摘要
目的为药物临床试验机构质量管理和保护受试者安全、合法权益提供参考。方法收集我院2014年~2019年上报的120例药物/器械严重不良事件(SAE)报告,按照SAE报告年份、科室、受试者性别、年龄、SAE发生类型、SAE与药物/器械相关性、SAE转归、受试者合并疾病等进行分析。结果我院SAE发生数量逐年递增;普通外科SAE发生例数最多(52例,43.3%);男性SAE发生例数高于女性;SAE主要发生在50岁以上人群(101例,84.2%);主要SAE发生类型是导致住院(72例,60.0%);SAE与药物/器械肯定无关占比例最大(58例,48.3%);受试者SAE转归达到症状消失(86例,71.7%);SAE受试者合并一种及以上疾病(104例,86.7%)。结论药物/器械严重不良事件关乎受试者生命安全,研究者应高度重视,临床试验各方应加强监管,共同提高项目质量和保障受试者安全和合法权益。
OBJECTIVE To provide a reference for the quality management of drug clinical trial institutions and for the protection of safety and legal rights of subjects.METHODS Collected 120 cases of serious adverse events(SAE) reported by our hospital from 2014 to 2019 and analyzed based on the year of SAE reported,department,subjects gender,age,type of SAE occurrence,correlation between SAE and drug/device,SAE progression,subjects comorbidities and etc.RESULTS The number of SAEs in our hospital increased annually;the number of SAEs in general surgery was the highest(52 cases,43.3%);the number of SAEs in men was higher than that of in women;SAEs mainly occurred in subjects over 50 years of age(101 cases,84.2%).The most common SAE occurrence was hospitalization(72 cases,60.0%);the proportion of SAE not associated with drug/medical device was the highest(58 cases,48.3%);SAE progressing towards symptoms disappearance in subjects(86 cases,71.7%);SAE comorbidities in subjects(104 cases,86.7%).CONCLUSION SAEs of drugs/medical devices are directly associated with subjects safety and that researchers should attach great importance on it.All clinical trial institutions should place intensive supervision in order to jointly improve project quality and to ensure the safety and legal rights of subjects.
作者
冯惠平
郑小敏
王志榕
刘艺群
翁小香
FENG Hui-ping;ZHENG Xiao-min;WANG Zhi-rong;LIU Yi-qun;WENG Xiao-xiang(Zhangzhou Municipal Hospital Affiliated to Fujian Medical University,Zhangzhou 363000,China)
出处
《海峡药学》
2020年第7期216-219,共4页
Strait Pharmaceutical Journal
关键词
药物临床试验
严重不良事件
报告
分析
Drug clinical trials
Serious adverse events
Report
Analysis