综合医院中药注射剂不良反应探讨和监督管理  

Discussion and supervision and management of adverse reactions of traditional chinese medicine injections in general hospitals

作　　者：牟景丽 陈婷 陈萍 玉鸾 顾腾 周平 MU Jing-li;CHEN Ting;CHEN Ping(Department of pharmacy,Liupanshui People’s Hospital,Liupanshui 553000,China)

机构地区：[1]六盘水市人民医院药学部,贵州六盘水553000

出　　处：《中国处方药》2024年第7期129-132,共4页Journal of China Prescription Drug

基　　金：六盘水市科技计划项目(52020-2021-0-3-35)。

摘　　要：目的对综合医院中药注射剂不良反应发生的特点及原因进行分析,为临床合理应用中药注射剂及管理提供参考,规避临床用药风险。方法回顾性统计分析六盘水市人民医院2020~2021年上报国家不良反应监测系统中的中药注射剂不良反应报告,对发生不良反应的特点及原因进行分析,并实施有效的管理对策。结果实施管理前(2020~2021年):皮肤及其附件(57.14%)、循环系统(18.37%)、消化系统(16.84%)是不良反应最常累及部位,多发生于老年患者(56.63%)、静脉给药(100%)及用药30 min内(42.35%),造成不良反应发生的主要因素为药物因素(67.86%)及不合理用药(32.14%),其中,说明书不规范引起的临床不合理用药是造成中药注射剂不良反应发生的原因之一。2022年实施管理后不良反应发生率明显低于实施前,差异有统计学意义(P<0.05)。结论医疗机构应加强中药注射剂的规范合理使用、管理及不良反应监测,避免造成更严重的后果。Objective To analyze the characteristics and causes of adverse reactions of traditional Chinese medicine injections in general hospitals,providing a certain reference for clinical rational application and management of traditional Chinese medicine injections,and avoiding the risk of clinical medication.Methods The adverse reaction reports of traditional Chinese medicine injections reported to the national adverse reaction monitoring system in Liupanshui People's Hospital from 2020 to 2021 were retrospectively analyzed,the characteristics and causes of adverse reactions were analyzed and effective management countermeasures were implemented.Results Before the implementation of management(2020~2021):Skin and its accessories(57.14%),circulatory system(18.37%)and digestive system(16.84%)were the most commonly involved parts of adverse reactions.Most occurred in elderly patients(56.63%),intravenous administration(100%)and within 30 min of administration(42.35%).The main factors causing adverse reactions were drug factors(67.86%)and irrational drug use(32.14%).Among them,the clinical unreasonable drug use caused by the non-standard instructions was one of the reasons for the adverse reactions of traditional Chinese medicine injection.The incidence of adverse reactions after the implementation of management in 2022 was significantly lower than that before the implementation,and the difference was statistically significant(P<0.05).Conclusion Medical institutions should strengthen the standardized and rational use,management and adverse reaction monitoring of traditional Chinese medicine injections to avoid more serious consequences.

关 键 词：中药注射剂 不良反应 监督管理 规范合理使用 

分 类 号：R288[医药卫生—中药学]