中国中药杂志

2014, v.39(20) 3889-3898

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中药注射剂的不良反应研究进展
Research progress of adverse reactions of traditional Chinese medicine injections

谭乐俊;王萌;朱彦;
TAN Le-jun;WANG Meng;ZHU Yan;Tianjin State Key Laboratory of Modern Chinese Medicine,Tianjin University of Traditional Chinese Medicine,Engineering Research Center of Modern Chinese Medicine Discovery and Preparation Technique;Tianjin International Joint Academy of Biotechnology and Medicine;

摘要(Abstract):

中药注射剂是我国创新型的一类药物,具有生物利用度高、作用迅速等特点。中药注射剂在临床上应用广泛,在治疗心脑血管疾病、感染性疾病、恶性肿瘤等疾病时显示出突出的治疗效果。随着中药注射剂应用范围的扩大,其不良反应的报道也日趋增多,从而使得中药注射剂的安全性受到质疑。针对于此,该文对近5年100余篇文章进行综述,较为全面的总结了常见的中药注射剂不良反应类型、产生不良反应的原因及中药注射剂安全性评价中关于不良反应成因的主要研究方法,为中药注射剂的临床合理应用提供详实可靠的数据支持。中药注射剂不良反应按涉及的器官系统和临床表现分类主要有过敏反应、呼吸系统损害、消化系统损害、心血管系统损害、泌尿系统损害等。从生产到使用的各环节中,引起中药注射剂安全性问题的因素以原料因素、制剂因素、调剂使用过程因素为主。中药注射剂不良反应成因的研究方法有很多,目前常用的流行病学研究方法包括描述性研究、分析性研究和实验性研究。该文通过对中药注射剂的不良反应研究进行系统梳理,对其现状、成因及研究方法加以总结,对中药注射剂临床安全合理使用具有一定指导意义。
Traditional Chinese medicine injections( TCMIs) originated in china,which was fast-acting with high bioavailability. TCMI is applied widely in clinic since it plays an important role for therapy severe and acute disease,such as cardiovascular diseases( CVD),infectious diseases,malignancy,and etc. However,the adverse reactions reported of TCMIs are increasing in recent years. For this,the review summarized systematically the reports and researches of adverse drug reactions( ADRs) of TCMIs according to about 100 literatures in the nearly five years. The ADR of TCMIs mainly includes allergic reaction,respiratory damage,digestive system damage,cardiovascular system damage and urinary system damage,and etc. The main causes are relative with complexity,uncertainty and instability of the drug material. Influence of excipients,pharmaceutical technologies,drug combination and application method was also discussed. There are many methods on adverse reactions of TCMIs,including descriptive studies,analytical epidemiology and experimental studies. This article provided necessary information for reasonable application of TCMIs in clinical practice.

关键词(KeyWords): 中药注射剂;不良反应;联合用药;安全性;稳定性
traditional chinese medicine injections(TCMIs);adverse reactions(ADRs);drug combination;safety;stability

Abstract:

Keywords:

基金项目(Foundation): 国家自然科学基金青年基金项目(81202850);; 天津市高等学校创新团队培养计划项目(TD12-5031);; 科技部国际合作项目(2013DFA31620)

作者(Author): 谭乐俊;王萌;朱彦;
TAN Le-jun;WANG Meng;ZHU Yan;Tianjin State Key Laboratory of Modern Chinese Medicine,Tianjin University of Traditional Chinese Medicine,Engineering Research Center of Modern Chinese Medicine Discovery and Preparation Technique;Tianjin International Joint Academy of Biotechnology and Medicine;

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