Song Yu, Ni Wenjing, Zheng Minghua, Sheng Huiping, Wang Jing, Xie Shilong, Yang YongFeng, Chi Xiaoling, Chen Jinjun, He Fangping, Fan Xiaotang, Mi Yuqiang, Zhang Jing, Wang Bingyuan, Bai Lang, Xie Wen, Zhong Bihui, Yeo Yee Hui, Rui Fajuan, Zang Shufei, Li Jie, Shi Junping
Department of Infectious Diseases and Hepatology, The Affiliated Hospital of Hangzhou Normal University, Hangzhou, Zhejiang 310015, P.R. China; Zhejiang Key Laboratory of Medical Epigenetics, Hangzhou, Zhejiang 310015, P.R. China.
Department of Infectious Diseases, Nanjing Drum Tower Hospital Clinical College of Nanjing University of Chinese Medicine, Nanjing, Jiangsu 210000, P.R. China; Department of Infectious Disease, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, Jiangsu 210000, P.R. China.
Cell Rep Med. 2025 Feb 18;6(2):101939. doi: 10.1016/j.xcrm.2025.101939.
The efficacy and safety of a lower dose of vitamin E for metabolic dysfunction-associated steatohepatitis (MASH) treatment are unclear. This multi-center, randomized, double-blind, placebo-controlled study includes 124 non-diabetic participants with biopsy-proven MASH. Participants are randomly assigned to receive oral vitamin E 300 mg or the placebo in a 1:1 ratio. The primary outcome is improvement in hepatic histology. In the modified intention-to-treat population, 29.3% of participants in the vitamin E group achieve the primary outcome compared with 14.1% in the placebo group. Significant improvement in steatosis, lobular inflammation, and fibrosis stages is observed in the vitamin E group. 12 serious adverse events are reported in this trial but are not considered to be related to the treatment. Vitamin E 300 mg daily achieves sound improvements in liver histology in the Chinese population with MASH. This study is registered at ClinicalTrials.gov (NCT02962297).
低剂量维生素E治疗代谢功能障碍相关脂肪性肝炎（MASH）的疗效和安全性尚不清楚。这项多中心、随机、双盲、安慰剂对照研究纳入了124名经活检证实患有MASH的非糖尿病参与者。参与者按1:1的比例随机分配接受口服300毫克维生素E或安慰剂。主要结局是肝脏组织学改善。在意向性分析的修正人群中，维生素E组29.3%的参与者达到主要结局，而安慰剂组为14.1%。维生素E组的脂肪变性、小叶炎症和纤维化阶段有显著改善。本试验报告了12例严重不良事件，但认为与治疗无关。每日300毫克维生素E可使中国MASH患者的肝脏组织学得到明显改善。本研究已在ClinicalTrials.gov（NCT02962297）注册。
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