热毒宁注射液上市后临床安全性文献研究  

Literature Study on Clinical Safety of Reduning Injection after Marketing

作　　者：江程 李春晓[2,3,4] 杨玉晴 郭静 Jiang Cheng;Li Chunxiao;Yang Yuqing;Guo Jing(College of Pharmacy,Henan University of Traditional Chinese Medicine,Zhengzhou 450046,China;The First Affiliated Hospital of Henan University of Traditional Chinese Medicine,Zhengzhou 450000,China;Henan Engineering Research Center of Clinical Application,Evaluation and Transformation of Traditional Chinese Medicine/Henan Key Laboratory of Clinical Pharmacy of Traditional Chinese Medicine,Zhengzhou 450000,China;Provincial Collaborative Innovation Center of TCM Prevention and Treatment of Respiratory Diseases,Henan University of Traditional Chinese Medicine,Zhengzhou 450046,China)

机构地区：[1]河南中医药大学药学院,郑州450046 [2]河南中医药大学第一附属医院,郑州450000 [3]河南省中药临床应用,评价与转化工程研究中心/河南省中药临床药学中医药重点实验室,郑州450000 [4]河南中医药大学呼吸疾病中医药防治省部共建协同创新中心,郑州450046

出　　处：《中国药事》2023年第11期1252-1265,共14页Chinese Pharmaceutical Affairs

基　　金：河南省中医药科学研究专项课题(编号2022ZY1049);河南省中医药拔尖人才培养项目(编号2022ZYBJ05);河南省中医药科学研究重点专项课题(编号2018ZY1007);河南省高等学校重点科研项目(编号19A360015);国家重点研发计划项目(编号2017YFC1703400)。

摘　　要：目的:对热毒宁注射液临床安全性的相关文献进行研究,获得临床安全性信息,为临床安全用药提供参考。方法:对热毒宁注射液临床安全性相关文献进行收集与筛选、提取、标准化及整合,形成热毒宁注射液不良反应/事件(ADR/ADE)文献数据库,采用描述性分析方法对ADR/ADE发生特点进行梳理分析。结果:共计纳入418篇符合标准的文献,其中临床研究345篇,个案报告22篇,ADR监测51篇;报告ADR/ADE共计5292例,其中ADR/ADE的临床表现为56个,累及19个器官/系统损害,以皮肤及其附件损害(46.35%)、胃肠系统损害(29.65%)和全身性损害(9.11%)为主;共计发生79例严重ADR,主要表现为过敏性休克、肝损害和血尿等;在发生时间和人群特征上表现为速发型不良反应,儿童为发生热毒宁注射液ADR/ADE的高发人群;有记录的ADR/ADE转归及预后情况均痊愈或好转。结论:通过文献研究可获取热毒宁注射液ADR/ADE临床表现、累及器官/系统损害情况、严重程度、发生时间、转归及预后情况等,但整体ADR/ADE发生发展过程的描述不够详细,对ADR/ADE的处理措施、转归时间等信息缺失较多,有待规范临床文献中对ADR/ADE发生情况的描述,以提高药品上市后临床安全性有效信息的获取,为临床合理用药提供科学的循证证据。Objective:To study the relevant literature on the clinical safety of Reduning injection,to obtain the clinical safety information,and to provide reference for clinical safe drug use.Methods:Literature related to the clinical safety of Reduning injection was collected,screened,extracted,standardized and integrated to form an ADR/ADE literature database for Reduning injection.Descriptive analysis was used to sort out and analyze the characteristics of adverse reactions/events.Results:A total of 418 literatures meeting the criteria were included,including 345 clinical studies,22 case reports and 51 ADR monitors.A total of 5292 ADR/ADE cases were reported,among which 56 were ADR/ADE clinical manifestations involved 19 organs/systems,mainly skin and accessory damage(46.35%),gastrointestinal system damage(29.65%)and systemic damage(9.11%).There were 79 cases of severe ADR occurred,mainly manifested as anaphylactic shock,liver damage and hematuria.In terms of occurrence time and population characteristics,the ADR was quick-onset,and the ADR/ADE of Reduning injection occurred in children with high incidence.All recorded ADR/ADE outcomes and prognosis were cured or improved.Conclusion:The clinical manifestations,organ/system damage involved,severity,occurrence time,outcome and prognosis of ADR/ADE for Reduning injection could be obtained through literature studies.However,the overall occurrence and development process of ADR/ADE is not described in detail,and there is much lack of information on the treatment measures and outcome time of ADR/ADE.The description of ADR/ADE occurrence in clinical literature needs to be standardized,so as to improve the acquisition of clinical safety and effective information of drugs after marketing and provide scientific evidence-based evidence for clinical rational drug use.

关 键 词：热毒宁注射液 药品不良反应/事件 安全性 文献研究 

分 类 号：R97[医药卫生—药品] R932[医药卫生—药学]