我院133例中药注射剂不良反应报告分析  

Analysis of 133 cases of adverse reaction of traditional Chinese medicine injection in our hospital

作　　者：刘梅霞[1] 赵小燕[1] LIU Meixia;ZHAO Xiaoyan(Chinese Medicine Hospital in Linyi City,Linyi 276002)

机构地区：[1]临沂市中医医院

出　　处：《药学研究》2019年第9期555-558,共4页Journal of Pharmaceutical Research

摘　　要：目的分析我院近两年的中药注射剂不良反应的发生规律及特点,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,对我院2017年1月1日~2018年12月31日收集上报国家药品不良反应中心的133份中药注射剂不良反应报告进行统计分析。对资料中患者的性别、年龄、累及系统/器官和临床表现、发生的时间、涉及的药物品种、不合理用药等方面进行分析。结果我院133例中药注射剂不良反应患者的年龄主要集中在60~70岁人群,引起不良反应的主要药物为活血化瘀类、补益类、清热解毒类,严重的不良反应中发生频率前五位的是注射用血塞通(冻干),舒血宁注射液,参附注射液、刺五加注射液、热毒宁注射液;涉及的器官和(或)系统主要是皮肤及其附件损害和全身性损害(占49.00%);不良反应通常发生在给药后30 min内;与不合理用药有关的病例共17例,占所有不良反应的12.78%。结论我院中药注射剂不良反应发生率较高,应谨慎活血化瘀类、补益类、清热解毒类中药注射剂的使用,关注注射用血塞通(冻干),舒血宁注射液、参附注射液、刺五加注射液和热毒宁注射液引起的严重的不良反应;加强合理应用中药注射剂的意识,提高合理用药的水平,做到辨证施治,减少不良反应,保证用药安全。Objective To analyze the occurrence and characteristics of adverse reactions of traditional Chinese medicine injection in our hospital in the past two years,and to provide reference for the rational use of traditional Chinese medicine injection.Methods Aretrospective study was used to make statistical analysis of 133 ADR reports of traditional Chinese medicine injections collected and reported to the National Center for Adverse Drug Reaction from January 1,2017 to December 31,2018.The data on the patient's sex,age,involvement and system/organ and clinical manifestations,the time of occurrence,the type of drug involved,unreasonable drug use,etc.Results The age of ADR patients with 133 traditional Chinese medicine injections in our hospital was mainly concentrated in people aged 60~70 years.The main drugs that caused ADR were blood circulation,blood stasis,tonic benefits,and heat and detoxification.The top five frequency of occurrence in the severe ADR were Xuesaitong Injection,Shuxuening Injection,Shenfu Injection,Ciwujia Injection,and Reduning Injection;The organs and/or systems involved were mainly skin and accessories damage and systemic damage(49.00%);ADR usually occurs within 30 min after administration;There were 17 cases related to irrational use of drugs,accounting for 12.78%of all ADRs.Conclusion The incidence of adverse reactions of traditional Chinese medicine injection in our hospital was high,we should be careful to use traditional Chinese medicine injection such as blood circulation,blood stasis,tonic benefits,heat and detoxification,and pay attention to Xuesaitong injection.Serious ADR caused by Shuxuening Injection,Shenfu Injection,Juwujia Injection and Reduning Injection;Strengthen the consciousness of rational application of traditional Chinese medicine injection,raise the level of rational use of drugs,achieve dialectical treatment,reduce adverse reactions,and ensure drug safety.

关 键 词：中药注射剂 不良反应 合理用药 

分 类 号：R969.3[医药卫生—药理学]