Department of Internal Medicine, Wilford Hall Medical Center, Lackland Air Force Base, TX, USA.
J Clin Gastroenterol. 2009 Nov-Dec;43(10):990-4. doi: 10.1097/MCG.0b013e31819c392e.
This study was designed to assess the utility of statin therapy in patients with biopsy proven nonalcoholic steatohepatitis (NASH) and hyperlipidemia.
Nonalcoholic fatty liver disease, as the hepatic manifestation of the metabolic syndrome, has become a growing public health concern. Nonalcoholic steatohepatitis (NASH) represents a subset of nonalcoholic fatty liver disease manifested by hepatic fatty infiltration and inflammation which may progress to cirrhosis and its subsequent complications, to include hepatocellular carcinoma. As the metabolic syndrome is thought to be central in the pathogenesis of NASH, it has been speculated that medications that improve metabolic profiles may be beneficial in treatment. In fact, recent studies have demonstrated potential benefit of 3-hydroxy-3-methyglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins), which are used in clinical practice to improve lipid panels.
This double-blinded randomized placebo-controlled trial compared the HMG-CoA reductase inhibitor, simvastatin, with placebo in the treatment of NASH over a 12-month period using serum aminotransferases and repeat liver biopsy to assess for improvement.
Sixteen patients with biopsy proven NASH were enrolled: 14 completed the study and 10 underwent 1-year repeat liver biopsy. Mean age: 53 years (+/-10.1), mean body mass index: 32.4 (+/-6.1) with 11 male and 5 female patients. Although a 26% reduction in low-density lipoprotein was seen in the simvastatin group compared with placebo, there was no statistically significant improvement in serum aminotransferases, hepatic steatosis, necroinflammatory activity or stage of fibrosis within or between groups.
In this pilot trial, monotherapy with simvastatin does not seem to be an effective treatment for NASH.
本研究旨在评估他汀类药物治疗经活检证实的非酒精性脂肪性肝炎（NASH）和高脂血症患者的疗效。
非酒精性脂肪性肝病作为代谢综合征的肝脏表现，已成为日益严重的公共卫生问题。非酒精性脂肪性肝炎（NASH）代表了非酒精性脂肪性肝病的一个亚组，其特征为肝脂肪浸润和炎症，可能进展为肝硬化及其随后的并发症，包括肝细胞癌。由于代谢综合征被认为是 NASH 的发病机制的核心，因此有人推测改善代谢谱的药物可能对治疗有益。事实上，最近的研究表明 3-羟基-3-甲基戊二酰辅酶 A（HMG-CoA）还原酶抑制剂（他汀类药物）具有潜在益处，这些药物在临床上用于改善血脂谱。
这项双盲、随机、安慰剂对照试验比较了 HMG-CoA 还原酶抑制剂辛伐他汀与安慰剂在 12 个月内治疗 NASH 的疗效，使用血清氨基转移酶和重复肝活检来评估改善情况。
16 例经活检证实的 NASH 患者入组：14 例完成研究，10 例接受 1 年重复肝活检。平均年龄为 53 岁（+/-10.1），平均体重指数为 32.4（+/-6.1），其中 11 例为男性，5 例为女性。尽管辛伐他汀组的低密度脂蛋白降低了 26%，但与安慰剂组相比，血清氨基转移酶、肝脂肪变性、坏死性炎症活动或纤维化分期均无统计学意义的改善。
在这项初步试验中，辛伐他汀单药治疗似乎不是 NASH 的有效治疗方法。
