三级医院5年162例中药注射剂不良反应报告分析

Analysis of 162 Untoward Effect Reports on Traditional Chinese Medicine Injection in Tertiary Hospitals During 5 Years

目的分析我院中药注射剂不良反应的发生规律及特点,为临床合理使用中药注射剂提供参考。方法分析我院2009~2013年期间上报药品不良反应监测中心的病例报告,对发生不良反应患者的年龄、性别、原发疾病、发生不良反应的时间、临床表现、涉及的注射剂品种、合并用药情况进行分析。结果导致不良反应的中药注射剂共涉及18种,年龄、性别、有无药物过敏史都是中药注射剂产生不良反应的重要因素。刺五加注射液、莪术油注射液、生脉注射液、红花注射液、注射用血塞通致不良反应位列前5位。不良反应的临床表现主要是皮肤过敏反应（46.38%）,严重的不良反应有过敏性休克（3.7%）等。结论重视中药注射剂致不良反应的相关因素,改进生产工艺,提高质量,坚持合理用药,以期最大限度地避免中药注射剂不良反应的发生。

Objective Analysis the regularity of outbreak and characteristic of the untoward effect for traditional Chinese medicine injection in our hospital, and provide the reference for intelligent use of traditional Chinese medicine injection in clinical. Methods Analysis the case report referred to Center of Adverse Drug Reaction during 2009 - 2013, analysis the age, gender, primary disease, time of untoward effect, clinical feature, referred variety of traditional Chinese medicine injection, condition of drug combination. Results The variety of traditional Chinese medicine injection which lead to untoward effect is 18 kinds, age, gender and have or not drug allergy history are all key factors of untoward effect. Injection of acanthopanax, oil of zedoary turmeric, pulse-activating, safflower carthamus, Xuesetong lead to untoward effect ranked the first 5 places. Main clinical display of untoward effect is cutaneous anaphylaxis（46.38%）, serious untoward effect is allergic shock（3.7%）. Conclusion Pay attention to relevant factor for untoward effect of traditional Chinese medicine injection, improve the manufacturing technique, improve the quality, insist rational drug use, view to avoid occur of untoward effect for traditional Chinese medicine injection.