Xie Yan-Ming, Liao Xing, Shen Hao
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Zhongguo Zhong Yao Za Zhi. 2013 Mar;38(5):768-72.
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 efficacy 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.
在中国，所有中药注射剂在上市前都应通过I、II、III期临床试验以确保其安全性和有效性。然而，这些临床试验大多局限于针对特定群体的标准治疗，并严格按照临床试验方案进行。在现实世界中，由于中药注射剂上市后的临床应用变化比实验环境中更多，监管机构对中药注射剂上市后再评估设定了更严格的要求。早期研究只能提供中药注射剂疗效和安全性最基本、最有限的数据。本文介绍了美国食品药品监督管理局（FDA）的微型哨点计划，以期为中药注射剂大样本量上市后临床安全性监测研究提供参考。
