practice, with a high incidence of adverse drug reactions, and the safety problem is very prominent. There are many factors that affect the occurrence, development and severity of adverse reactions caused by anti-bacterial agents. The research on the related risk factors is one of the measures to ensure the safety and effectiveness of anti-  infection treatment, and it is also the premise of preventing and identifying adverse reactions caused by anti-bacterial agents. This paper summarizes and evaluates the research hotspots and methods on common adverse reactions risk factors for anti-bacterial agents, and puts forward relevant suggestions according to the problems and deficiencies existing in the current research status, with the aim of promoting research on adverse reactions-related risk factors for anti-bacterial drugs in China and ensure the safety of patients′ medi-cation.

Objective To actively monitor and analyze the safety of levofloxacin and sodium chloride injection produced by Guangzhou Green Cross Pharmaceutical Co., Ltd (generic drug). and levofloxacin and sodium chloride injection produced by Daiichi Sankyo (Beijing) Pharmaceutical Co., Ltd (original drug).　Methods The data in this study came from the adverse drug reaction reports on levofloxacin and sodium chloride injection voluntarily monitored and reported to the National Adverse Drug Reaction Monitoring System Database by the First Affiliated Hospital of Sun Yat-sen University, Guangdong Provincial People′s Hospital, and the First Affiliated Hospital of Ji'nan University from October 1, 2022, to September 30, 2023. The information on patients′ age, gender, medication use, primary disease, time from medication to the occurrence of adverse reactions, clinical manifestations, treatment and prognosis of adverse reactions, and the occurrence of serious adverse reactions were collected. The incidence of adverse reactions was calculated.　Results A total of 30 adverse reaction reports involving levofloxacin and sodium chloride injection were collected, involving 30 patients. In the generic drug group, there were 21 cases, including 8 males and 13 females, aged from 20 to 91 years with a median age of 43 years; 2 cases of serious adverse reactions were reported. In the original drug group, there were 9 cases, including 3 males and 6 females, aged from 20 to 96 years with a median age of 56 years; no serious adverse reactions were reported. In the generic drug group, a total of 36 adverse reactions occurred in 21 patients, while in the original drug group, a total of 13 adverse reactions occurred in 9 patients. These adverse reactions involved the skin and appendages, digestive system, nervous system, musculoskeletal system, urinary system, and medication site, with skin itching and rash being the most common allergic reactions (15 case time in the generic drug group, accounting for 41.7%; 6 case time in the original drug group, accounting for 46.2%). Two cases of serious adverse reactions occurred in the generic drug group, and both were anaphylactic shock. After discontinuation of the drug, switching to other antibiotics, and symptomatic treatments, 5 cases in the generic drug group were cured, 15 cases were improved, and 1 case was unknown. In the original research drug group, 2 cases were cured and 7 cases were improved. There were no deaths in either the generic or original drug groups. The incidence of adverse reactions in outpatients and/or inpatients in the generic drug group was 0.07% (21/29 557), while that in the original research drug group was 0.08% (9/10 686). There was no statistically significant difference between the 2 groups (χ2=0.183, P=0.669).　Conclusion The results of active monitoring show that there is no significant difference in safety between the generic and original drugs of levofloxacin and sodium chloride injection.

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.

Antineoplastic agents; Acute kidney injury; Renal insufficiency; Guideline; Interpretation

