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非酒精性脂肪性肝病中医/中西医结合诊疗指南/共识的质量评价
DOI: 10.12449/JCH250309
利益冲突声明：本文不存在任何利益冲突。
作者贡献声明：尤红、徐春军负责课题设计；焦睿珉、李娟娟、陈伟、韩超汝参与资料分析；焦睿珉负责撰写论文；赵静洁、李丽负责修改论文；尤红、徐春军指导撰写文章并最后定稿。
Quality assessment of guidelines/consensuses on traditional Chinese medicine/integrated traditional Chinese and Western medicine diagnosis and treatment of nonalcoholic fatty liver disease
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摘要:
目的 评价已发表的非酒精性脂肪性肝病（NAFLD）中医/中西医结合诊疗指南/共识的方法学和报告质量，以期为今后代谢相关脂肪性肝病中医/中西医结合指南/共识的制定提供参考依据。 方法 计算机检索 PubMed、Embase、Web of Science、中国知网、万方和中国生物医学文献数据库，以及中华中医药学会和中国中西医结合学会的网站（自建库至2024年9月1日）。由两位临床研究人员分别使用指南的研究和评估工具第二版（AGREEⅡ）和国际实践指南报告规范（RIGHT）评价纳入NAFLD中医/中西医结合诊疗指南/共识的方法学质量及报告质量。 结果 通过文献筛选，最终纳入9篇指南/共识，其中指南4篇，专家共识5篇；采用AGREE Ⅱ评价9篇指南/共识不同领域得分依次为范围和目的（47.1%）、参与人员（41.0%）、严谨性（21.6%）、清晰性（40.2%）、应用性（19.1%）、独立性（19.6%）。文献推荐级别划分为：B级（修订后推荐）4篇，C级（不推荐）5篇。RIGHT评估显示，“基本信息”与“证据”报告率高，其他领域有待提升。目前，对于NAFLD的中医/中西医结合诊疗指南/共识，尚无国际标准且质量需加强以确保全面性和可信度。 结论 NAFLD中医/中西医结合诊疗指南/共识的质量仍有提升潜力，应严格遵循AGREEⅡ与RIGHT清单，以确保指南/共识的公正性、科学性与透明度。 Abstract:Objective To evaluate the methodological quality and reporting quality of published guidelines/consensuses on traditional Chinese medicine （TCM）/integrated traditional Chinese and Western medicine diagnosis and treatment of nonalcoholic fatty liver disease （NAFLD）， and to provide a basis for formulating guidelines/consensuses on TCM/integrated traditional Chinese and Western medicine diagnosis and treatment of NAFLD in the future. Methods Databases including PubMed， Embase， Web of Science， CNKI， Wanfang Data， and CBM and the websites of China Association of Chinese Medicine and China Association of Integrative Medicine were searched for related articles published up to September 1， 2024. Two clinical researchers independently assessed the methodological quality and reporting quality of the guidelines/consensuses on TCM/integrated traditional Chinese and Western medicine diagnosis and treatment of NAFLD by using Appraisal of Guidelines for Research and Evaluation Ⅱ （AGREE Ⅱ） and Reporting Items for Practice Guidelines in Healthcare （RIGHT）. Results A total of nine guidelines/consensuses were included after literature screening， with four guidelines and five expert consensuses. The