邓志清 罗忠勇 贺少仕 禹琦

[摘要]目的分析娄底市中心医院中药注射剂不良反应/事件（ADR/ADE）发生的特点，为临床合理用药提供参考。方法对我院2014年1月至2019年12月上报的296例中药注射剂 ADR/ADE 报告进行统计分析，包括患者性别与年龄，引发 ADR/ADE 的药品分布，ADR/ADE 累及器官/系统的主要临床表现，严重 ADR/ADE 的转归情况等。结果在296例 ADR/ADE 报告中，共涉及药物品种22种，出现例次排名前3位的为注射用血塞通、注射用血栓通、参麦注射液;ADR/ADE 主要累及的器官/系统为皮肤及其附件损害（184例次，占39.57%）;严重的 ADR/ADE 有18例（6.08%），17例痊愈，1例好转，主要临床表现为高热、寒战、血压降低、呼吸困难等全身性损害。结论中药注射剂因成分复杂和临床不合理使用易发生 ADR/ADE，临床上应采取辨证论治、处方前置审核、输液安全监测等措施减少 ADR/ADE 的重复发生。

[关键词]药品不良反应;药品不良事件;合理用药;回顾性分析

[中图分类号] R285.6  [文献标识码] A   [文章编号]2095-0616（2021）24-0137-05

An analysis of reports of 296 TCM injection adverse reactions or events in a hospital from 2014 to 2019

DENG  Zhiqing    LUO  Zhongyong    HE  Shaoshi    YU  Qi

Pharmacy Department， Loudi Central Hospital of Hu'nan Province， Hu'nan， Loudi 417000， China

[Abstract] Objective To analyze the characteristics of the incidence of traditional Chinese medicine （TCM） injection adverse reactions or events （ADRs/ADEs） in Loudi Central Hospital， and to provide reference for rational use of medicine in clinical practice. Methods A total of 296 TCM injection ADR/ADE reported in our hospital from January 2014 to December 2019 were statistically analyzed， covering the patients' gender and age， the distribution of medicines that incur ADR/ADE， main clinical manifestations of ADR/ADE involving organs or systems， the prognosis of severe ADR/ADE， etc. Results Among the 296 ADR/ADE reports， 22 medicine varieties were involved， and the top three were Sanqi Panax Notoginseng for Injection， hrombus scavenger injection and Shenmai injection. The main ADR/ADE involving organs or systems were skin and its accessories that had been injured （184 cases which accounted for 39.57%）. There were 18 cases （6.08%） of severe ADR/ADE， among which 17 cases were cured and 1 case was ameliorated， with the clinical manifestations being mainly systemic damage such as high fever， chills， decreased blood pressure， dyspnea， etc. Conclusion TCM injections are prone to ADR/ADE due to complex components and irrational clinical use， and measures such as treatment based on syndrome differentiation， pre-prescription review， infusion safety monitoring， etc. should be taken in clinical practice to reduce the recurrence of ADR/ADE.

[Key words] Adverse medicine reaction; Adverse medicine event; Rational use of medicine; Retrospective analysis

中藥注射剂是利用中医药理论与现代生产工艺相结合而制成的中药制剂。近年来，中药注射剂因安全性频发、修订说明书、医保支付限定范围、重点监控等政策影响，临床应用大受影响。2018年《国家药品不良反应监测年度报告》显示中药不良反应/事件（ADR/ADE）报告中静脉注射给药占48.7%[1]。王丹等[2]对2009年至2018年《国家药品不良反应监测报告》统计发现，近十年中药注射剂的不良反应发生趋势仍在上升。因此，客观理性认识中药注射剂，以中医临床为导向中药安全性评价、上市后再评价研究、合理使用是当务之急。……