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 pre-warnings of contraindicated drugs in medical advices in patients with renal insufficiency by the pre-audit system.　Methods The pre-warnings of contraindicated drugs in medical advices in patients with renal insufficiency by the pre-audit system in Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from January 1, 2021 to December 31, 2021 were collected. The drugs involved were analyzed and determined as drugs in the correct pre- warnings and drugs in the audit rules that needed to be corrected. The drugs involved in the correct pre- warnings and the acceptance of pre-warnings by clinicians were analyzed; drugs that can be used off-label according to the evidence-based information were recorded and the proposed suggestions on the revision of the audit rules were provided.　Results A total of 259 medical advices about pre-warnings related to contraindicated drugs in patients with renal insufficiency were included in the analysis, involving 47 drugs. Among the 259 pre-warnings, 169 were correct, with the correct rate of 65.25%, and 107 (63.31%) of them were accepted by clinicians. The rate of acceptance by surgeons was higher than that by physicians, and the difference was statistically significant ［76.39% (55/72) vs. 53.61% (52/97), P<0.01］. The audit rules in the 90 pre-warnings that needed to be modified involved 12 drugs. Of them, one drug (dapagliflozin tablets) had updated instruction, thus the rules can be modified directly according to it. The other 11 drugs were recorded for off-label drug use in the system based on evidence-based information, and of them, pre-warning levels were adjusted for 6 drugs, and audit rules were adjusted for 5.　Conclusions The pre-audit system can effectively pre-warning the contraindicated drug prescriptions of CKD patients, and the correct rate of pre-warning and clinician acceptance rate are more than 60%. The audit rules of some pre-warnings need to be adjusted with the update of the instructions and additional evidence-based information for off- label drug use after recording.

Objective To understand the adverse event (AE) risk signal of doxycycline in children and provide reference for the safe use of the drug in clinic.　Methods AE reports of children with doxycycline as primary suspect drug were collected from the US FDA Adverse Event Reporting System (FAERS) database during the 1st quarter of 2004 to the 3rd quarter of 2023. AEs were standardized and classified according to the preferred term (PT) and system organ class (SOC) in Medical Dictionary for Regulatory Activities 26.1. The AE risk signals of doxycycline were mined using reporting odds ratio (ROR) method. An AE with reports ≥3 and the lower limit of the 95%CI of ROR >1 was defined as a risk signal. Descriptive analysis on the risk signals was performed.　Results A total of 637 AE reports related to doxycycline in children were collected, involving 107 PTs and 21 SOCs. The top 10 PTs in the number of reports (including juxtaposition) were vomiting, depression, dysphagia, Jarisch-Herxheimer reaction, cholangitis sclerosing, headache, colitis ulcerative, oesophageal ulcer, nausea, oesophagitis, and suicidal ideation. Among them, depression, Jarisch-Herxheimer reaction, cholangitis sclerosing, colitis ulcerative and suicidal ideation were not recorded in labels. The top 10 PTs in signal intensity were Jarisch-Herxheimer reaction, photoonycholysis, hypnopompic hallucination, oesophageal ulcer, oesophageal injury, hypnagogic hallucination, vitritis, onycholysis, cholangitis sclerosing, erosive oesophagitis. Among them, Jarisch-Herxheimer reaction, hypnopompic hallucination, hypnagogic hallucination, vitritis and cholangitis sclerosing were not recorded in labels. Psychiatric disorders were not covered by adverse reactions in the label.　Conclusions The main AEs of doxycycline in children are vomiting, dysphagia, oesophageal ulcer, nausea, oesophagitis, all of which are recorded in the drug label. In addition, doxycycline may also cause AEs that are not recorded in drug label, such as Jarisch-Herxheimer reaction, sclerosing cholangitis, ulcerative colitis, and psychiatric disorders.

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.

Old drugs are generally considered as drugs that have been on the market for many years and are well known by medical workers and the public. There are still many unsolved problems about the safety of older drugs. Some adverse reactions of old drugs may not be fully understood at present, the safety of their application in special populations still needs long-term monitoring, the study on mechanism of many adverse reactions of old drugs need to be strengthened, and most adverse reactions lack specific diagnostic biomarkers and effective prevention and treatment measures. The adverse reaction content in the old drug labels needs to be continuously improved, and many safety issues in drug application still require standardized expert consensus and guidance.

