目的 探讨中药注射剂不良反应（ADR）的发生特点与规律，为中药注射剂的临床合理使用，及时预防与处理ADR提供参考。方法 收集上海中医药大学附属曙光医院2015年1月—2019年12月报告国家不良反应监测系统的中药注射剂引起的ADR报告206例，运用回顾性分析方法进行统计分析。结果 206例中药注射剂ADR报告共涉及28个品种，男性88例，女性118例，年龄>60岁患者最多（62.62%）；ADR排名前3的注射剂分别是华蟾素注射液、刺五加注射液和复方苦参注射液，抗肿瘤类中药注射剂ADR发生率最高；用药30 min内即发生的ADR最多（23.79%），中药及2种以上中药联用致ADR占35.44%，ADR临床表现以累及皮肤及附件损害为常见（35.83%）。结论 中药注射剂ADR的发生可能与患者年龄、药品种类、联合用药等多种因素相关。沟通、反馈药品ADR发生特点和规律，有利于临床医生重视药品ADR，确保患者合理安全用药。

Objective To explore the feature and regularity of adverse drug reactions (ADRs) caused by traditional Chinese medicine injection, so as to provide reference for the rational clinical use of traditional Chinese medicine injection and prevent adverse reactions as early as possible. Methods A retrospective analysis was performed on 206 traditional Chinese medicine injection cases with all ADR reports which were reported to the National Drug Adverse Reaction Monitoring System from January 2015 to December 2019. Results A total of 28 traditional Chinese medicine injection were involved among the 206 traditional Chinese medicine injection of ADR reports from Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, there were 88 males and 118 females, and the majority were patients aged over 60 years old (62.62%). The most of ADR occureed in Huachansu Injection, followed by Ciwujia Injection, and Compound Kushen Injection. The incidengce of ADR induced by anti-tumor traditional Chinese medicine injection took the lead. The most ADRs occurred within 30 min, accounting for 23.79%. The ADR induced by the combination of two or above two traditional Chinese medicine injection accounted for 35.44%. Skins and accessories were the major clinical manifestations (35.83%). Conclusion The occurrence of traditional Chinese medicine injection ADR may be associated with age, classes of drugs, and the combinations of drugs. Communicate and feedback the regularity and characteristics of ADR, which is beneficial for clinicians to strengthen their vigilance against ADR and ensure rational medication and safety of patient.

R969.3

上海市科学技术委员会科研项目（16DZ192010B）