中药注射剂不良反应分析及防治对策

摘要

中药注射剂(TCMI)在临床应用广泛,疗效确切,但随着其应用的发展,不良反应也日益被关注.有关TCMI不良反应报道的不断增加,人们越来越担心其安全性,TCMI的发展正面临着前所未有的严峻挑战,如何以理性的态度来看待TCMI及其安全性,为TCMI寻找符合时代精神、切合科学发展规律的道路是目前中药研究者的迫切任务.本文通过分析TCMI常见不良反应的表现及产生原因,对药物组成、安全性、有效性、药物经济学、质量标准、与化学药的联合应用和TCMI的上市后的再评价问题提出相应的建议,为提高TCMI质量及安全合理用药提供参考,减少其临床应用中不良反应的发生.%Traditional Chinese medicine injections (TCMI) used in clinic is effective and wide. But with the development and use, the related TCMI adverse reaction report unceasingly increase, people worried more and more about its security, the development of TCMI is facing the unprecedented strain challenge, how to regard the TCMI and its security by the ra -tional manner, seek for the TCMI conforms to the spirit of the age, suit the science law of development the path is the urgent duty of researcher of traditional Chinese medicine. This article by analyzing the characteristics on adverse drug reac -tion of TCMI, in order to put forward the some problems from component of drug, safety, efficiency, pharmacoeconomics, quality criteria, drug combination and drug reevaluation for providing a reference to quality improvement and rational drugs use of TCMI, and reduce or avoid ADR events.