我院药物临床试验65例严重不良事件报告分析

Reports of Serious Adverse Events in Drug Clinical Trials in Our Hospital:An Analysis of 65 Cases

目的促进药物临床试验的质量控制和规范化管理,保障受试者的安全和合法权益。方法统计医院2016年至2019年上报的药物临床试验中发生的65例(129例次)严重不良事件(SAE),分析SAE上报科室分布,SAE药物种类及临床试验项目,对受试者的影响,发生SAE受试者的性别与年龄分布及转归,以及SAE与试验药物的相关性。结果SAE中,血液科发生例数(18例)最多;男性发生例数(50例)多于女性(15例);主要发生于50岁以上(37例)受试者;药物种类中,治疗用生物制品发生例数最多(25例);对受试者的最主要影响是SAE导致住院(46例);SAE与试验药物"肯定无关"例数最多(23例),对临床试验的最主要影响是继续用药(30例);受试者治疗后,好转的例数最多(44例)。结论通过加强对药物临床试验的质量控制和规范化管理,能及时、合理救治出现SAE的受试者,切实保障其生命安全和合法权益。

Objective To promote the quality control and standardized management of drug clinical trials,and to ensure the safety and legitimate rights and interests of subjects.Methods A total of 65 subjects(129 cases)with serious adverse events(SAEs)in the drug clinical trials reported by the hospital from 2016 to 2019 were collected to analyze the distribution of SAEs reporting departments,types of drugs causing SAEs,clinical trial items,the effect of SAEs on subjects,the gender and age distribution and outcome of subjects with SAEs,and the correlation between SAEs and trial drugs.Results Among 129 SAEs,the incidence of SAEs in the hematology department was the highest(18 cases),and that in the male(50 cases)was higher than that in the female(15 cases).SAEs mainly occurred in subjects over 50 years old(37 cases).Among the types of drugs,the incidence of therapeutic biological products was the highest(25 cases).The main effect of SAEs on subjects was hospitalization caused by SAEs(46 cases).The largest number of cases(23 cases)with SAEs were definitely unrelated to the test drug,and the main effect of SAEs on the clinical trial was continued medication(30 cases).After treatment,the number of subjects improved was the largest(44 cases).Conclusion Strengthening the quality control and standardized management of drug clinical trials can timely and reasonably treat the subjects with SAEs,and effectively protect their life safety and legitimate rights and interests.