| 江程,李春晓,杨玉晴,郭静.热毒宁注射液上市后临床安全性文献研究[J].中国药事,2023,(11):1252-1265 |
| 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 |
| 投稿时间：2023-03-20 |
| DOI：10.16153/j.1002-7777.2023.11.005 |
| 中文关键词: 热毒宁注射液 药品不良反应/事件 安全性 文献研究 |
| 英文关键词: Reduning injection adverse drug reaction/event security literature research |
| 基金项目: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） |
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| 中文摘要: |
| 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。 |
| 英文摘要: |
| 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. |
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