Objective To explore the influencing factors of coagulation disorders caused by cefoperazone sodium and sulbactam sodium in patients with chronic renal insufficiency.　Methods The medical records of adult patients with chronic renal insufficiency, who were hospitalized and treated with cefoperazone sodium and sulbactam sodium in the Department of Nephrology of the Affiliated Qingyuan Hospital, Guangzhou Medical University, Qingyuan People′s Hospital from January 2021 to December 2022, were collected. Patients who developed coagulation disorders related to cefoperazone sodium and sulbactam sodium were imputed as having an end-point event, and the occurrence of end-point events in these patients was analyzed descriptively. According to whether an end-point event occurred, patients were divided into end-point event group and non-end point event group. Univariate and multivariate logistic regression analysis were performed on the risk of end-point events.　Results A total of 121 patients with renal insufficiency were included in the analysis, including 76 males (62.8%) and 45 females (37.2%), aged (66±13) years. Among 121 patients, 39 (32.2%) had end-point events, and 6 (5.0%) had clinical bleeding. The results of univariate analysis showed that the differences in age, renal replacement therapy, and daily and total doses of cefoperazone sodium and sulbactam sodium of patients between 2 groups were statistically significant (all P<0.05). Multivariate logistic regression analysis was performed using the occurrence of end-point events as dependent variables, and age, renal replacement therapy, and daily and total doses of cefoperazone sodium and sulbactam sodium as independent variables. The results showed that only older age was an independent risk factor for the occurrence of end-point events (odds ratio=1.044, 95% confidence interval: 1.004-1.086, P=0.029).　Conclusions Patients with renal insufficiency have a higher risk of coagulation disorders in treatment with cefoperazone sodium and sulbactam sodium, and older age is an independent risk factor. Cefoperazone sodium and sulbactam sodium should be used cautiously in elder patients, and coagulation function monitoring should be strengthened in clinical use.

The "Top 10 drug tips for the public in 2023" issued by the Chinese Pharmaceutical Association emphasizes the importance of drinking water correctly to the safety and efficacy of drugs. Each drug has an optimal amount of drinking water, and only the appropriate amount can ensure the efficacy and avoid adverse reactions. According to UpToDate clinical consultant, Micromedex, MCDEX evidence-based databases and the drug labels of the US FDA and the European Medicines Agency, a total of 164 drugs in 20 categories, including drugs for metabolism and endocrine system, anti-infective drugs, anti-tumor drugs, etc., were labeled with the recommendation of adequate water intake. Here we summarize the above-mentioned drugs and their recommended water intake. The common reasons to drink enough water include preventing esophageal and gastric injury, preventing kidney injury, preventing dehydration, water and electrolyte disorders, preventing constipation, reducing bladder toxicity, reducing radiation damage, and promoting stone discharge. In addition, different people have different requirements for the amount of water when taking medicine. Mastering the correct amount of water is conducive to controlling the disease and reducing the adverse drug events.

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 analyze the general rules and characteristics of adverse reactions of succinylated gelatin injection and provide reference for safe and rational clinical use.　Methods Adverse reaction reports related to succinylated gelatin injection in National Adverse Drug Reaction Monitoring System database from January 2004 to August 2021 were collected. Retrospective analysis of patients′ gender, age, primary disease, reason for drug use, combined drugs, and time of adverse reaction occurrence from drug use, clinical manifestations, severity and patient outcomes were performed, and classified statistics were performed according to systematic organ class (SOC) and preferred terms of Medical Dictionary for Regulatory Activities.　Results A total of 3-036 adverse reaction reports of succinylated gelatin injection were entered, including 710-serious cases (23.39%), and the top 5 SOCs involved diseases of the immune system, systemic diseases and various reactions at the administration site, skin and subcutaneous tissue diseases, vascular and lymphatic diseases, and respiratory/thoracic and mediastinal diseases. The main symptoms were anaphylactic shock, similar rapid severe allergic reaction, chills, fever, and other rapid severe allergic reactions. Among the 3-036 patients, 1-543 were cured, 1-480 were improved, 3 were not improved, 2 had sequelae, 2 died, and 6 had unknown results. The SOCs involved in adverse reactions and not recorded in labels included ocular organ diseases, various musculoskeletal and connective tissue diseases, metabolic and nutritional diseases, kidney and urinary system diseases, etc.　Conclusions The adverse reactions related to succinylated gelatin injection are mostly associated with anaphylaxis. Severe adverse reactions are consistent with the characteristics of rapid severe anaphylaxis, but there may be related risks not covered in labels.

