代谢相关脂肪性肝病肝纤维化的中医药治疗进展

周志佳; 李新月; 郑超; 孙学华

doi:10.12449/JCH251002

代谢相关脂肪性肝病肝纤维化的中医药治疗进展

DOI: 10.12449/JCH251002

周志佳^{1, 2},
李新月³,
郑超^{1, 2},
孙学华^3, , ,

1.
浙江大学医学院附属第二医院内分泌科，杭州 310000
2.
浙江省代谢内分泌疾病研究中医药重点实验室，杭州 310000
3.
上海中医药大学附属曙光医院肝病科，上海 200000

基金项目:

国家自然科学基金 (82074336);

国家自然科学基金 (82374251);

2023年上海市卫生健康领军人才计划 (2022LJ013);

浦东新区卫生健康委员会学科建设项目（中医肝病临床专科重点学科） (PWZxq2022-04);

2022年国家中医药管理局高水平中医药重点学科建设项目（中医肝胆病学） (zyyzdxk-2023060);

2023年中央财政转移支付地方项目-中医药防治肝胆病循证能力提升建设 ;

浙江省“尖兵”“领雁”研发攻关计划项目 (2024C03269)

利益冲突声明：本文不存在任何利益冲突。

作者贡献声明：周志佳、李新月和郑超负责资料查找，撰写、修改与校对论文；孙学华指导修改论文并最终定稿。

详细信息

通信作者:
孙学华， susan_sxh@shutcm.edu.com （ORCID： 0000-0003-3418-9537）

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出版历程
- 收稿日期: 2025-07-15
- 录用日期: 2025-08-11
- 出版日期: 2025-10-25

Advances in traditional Chinese medicine treatment of liver fibrosis in metabolic associated fatty liver disease

Zhijia ZHOU^{1, 2},
Xinyue LI³,
Chao ZHENG^{1, 2},
Xuehua SUN^{3
, ,
,}

1.
Department of Endocrinology，The Second Affiliated Hospital of Zhejiang University School of Medicine，Hangzhou 310000，China
2.
Zhejiang Provincial Key Laboratory of Traditional Chinese Medicine for Metabolic and Endocrine Diseases Research，Hangzhou 310000，China
3.
Department of Hepatology，Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine，Shanghai 200000，China

Research funding:

National Natural Science Foundation of China (82074336);

National Natural Science Foundation of China (82374251);

the 2023 Shanghai Leading Talent Program in Health and Wellness (2022LJ013);

the Discipline Construction Project of Pudong New Area Health Commission-Key Clinical Specialty in Traditional Chinese Medicine for Liver Diseases (PWZxq2022-04);

the 2022 Key Discipline Construction Project of High-level Traditional Chinese Medicine under the National Administration of Traditional Chinese Medicine （Discipline of TCM Hepatobiliary Diseases） (zyyzdxk-2023060);

the 2023 Central Government Transfer Payment to Local Projects-Capacity Building for Evidence-based TCM Prevention and Treatment of Hepatobiliary Diseases ;

Zhejiang Province “Pioneer” and “Leading Goose” R&D Tackling Program (2024C03269)

More Information

Corresponding author: SUN Xuehua， susan_sxh@shutcm.edu.com （ORCID： 0000-0003-3418-9537）

