中国药物警戒 ›› 2023, Vol. 20 ›› Issue (5): 524-529.
DOI: 10.19803/j.1672-8629.20220527

• 法规与管理研究 • 上一篇    下一篇

药品风险最小化评价研究报告规范解读

聂晓璐1,2,3, 唐少文4, 喻锦扬5, 宋海波6, 符祝3,7, 孙凤1,3,*   

  1. 1北京大学公共卫生学院流行病与卫生统计学系,北京 100191;
    2国家儿童医学中心,首都医科大学附属北京儿童医院临床流行病学与循证医学中心,北京100045;
    3海南省真实世界数据研究院,海南 琼海 571437;
    4南京医科大学公共卫生学院流行病学系,江苏 南京 211166;
    5广东省药品不良反应监测中心,广东 广州 510080;
    6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 100022;
    7海南博鳌乐城国际医疗旅游先行区管理局,海南 琼海 571437
  • 收稿日期:2022-09-09 出版日期:2023-05-15 发布日期:2023-05-16
  • 通讯作者: *孙凤,女,博士,教授,药物流行病学与循证医学。E-mail: sunfeng@bjmu.edu.cn
  • 作者简介:聂晓璐,女,在读博士,副研究员,药物流行病学与循证医学。
  • 基金资助:
    国家自然科学基金资助项目（72074011、82204149）; 海南博鳌乐城国际医疗旅游先行区真实世界研究专项计划项目(HNLC2022RWS012、HNLC2022RWS015); 北京市医院管理中心“青苗”计划专项经费资助（QML20231204）

Interpretations of reporting recommendations intended for pharmaceutical risk minimization evaluation studies(RIMES) statement

NIE Xiaolu1,2,3, TANG Shaowen4, YU Jinyang5, SONG Haibo6, FU Zhu3,7, SUN Feng1,3,*   

  1. 1Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China;
    2Center for Clinical Epidemiology and Evidence-based Medicine, Beijing Children’s Hospital, Capital Medical University, National Center for Children’s Health, Beijing 100045, China;
    3Hainan Institute of Real World Data, Qionghai Hainan 571437, China;
    4Department of Epidemiology, School of Public Health, Nanjing Medical University, Nanjing Jiangsu 211166, China;
    5Center for ADR Monitoring of Guangdong, Guangzhou Guangdong 510080, China;
    6Center for Drug Reevaluation, NMPA/ NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100022, China;
    7The Administration of Boao Lecheng International Medical Tourism Pilot Zone, Qionghai Hainan 571437, China
  • Received:2022-09-09 Online:2023-05-15 Published:2023-05-16

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摘要： 目的 通过介绍国际药品风险最小化评价研究（pharmaceutical risk minimization evaluation studies, RIMES）报告规范（RIMES报告规范）条目并开展实例解读,帮助实施者和读者更好理解并应用RIMES清单工具。方法 总结药品风险最小化项目的特点及研究现状,同时基于翻译完整过程（translation integrity procedure, TIP）经过前向、后向对译等多环节,完成RIMES清单翻译并开展实例解读。结果 梳理RIMES清单所包含的关键信息、研究设计、实施和评价等4个维度共43个条目。结论 随着全球药物警戒管理机构进一步的推行,RIMES报告规范将为RIMES提供重要的框架指导。

关键词: 药品风险最小化评价研究, 复杂干预, 效果评价, 报告规范

Abstract: Objective To help implementers and readers better understand and apply the reporting recommendations intended for pharmaceutical risk minimization evaluation studies(RIMES) statements by introducing the checklist of RIMES statements and interpreting them. Methods The characteristics and current research of RIMES were summarized. Meanwhile, the checklist of RIMES statements was translated based on the translation integrity procedure (TIP) through forward and backward translation. Results There were 43 items in the RIMES checklist in four dimensions, including key information, research design, implementation and evaluation. Conclusion With the increasing regulators of global pharmacovigilance, RIMES statements will provide an important framework for RIMES.

Key words: Pharmaceutical Risk Minimization Evaluation Studies(RIMES), complex intervention, effectiveness evaluation, statement

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