scores of different domains assessed by AGREE Ⅱ for the nine guidelines/consensuses were as follows： scope and purpose （47.1%）， stakeholder involvement （41.0%）， rigor of development （21.6%）， clarity of presentation （40.2%）， applicability （19.0%）， and editorial independence （19.6%）. The recommendation level of the articles was B level （recommended after revision） for four articles and C level （not recommended） for five articles. The RIGHT assessment showed high reporting rates for “Basic Information” and “Background”， while other areas needed to be improved. Currently， there was no international standard for the guidelines/consensuses on TCM/integrated traditional Chinese and Western medicine diagnosis and treatment of NAFLD， and the quality of these guidelines/consensuses needed to be enhanced to ensure comprehensiveness and credibility. Conclusion There is still potential for improving the quality of guidelines/consensuses on TCM/integrated traditional Chinese and Western medicine diagnosis and treatment of NAFLD， and AGREE Ⅱ and RIGHT checklists should be strictly followed to ensure the fairness， scientific rigor， and transparency of these guidelines/consensuses. -
【据Hepatology international 2021年1月报道】题：低剂量利福昔明可预防肝硬化失代偿期患者的并发症并提高生存率(作者Zeng X等)
利福昔明已被推荐作为肝性脑病(HE)和自发性细菌性腹膜炎(SBP)的预防药物。该研究旨在探讨低剂量利福昔明是否能预防肝硬化患者的整体并发症和延长生存期。
在这项多中心随机开放标签的前瞻性研究中，200例失代偿期肝硬化患者按1∶1的比例随机分配。利福昔明组患者给予利福昔明400 mg，每日2次，疗程6个月，其余治疗策略在两组患者中尽量保持不变。主要疗效终点是总并发症发生率和无肝移植生存率。次要终点是各种主要肝硬化相关并发症的发生率，以及Child-Pugh评分和分级。
除HE外，两组主要的基线特征相似。利福昔明组总并发症的累积发生率明显低于对照组(P＜0.001)。虽然两组间无肝移植生存率无显著差异，但亚组分析显示，利福昔明显著延长Child-Pugh评分≥9的患者无肝移植生存率(P=0.007)。此外，利福昔明显著减少腹水加重(P＜0.001)、HE (P＜0.001)和胃静脉曲张出血(P=0.031)的发生。两组不良事件发生率相似。
在该研究中，低剂量利福昔明显著降低了总体并发症的发生，延长了晚期肝硬化患者的生存期。低剂量利福昔明与正常剂量(1200 mg/d)利福昔明在预防肝硬化相关并发症方面的效果有待进一步研究。
摘译自ZENG X, SHENG X, WANG PQ, et al. Low-dose rifaximin prevents complications and improves survival in patients with decompensated liver cirrhosis[J]. Hepatol Int, 2021, 15(1): 155-165.
(吉林大学第一医院感染病中心肝病科 朱玉凡 牛俊奇 报道)
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表 1 纳入指南/共识的基本特征
Table 1. The characteristics of the guidelines/consensus
