中药注射剂安全性现状与评价方法的研究.pdf

中药注射剂安全性现状与评价方法的研究 1* 刘兆平 ，李中港，汪怀山，秦慧迪 （山东大学新药评价中心，山东济南，250012 ） 摘要：中药注射剂是我国独创的新剂型，由于其起效快、作用强，在危重疾病急 救及感染性疾病等的治疗上具有一定的优势。然而，近年来，随着中药注射剂在 临床上的广泛应用，不良反应报道也逐渐增多，安全性问题越来越突出。本研究 调研了中药注射剂不良反应的有关文献报道，分析了中药注射剂的安全性现状， 并提出了中药注射剂安全性评价的若干方法，希望能为解决中药注射剂的安全性 问题提供一些研究思路。 关键词：中药注射剂；药物不良反应；安全性评价；类过敏反应；代谢组学 The state and safety evaluation of Traditional Chinese Medicine Injection 1 LIU Zhao-Ping *, LI Zhong-Gang, WANG Huai-Shan, QIN Hui-Di (Center for New Drug Evaluation, Shandong University, Jinan 250012, China) Abstract: Traditional Chinese Medicine Injections(TCMI ）originated in China are special in the treatment of some severe and acute diseases and infectious diseases because of their rapid effect and high efficiency. However, more adverse reactions of TCMI have been reported along with their wide use in clinic recently, and the concerns to the safety of TCMI are much focused. On the basis of the Chinese journal full-text data base, literatures about the adverse effects of TCMI were searched and investigated. The safety state of TCMI was analyzed and several safety evaluation methods were offered. We hope it could supply any research ideas for solving the safety problems of TCMI. 基金项目：国家科技部支撑计划资助项目（2006BAI14B05 ）. 作者简介：刘兆平（1958-），男，山东省济宁人，教授，硕士研究生导师，研究方向为药物 毒理学。 *联系作者.E-mail: liuzhaoping@sdu.edu.cn Key words: Traditional Chinese Medicine Injection; drug adverse reaction; safety evaluation; anaphylactoid reaction; metabolomics Foundation item ：The project supported by The National Science and Technology Department Pilar Program （2006BAI14B05 ） *Corresponding author. 中药注射剂是我国独创的新剂型，已广泛应用于危重疾病的急救及感染性、 心脑血管和恶性肿瘤等疾病的治疗，是制药产业开拓未来国际市场独具优势的项 目之一，存在着巨大的市场需求。但是中药注射剂临床不良反应报道日益增加， 其不良反应可能