74例中药注射剂不良反应报告分析与探讨

Retrospective analysis and discussion on 74 cases of adverse reactions of traditional Chinese medicine injection

中药注射剂作为一种起效快速的现代剂型药品,在临床中的使用率日益增加,但同时中药注射剂的安全性也日益引起关注。该文通过对北京中医药大学第三附属医院2007-2016年间收集的74例中药注射剂不良反应报告进行回顾性分析,结果显示发生不良反应的患者男女比例为0.54∶1,平均年龄62.5岁,共涉及中药注射剂21种,其中涉及理血剂的报告最多,不良反应发生率最高的前4种中药注射剂为:痰热清注射液、丹红注射液、舒血宁注射液、注射用血塞通,不良反应的临床表现前3位是皮肤及其附件损害、循环系统损害和神经系统损害。对中药注射剂不良反应发生的潜在原因进行分析,认为个体差异、药物、辅料、溶媒、中医辨证等5个方面可能是中药注射剂不良反应发生的主要原因。为减少中药注射剂不良反应的发生,建议临床药师参与到中药注射剂在医院内的应用管理当中,生产企业需要加强药品的全生命周期管理,同时药品监管部门还需要不断完善药品管理办法,鼓励中药注射剂向高质量发展。

As a modern dosage form drug with rapid effect, traditional Chinese medicine(TCM) injection has been more and more used in clinical practice. Meanwhile the safety of TCM injection has attracted more and more attention. The retrospective analysis on 74 cases of adverse reaction of TCM injections collected from 2007 to 2016 in the Third Affiliated Hospital of Beijing University of Chinese Medicine showed that the proportion of men and women with adverse reactions was 0.54∶1;the average age was 62.5 years old;21 kinds of TCM injections were involved. Among them, the most reported were blood-regulating agents. The top four kinds of TCM injections with highest adverse drug reactions(ADRs) were Tanreqing injection, Danhong Injection, Shuxuening Injection and Xuesaitong for injection. The top three clinical manifestations of adverse reactions were lesions of skin and its appendages, damage of circulatory system and damage of nervous system. The potential causes of the adverse reactions of TCM injections were analyzed, and it was believed that individual difference, medicine, pharmaceutical excipients, solvent and TCM syndrome differentiation may be the main five causes for the adverse reactions of TCM injections. In order to reduce the adverse reactions of TCM injections, it is suggested that the clinical pharmacists should participate in the application management of TCM injections in the hospital;the production enterprises shall strengthen the whole life cycle management of the drugs;and at the same time, the drug control and administration authorities should improve the drug management methods constantly and encourage the development of TCM injections to the high quality level.