120例中药注射剂致药品不良反应报告分析

Analysis on 120 Cases of Adverse Drug Reactions Caused by Traditional Chinese Medicine Injection

目的:了解该院10年间中药注射剂致药品不良反应(ADR)发生情况,探讨其ADR的发生特点,促进临床合理应用中药注射剂,规避用药风险。方法:检索2010—2020年该院上报至国家ADR监测系统的涉及中药注射剂的ADR报告,进行回顾性统计分析。结果:共上报120例中药注射剂致ADR报告,一般的ADR 118例(包括新的、一般的ADR 10例),严重的ADR 2例;男女患者比例为0.48∶1;≥60岁的老年患者86例(占71.67%);有药物过敏史者10例;涉及10种中药注射剂,发生ADR病例数排序居前3位的中药注射剂为丹红注射液、醒脑静注射液和痰热清注射液;ADR的临床表现以皮肤及其附件损害较多;82例ADR(占68.33%)在用药第1日发生,其中32例ADR(占26.67%)在用药后30 min内出现;存在超剂量用药情况。结论:应规范、合理应用中药注射剂,加强对中药注射剂的ADR监测,促进安全用药。

OBJECTIVE:To investigate the occurrence of adverse drug reactions(ADR)induced by traditional Chinese medicine(TCM)injection in this hospital in the past 10 years,explore the characteristics of ADR,so as to promote clinical rational application of TCM injection and to avoid medication risks.METHODS:ADR cases related to TCM injection in the National ADR Monitoring System reported by this hospital from 2010 to 2020 were retrieved and retrospectively analyzed.RESULTS:Among the 120 reports of ADR induced TCM injection,118 cases(including 10 cases of new and general ADR)of general ADR,2 cases of severe ADR;the ratio of male to female patients was 0.48∶1;86 cases(71.67%)were elderly patients≥60 years old;10 cases had a history of drug allergy;10 categories of TCM injection were involved,and the top 3 TCM injection ranked by the number of ADR cases were respectively Danhong injection,Xingnaojing injection and Tanreqing injection;the clinical manifestations of ADR were mostly damage on skin and its accessories;82 cases of ADR(68.33%)occurred on the first day of drug administration,of which 32 cases(26.67%)occurred within 30 min after drug administration;and there were cases of overdose.CONCLUSIONS:The application of TCM injection should be standardized and rationalized,and the monitoring on ADR induced by TCM injection should be strengthened to promote safe medication.