3811例中药注射剂新的和严重的不良反应/事件报告分析

Analysis of 3811 Cases of New and Severe Adverse Drug Reactions/Events Induced by Traditional Chinese Medicine Injections

目的:分析中药注射剂临床应用安全性,研究药品不良反应发生原因、特点,为临床用药安全提供参考。方法:采用回顾性研究方法,对山东省药品不良反应监测中心2018年1月~2020年9月收集的中药注射剂新的和严重的不良反应报告/事件(ADR/ADE)中患者的性别、年龄、药品的种类、给药途径、ADR/ADE诱导时间、累及系统-器官及临床表现、治疗、转归等进行统计分析。结果:共收集到中药注射剂新的和严重的ADR/ADE 3811例,男女比例为0.87∶1,主要人群为45岁以上的中老年患者。导致新的和严重的ADR/ADE的中药注射剂主要有理血剂、补益剂、清热剂;ADR/ADE主要发生在治疗后1h内,严重的ADR/ADE累及的系统-器官主要有全身性损害、呼吸系统损害、皮肤及其附件损害;新的ADR/ADE发生例次位居前5位的分别是注射用血塞通(冻干)、脉络宁注射液、丹参注射液、丹红注射液、注射用血栓通(冻干),在得到及时干预后ADR/ADE的症状缓解。结论:应注意中药注射剂的使用安全,尽可能避免超说明书用药,加强ADR监测,努力提高临床用药安全性。

Objective:To analyze the safety of traditional Chinese medicine(TCM)injections in clinical application and study the causes,characteristics of adverse drug reaction(ADR),so as to provide reference for the safety of clinical drug use.Methods:A retrospective study was conducted to analyze the gender,age,drug type,route of administration,induction time of ADR/adverse drug event(ADE),involved system-organ and clinical manifestations,treatment,outcome and other factors of patients in the new and serious ADR/ADE reports of TCM injections collected by Shandong Adverse Drug Reaction Monitoring Center in January 2018 and September 2020.Results:A total of 3811 cases of TCM injection ADR/ADE occurred,with the male to female ratio was 0.87∶1,and the ADRs mostly occurred in middle-aged and elderly patients over 45 years old;The main drugs that caused new and severe ADR/ADE were blood-regulating prescriptions,tonic prescriptions,heat-clearing prescriptions;The ADR/ADE mainly occurred within 1 hour after treatment.The systems-organs involved in serious ADR/ADE include systemic damage,respiratory damage,skin and its appendages damage;The top five new ADR/ADE cases were Xuesaitong injection(lyophilized),Mailuoning injection,Danshen injection,Danhong injection and Xueshuantong injection(lyophilized).If the ADRs got timely intervention,the symptoms could be relieved;Prompt interventions in ADRs could help alleviate or cure the symptoms.Conclusion:Attention should be paid to the rational use of TCM injections,avoid excessive label use as far as possible,strengthen ADR monitoring,and strive to improve the safety of clinical medication.