Xiang Liu-Lan, Cao Yu-Tian, Wang Xiao-Xiao, Wang Gao-Xiang, Zhang Yu-Juan, Li Rui-Han, Qi Fang, Huai Jia-Xuan, Sun Jing, He Xiao-Jin, Zhou Xi-Qiao
Department of Endocrinology, Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine, Nanjing, People's Republic of China.
The First Clinical Medical College of Nanjing University of Chinese Medicine, Nanjing, People's Republic of China.
J Multidiscip Healthc. 2025 Jul 29;18:4377-4389. doi: 10.2147/JMDH.S522519. eCollection 2025.
This study aims to evaluate the efficacy of the Xietu Hemu prescription (XHP) in improving metabolic dysfunction-associated steatotic liver disease (MASLD) through a Real World Study approach.
This was a single-center, prospective, real-world cohort study of 262 patients with MASLD who met the inclusion and exclusion criteria from November 2021 to November 2023 at Jiangsu Provincial Hospital of Traditional Chinese Medicine. The exposure of this study was who took the XHP. We assessed the efficacy of the XHP on MASLD by comparing FibroScan parameters, body composition indicators, and liver serological indicators. The XHP was then evaluated for MASLD by inverse probability of treatment weighting (IPTW) as well as log-binomial analysis.
We ended up collecting the exposure cohort (n=163) and the referent cohort (n=99). Patients were categorized into an exposure cohort (n=163, XHP + basic treatment) subdivided by treatment duration: 4 weeks (n=28), 8 weeks (n=60), 12 weeks (n=51), and ≥16 weeks (n=24), and a referent cohort (n=99, basic treatment alone). The results showed significant improvements in Liver stiffness measurement (LSM), controlled attenuation parameter (CAP), body mass index (BMI), waist-to-hip ratio (WHR), visceral fat area (VFA), the fatty liver index (FLI), and FibroScan-AST (FAST) in the exposure cohort after treatment compared to before treatment. After controlling confounding by IPTW, log-binomial analysis revealed that XHP administration was significantly more effective for MASLD in the exposure cohort than in the referent cohort (weighted risk ratio=2.99, 95% CI=1.86 to 4.89, p<0.001). Subgroup analyses revealed a significantly greater efficacy of the XHP in the exposure cohort compared to the MASLD referent cohort, across various durations and dosages of XHP and varying degrees of hepatic steatosis and fibrosis. No serious adverse events occurred; occasional mild gastrointestinal reactions were self-limiting.
The results of our study suggest that XHP has a significant treatment effect on MASLD, which hopes to complement the current lack of treatment for MASLD.
本研究旨在通过真实世界研究方法评估泄土和木方（XHP）改善代谢功能障碍相关脂肪性肝病（MASLD）的疗效。
这是一项单中心、前瞻性、真实世界队列研究，于2021年11月至2023年11月在江苏省中医院纳入262例符合纳入和排除标准的MASLD患者。本研究的暴露因素为服用XHP者。我们通过比较FibroScan参数、身体成分指标和肝脏血清学指标来评估XHP对MASLD的疗效。然后通过治疗权重逆概率（IPTW）以及对数二项式分析对XHP治疗MASLD进行评估。
最终收集到暴露队列（n = 163）和对照队列（n = 99）。患者被分为暴露队列（n = 163，XHP + 基础治疗），根据治疗持续时间进一步细分：4周（n = 28）、8周（n = 60）、12周（n = 51）和≥16周（n = 24），以及对照队列（n = 99，仅基础治疗）。结果显示，与治疗前相比，暴露队列治疗后肝脏硬度测量值（LSM）、受控衰减参数（CAP）、体重指数（BMI）、腰臀比（WHR）、内脏脂肪面积（VFA）、脂肪肝指数（FLI）和FibroScan - AST（FAST）均有显著改善。通过IPTW控制混杂因素后，对数二项式分析显示，暴露队列中XHP治疗MASLD的效果显著优于对照队列（加权风险比 = 2.99，95%CI = 1.86至4.89，p < 0.001）。亚组分析显示，在不同的XHP疗程和剂量以及不同程度的肝脂肪变性和纤维化情况下，暴露队列中XHP的疗效显著优于MASLD对照队列。未发生严重不良事件；偶尔出现轻度胃肠道反应，可自行缓解。
我们的研究结果表明，XHP对MASLD有显著治疗效果，有望弥补目前MASLD治疗方法的不足。
