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瑞美替罗(Resmetirom)治疗代谢相关脂肪性肝炎的临床试验进展
刘爱芳, 罗磊, 杨文龙
PDF(1353 KB)
PDF(1353 KB)
瑞美替罗(Resmetirom)治疗代谢相关脂肪性肝炎的临床试验进展
Advances of clinical trials related to Resmetirom as an approved new drug for metabolic dysfunction-associated steatohepatitis
代谢功能障碍相关脂肪性肝病是全球第一大肝病,严重危害公众健康,但一直缺乏获批的治疗药物。2024年3月14日,Resmetirom(瑞美替罗)成为全球首个美国食品药品监督管理局批准用于治疗代谢相关脂肪性肝炎(MASH)的药物。本文归纳和总结了Resmetirom治疗MASH的作用机制、相关临床试验设计及部分研究结果,并分析其不足和展望未来。基于目前已有的研究数据,Resmetirom在改善脂肪性肝炎和肝纤维化方面是有效的,但距离理想的MASH治疗药物还有不小的距离,期待更多、更有效的药物参与其中。
Metabolic dysfunction-associated steatotic liver disease is the largest liver disease around the world and is a serious public health hazard, but there has always been a lack of drugs approved for treatment. On March 14, 2024, Resmetirom became the first drug approved by the US Food and Drug Administration for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). This article summarizes the mechanism of action of Resmetirom in the treatment of MASH, related clinical trial designs, and some research results and analyzes shortcomings and future prospects. Current data have shown that Resmetirom is effective in improving steatohepatitis and liver fibrosis, but there is still a large gap between Resmetirom and the ideal drug for the treatment of MASH, and it is expected to develop more effective drugs for MASH.
Metabolic Dysfunction-Associated Steatohepatitis / Resmetirom / Clinical Trial
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ClinicalTrials.gov. phaseA 3 study to evaluate safety and biomarkers of Resmetirom (MGL-3196) in patients with non-alcoholic fatty liver disease (NAFLD), MAESTRO-NAFLD-open-label-extension(MAESTRO-NAFLD-OLE)[EB/OL]. (2023-12-04)[2024-04-16].
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ClinicalTrials.gov. A phase 3 study to evaluate the effect of Resmetirom on clinical outcomes in patients with well-compensated NASH cirrhosis (MAESTRO-NASH-OUTCOMES)[EB/OL]. (2024-03-25)[2024-04-16].
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The Lancet Gastroenterology Hepatology. Resmetirom for NASH: Balancing promise and prudence[J]. Lancet Gastroenterol Hepatol, 2024, 9(4): 273. DOI: 10.1016/S2468-1253(24)00049-9 .
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刘爱芳负责论文构思,设计及撰写;罗磊和杨文龙负责论文修订、指导、质量控制与审校。
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