中药注射剂的不良反应探讨及预防措施

Investigation on the adverse reactions of Chinese medicine injection and the preventive measures

目的：探讨中药注射剂的不良反应，并进行分析和统计，提出相应的预防措施。方法：对2011年6月-2013年6月某院收集的中药注射剂不良反应的病历报告共130例，对患者的性别、年龄、不良反应史、不良反应累及系统、临床表现、中药注射剂品种、给药途径等进行分析。结果：130例发生中药注射剂不良反应的患者中，男女比例为1．13：1；既往有不良反应史者14例，占10．8％，无不良反应史者91例，占70％；年龄为60~80岁的患者最多，共57例，占43．8％；所累及的系统主要为全身性损害，共68例，占52．3％，其次为皮肤及附件系统，共28例，占21．5％，再次为消化系统，共10例，占7．7%；发生不良反应的中药注射剂排名前十的分别为疏血通注射液、血塞通注射液、生脉注射液、丹参注射液、参麦注射液、双黄连注射液、刺五加注射液、鱼腥草注射液、痰热清注射液和灯盏细辛注射液；给药途径为静脉滴注者，共126例，占96．9G。结论：应当加大中药注射剂的安全评价工作，完善中药注射剂临床前的安全评价体系以及上市后安全性再评价，对特殊人群使用初期应进行密切观察。

OBJECTVE To explore and analyze the adverse reactions of traditional Chinese medicine injection, in order to propose appropriate preventive measures. METHODS 130 cases of reports on the adverse reactions of traditional Chinese medi- cine injection received in our hospital from Jun 2011 to Jun 2013 were collected, the patient＇s gender, age, adverse reaction his- tory, adverse reactions-involved systems, clinical manifestations, traditional Chinese medicine injections varieties, route of ad- ministration were analyzed. RESULTS The ratio of male to female in 130 cases of adverse reactions patients using traditional Chinese medicine injection was 2.13： 1. 14 Patients had previous history of adverse reactions （10. 8%）, while 9l cases had no history of adverse reactions （70%）. Adverse reactions-involved systems mainly were systemic damage occurred in 68 cases （52. 3%）, followed by skin and attachment system in 28 cases （21.5%）, the digestive system in 10 cases （7. 7%） The top 10 of adverse reactions of TCM injections were Shu Xue Tong injection, XST injection, Shengmai injection, Danshen injection, SHL injection, Acanthopanax injection, fish fishy grass injection, Tanreqing injection and Erigeron injectiom the involved- route of administration was mainly intravenous injection with 126 cases, which accounting for 96. 9%. CONCLUSION The safety evaluation of traditional Chinese medicine injection should be increased; TCM injections preclinical safety evaluation sys- tem and post-marketing safety re-evaluation should be improved, and for the special populations they should be closely observed during the initial period.