Li Shuzhai, Zou Wangyuan, Zhou Yingying, Li Wenjie, Liao Wei, Li Tao, Zhang Zhiming
Department of Anesthesiology, The First People's Hospital, The Affiliated Chenzhou Hospital, Hengyang Medical School, University of South China, Chenzhou, Hunan, China.
Department of Anesthesiology, Xiangya Hospital, Central South University, Changsha, Hunan, China.
Front Pharmacol. 2025 May 30;16:1594091. doi: 10.3389/fphar.2025.1594091. eCollection 2025.
BACKGROUND & AIMS: Efruxifermin is a potential treatment for non-alcoholic steatohepatitis (NASH, now termed metabolic dysfunction-associated steatohepatitis, MASH). This study aimed to analyze the effectiveness of efruxifermin in improving liver fibrosis in patients with MASH.
Systematic searches of PubMed, Cochrane Library, and Embase databases were conducted. Randomized controlled trials evaluating the efficacy of efruxifermin compared with placebo in patients with MASH were included. The primary outcome was the proportion of patients with improvement in liver fibrosis by 1 or more stages without worsening of MASH. The secondary outcomes were non-invasive biomarkers of fibrosis and treatment-emergent adverse events (TEAEs).
This meta-analysis included 4 studies with a total of 325 patients with biopsy-proven MASH and stage F1-F4 fibrosis. All studies reported histological outcomes. Compared to placebo, efruxifermin demonstrated a higher relative risk (RR) of 1.97 (95% CI 1.21 to 3.19, = 0%, = 0.006) for achieving improvement in fibrosis by ≥ 1 stage without worsening of MASH. Furthermore, efruxifermin improved fibrosis-related non-invasive biomarkers (enhanced liver fibrosis [ELF]score, N-terminal type-III collagen pro-peptide [ProC3], and liver stiffness by FibroScan). However, efruxifermin was associated with an increased risk of adverse events compared to placebo, but this finding was not robust in sensitivity analysis.
Efruxifermin may be a potential therapeutic for MASH-related fibrosis, with the available data indicating seemingly favorable tolerability.
https://www.crd.york.ac.uk/PROSPERO/view/CRD42023491895, CRD42023491895.
艾弗鲁西费明是一种治疗非酒精性脂肪性肝炎（NASH，现称为代谢功能障碍相关脂肪性肝炎，MASH）的潜在药物。本研究旨在分析艾弗鲁西费明改善MASH患者肝纤维化的有效性。
对PubMed、Cochrane图书馆和Embase数据库进行系统检索。纳入评估艾弗鲁西费明与安慰剂相比对MASH患者疗效的随机对照试验。主要结局是肝纤维化改善1个或更多阶段且MASH未恶化的患者比例。次要结局是纤维化的非侵入性生物标志物和治疗中出现的不良事件（TEAE）。
本荟萃分析纳入4项研究，共325例经活检证实为MASH且纤维化分期为F1 - F4的患者。所有研究均报告了组织学结局。与安慰剂相比，艾弗鲁西费明在肝纤维化改善≥1个阶段且MASH未恶化方面的相对风险（RR）更高，为1.97（95%CI 1.21至3.19，P = 0%，I² = 0.006）。此外，艾弗鲁西费明改善了与纤维化相关的非侵入性生物标志物（增强肝纤维化[ELF]评分、N端III型前胶原肽[ProC3]以及通过FibroScan检测的肝脏硬度）。然而，与安慰剂相比，艾弗鲁西费明不良事件风险增加，但这一发现在敏感性分析中并不稳健。
艾弗鲁西费明可能是治疗MASH相关纤维化的一种潜在药物，现有数据表明其耐受性似乎良好。
https://www.crd.york.ac.uk/PROSPERO/view/CRD42023491895，CRD42023491895
