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。
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 RIMESSE 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.
作者
聂晓璐
唐少文
任经天
孙一鑫
孙凤
NIE Xiaolu;TANG Shaowen;REN Jingtian;SUN Yixin;SUN Feng(Center for Clinical Epidemiology and Evidencebased Medicine,Beijing Children's Hospital,Capital Medical University,National Center for Children's Health,Beijing 100045,China;Department of Epidemiology,School of Public Health,Nanjing Medical University,Nanjing Jiangsu 211166,China;Center for Drug Reevaluation,NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance,Beijing 100076,China;Clinical Research Center,Beijing Children's Hospital,Capital Medical University,National Center for Children's Health,Beijing 100045,China;Department of Pharmacy,Beijing Children's Hospital,Capital Medical University,National Center for Children's Health,Beijing 100045,China;Department of Epidemiology and Biostatistics,School of Public Health,Peking University,Beijing 100191,China;Key Laboratory of Epidemiology of Major Diseases(Peking University),Ministry of Education,Beijing 100191,China;Department of Ophthalmology,Peking University Third Hospital,Beijing 100191,China;School of Publish Health,Shihezi University,Shihezi Xinjiang 832003,China)
出处
《中国药物警戒》
2025年第12期1365-1369,共5页
Chinese Journal of Pharmacovigilance
基金
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)。
