摘要
目的探讨我国药品临床综合评价政策的优化思路。方法采用ROST CM 6软件对国务院及各部委2014年1月至2024年10月出台的21项药品临床综合评价相关政策文件进行文本挖掘,构建政策一致性(PMC)指数模型,并对其进行量化分析,计算PMC指数和PMC凹陷指数,进行PMC曲面分析。结果21项政策文件评价结果中,仅有1项为优秀,2项为合格,其余均为良好;PMC指数均值为5.94,PMC凹陷指数均值为4.06,整体处于良好状态,但仍有提升空间。结论我国药品临床综合评价政策基本完善,建议加强各部委联合发文,畅通政策衔接;拓展政策内容中的评价对象,重视评价质量控制;强调评价结果服务于国家药物政策决策及对企业的反哺作用。
Objective To investigate the optimization ideas for the policies of drug clinical comprehensive evaluation in China.Methods A total of 21 policies issued by the State Council and various ministries from January 2014 to October 2024 were conducted text mining by ROST CM 6 software.The Policy Modeling Consistency(PMC)index model was constructed and quantitatively analyzed to calculate the PMC index and PMC depression index,and perform PMC surface analysis.Results Among the 21 policies,only one was excellent,two were rated as qualified,while the others were rated as good.The average PMC index was 5.94.The average PMC indentation index was 4.06,which was a generally acceptable level but still had room for improvement.Conclusion The policy for drug clinical comprehensive evaluation in China is basically perfect.It is suggested to strengthen the joint issuance of documents by various ministries and commissions,and to facilitate policy coherence.It is suggested to expand the evaluation objects in the policy content,to attach importance to the quality control of evaluation,and to emphasize that the evaluation results should serve the national drug policy decision-making and have a feedback effect on enterprises.
作者
赵越
鞠晓宇
ZHAO Yue;JU Xiaoyu(Hebei General Hospital,Shijiazhuang,Hebei 050051,China;Hebei Key Laboratory of Clinical Pharmacy,Shijiazhuang,Hebei 050051,China;Hebei Provincial Hospital of Chinese Medicine,Shijiazhuang,Hebei 050011,China)
出处
《中国药业》
2026年第1期19-25,共7页
China Pharmaceuticals
基金
河北省中医药管理局科研计划项目[2025216]
国家卫生健康委员会2025年药品临床综合评价项目[国卫药政目录便函〔2025〕56号-258]。
关键词
政策一致性指数模型
政策量化
药品临床综合评价
Policy Modeling Consistency index model
policy quantification
drug clinical comprehensive evaluation
