中药注射剂超敏反应评价和风险控制相关问题的思考

Thoughts on the Related Issues of Hypersensitivity Evaluation and Risk Control of Traditional Chinese Medicine Injection

中药注射剂安全性再评价工作有关文件自2009年发布至今十余年,落实工作推进缓慢,既有管理上的难度,也有方法学上的瓶颈问题未解决。笔者从中药注射剂的临床应用、不良反应特点入手,分析总结中药注射剂不良反应性质和评价方法等共同关注的问题,同时介绍笔者课题组围绕中药注射剂超敏反应特点、评价新方法及产品风险控制等相关问题开展的研究,旨在为中药注射剂安全性再评价的机构和企业提供参考。

Reevaluation of traditional Chinese medicine injections(TCMI)has not made substantial progress over the last more than ten years since 2009 due to the difficulties of management and the lack of right methodology.This paper analyses the common concerns on the characteristics and nature of adverse reactions of TCMI,and the current problem with the methods of preclinical safety evaluation.The authors also introduce their researches on hypersensitivity characteristics,the new methods on safety evaluation and risk control of TCMI in the hope of providing reference for the institutions and enterprises in the safety reevaluation of TCMI.