中药注射剂安全性现状与挑战  

Status and Challenges of the Safety of Traditional Chinese Medicine Injections

作　　者：刘兆平[1] 汪怀山[2] 

机构地区：[1]山东大学新药评价中心,济南250012 [2]山东大学药学院,济南250012

出　　处：《临床药物治疗杂志》2009年第2期18-22,62,共6页Clinical Medication Journal

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。本文以中国期刊全文数据库等为依托,调研了1989—2008年有关中药注射剂不良反应的有关文献及报道,分析了中药注射剂安全性现状与挑战,并在中药注射剂的临床使用、质量控制和安全性评价等方面提出了应对策略。Traditional Chinese Medicine Injections （TCMI） are special in the treatment of some severe and acute diseases and infectious diseases because of their rapid effect and high efficiency. However, some ad- verse reactions of TCMI have been reported with their wide use in clinic recently, and the concerns to the safety of TCMI is highly focused on. On the basis of the Chinese journal full- text data base, literatures about the adverse effects of TCMI from 1989 to 2008 were searched and investigated. The strategy in the clinical use, quality control and safety evaluation of TCMI are raised according to the result of analysis of the safety state and developmemt of TCMI.

关 键 词：中药注射剂:安全性评价 过敏反应 不良反应 

分 类 号：R203[医药卫生—中医学] R944.11