中国药物警戒 ›› 2025, Vol. 22 ›› Issue (12): 1365-1369.
DOI: 10.19803/j.1672-8629.20250583

• 基础与临床研究 • 上一篇    下一篇

药品风险最小化措施评价研究报告规范：实施科学扩展报告标准的解读

聂晓璐1, 唐少文2, 任经天3, 孙一鑫4,5, 孙凤6,7,8,9*   

  1. 1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;
    2南京医科大学公共卫生学院流行病学系,江苏 南京 211166;
    3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 100076;
    4国家儿童医学中心,首都医科大学附属北京儿童医院临床研究中心,北京 100045;
    5国家儿童医学中心,首都医科大学附属北京儿童医院药学部,北京 100045;
    6北京大学公共卫生学院流行病与卫生统计学系,北京 100191;
    7重大疾病流行病学教育部重点实验室（北京大学）,北京 100191;
    8北京大学第三医院眼科,北京 100191;
    9石河子大学公共卫生学院,新疆 石河子 832003
  • 收稿日期:2025-08-19 发布日期:2025-12-19
  • 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,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（82204149）; 国家自然科学基金国际（地区）合作与交流项目（72361127500）; 海南省科学技术厅重点研发专项（ZDYF2024LCLH002）

Interpretation of Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension

NIE Xiaolu1, TANG Shaowen2, REN Jingtian3, SUN Yixin4,5, SUN Feng6,7,8,9*   

  1. 1Center for Clinical Epidemiology and Evidence-based Medicine, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100045, China;
    2Department of Epidemiology, School of Public Health, Nanjing Medical University, Nanjing Jiangsu 211166, China;
    3Center for Drug Reevaluation, NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100076, China;
    4Clinical Research Center, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100045, China;
    5Department of Pharmacy, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100045, China;
    6Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China;
    7Key Labo-ratory of Epidemiology of Major Diseases (Peking University), Ministry of Education, Beijing 100191, China;
    8Department of Ophthalmo-logy, Peking University Third Hospital, Beijing 100191, China;
    9School of Publish Health, Shihezi University, Shihezi Xinjiang 832003, China
  • Received:2025-08-19 Published:2025-12-19

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摘要： 目的 介绍药品风险最小化措施评价研究报告规范：实施科学扩展报告标准（RIMES-SE）的制定过程及条目,促进理解并应用RIMES-SE清单工具。方法 总结药品风险最小化措施评价研究的报告规范更新背景,同时基于翻译完整过程,经过前向、后向对译等多环节,完成RIMES-SE清单翻译,并针对欧洲开展的丙戊酸风险最小化措施评价研究进行实例解读。结果 梳理RIMES-SE清单包含的风险最小化措施与实施策略等2个维度共27个条目。丙戊酸风险最小化措施报告规范条理清楚,分析方法合理,但需加强对实施性研究原理、风险最小化措施的结局定义及阈值设定、是否完全按预期交付给所有参与者的程度等方面的描述。结论 随着全球药物警戒管理机构进一步推行,RIMES-SE报告规范将为我国更好开展药品风险最小化措施评价研究提供框架参考。

关键词: 风险最小化措施评价研究, 实施科学扩展报告标准, 复杂干预, 实施策略, 效果评价, 报告规范

Abstract: Objective To describe the formulation process and checklist items of the Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension (RIMES-SE), and to advance our understanding and applications of the RIMES-SE checklist tool. Methods The background of updating the reporting standards for pharmaceutical risk minimization evaluation studies was summarized. Following a translation integrity procedure involving forward and backward translation steps, the translation of the RIMES-SE checklist was completed. An illustrative interpretation using the effective evaluation research of valproate risk minimization measures implemented in Europe was attempted. Results The RIMES-SE checklist was organized into two dimensions—risk minimization interventions and implementation strategies—comprising a total of 27 items. The reporting of the valproate risk minimization program was clear in structure and methodologically sound. However, the principles about implementation science, explicit definitions and threshold setting for effectiveness of risk minimization measures, and clarity regarding the extent to which interventions were delivered as intended to all participants needed to be improved. Conclusion With the progressive adoption of RIMES-SE by pharmacovigilance authorities worldwide, this reporting standard will provide an important framework to guide more rigorous and standardized pharmaceutical risk minimization evaluation studies in China.

Key words: Risk Minimization Evaluation Studies, RIMES-SE, Complex Intervention, Implementation Strategy, Effectiveness Evaluation, Reporting Statements

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