心血管类中药注射剂的不良反应分析

Analysis of Adverse Drug Reactions of Traditional Chinese Medicine Injection for Cardiovascular Disease

目的总结心血管类中药注射剂不良反应(ADRs)的发生情况,并探讨其相关的影响因素。方法收集2003年1月至2014年3月心血管类中药注射剂的ADRs病例报告,对其年龄、性别、剂型、品种、临床表现、转归、用药方法合理性等进行统计分析。结果参麦、血塞通、灯盏花素等13种注射液可引起ADRs,可累及神经系统、皮肤及其附属器官、循环系统、消化系统等。从年龄分布显示,60岁以上患者发生ADRs的构成比较高;部分报告在剂量、溶媒、疗程等方面存在不合理用药的问题。结论心血管类中药注射剂ADRs的临床表现具有多样性,不合理用药可能是导致ADRs发生的一个重要因素。

Objective To summarize the incidence of adverse drug reactions（ADRs） of traditional Chinese medicine injection for cardiovascular disease and to investigate the related influence factors. Methods We retrospectively investigated ADRs of traditional Chinese medicine injection for cardiovascular disease in our hospital from January of 2003 to March of 2014. Moreover, the age, sex, dosage form, ADRs types, clinical manifestations, prognosis and rationality of medication methods were analyzed. Results Thirteen kinds of traditional Chinese injections such as Shenmai, Xuesaitong and Breviscapin could give rise to ADRs, and ADRs were involved in various systems such as nervous system, skin and its accessory organ, circulatory system and digestive system. In addition, the patients over 60 years old were prone to have ADRs, and unreasonable issues of the dosage, solvent, course of treatment may cause ADRs. Conclusion ADRs of traditional Chinese medicine injection for cardiovascular disease present various clinical manifestations, and irrational use of medicine is one important factors of ADRs.