Clinical trials tracking nonalcoholic fatty liver disease: Noninvasive measures
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摘要: 非酒精性脂肪性肝病(NAFLD)已成为当前肝病领域的研究热点之一,但迄今为止,美国食品药品监督管理局尚未批准用于非酒精性脂肪性肝炎的治疗药物,NAFLD的临床治疗试验仍面临诸多机遇与挑战。肝脏组织学目前被认为是追踪NAFLD进展的可靠替代终点,但由于其有创性也制约了NAFLD治疗药物的开发。近年来,一些非侵入测量方法已被应用于当前临床试验的次要或探索性终点。Abstract: Nonalcoholic fatty liver disease (NAFLD) has become one of the research hotspots in the field of liver disease. However, so far, no drugs have been approved by the U. S. Food and Drug Administration for the treatment of nonalcoholic steatohepatitis, which brings opportunities and challenges to the clinical trials on the treatment of NAFLD. Liver histology is currently considered a reliable surrogate endpoint for tracking the progression of NAFLD, but its invasiveness has limited the development of drugs for the treatment of NAFLD. In recent years, some noninvasive measurement methods have gradually been used as secondary or exploratory endpoints in existing clinical trials.
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Key words:
- non-alcoholic fatty liver disease /
- clinical trial /
- noninvasive makers
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