中成药临床实践指南质量评价
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浙江中医药大学药学院,杭州311403,浙江,中国

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Appraising the quality of clinical practice guidelines in Chinese patent medicine
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School of Basic Medical Sciences, Zhejiang Chinese Medical University, Hangzhou 310053, Zhejiang, China

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    摘要:

    背景:中成药(Chinese patent medicine,CPM)是指以中药为主要原料,按照一定的处方和工艺制成的药品,具有一定的药理作用和临床应用价值。在临床中,我们应用中成药临床实践指南指导临床医师和患者用药。中成药临床实践指南辨证分型具有独特的特点,应注重诊疗过程中的中医辨证理论体系,而国内外现行的中成药临床实践指南,在方法学和报告质量方面存在局限性,不能充分满足大多数临床医师和患者的需求。目的:该研究评价中成药临床实践指南(clinical practice guidelines,CPGs)的方法学严谨性和报告质量,评估当前指南的质量,为指南制定提供建议。方法:采用指南研究与评价工具(Appraisal of Guidelines for Research & Evaluation II, AGREE Ⅱ)和中医实践指南报告条目核查表(Reporting Items for Practice Guidelines in Healthcare for Traditional Chinese Medicine,RIGHT for TCM)对CPM指南的方法学严谨性和报告质量进行评价,4名研究者经过培训后分为两组,按照上述标准,对纳入研究的中成药指南进行评价。对于评分不一致的情况,4名研究者在2名临床专家的指导下进行了二次评分,以确保评估结果的公平性。随后计算各领域的平均得分和平均报告率。结果:研究共纳入32篇符合纳入标准的中成药临床实践指南。其中,AGREE Ⅱ的平均得分为67.2%,各领域得分依次为:范围和目的(93.3%)、利益相关者参与度(50.1%)、严谨性(76.8%)、清晰性(79.4%)、应用性(40.1%)和编辑独立性(63.6%)。RIGHT for TCM的平均报告率为70.0%,7个领域的报告率分别为:基本信息(94.2%)、背景(87.9%)、证据(97.5%)、推荐意见(57.5%)、审查与质量保证(11.4%)、资助、声明和利益管理(26.6%)、其他信息(68.8%);结论:自2020年以来,中成药临床实践指南的方法学和报告质量差强人意,尤其是在报告质量方面,领域5(审查和质量保证)和领域6(资助、声明和利益管理)的指南报告率过低,提升中成药临床实践指南的报告率仍有相当大的空间。为临床医师和患者提供更有效、更全面的指导尤为重要。此外,制定一个针对中成药临床实践指南的全面性报告清单刻不容缓。

    Abstract:

    Background Chinese patent medicine (CPM) is a type of traditional Chinese medicine (TCM) that utilizes Chinese medicinal materials as its raw ingredients. Following the principles of TCM theory, it undergoes specific processing techniques to create various dosage forms for the prevention and treatment of diseases. The current CPM guidelines, both domestically and internationally, are constrained by limitations in methodological quality and reporting, which do not adequately address the requirements of the majority of clinicians and patients. Objective To evaluate the methodological rigor and reporting quality of clinical practice guidelines (CPGs) in CPM, with aim to assess their current quality and to provide recommendations for improving guideline development. Methods The study utilized the Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool and the Reporting Items for Practice Guidelines in Healthcare for Traditional Chinese Medicine (RIGHT for TCM) checklist to evaluate the methodological rigor and reporting quality of CPM guidelines. After the training session, the four investigators were divided into two groups to evaluate the guidelines of patent Chinese medicine included in this study based on the aforementioned criteria. In case of any discrepancies, a secondary analysis was conducted by all four researchers under the guidance of two clinical experts, ensuring an impartial evaluation outcome. Average score or average reporting rate were calculated for each domain. Results A total of 32 CPM guidelines that met the inclusion criteria were analyzed. The AGREE II yielded an average score of 67.2%. The domain scores were as follows: scope and purpose (93.3%), stakeholder involvement (50.1%), rigor of development (76.8%), clarity of presentation (79.4%), applicability (40.1%), and editorial independence (63.6%). The average reporting rate of the RIGHT for TCM checklist was 70.0%, with the reporting rates for the seven domains as follows: basic information (94.2%), background (87.9%), evidence (97.5%), recommendation (57.5%), review and quality assurance (11.4%), funding and declaration and management of interests (26.6%), and other information (68.8%). Conclusions The methodological and reporting quality of CPGs for CPM have been deemed acceptable since 2020. However, there is still room for improvement, particularly in enhancing the reporting quality to provide clinicians and patients with more effective and comprehensive guidance. Additionally, it may be beneficial to develop a comprehensive reporting checklist specifically tailored for CPM guideline development.

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  • 在线发布日期: 2024-11-12
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