美国FDA“迷你哨点监测研究计划”的解读  

Introduction of U.S.FDA mini-sentinel program

作　　者：谢雁鸣[1] 廖星[1] 申浩[1] 

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700

出　　处：《中国中药杂志》2013年第5期768-772,共5页China Journal of Chinese Materia Medica

基　　金：中国中医科学院第6批自主选题项目(Z0215);2012年度留学人员科技活动项目择优项目(Z0241)

摘　　要：中药注射剂上市前需经过I,II,III期临床试验,以检测其是否安全与有效,但是这些临床试验多限于有限人群的标准治疗使用,而且是严格按照试验方案进行。真实世界中,中药注射剂上市后的临床应用远比实验环境下的使用更为多变,对开展中药注射剂上市后再评价的要求也更为严格。上市前研究所获得的仅是中药注射剂最基本的疗效和安全数据,有很大局限性。该文通过对美国FAD"迷你哨点研究计划"进行解析,以期为中药注射剂上市后开展大样本的临床安全监测研究提供参考。In China, all of traditional Chinese medicine injections should pass clinical trials I, II and III for their safety and effectiveness before coming into the market. However, these clinical tests are mostly restricted to standard treatment for specific groups, and conducted in strict accordance with clinical trial protocols. In the real world, as there are more changes in the post-market clinical application of traditional Chinese medicine injections than in the experiment environment, regulatory bodies set stricter requirements for the post-market re-assessment on traditional Chinese medicine injections. Early-stage studies could only provide the most fundamental and restricted data of efficacsy and safety of traditional Chinese medicine injections. In this essay, mini-sentinel program of U. S. FDA is introduced in order to provide reference for large-sample-size post-market clinical safety monitoring studies for traditional Chinese medicine injections.

关 键 词：美国FDA 迷你哨点研究 中药注射剂 上市后监测 

分 类 号：R95[医药卫生—药学]