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目的:了解中药注射剂致过敏性休克发生的特点,为临床应用提供参考。方法:检索江苏省药品不良反应监测中心2004-2009年数据库,对患者的一般情况、发生时间、怀疑药品等进行分析。结果:2004-2009年共发生中药注射剂致过敏性休克225例,绝大部分病例发生在用药10 min内。男女比例相当,50～59岁年龄段病例数最多,占21.33%。居前10位的药物分别是:参麦注射液、双黄连注射液、炎琥宁注射液、鱼腥草注射液、莪术油注射液、脉络宁注射液、清开灵注射液、生脉注射液、血塞通注射液和穿琥宁注射液。绝大部分病例经治疗后好转或治愈,其中死亡3例。结论:应严格掌握中药注射剂的用药指征,密切关注用药后反应,确保用药安全。
Objective: To understand the characteristics of anaphylactic shock induced by traditional Chinese medicine injection and provide reference for clinical application. Methods: The database of ADR surveillance center in Jiangsu Province was searched from 2004 to 2009, and the general situation, occurrence time and suspected drugs of the patients were analyzed. Results: In 2004-2009, there were 225 cases of anaphylactic shock caused by traditional Chinese medicine injections, the vast majority of cases occurred within 10 min. The proportion of males and females is quite high, with the highest number in the age group of 50 to 59 years, accounting for 21.33%. The top 10 drugs were Shenmai Injection, Shuanghuanglian Injection, Yanhuoning Injection, Houttuynia Injection, Curcuma Oil Injection, Mailuoning Injection, Qingkailing Injection and Shengmai Injection Liquid, Xuesaitong injection and Chuanhuning injection. The vast majority of cases improved or cured after treatment, of which 3 died. Conclusion: It is necessary to strictly grasp the indications for the use of traditional Chinese medicine injections and pay close attention to the reaction after medication to ensure the safety of medication.