Division of Gastroenterology and Hepatology, Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Soonchunhyang University College of Medicine, Seoul, Korea.
Diabetes Metab J. 2020 Oct;44(5):640-657. doi: 10.4093/dmj.2020.0115. Epub 2020 Oct 21.
The worldwide prevalence of non-alcoholic fatty liver disease is around 25%, and that of nonalcoholic steatohepatitis (NASH) ranges from 1.5% to 6.45%. Patients with NASH, especially those with fibrosis, are at higher risk for adverse outcomes such as cirrhosis and liver-related mortality. Although vitamin E, pioglitazone, and liraglutide improved liver histology in randomized trials, there are currently no Food and Drug Administration-approved drugs for NASH. Five pharmacologic agents-obeticholic acid, elafibranor, cenicriviroc, resmetirom, and aramchol-are being evaluated in large, histology-based phase 3 trials. Within 2 to 4 years, new and effective drugs for the treatment of NASH are expected. Additionally, many phase 2 trials are ongoing for various agents. Based on the results of phase 2 and 3 trials, combination treatments are also being investigated. Future treatment strategies will comprise drug combinations and precision medicine based on the different phenotypes of NASH and treatment response of the individual patient.
全球非酒精性脂肪性肝病的患病率约为 25%，非酒精性脂肪性肝炎（NASH）的患病率为 1.5%至 6.45%。NASH 患者，尤其是有纤维化的患者，发生肝硬化和与肝脏相关死亡等不良结局的风险更高。尽管随机试验表明维生素 E、吡格列酮和利拉鲁肽改善了肝脏组织学，但目前尚无获得美国食品和药物管理局批准的 NASH 药物。正在大型基于组织学的 3 期试验中评估五种药物：奥贝胆酸、艾拉酚胺、西尼利尤单抗、雷美替胺和阿瑞匹坦。在 2 至 4 年内，预计将有新的、有效的 NASH 治疗药物问世。此外，还有许多针对各种药物的 2 期试验正在进行中。基于 2 期和 3 期试验的结果，正在研究联合治疗。未来的治疗策略将包括基于 NASH 的不同表型和个体患者治疗反应的药物联合治疗和精准医学。
