摘要
目的加强对生物等效性试验安全性的认识及监管,降低不良事件发生率,提高药物临床试验质量。方法收集2019年1月—6月的本院1期临床研究室完成的3项生物等效性试验项目,对项目总结/统计报告中的不良反应/事件进行汇总,分析试验中不良事件发生率及其相关影响因素,探讨生物等效性试验的风险管理,加强对临床试验安全性的认识及监管,制订并采取相应的风险防范措施,并对实施6个月后的效果进行评价。结果 3项生物等效性试验风险防范措施前的不良事件发生率为48.98%,实施后不良事件发生率为28.57%,不良事件发生率显著下降(P<0.01)。结论应在生物等效性试验的各个环节实施针对性风险防范措施,加强风险管理,减少不良事件的发生,保护受试者的安全,从而提高药物临床试验质量。
Objective To strengthen the understanding and supervision of the safety of bioequivalence clinical trials and improve the quality of drug clinical trials.Methods Three bioequivalence trials completed by Phase 1 Clinical Laboratory in our Center from January 2019 to June 2019 were collected,and the adverse reactions/events in the project summary/statistical report were summarized.The incidence of adverse events in bioequivalence clinical trials and related factors were analyzed.The effect was evaluaed after 6 months.Results The incidence of adverse events in the three bioequivalence tests before and after the risk prevention measures was 48.98% and 28.57%,respectively.Conclusion Targeted risk prevention measures should be implemented in all aspects of bioequivalence clinical trials to reduce the occurrence of adverse events and protect the safety of subjects.
作者
郭彩会
孙雪
李颖
李宵
宋浩静
王祁民
董占军
GUO Cai-hui;SUN Xue;LI Ying;LI Xiao;SONG Hao-jing;WANG Qi-min;DONG Zhan-jun(Department of Pharmacy,Hebei General Hospital,Shijiazhuang 050051)
出处
《中南药学》
CAS
2020年第12期2060-2064,共5页
Central South Pharmacy
