药物临床试验中严重不良事件案例收集及规范化干预对策设计探讨  

Collection of Serious Adverse Event Cases in Drug Clinical Trials and Exploration of Standardized Intervention Strategy Design

作　　者：李颖 LI Ying(Drug Clinical Trial Institutions,The Second Affiliated Hospital of Xuzhou Medical University,Xuzhou,Jiangsu 221006,China)

机构地区：[1]徐州医科大学第二附属医院药物临床试验机构,江苏徐州221006

出　　处：《中国医药指南》2025年第1期141-144,共4页Guide of China Medicine

摘　　要：目的分析药物临床试验中严重不良事件(SAE)案例,并探讨、设计规范化干预对策方案。方法纳入徐州医科大学第二附属医院2017年5月至2023年12月上报的药物临床试验SAE报告58例,分析受试者基本情况以及SAE发生情况及原因。结果58例报告中男性受试者SAE发生率高于女性(P<0.05),并且SAE发生率随年龄增加呈上升趋势;SAE在内分泌科发生率最高,占比34.48%;SAE导致住院发生率最高,占比67.24%;SAE中生物制品占比最高,为51.72%;SAE报告呈逐年递增趋势,其中大部分SAE可在15 d内上报,占比81.03%(47/58);多数(46.56%)SAE被判定与试验药物无关;SAE报告表填写不规范是出现频次最多的问题,占比65.00%。结论为确保药物临床试验的完整性和受试者生命健康,应加强SAE规范性干预对策,获知并上报SAE,对发生SAE的受试者进行相应的救治。Objective To analyze serious adverse events(SAE)cases in drug clinical trials and explore and design standardized intervention strategies.Methods From May 2017 to December 2023,the Second Affiliated Hospital of Xuzhou Medical University reported 58 cases of drug clinical trials with SAE.The basic information of the subjects,as well as the occurrence and causes of SAE,were analyzed.Results The incidence of SAE in 58 cases reported by male subjects was higher than that of female subjects(P<0.05),and the incidence of SAE showed an increasing trend with age,SAE has the highest incidence rate in endocrinology,accounting for 34.48%,SAE has the highest hospitalization rate,accounting for 67.24%.The proportion of biological products in SAE is the highest,at 51.72%.SAE reports are showing an increasing trend year by year,with the majority of SAEs being able to be reported within 15 days,accounting for 81.03%(47/58).Most(46.56%)SAE were determined to be unrelated to the investigational drug.Improper filling of SAE report forms is the most frequent issue,accounting for 65.00%.Conclusions To ensure the integrity of drug clinical trials and the health of subjects,it is necessary to strengthen SAE standardized intervention measures,obtain and report SAE,and provide corresponding treatment for subjects with SAE.

关 键 词：药物临床试验 严重不良事件 规范化干预对策 

分 类 号：R95[医药卫生—药学]