Anticancer drugs play an important role in the treatment for malignant tumors. The kidney function of patients has an important impact on the choice of anticancer drugs, the safety during treatments, and the prognosis of patients. All cancer patients should undergo comprehensive kidney function assessment before using anticancer drugs, so as to formulate an individualized anticancer regimen. The Japanese Society of Nephrology, Japan Society of Clinical Oncology, Japanese Society of Medical Oncology, and Japanese Society of Nephrology and Pharmacotherapy have formulated the Clinical Practice Guidelines for Management of Kidney Injury During Anticancer Drug Therapy 2022 and made special discussions and suggestions on the evaluation of kidney function of tumor patients before anticancer drug treatment. This article interprets this part in order to made a more comprehensive understanding on the occurrence and risk factors of kidney disease in cancer patients in the clinic. Paying attention to the kidney function assessment of cancer patients before anticancer drug treatment and mastering the correct assessment methods can help improve the kidney safety of cancer patients during treatments.

Objective To explore the adverse cardiac event risk signals in arsenical for injection, improve the clinical understanding of the cardiac toxicity of arsenical.　Methods The risk signals of adverse cardiac events associated with arsenical for injection were mined using 3 methods, including reporting odds ratio (ROR) method, proportional reporting ratio (PRR) method, and the Medicines and Healthcare Products Regulatory Agency (MHRA) comprehensive standard method based on data in Shandong Provincial Center of Adverse Drug Reaction Monitoring (Shandong data) in China from the first quarter of 2003 to the fourth quarter of 2022 and the data in US FDA Adverse Event Reporting System (FAERS) database from the fourth quarter of 2003 to the third quarter of 2023. The definition of risk signal in ROR and PRR method was the number of adverse event reports ≥3 and the lower limit of 95% confidence interval (CI) of ROR and PRR >1. The definition of risk signals in MHRA comprehensive standard method was the number of adverse event reports ≥3, PRR>2, and χ2>4.　Results There were a total of 358 reports on arsenical for injection in Shandong data, of which 275 (76.8%) were related to arsenious acid and sodium chloride injection, and 83 (23.2%) were related to arsenic trioxide for injection. Among the 358 reports, adverse cardiac reactions were reported in 25 reports (7.0%), and severe cases accounted for 28.0% (7/25). There were a total of 1-294 reports on ATO in FAERS, and adverse cardiac events were reported in 418 reports (32.3%), of which severe cases accounted for 62.2% (260/418). The signal mining results form 275 reports on arsenious acid and sodium chloride injection in Shandong data showed that QT interval prolonged, chest tightness, cardiopalmus, and palpitations were risk signals. Among them, the signal strength of QT interval prolonged was the strongest. A total of 35 adverse cardiac event signals were mined in FAERS data, of which the signal strength of QT interval prolonged and long QT syndrome were the strongest. In addition, the strength of 6 arrhythmia signals (bradyarrhythmia, supraventricular premature contraction, ventricular premature contraction, torsade de pointes, ventricular tachycardia, and atrioventricular block) and 6 cardiac organic lesion signals (pericarditis, endocarditis, pericardial effusion, myocarditis, mitral regurgitation, and cardiac enlargement) also ranked high.　Conclusions Arsenical for injection is strongly associated with cardiotoxicity, and the proportion of severe cases is relatively high. The cardiotoxicity mainly affects the QT interval, and can also manifest as various types of arrhythmias and some cardiac organic lesions. 

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.

Chronic kidney disease (CKD) has become a global public health problem. Slowing disease progression is vital in CKD management, and drug therapy is an important part of the treatment for CKD patients. However, the risk for adverse drug event is higher in patients with CKD due to impaired renal function, prolonged disease duration, presence of multimorbidity and polypharmacy. Therefore, it was recommended to promote medication safety in patients with CKD through the following 4 specific strategies: (1) carrying out more studies to improve evidence-based practice for medication in patients with CKD; (2) conducting dose adjustments according to glomerular filtration rate and continuous drug therapy monitoring to a dynamic management of the dose; (3) implementing multidisciplinary care； （4） utilizing appropriate information technology actively.

