A placebo-controlled trial of pioglitazone in subjects with nonalcoholic steatohepatitis
A placebo-controlled trial of pioglitazone in subjects with nonalcoholic steatohepatitis
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DOI：
10.1056/nejmoa060326
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发表时间：
2006-11-30
影响因子：
158.5
通讯作者：
Cusi, Kenneth
中科院分区：
文献类型：
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作者：
Belfort, Renata;Harrison, Stephen A.;Cusi, Kenneth
背景：目前尚无确切的药物治疗证明对非酒精性脂肪性肝炎有效。非酒精性脂肪性肝炎以胰岛素抵抗、脂肪变性和伴有或不伴有小叶中心纤维化的坏死性炎症为特征。吡格列酮是一种噻唑烷二酮，可改善2型糖尿病患者的胰岛素抵抗和糖脂代谢。方法：我们随机分配55例糖耐量受损或2型糖尿病和肝活检证实的非酒精性脂肪性肝炎患者，接受6个月的低热量饮食（与维持体重所需的计算每日摄入量相比，每天减少500千卡）加吡格列酮（每天45毫克）或低热量饮食加安慰剂的治疗。在治疗前后，我们通过磁共振波谱评估肝脏组织学特征，肝脏脂肪含量，以及口服葡萄糖耐量试验中的葡萄糖周转(口服葡萄糖负荷给予[（C-14]葡萄糖，静脉滴注[H-3]葡萄糖）。结果：与饮食加安慰剂相比，饮食加吡格列酮改善了血糖控制和葡萄糖耐量(P
BACKGROUND:No pharmacologic therapy has conclusively proved to be effective for the treatment of nonalcoholic steatohepatitis, which is characterized by insulin resistance, steatosis, and necroinflammation with or without centrilobular fibrosis. Pioglitazone is a thiazolidinedione that ameliorates insulin resistance and improves glucose and lipid metabolism in type 2 diabetes mellitus.METHODS:We randomly assigned 55 patients with impaired glucose tolerance or type 2 diabetes and liver biopsy-confirmed nonalcoholic steatohepatitis to 6 months of treatment with a hypocaloric diet (a reduction of 500 kcal per day in relation to the calculated daily intake required to maintain body weight) plus pioglitazone (45 mg daily) or a hypocaloric diet plus placebo. Before and after treatment, we assessed hepatic histologic features, hepatic fat content by means of magnetic resonance spectroscopy, and glucose turnover during an oral glucose tolerance test ([(C-14]glucose given with the oral glucose load and [H-3]glucose given by intravenous infusion).RESULTS:Diet plus pioglitazone, as compared with diet plus placebo, improved glycemic control and glucose tolerance (P