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我国药品临床综合评价相关案例评价机制及方法学探析
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| 篇名： | 我国药品临床综合评价相关案例评价机制及方法学探析 |
| TITLE： | Analysis of the evaluation mechanism and methodology of clinical comprehensive evaluation cases of drugs in China |
| 摘要： | 目的 梳理我国药品临床综合评价已发表案例的评价机制及方法学，为规范开展药品临床综合评价及加强决策转化提供参考。方法检索中国知网、万方数据、PubMed、WebofScience等数据库，检索时限为建库至2023年12月31日，筛选我国已发表的药品临床综合评价案例，并从主题遴选、指标体系构建、评价方法、综合决策、质量控制等方面进行汇总分析。结果2014－2023年，我国共发表药品临床综合评价案例143篇，其发文量在2019年之后呈逐年快速上升趋势。评价案例的主题以儿童用药、中成药、心血管药品、抗肿瘤药品为主；评价维度为3～8个，均涉及安全性和有效性维度；多数案例采用基于文献综述和专家访谈/问卷调研的快速评估方法，较少开展真实世界研究；大部分案例未涉及综合决策、质量控制及决策转化的相关内容。结论在国家政策的引领下，我国药品临床综合评价已取得了较快进展，但仍存在评价方法及标准尚待完善、评价结果向决策转化的案例较少、质量控制机制缺乏等问题和挑战。未来应探索标准化的评价路径及质量控制机制，在循证依据不充分时，应尽可能地开展真实世界研究，加快推进评价结果的决策转化。 |
| ABSTRACT： | OBJECTIVE To sort out the evaluation mechanism and methodology of published cases of comprehensive clinical evaluation of drugs in China， and provide a reference for promoting standardized comprehensive clinical evaluation of drugs and strengthening policy transformation in China. METHODS Clinical comprehensive evaluation cases of drugs published in China from CNKI， Wanfang Data， PubMed and Web of Science were systematically searched， and the retrieval time was from the inception to December 31st， 2023. The summary and analysis were performed from the aspects of theme selection， indicator system construction， evaluation methods， comprehensive decision-making， quality control， etc. RESULTS A total of 143 pieces of literature were ultimately included from 2014 to 2023. The number of publications has shown a rapid upward trend since 2019. The subjects of the evaluation cases were mainly pediatric drugs， Chinese patent medicines， cardiovascular drugs and anti-tumor drugs. The evaluation dimensions were between 3-8， all involving safety and effectiveness dimensions. Most cases adopted rapid evaluation methods based on literature review and expert interviews/questionnaire surveys with less emphasis on real-world research. Most cases did not involve comprehensive decision-making， quality control， or policy transformation. CONCLUSIONS The clinical comprehensive evaluation of drugs in China has made rapid progress under the guidance of national policies. However， there are still issues and challenges such as incomplete evaluation methods and standards， few cases of evaluation results being converted into decision-making， and a lack of quality control mechanisms. It is suggested that standardized evaluation paths and quality control mechanisms should be explored； when the evidence-based basis is insufficient， real-world research should be conducted as much as possible， so as to accelerate the policy transformation of evaluation results. |
| 期刊： | 2025年第36卷第02期 |
| 作者： | 乔元；马方怡；韩雨倍；赵明月；姜明欢；方宇 |
| AUTHORS： | QIAO Yuan，MA Fangyi，HAN Yubei，ZHAO Mingyue，JIANG Minghuan，FANG Yu |
| 关键字： | 药品临床综合评价；评价机制；方法学；指标体系；决策转化 |
| KEYWORDS： | clinical comprehensive evaluation of drugs； evaluation mechanism； methodology； index system； policy |
| 阅读数： | 4 次 |
| 本月下载数： | 0 次 |
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