Acetaminophen is currently the most widely used antipyretic analgesics in clinical practice. The conventional dose of acetaminophen is safe and reliable, and long-term use in large quantities can cause damage to important organs. In recent years, some new safety issues of acetaminophen have been found, such as its possibility to increase blood pressure in patients with hypertension, its association with increased risk of cardiovascular disease and all-cause mortality with sodium-containing acetaminophen, the discovery of multiple biomarkers for predicting and diagnosing acetaminophen-related liver injury and its prognosis, and its possibility to increase the risk of kidney injury. The safety prevention strategies for important organ injuries related to acetaminophen include strict restrictions on medication dosage and duration, and attention to medication safety for special populations. For patients who have experienced significant organ damages, their causal relationship should be evaluated, acetaminophen should be stopped, and specific treatment, and symptomatic and supportive treatments should be provided.

Objective To explore the clinical characteristics of cardiotoxicity due to 5-hydroxytryptamine 3 receptor (5-HT3) antagonists.　Methods Relevant databases at home and abroad (up to June 20, 2023) were searched and case literature of cardiotoxicity induced by 5-HT3 receptor antagonist were collected. Relevant information of patients, medication status (drug name, usage and dosage, indication, combined drugs), occurrence of cardiotoxicity, evaluation of the association between 5-HT3 receptor antagonists and cardiotoxicity, intervention measures and outcomes were extracted and analyzed descriptively and statistically.　Results A total of 23 case reports, 22 in English and 1 in Chinese, were enrolled in the analysis. There were 26 patients, 6 males and 20 females, and the age ranged from 8 to 60 years, with an average of 40 years. The reasons for drug use were perioperative antiemesis in 19 patients, chemotherapy antiemesis in 2 patients, and other reasons in 5 patients. Ondansetron was used in 19 patients, dolasetron in 4 patients, granisetron, tropisetron and palonosetron in 1 patient each. Except for 1 patient with overdose by self-medication, the dosage in 25 patients was within the recommended range in labels. A total of 50 case time of cardiotoxicity occurred in 26 patients, mainly including tachycardia (12 cases), electrocardiogram (ECC) changes (11 cases), bradycardia (9 cases), cardiac arrest (1 case), and myocardial infarction (1 case), etc. Twenty-one patients experienced cardiotoxicity after initial medication, of which 8 occurred immedia- tely after the initial medication, 5 patients occurred after ≥2 times of medication. After the occurrence of cardiotoxicity, 26 patients stopped 5-HT3 receptor antagonists successively, of which 24-stopped the drug immedia- tely and received symptomatic treatments, 1 stopped the drug after 8 days of medication without other intervention, and 1 stopped the drug and received symptomatic treatment after the symptoms aggravated. After drug withdrawal and/or symptomatic treatments, the mentioned symptoms disappeared and ECC returned to normal in 25 patients. Of them, 22 patients had a recovery time of ≤48-hours, while the other 3 patients had their ECG returned to normal at 1 week, 2 weeks, and 2 months, respectively; one patient died due to ineffective treatment for ventricular fibrillation.　Conclusions The cardiotoxicity induced by 5-HT3 receptor antagonists mostly occurs after the initial medication, and mainly manifests as tachycardia, bradycardia, ECG changes, etc. Most patients have a good prognosis after timely drug withdrawal and symptomatic treatments, and in severe cases, it can lead to death.

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.

A 64-year-old female patient received treatments such as antibacterial, analgesic, etc. due to local swelling and blisters caused by application of domestically made drug for external use for knee joint pain. After 7 days, local skin redness and swelling appeared, with scattered rashes. Anti-allergic treatments including intravenous infusion of calcium gluconate and oral desloratadine cirate were given. On the second day, the patient developed a wheal like rash all over her body, and intravenous infusion of anti-allergic drugs were continued. On the same day, the patient′s skin symptoms were improved. The patient′s systemic rash worsened again after 1.5-hours of reapplication of desloratadine cirate, and the next day, angioneurotic edema appeared. Desloratadine cirate was stopped, dexamethasone, promethazine, and other symptomatic treatments were continued. Four days later, the patient′s symptoms completely disap- peared.

