Background

The prevalence of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis (NAFLD/NASH) is increasing. NAFLD/NASH may progress to cirrhosis and hepatocellular carcinoma. However, most patients with NAFLD/NASH will die from a vascular cause. There are no currently approved pharmacological treatments for NASH/NAFLD. A large number of clinical trials have been, or are being, undertaken; however, the challenge is the assessment of the clinical endpoint.

Scope of review

The main objective of this narrative review was to evaluate the efficacy of drugs used in clinical trials for the treatment of NAFLD/NASH that included a liver biopsy as the gold standard. A literature search was carried out using 3 databases (PubMed, Scopus, and Google Scholar) to identify the clinical trials that included liver biopsy assessment before and after treatment. Interventional clinical trials (n=33) involving 18 different agents, alone and in combination, were identified.

Major conclusions

Pioglitazone is the only agent that has shown consistent benefit and efficacy in a number of clinical trials. Pentoxifylline, rosiglitazone and ursodeoxycholic acid had both positive and negative results from clinical trials. There is also evidence for vitamin E and metformin. Other drugs including bicyclol, cysteamine bitartrate, L-carnitine, liraglutide, obeticholic acid, oligofructose, selonsertib, silymarin, and statins each had a single clinical study. There is an urgent need for further research in this field.

中文翻译：

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非酒精性脂肪性肝病和脂肪性肝炎：基于诊断金标准方法的有效治疗的最新技术。

背景

非酒精性脂肪性肝病和非酒精性脂肪性肝炎 (NAFLD/NASH) 的患病率正在增加。NAFLD/NASH 可能进展为肝硬化和肝细胞癌。然而，大多数 NAFLD/NASH 患者会死于血管原因。目前没有批准用于 NASH/NAFLD 的药物治疗。已经或正在进行大量临床试验；然而，挑战在于临床终点的评估。

审查范围

这篇叙述性综述的主要目的是评估临床试验中用于治疗 NAFLD/NASH 的药物的疗效，其中包括肝活检作为金标准。使用 3 个数据库（PubMed、Scopus 和 Google Scholar）进行文献检索，以确定包括治疗前后肝活检评估的临床试验。确定了涉及 18 种不同药物的干预性临床试验（n=33），单独和联合使用。

主要结论

吡格列酮是唯一在许多临床试验中显示出一致的益处和功效的药物。己酮可可碱、罗格列酮和熊去氧胆酸在临床试验中均有阳性和阴性结果。还有证据表明维生素 E 和二甲双胍。其他药物，包括双环醇、酒石酸半胱胺、左旋肉碱、利拉鲁肽、奥贝胆酸、低聚果糖、selonsertib、水飞蓟素和他汀类药物，均进行了一项临床研究。迫切需要对该领域的进一步研究。