基于药物警戒系统分析中药注射剂不良反应发生特点  

To Analyze the Characteristics of Adverse Reactions of Traditional Chinese Medicine Injections based on Pharmacovigilance System

作　　者：何洁 张梦颖 胡建新[1] HE Jie;ZHANG Mengying;HU Jianxin(Jiangxi Provincial People’s Hospital(The First Affiliated Hospital of Nanchang Medical College),Jiangxi Nanchang 330006,China)

机构地区：[1]江西省人民医院(南昌医学院第一附属医院),江西南昌330006

出　　处：《中医药临床杂志》2023年第3期550-554,共5页Clinical Journal of Traditional Chinese Medicine

基　　金：江西省中医药管理局中药制剂临床安全监测和转化应用重点研究室项目;江西省卫生健康委科技计划资助项目(202310170)。

摘　　要：目的:基于医院药物警戒系统对该院中药注射剂不良反应(ADR)发生的规律和特点分析,为中药注射剂在临床上应用提供参考依据。方法:基于中国医院药物警戒系统,以该院2016年12月—2021年12月的276例中药注射剂的ADR数据为依据,运用回顾性分析方法对药物品种、患者性别、年龄、临床表现等进行分析。结果:表明276例中药注射剂ADR数据共关联28个品种,银杏内酯注射液(18.48%)、参麦注射液(9.06%)、注射用丹参多酚酸盐(7.25%)排名前3;用药后ADR时间<30min发生率高达40.58%。ADR临床表现中累及皮肤及其附件损害(25.95%)、全身性损害(22.14%)、神经系统损害(12.38%)等。临床表现在瘙痒、皮疹、寒战、潮红、恶心、胸闷等占比较大。其中男女比例1:0.83,年龄≥51岁患者数量最多达78.99%。结论:中药注射剂ADR的发生规律跟患者年龄、性别、药品种类等因素相关。分析、了解ADR情况,并及时反馈相关中药注射剂ADR发生的规律特点,有利于临床上对其ADR的监测,确保患者临床用药安全。Objective:To provide a reference for the clinical application of traditional Chinese medicine injections based on the analysis of the law and characteristics of adverse reactions(ADRs)of traditional Chinese medicine injections in the hospital based on the pharmacovigilance system of the hospital.Methods:Based on the pharmacovigilance system of Chinese hospitals,based on the ADR data of 276 cases of traditional Chinese medicine injections in the hospital from December 2016 to December 2021,a retrospective analysis method was used to analyze the types of drugs,patient gender,age,clinical manifestations,etc.analyze.Results:It showed that 276 cases of traditional Chinese medicine injection ADR data were associated with 28 varieties,and ginkgolide injection(18.48%),Shenmai injection(9.06%),and salvianolate for injection(7.25%)ranked the top 3;The incidence rate of post-ADR time<30min was as high as 40.58%.The clinical manifestations of ADR involved skin and its appendages(25.95%),systemic damage(22.14%),and nervous system damage(12.38%).Clinical manifestations include itching,rash,chills,flushing,nausea,and chest tightness.Among them,the ratio of male to female was 1:0.83,and the number of patients aged≥51 years was as high as 78.99%.Conclusion:The incidence of ADR of traditional Chinese medicine injections is related to factors such as patient age,gender,and drug type.Analyzing and understanding the situation of ADR,and giving timely feedback on the regularity and characteristics of ADR of related traditional Chinese medicine injections are beneficial to clinical monitoring of ADR and ensuring the safety of clinical medication of patients.

关 键 词：中药注射剂 药品不良反应 药物警戒系统 银杏内酯注射液 参麦注射液 注射用丹参多酚酸盐 

分 类 号：R285.6[医药卫生—中药学]