A 67-year-old male patient with primary liver cancer was given combination treatment with regorafenib and sintilimab because of disease progression after multiple interventional therapy. After one cycle of medication, the patient developed weakness in the left facial expression muscle and left upper eyelid, and generalized muscle pain with dyspnea. Laboratory tests showed myoglobin 8-614-μg/L, creatine kinase (CK) 17-480-U/L, CK-MB mass 528-μg/L, troponin I 0.465-μg/L, aspartate aminotransferase (AST) 1-069-U/L, alanine aminotransferase (ALT) 493-U/L, and lactate dehydrogenase (LDH) 2-469-U/L. The electrocardiogram showed the new onset of left bundle branch block. It was considered to be immune-related myositis, immune-related myalgia, and immune-related hepatitis caused by sintilimab, not excluding immune-related cardiac toxicity. Regorafenib and sintilimab were discontinued immediately while methylprednisolone pulse therapy was initiated at a dose of 500-mg (gradually reduced after 5 days), monoammonium glycyrrhizinate and cysteine and sodium chloride injection and bicyclol were administered for liver protection and reducing liver enzyme levels. After 7 days of treatments, weakness in the left facial expression muscle and eyelid were improved significantly along with relief from chest tightness and alleviation of generalized muscle pain throughout the body. After 15 days of treatments, laboratory tests showed myoglobin 494-μg/L, CK 537-U/L, CK-MB mass 115-μg/L, AST 52-U/L, ALT 77-U/L, and LDH 519-U/L. After half a year of treatments, glucocorticoids therapy was discontinued, and all indicators returned basically to normal. The patient did not receive immunotherapy again.

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.

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.

Objective To explore the clinical characteristics of adverse reactions induced by levofloxacin in the emergency infusion unit.　Methods The study was designed as a single center prospective cohort study. Data of adverse drug reaction (ADR) in the Infusion Unit of Emergency Medicine Center of First Affiliated Hospital of Nanjing Medical University was managed, recorded and collected according to the pre-formulated "emergency infusion unit drug adverse reaction management process" and "strengthening the reporting of observational studies in epidemiology (STROBE)". The incidence, severity, clinical characteristics, intervention measures, outcomes, and follow-up of adverse reactions induced by levofloxacin from November 2019 to October 2022 was summarized and analyzed.　Results A total of 426 cases of ADR occurred within the set time period, of which 62 (14.55%) were related to levofloxacin, involving 27 males (43.55%) and 35 females (56.45%) with a median age of 39 years. Among the 62 levofloxacin-related ADRs, 96.77% (60/62) occurred within 2 hours of intravenous infusion of levofloxacin; the severity of 44 (70.97%), 10 (16.13%) and 8 (12.90%) cases of ADRs was classified as grade 1, 2, and 3, respectively, and no grade 4 ADRs occurred. The most common clinical symptoms were skin and mucosa reactions, including rash and itching, followed by cardiovascular system and nervous system manifestations, including hypotension, palpitation, and dizziness. The skin and mucosa manifestations were more common in patients with severity grade 1 ADRs, while the cardiovascular, digestive, respiratory nervous system and systemic manifestations were more common in those with severity grade 2 and 3 ADRs; the differences were statistically significant (all P<0.05). After the occurrence of ADRs, levofloxacin was withdrawn in all the 62 patients, the infusion set was replaced, and infusion of 0.9% sodium chloride injection were used to flush the tube. Additionally, 24 patients (38.71%) were given drug intervention, including epinephrine in 2 patients. After the above intervention, the symptoms of all patients were relieved, with a median response time of 49-minutes.　Conclusions Levofloxacin was one of the common drugs causing ADR in the emergency infusion unit. The clinical manifestations were mainly rashes and itching, most of which were mild in severity. Timely disconti- nuation of levofloxacin and drug interventions often help get a good prognosis. However, the treatment procedure of severe ADRs remain to be standardized.

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 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 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.