摘要
目的:对疏血通注射液上市后临床安全性的文献进行再评价研究,获取药品临床安全性信息,为临床安全用药提供参考.方法:检索截至 2023 年 5 月中国知网、万方数据库、维普数据库、中国生物医学文献数据库、PubMed中收载的疏血通注射液的药品不良反应(ADR)/药品不良事件(ADE)文献,采用描述性分析方法,对ADR/ADE发生特点进行总结分析.结果:纳入 212 篇符合标准的文献,其中临床研究151 篇,个案报告41 篇,安全性监测20 篇,共报告ADR/ADE 1 361 例.疏血通注射液的不良反应累及 16 个器官和或(系统),90 种临床表现,合计2 109 例次,主要集中在皮肤及其附件损害(637 例次,占30.20%),表现为皮疹、瘙痒、皮肤红肿等;其次是胃肠系统损害(447 例次,占 21.19%),表现为恶心、呕吐、腹泻等.802 例给出了具体用药剂量,其中发生ADR/ADE的单次超剂量(>6 mL)使用情况占 11.10%(89 例).314 例有ADR/ADE发生时间的具体描述,其中给药后 0～30 min发生的占36.94%(116例),>7 d发生的占11.78%(37例).319例记录了ADR/ADE处理转归情况,其中 317 例好转或痊愈.严重的ADR/ADE共发现9例,表现为上消化道出血、严重皮疹、过敏性休克等.结论:通过描述性文献研究可以系统梳理疏血通注射液相关ADR/ADE的发生时间、临床表现、累及器官和(或)系统、ADR转归及预后情况,为其临床合理应用和安全监管提供参考.
Abstract
OBJECTIVE:To conduct reassessment on literature related to the post-marketing clinical safety of Shuxuetong injection,and to acquire the information on clinical safety of drugs,so as to provide references for clinical safe medication.METHODS:Literature of adverse drug reactions(ADR)/adverse drug events(ADE)of Shuxuetong injection recorded in CNKI,Wanfang Data,VIP,CBM and PubMed up to May 2023 were retrieved,descriptive analysis method was adopted to conduct summary and analysis on the occurrence characteristics of ADR/ADE.RESULTS:A total of 212 eligible studies were enrolled,including 151 clinical researches,41 case reports,20 safety monitoring,and 1 361 cases of ADR/ADE were reported.The ADR of Shuxuetong injection involved 16 organs and or(systems),90 types clinical manifestations,totally 2 109 case-times,mainly focused on skin and its accessory damage(637 case-times,30.20%),manifested by rash,itching,skin redness and swelling,etc.;followed by gastrointestinal system damage(447 case-times,21.19%),manifested by nausea,vomiting,diarrhea,etc.Eight hundred and two cases provided specific dosage,of which 11.10%(89 cases)had ADR/ADE in a single overdose(>6 mL).Three hundred and fourteen cases provided specific descriptions for the occurrence time of ADR/ADE,of which 36.94%(116 cases)occurred between 0 to 30 min after drug administration,and 11.78%(37 cases)occurred>7 d.Three hundred and nineteen cases recorded the ADR/ADE treatment outcome,of which 317 cases were improved or recovered.Nine cases of severe ADR/ADE were found,manifested by upper gastrointestinal hemorrhage,severe skin rash and anaphylactic shock.CONCLUSIONS:Descriptive literature research can systematically sort out the occurrence time,clinical manifestations,involved organs and/or systems,ADR outcomes and prognoses of ADR/ADE associated with Shuxuetong injection,which can provide references for its rational clinical application and safety control.
基金项目
河南省科技攻关项目(232102310476)
河南省中医药拔尖人才培养项目资助(2022ZYBJ05)
河南省中医药科学研究专项课题(2022ZY1049)
维普
万方数据