2018—2020年常州市儿童医院中药注射剂不良反应报告分析

Analysis on adverse drug reaction induced by traditional Chinese medicine injections in Changzhou Children’s Hospital from 2018 to 2020

目的探讨常州市儿童医院2018—2020年中药注射剂引起药品不良反应(ADR)发生规律及特点,为临床合理使用中药注射剂提供参考。方法采用回顾性研究的方法,对常州市儿童医院2018—2020年收集上报国家药品不良反应监测中心的98份中药注射剂ADR报告进行统计分析。结果 98例ADR报告中,男性患儿58例(59.18%),女性患儿40例(40.82%),16岁年龄段患儿ADR构成比最高,占86.7%。ADR涉及药物均为清热解毒类中药注射剂,包括喜炎平注射液、热毒宁注射液和痰热清注射液,分别占74.49%、23.47%、2.04%;累及器官/系统以皮肤及其附件为主,占95.92%;不良反应发生时间主要集中在用药3 d之内(55.10%)。ADR多为一般不良反应(98.99%),且经治疗后大多痊愈。结论临床医师和药师应重视儿童中药注射剂的合理使用,加强ADR的监测和上报工作,保证用药安全。

Objective To analyze the occurrence and characteristics of adverse reactions(ADR) of traditional Chinese medicine(TCM) injections in Changzhou Children’s Hospital from 2018 to 2020, and to provide reference for the rational use of TCM injections. Methods A retrospective study was used to make statistical analysis of 98 ADR reports of TCM injections collected and reported to the National Center for Adverse Drug Reaction from 2018 to 2020. Results Among the 98 cases of ADR reported, there were 58 males(59.18%) and 40 females(40.82%). The proportion of ADR in children aged 1 — 6 years was the highest, accounting for 86.7%.The drugs involved in ADR were antipyretic and detoxifying TCM injection, including Xiyanping Injection, Reduning Injection and Tanreqing Injection, accounting for 74.49%, 23.47%, and 2.04%, respectively. Skin and its accessory reactions were the most prominent in the involved organs/systems, accounting for 95.92%. The occurrence time of ADR was mainly within 3 d(55.10%). Most ADRs were mostly general adverse reactions(98.99%), and most of them were cured. Conclusion Clinicians and pharmacists should pay attention to the rational use of TCM injections for children, strengthen the monitoring and reporting of ADR, and ensure the safety of medication.