摘要

摘要: 代谢相关脂肪性肝病（MAFLD）已成为全球最常见的慢性肝病之一，其进展至肝纤维化是影响患者预后和并发症风险的关键节点。近年来，选择性甲状腺激素受体β激动剂、胰高血糖素样肽-1受体激动剂、成纤维细胞生长因子21类似物等新型药物在MAFLD肝纤维化治疗中取得初步进展，但整体疗效仍有限，尚缺乏覆盖不同病程阶段的理想治疗策略。中医药凭借其多靶点、系统调节等特点，在该领域展现出独特的干预优势。本文系统梳理了近年来中药复方及其活性成分在基础与临床研究中的抗肝纤维化作用机制，重点涉及肝星状细胞激活、脂质代谢紊乱、氧化应激、免疫炎症及肠-肝轴功能障碍等关键环节。同时，指出当前研究中存在如机制阐释不清、评价体系不统一、临床证据质量有待提升等问题。未来应重视中药制剂的标准化与质量可控性，并结合组学分析、类器官模型和真实世界数据等新兴技术，推动中医药干预MAFLD肝纤维化向机制明确、路径清晰、证据坚实的方向发展。中医药有望在MAFLD肝纤维化的多维靶向干预与分期管理中发挥重要作用，为慢性肝病精准治疗提供新思路与整合性解决方案。
- 代谢相关脂肪性肝病 /
- 肝纤维化 /
- 抗肝纤维化药（中药） /
- 治疗学
Abstract: Metabolic associated fatty liver disease （MAFLD） has become one of the most prevalent chronic liver disease worldwide， and its progression to liver fibrosis is a key influencing factor for prognosis and the risk of complications. In recent years， novel drugs， such as selective thyroid hormone receptor-β agonists， glucagon-like peptide-1 receptor agonists， and fibroblast growth factor 21 analogs， have shown preliminary efficacy in the treatment of MAFLD-related liver fibrosis； however， such drugs have limited overall effectiveness， and there is still a lack of ideal therapeutic strategy to address the disease across its different stages. Traditional Chinese medicine （TCM）， with its characteristics of multiple targets and systemic regulation， has shown unique advantages in this field. This article systematically reviews the basic and clinical research on the anti-fibrotic mechanisms of compound TCM prescriptions and their active components in recent years， focusing on the key processes including hepatic stellate cell activation， lipid metabolism disorders， oxidative stress， immune inflammation， and gut-liver axis dysfunction. Meanwhile， it is pointed out that there are still certain issues in current research， including ambiguities in the clarification of mechanisms， a lack of standardized evaluation systems， and the need to improve the quality of clinical evidence. Future research should emphasize the standardization and quality control of TCM herbal preparations and integrate emerging technologies， such as omics analysis， organoid models， and real-world data， to advance TCM intervention of MAFLD-related liver fibrosis toward well-defined mechanisms， clear therapeutic pathways， and robust scientific evidence. TCM is expected to play a vital role in the multi-dimensional targeted intervention and stage-specific management of MAFLD-related liver fibrosis， in order to provide new perspectives and comprehensive solutions for the precise treatment of chronic liver diseases.
- Metabolic Associated Fatty Liver Disease /
- Hepatic Fibrosis /
- Anti-Hepato Fibrosis Agents （TCD） /
- Therapeutics

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表 1 中医药干预 MAFLD 肝纤维化的基础研究总结

Table 1. Summary of basic research on traditional Chinese medicine interventions for liver fibrosis in MAFLD

方药/成分	模型类型	主要靶点通路	主要作用
灯盏乙素^［14］	HFD，MCD	TGF-β/TAK1/MAPK	抗炎、抗纤维化
虫草素^［15］	HFD，MCD，HFHC	AMPK，脂质代谢通路	调脂、抗应激
黄芩-黄连药对^［16］	HFD	Nrf2/FXR，胆汁酸通路	抗氧化、调代谢
葛根素、地黄多糖^［17］	CCl₄	ZO-1/Occludin，TLR4/NF-κB	维护屏障、抗炎
抗纤软肝胶囊^［18］	HFD	TGF-β1/Smad2/3，PI3K/Akt	抑制HSC活化、抗纤维化
加味桃核承气汤^［19］	HFD	NF-κB，TNF-α/IL-6	抗炎、抗纤维化
逍遥散^［20］	HFD+CCl₄	TGF-β/Smad，Wnt/β-catenin	调脂、抗纤维化
甘塘益方^［21］	HFD	NLRP3炎症小体，IL-1β	抗炎、抑制肝损伤
芪甲柔肝方^［22］	HFD	PTEN/PI3K/Akt	抑制HSC活化、调脂
清脂调肝汤^［23］	HFD	Nrf2/HO-1，SREBP-1c	抗氧化、调脂
姜黄素^［24］	HFD，MCD	NF-κB/STAT1	促进巨噬细胞向抗炎修复型M2极化
川陈皮素^［25］	HFD	激活PPARγ/STAT6	抑制HSC激活
当归芍药散^［26］	HFD	PI3K/Akt，肠道菌群调节	改善胰岛素抵抗、抗炎
注：HFD，高脂饮食；MCD，蛋氨酸胆碱缺乏饮食；HFHC，高脂高糖饮食；CCl₄，四氯化碳；TAK1，转化生长因子β激活激酶1；MAPK，丝裂原活化蛋白激酶；Nrf2，核因子E2相关因子2；FXR，法尼醇X受体；ZO-1，紧密连接蛋白1；TLR4，Toll样受体4；NF-κB，核因子-κB；Smad，SMAD蛋白家族；PI3K，磷脂酰肌醇3激酶；Akt，蛋白激酶B；TNF-α，肿瘤坏死因子α；IL-6，白细胞介素6；Wnt，Wnt信号通路；β-catenin，β-连环蛋白；NLRP3，NLR家族吡啶结构域蛋白3；IL-1β，白细胞介素1β；PTEN，磷酸酶和张力蛋白同源物；HO-1，血红素氧合酶1；SREBP-1c，固醇调节元件结合蛋白1c；STAT1，信号转导与转录激活因子1；PPARγ，过氧化物酶体增殖物激活受体γ；STAT6，信号转导与转录激活因子6。

