清开灵口服制剂安全性风险分析

doi:10.19803/j.1672-8629.20220676

中国药物警戒 ›› 2023, Vol. 20 ›› Issue (9): 1046-1048.
DOI: 10.19803/j.1672-8629.20220676

清开灵口服制剂安全性风险分析

于洪礼¹, 于冬梅^2,Δ, 肖爱丽¹, 朱兰¹, 宋海波^1,*

¹国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京 100045;
²国家市场监督管理总局食品审评中心,国家中药品种保护审评委员会,北京 100070

收稿日期:2023-03-24 出版日期:2023-09-15 发布日期:2023-09-14
通讯作者: ^*宋海波,男,博士,主任药师,药品安全性评价。E-mail:songhaibo@cdr-adr.org.cn
作者简介:于洪礼,男,硕士,副主任药师,药品不良反应监测与评价。^Δ为并列第一作者。
基金资助:
国家重点研发计划（2018YFC1707409）

Risks of safety Qingkailing oral preparation

YU Hongli¹, YU Dongmei^2,Δ, XIAO Aili¹, ZHU Lan¹, SONG Haibo^1,*

¹Center for Drug Reevaluation, NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100076, China;
²Center for Food Evaluation, State Administration for Marker Regulation/National Committee on the Assessment of the Protected Traditional Chinese Medicinal Products, Beijing 100070, China

Received:2023-03-24 Online:2023-09-15 Published:2023-09-14

摘要/Abstract

摘要： 目的通过对清开灵口服制剂安全性风险的分析,为临床合理用药提供参考。方法对国家药品不良反应监测系统（2015年1月1日至2021年12月31日）及国内外文献数据库（建库至2021年12月31日）中清开灵口服制剂相关不良反应情况、监管机构发布的有关清开灵口服制剂风险控制措施等进行分析。结果国家药品不良反应监测系统共收到涉及清开灵口服制剂的不良反应/事件报告7 185例,累及胃肠系统、皮肤、神经系统等多个系统-器官;文献报道的清开灵口服制剂不良反应/事件累及系统-器官与国家药品不良反应监测系统中的报告数据基本一致。结论清开灵口服制剂相关不良反应涉及多个系统-器官,临床应关注清开灵口服制剂相关不良反应,促进安全合理用药。

关键词: 清开灵, 口服制剂, 安全性, 不良反应

Abstract: Objective To analyze the risk of Qingkailing oral preparation in order to provide reference for rational clinical use. Methods Cases of adverse reactions related to Qingkailing oral preparation that were retrieved from National ADR Monitoring System and literature , and the relevant control measures issued by regulatory agencies were analyzed. Results From 2015 to 2021, the National ADR Monitoring System has received 7 185 ADR/ADE reports involving Qingkailing oral preparations, which involved gastrointestinal, skin, nervous and other systems and organs. The systems and organs literature reports involved in ADR/ADE of Qingkailing oral preparations were basically consistent with the reports in National ADR Monitoring System. Conclusion Adverse drug reaction associated with oral preparations of Qingkailing involve multiple systems-organs, and clinical attention should be paid to the adverse reactions associated with oral preparations of Qingkailing to promote the safe and rational use of drugs.

Key words: Qingkailing, oral preparation, safety, adverse reaction

中图分类号:

R994.11

于洪礼, 于冬梅, 肖爱丽, 朱兰, 宋海波. 清开灵口服制剂安全性风险分析[J]. 中国药物警戒, 2023, 20(9): 1046-1048.

YU Hongli, YU Dongmei, XIAO Aili, ZHU Lan, SONG Haibo. Risks of safety Qingkailing oral preparation[J]. Chinese Journal of Pharmacovigilance, 2023, 20(9): 1046-1048.

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清开灵口服制剂安全性风险分析

Risks of safety Qingkailing oral preparation

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