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慢性乙型肝炎中医临床疗效评价体系的构建与思考
DOI: 10.12449/JCH260502
利益冲突声明：本文不存在任何利益冲突。
作者贡献声明：赵孝良负责撰写论文；雒琳负责相关文献的检索、筛选与整理；何丽云负责拟定写作思路，指导文章框架结构，修改论文。何丽云和赵孝良对本文贡献等同，同为第一作者。
Construction of a clinical efficacy evaluation system for traditional Chinese medicine treatment of chronic hepatitis B and related reflections
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摘要: 中医药在我国慢性乙型肝炎的临床实践中应用广泛，在改善症状、调节机体状态及辅助干预疾病进展等方面具有一定优势。但是，慢性乙型肝炎中医临床疗效评价尚存在评价体系不完整，评价指标选择不一致，证候与症状评价的客观化和标准化程度有限，制约了中医药疗效证据的系统积累及其在临床指南和专家共识中的应用。本文系统梳理慢性乙型肝炎中医临床疗效评价的研究现状，分析了国家科技计划“十一五”至“十三五”期间，我国重大传染病专项的中医、中西医结合治疗慢性肝病领域取得的成就，以及目前仍然需要解决的评价体系相关问题，从评价目标、指标构成和应用场景等方面提出构建中医临床疗效评价体系的思路与具体内容，以期为相关标准制定、临床研究及中西医结合诊疗规范提供参考。Abstract: Traditional Chinese medicine （TCM） is widely used in the clinical management of chronic hepatitis B in China and has exhibited certain advantages in alleviating symptoms， regulating overall physiological status， and assisting in the intervention against disease progression. However， there is still a lack of a comprehensive clinical efficacy evaluation system for TCM treatment of chronic hepatitis B， with inconsistencies in the selection of evaluation indicators and limited objectivity and standardization in the assessment of syndromes and symptoms， which have limited the systematic accumulation of evidence regarding TCM efficacy and the incorporation of TCM into clinical guidelines and expert consensus statements. This article systematically reviews the current status of research on the clinical efficacy evaluation of TCM for chronic hepatitis B and analyzes the achievements made in the field of TCM therapy and integrated traditional Chinese and Western medicine therapy for chronic liver diseases in China’s national major infectious disease research programs during the periods of the Eleventh to Thirteenth Five-Year Plans. It also points out related issues that remain to be addressed and proposes a conceptual framework and specific components for constructing a TCM clinical efficacy evaluation system from the perspectives of evaluation objectives， indicator composition， and application scenarios， in order to provide a reference for the development of related standards， clinical research， and the standardization of integrated traditional Chinese and Western medicine diagnosis and treatment.
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注： PRO，患者报告结局；ALT，丙氨酸氨基转移酶；AST，天冬氨酸氨基转移酶；TBil，总胆红素；LSM，肝硬度值；HBV，乙型肝炎病毒；HCC，肝细胞癌。
图 1 慢性乙型肝炎中医临床疗效评价体系构建思路图
Figure 1. Diagram of the construction framework for the traditional Chinese medicine clinical efficacy evaluation system in chronic hepatitis B
表 1 中医药参与CHB 治疗的历程分析
Table 1. Analysis of the participation of traditional Chinese medicine in the treatment of chronic hepatitis B
阶段 主要背景与政策环境 中医药参与方式 评价与研究关注重点 阶段性意义 国际指南主导阶段
（2007年至今）WHO［14］、EASL［15］、AASLD［16］ 等
发布CHB诊疗指南中医药仅作为补充
或替代医学被提及HBV DNA、ALT、肝纤维
化分期及并发症风险确立以抗病毒治疗为
核心的国际诊疗范式国内中西医并行探索
期（1990—2018年）我国CHB防治需求突出［17］ 中医药作为协同干
预参与临床实践症状改善、肝功能变化 形成中西医并行治疗
的实践基础国家指南纳入阶段
（2019年至今）《慢性乙型肝炎防治指南（2019
年版）》［4］和《慢性乙型肝炎防治
指南（2022年版）》［5］发布部分中成药以“可考
虑”形式纳入抗纤维
化治疗抗纤维化治疗证据与辅
助干预疗效中医药首次以循证形
式进入国家级CHB指
南体系中医/中西医结合指南
细化阶段（2018年
至今）中医及中西医结合诊疗指南、专
家共识发布基于疾病分期引入
证候分型，形成分阶
段干预策略病程分期+证候分层+分
阶段干预构建“病程分期-证候
分层”的中西医结合诊
疗路径国家科研系统推进阶
段（约2006年至今）“十一五”以来国家重大专项与
重点研发计划中医药系统介入
CHB全病程治疗和
管理症状、生活质量、血清学
应答、纤维化及重症
结局构建覆盖早期-活动
期-重症-肿瘤预防的
研究体系结局导向与长期管理
阶段（2019年至今）大样本、多中心与长期随访研究
开展中医/中西医结合用
于重症及长期管理病死率、纤维化逆转、远
期预后疗效评价由症状导向
延伸至关键临床结局评价方法学规范化阶
段（2020年至今）核心结局指标集研究推进 建立标准化结局指
标体系患者报告结局、客观指
标与现代终点对接提升中医证据的可重
复性与国际可对话性注：CHB，慢性乙型肝炎；WHO，世界卫生组织；EASL，欧洲肝病学会；AASLD，美国肝病学会；HBV，乙型肝炎病毒；ALT，丙氨酸氨基转移酶。
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