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表 2 MAFLD/MASH 人群的中医药与天然活性物干预研究

Table 2. Clinical studies on traditional Chinese medicine and natural active compounds for intervention in MAFLD/MASH populations

年份/PMID	试验类型	纳入对象及干预时间	主要干预方式	肝纤维化相关指标	作用机制
2025/38809154^［29］	随机双盲	MASH 52例， 72周	磷脂姜黄素1 g/d	随访活检示炎症、纤维化级别双下降，NAS降低	可能经Nrf2/ PPARα 协同
2024/38788390^［30］	RCT	MAFLD 246例， 24周	祛湿化瘀方vs当飞利肝宁	ALT、AST、CAP 均优于当飞利肝宁组，肠道 Veillonella丰度下降	调控TLR4/FXR- FGF15轴
2024/38879879^［31］	双盲安慰剂	NAFLD 121例， 24周	由水飞蓟宾、葛根素和丹参酸组成，分别为23.0 mg、 11.4 mg和10.9 mg	肝脂肪分数下降趋势； CRP降低，ALDH 活性增强	提高ALDH相关醛代谢能力，减轻脂质过氧化与下游炎症通路
2024/38773414^［32］	RCT	MAFLD 46例， 12周	大豆异黄酮100 mg/d	TG、LDL-C、TC下降；腰围减小	PPARγ 激活
2023/36799355^［33］	双盲	MASH 30例， 12周	姜黄素1 g+胡椒碱10 mg	ALT、AST、TC、FBG、SBP 降低	调控NF-κB/ AMPK通路
2023/36829229^［34］	随机假针	MASH 60例， 12周	电针（肝俞-足三里）	MRI-PDFF、ALT降低	肠-脑-肝轴神经调节
2023/35999630^［35］	多臂平行	MAFLD 260例， 16周	丹芍疏肝颗粒±水飞蓟宾	超声脂肪评分、TC、TG、 AST、GGT均改善	疏肝活血，清肝解毒
2022/36743913^［36］	RCT	MAFLD 82例， 12周	健脾疏肝方+生活方式	ALT、HOMA-IR降低； Bifidobacterium丰度增加	PI3K-Akt/菌群- 胆汁酸互作
2022/35471471^［37］	双盲	超重MAFLD 243例， 12周	苓桂术甘汤9 g/d	改善胰岛素抵抗；介导 ATG3与PPP1R3A的 m⁶A 修饰重塑	自噬-糖原通路
2020/32507446^［38］	RCT	MAFLD 54例， 8周	姜黄素1.5 g/d	近端 MLH1、MSH2 启动子甲基化水平降低；TG 下降	DNA修复-表观调控
2019/30895694^［39］	对照	NAFLD 54例， 8周	马齿苋籽粉10 g/d	FBG、HOMA-IR、LDL-C 降低	调控AdipoR1- AMPK通路
2017/28932090^［40］	三臂剂量	NAFLD 74例， 12周	厚朴提取物200/400 mg	400 mg 组肝脂肪含量下降	调控FXR/LXR 通路
2015/26032587^［41］	RCT	MAFLD 60例， 12周	二氢杨梅素胶囊150 mg， 2次/d	ALT、AST、GGT、HOMA- IR、CK-18、TNF-α、FGF21 均下降，脂联素水平升高	改善胰岛素抵抗，抑制炎症因子与细胞凋亡
2014/24461315^［42］	RCT	MAFLD 80例， 12周	肉桂1.5 g/d	HOMA-IR、TC降低；AST 下降趋势	调控IR/IRS-1-Akt 通路
注：NAS，NAFLD活动度评分；CAP，受控衰减参数；CRP，C反应蛋白；ALDH，乙醛脱氢酶；TG，甘油三酯；LDL-C，低密度脂蛋白胆固醇；TC，总胆固醇；FBG，空腹血糖；SBP，收缩压；FibroScan，瞬时弹性成像；HOMA-IR，胰岛素抵抗指数；ATG3，自噬相关蛋白3；PPP1R3A，蛋白磷酸酶1调节亚基3A；m⁶A，N6-甲基腺苷修饰；MLH1/MSH2，错配修复基因；AdipoR1，脂联素受体1；LXR，肝X受体；IR/IRS-1，胰岛素受体/胰岛素受体底物1。

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