目的 了解北京中医药大学东方医院中药注射剂不良反应（ADR）发生情况，掌握ADR发生特点，为临床安全合理用药提供依据。方法 检索该院上报至国家药品不良反应监测系统、发生于2011年6月-2016年5月的中药注射剂ADR，进行回顾分析。结果 18种中药注射剂导致135例ADR，其中男性50例、女性85例；主要为清热解毒类和活血化瘀类中药注射剂；存在与中药注射剂、抗生素、生物制品等药物联用，超剂量使用和配液不当等不合理用药；临床表现以皮肤及其附件损害较多；所有ADR患者均痊愈。结论 审慎合理用药，规范临床使用操作，开展临床再评价工作，是降低中药注射剂ADR发生率、安全合理用药的关键。

Objective To learn the adverse drug reaction (ADR) of traditional Chinese medicine injection (TCMI) in Dongfang Hospital of Beijing University of Chinese Medicine (BUCM), to master the characteristics of the occurrences of ADR, and to provide basis for safe and rational clinical drug use. Methods Locating all the reported ADR cases by Dongfang Hospital of BUCM to national ADR monitoring system from June 2011 to May 2016, and make retrospective analysis of them. Results Eighteen kinds of TCMI that caused the total 135 ADR cases, 50 out of all the 135 instances were male patients, whilst the rest 85 instances were female patients; The main kinds of TCMI that caused ADR problems were TCMI for relieving heat and toxic material and TCMI for promoting blood circulation to remove blood stasis; TCMI was used jointly with antibiotics and biological product etc.; And the circumstances of ultra-dose and improper infusion allocation existed. The clinical manifestation included many skin lesion cases. All the patients suffered from ADR were cure. Conclusion Prudent and rational use of drugs, standardized clinical use procedure, and clinical re-evaluation are key aspects to lower the incidence rate of ADR of TCMI and to safe and rational use of drugs.

国家自然科学基金面上项目“基于三维立体数据库和多维数据挖掘的中药注射剂致过敏反应关键影响因素研究”（81473547）