《新型冠状病毒肺炎诊疗方案(试行第八版)》收录的中药注射剂的不良反应分析

Analysis of Adverse Drug Reactions Caused by TCM Injections in Diagnosis and Treatment Protocol for COVID-19(Trial Version 8)

目的:归纳和分析《新型冠状病毒肺炎诊疗方案(试行第八版)》中收录的8种中药注射剂的不良反应(adverse drug reaction,ADR),为临床诊疗过程中安全、合理使用中药注射剂提供参考。方法:分别以8种中药注射剂名称和“不良反应”为主题关键词,检索2010年1月—2019年12月在中国知网数据库、万方数据库和维普中文科技期刊数据库公开发表的文献,并进行分析。结果:共检索到168例发生相应中药注射剂的不良反应病例,其中39.88%的患者有慢性基础疾病,13.69%有过敏史,53.57%存在联合静脉用药情况,仅4.44%的患者记录了规范的冲管操作;ADR主要累及全身、呼吸系统、心血管系统、皮肤及皮肤附件、神经系统,其中85.12%为过敏或类过敏反应。结论:中药注射剂成分复杂,在COVID-19诊疗过程中应警惕其不良反应的发生,规范输液治疗,注重用药监护,保障患者的用药安全。

Objective:To summarize and analyze the adverse drug reactions of 8 kinds of TCM injections included in the Diagnosis and Treatment Protocol for COVID-19(Trial Version 8) so as to provide reference for the safe and rational use of TCM injections during clinical diagnosis and treatment. Methods: The literatures published in CNKI, Wanfang Database and CQVIP database from January 2010 to December 2019 were searched and analyzed with the names of 8TCM injections and "adverse reaction" as the subject keywords. Results: A total of 168 cases of adverse reactions of TCM injections were searched, among which 39.88% patients had chronic underlying diseases, 13.69% had allergic history, 53.57% had combined intravenous medication, and only 4.44% patients recorded standard flushing operation. ADR mainly affected the whole body, respiratory system, cardiovascular system, skin and skin accessories, and nervous system,of which 85.12% were allergic or anaphylactic reactions. Conclusion: The compositions of TCM injections are complex,so it is necessary to be alert to the occurrence of ADR, standardize infusion therapy and pay attention to medication monitoring during the diagnosis and treatment of COVID-19 so as to ensure the safety of medication for patients.