指南名称 制定年份 指南/共识类型 制定机构 文献内容 参考文献数 参与专家数（人） 是否更新 利益冲突 基金资助 非酒精性脂肪性肝病的中西医结合诊疗共识意见［3］ 2011 专家共识 中国中西医结合学会消化系统疾病专业委员会 诊断、治疗 4 106 是 未报告 未报告 非酒精性脂肪性肝病中医诊疗共识意见［4］ 2011 专家共识 中华中医药学会脾胃病分会 诊断、治疗 17 109 是 未报告 未报告 非酒精性脂肪性肝病中西医结合诊疗共识意见（2017年）［6］ 2017 专家共识 中国中西医结合学会消化系统疾病专业委员会 诊断、治疗 27 41 否 未报告 未报告 非酒精性脂肪性肝病中医诊疗专家共识意见（2017）［5］ 2017 专家共识 中华中医药学会脾胃病分会 诊断、治疗 13 90 是 未报告 未报告 非酒精性脂肪性肝病中医诊疗指南（基层医生版）［7］ 2019 诊疗指南 中华中医药学会脾胃病分会 诊断、治疗 0 18 否 未报告 未报告 肝癖（非酒精性脂肪性肝炎）诊疗方案［8］ 2021 诊疗指南 国家中医药管理局华南区中医肝病诊疗中心联盟 诊断、治疗 28 51 否 未报告 未报告 穴位埋线治疗非酒精性脂肪性肝病中医实践指南［2］ 2022 诊疗指南 中华中医药学会肝胆病分会 诊断、治疗 31 60 否 报告 未报告 非酒精性脂肪性肝炎中医诊疗指南［9］ 2023 诊疗指南 中华中医药学会肝胆病分会 诊断、治疗、预后 34 38 否 报告 未报告 非酒精性脂肪性肝病中医诊疗专家共识（2023）［11］ 2024 专家共识 中华中医药学会脾胃病分会 诊断、治疗、预后 29 27 否 报告 未报告 
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表 2 基于AGREEⅡ方法学质量评价结果
Table 2. Methodological quality evaluation of guidelines/consensus by AGREE Ⅱ
指南/共识 AGREEⅡ各领域得分率（%） AGREEⅡ推荐级别 目的
范文和
参与人员 严谨性 清晰性 应用性 独立性 得分率≥30%的领域数 得分率≥60%的领域数 推荐等级 非酒精性脂肪性肝病的中西医结合诊疗共识意见［3］ 35.7 26.2 21.4 21.4 14.3 9.5 1 0 C 非酒精性脂肪性肝病中医诊疗共识意见［4］ 33.3 28.6 24.1 21.4 14.3 9.5 1 0 C 非酒精性脂肪性肝病中西医结合诊疗共识意见（2017年）［6］ 19.1 26.2 20.5 21.4 14.3 9.5 0 0 C 非酒精性脂肪性肝病中医诊疗专家共识意见（2017）［5］ 38.1 31.0 21.4 40.5 14.3 9.5 3 0 B 非酒精性脂肪性肝病中医诊疗指南（基层医生版）［7］ 38.1 47.6 21.4 38.1 14.3 9.5 3 0 B 肝癖（非酒精性脂肪性肝炎）诊疗方案［8］ 47.6 19.1 21.4 31.0 14.3 9.5 2 0 C 穴位埋线治疗非酒精性脂肪性肝病中医实践指南［2］ 92.9 78.6 21.4 73.8 26.2 47.6 4 3 B 非酒精性脂肪性肝炎中医诊疗指南［9］ 83.3 85.7 21.4 92.9 45.2 61.9 5 4 B 非酒精性脂肪性肝病中医诊疗指南［11］ 35.7 26.2 21.4 21.4 14.3 9.5 1 0 C 平均 47.1 41.0 21.6 40.2 19.1 19.6
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表 3 基于RIGHT 报告质量评价
Table 3. Reporting quality evaluation of guidelines/consensus by RIGHT
指南/共识 RIGHT各领域报告率（%） 总体报告率（%） 基本信息 背景 证据 推荐意见 评审和
质量保证
资助和利益冲突 其他 非酒精性脂肪性肝病的中西医结合诊疗共识意见［3］ 42.9 14.3 28.6 14.3 0.0 0.0 14.3 16.3 非酒精性脂肪性肝病中医诊疗共识意见［4］ 42.9 28.6 42.9 14.3 0.0 0.0 14.3 20.4 非酒精性脂肪性肝病中西医结合诊疗共识意见（2017年）［6］ 42.9 28.6 28.6 14.3 0.0 0.0 14.3 18.4 非酒精性脂肪性肝病中医诊疗专家共识意见（2017）［5］ 42.9 28.6 100.0 14.3 0.0 0.0 14.3 28.6 非酒精性脂肪性肝病中医诊疗指南（基层医生版）［7］ 42.9 14.3 100.0 14.3 0.0 0.0 14.3 26.5 肝癖（非酒精性脂肪性肝炎）诊疗方案［8］ 42.9 28.6 42.9 14.3 0.0 0.0 14.3 20.4 穴位埋线治疗非酒精性脂肪性肝病中医实践指南［2］ 42.9 14.3 85.7 71.4 57.1 0.0 14.3 40.8 非酒精性脂肪性肝炎中医诊疗指南［9］ 42.9 28.6 100.0 71.4 57.1 14.3 14.3 46.9 非酒精性脂肪性肝病中医诊疗指南［11］ 42.9 14.3 28.6 14.3 0.0 0.0 14.3 16.3 总体评价 42.9 22.2 61.9 27.0 12.7 1.6 14.3 26.1
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