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摘要: 临床实践指南是医疗实践的指导性文件, 及时修订的指南推荐意见对于指导医生进行临床决策具有重要意义和价值。因此, 指南应基于最新的研究证据, 形成对当前医疗实践的最佳推荐意见, 并保持与时俱进。本文针对指南修订的现状、方法、流程及存在的问题展开讨论, 提出指南修订最长周期为5年, 最短可以做到实时更新; 修订方法目前国内外无统一标准, 建议可参考本文提出的流程及RIGHT和CheckUp报告清单。此外, 本文就如何有效开展修订工作, 从指南管理者、制订者、研究者和使用者四个层面提出思考与建议。Abstract: Clinical practice guidelines are guiding documents in medical practices. Timely updated recommendations are important and valuable to guide physicians in making clinical decisions. Guidelines should be developed on the latest research evidence for the best recommendations in clinical practice and updated regularly to remain valid. Based on the discussion about the status quo, methods and procedures, and challenges of updating guidelines, our results showed that the longest update period is 5 years, and the shortest period can be constantly updated. Since there are no standardized methods for guideline updating, we proposed in this article the procedures for Chinese guideline developers, and recommended RIGHT and CheckUp as the reporting checklists. In addition, the related strategies and suggestions to effectively update guidelines were proposed for the guideline managers, developers, researchers, and users.利益冲突 无
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表 1 影响指南修订的主要因素及示例
主要影响因素 示例 研究证据 疾病定义或诊断标准发生改变 2015年，强化血压控制试验[12]和相关研究结果发表；2017版美国成人高血压指南将高血压定义为血压≥130/80 mm Hg[13] 新的疗法更有效 2013年，中国研究显示氯吡格雷联合阿司匹林较单独使用阿司匹林可显著降低卒中再发风险[14]；2014年美国心脏协会/美国卒中协会发布的新版缺血性卒中及短暂性脑缺血发作患者卒中预防指南将联合疗法作为新的推荐意见[15] 原有疗法无效 2017年，研究证实补充钙和维生素D不能降低社区老年人的骨折风险[16]；2018年，美国预防医学工作组将其不推荐的意见写进指南[17] 新发不良事件 2019年11月，美国疾病预防控制中心发布电子烟相关肺损伤爆发的报告[18]，当月即修订了电子烟指南[19] 卫生政策及其他 国家政策 2016年，中国政府全面实施两孩政策，此前的辅助生殖指南，缺乏对高龄产妇的关注，以及相关证据的纳入；2017年，中华医学会生殖医学分会修订了高龄产妇辅助生殖指南并于2019年发表[20] 药品审批 2019年，贝利尤单克隆抗体被我国国家食品药品监督管理局批准可用于治疗系统性红斑狼疮[21]；2020年，中华医学会修订的系统性红斑狼疮诊疗指南将其纳入推荐意见[22] 医疗保险 2019年，丙酚替诺福韦确定将被纳入国家医保目录；当年更新后的慢性乙型肝炎防治指南将其作为首选抗病毒药物之一[23] 突发公共卫生事件 2019年12月中国发现新型冠状病毒疫情，截至2020年3月3日，2个月内国家卫生健康委员会已将《新型冠状病毒肺炎诊疗方案》更新到第7版[24]。除新出现的研究证据外，全国疫情防控形势的变化、对诊断和治疗措施利弊在不同时间的考量、社会、经济、政治等多种因素都影响到诊疗方案短期内的快速更新。突发公共卫生事件既是指南制订的触发因素，也是全程推动其不断更新的主要因素对于国内指南的修订，中华医学会的指南修订周期为2~5年[25]，我国指南修订的比例仅为10%，其中最长修订周期达10年[30]。 
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表 2 国内外主要指南制订机构指南修订周期
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条目 内容 1 修订版指南与原版指南能够被区分开 2 报告了修订指南的缘由 3 报告了修订版指南与原版指南间范围和目的的变化，并提供了支撑材料 4 报告了在修订过程中对其更新和审阅过的章节 5 报告了哪些推荐意见被保留、删除、增加或修改 6 报告了被修改的推荐意见并提供了支撑材料 7 报告了修订版指南中的专家组成员 8 报告了负责指南修订的专家的利益冲突情况 9 报告了修订版指南的资助机构及其所发挥的作用 10 报告了在指南修订中检索证据的方法 11 报告了在指南修订过程中遴选证据的方法 12 报告了在指南修订过程中评估证据质量的方法 13 报告了在指南修订过程中证据合成的方法 14 报告了修订版指南的外部评审方法 15 报告了要实施修订版指南中更改推荐意见的方法和计划 16 报告了未来再次修订的计划和方法
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