作者：
Shira Zelber–Sagi, Muriel Webb, Yoav Lurie, Moshe Santo, Moshe Leshno, Laurence Blendis, Zamir Halpern,Ran Oren, Ada Kessler, Eli Brazowsky.
作者单位：
Shira Zelber–Sagi, Muriel Webb, Yoav Lurie, Moshe Santo, Moshe Leshno, Laurence Blendis, Zamir Halpern,Ran Oren : 以色列特拉维夫大学-特拉维夫医疗中心-肝脏胃肠科；
Ada Kessler : 以色列特拉维夫大学-特拉维夫医疗中心-放射科；
Eli Brazowsky : 以色列特拉维夫大学-特拉维夫医学中心-病理学科。
【摘自】临床胃肠病学和肝病学杂志 2006年第4期:639-644
【摘要】
背景和目的：有不多的研究对如何有效治疗非酒精性脂肪肝进行了相应的论述。在这里，我们主要评估奥利司他对非酒精性脂肪肝的疗效。
方法：通过随机、双盲、安慰剂对照等方法对52例非酒精性脂肪肝患者进行研究，其中52例患者通过超声检验，其中40例患者通过肝活检进行确认。这些患者被随机分配服用奥利司他6个月(120mg,每日3次)或安慰剂。除此以外，所有的患者参与相同的减肥计划，每个月所有患者都要检查腹部超声、肝酶水平、血脂水平、胰岛素水平以及人体体格参数等，所有患者接受营养后续评估。22名患者在结束后接受肝活检检查。
结果：52名招募的患者中，44名（平均年龄47.7岁，平均BMI指数为33）的患者完成了研究。其中奥利司他组中，血糖、血脂水平更为显著，同时肝纤维化水平也有一定的升高。两组中BMI指数均显著降低，但两组间无明显差异。两组中血浆谷丙转氨酶均显著降低，但奥利司他组较对照组降低了近2倍(48%vs26.4%)。只有奥利司他组在统计学上有显著逆转脂肪肝的作用。
结论：根据超声波诊断结果分析，奥利司他除了能够减少非酒精脂肪肝患者的体重以外，还能够改善其血浆中的ALT浓度水平。
【文献原文】
A double-blind randomized placebo-controlled trial of orlistat for the treatment of nonalcoholic
fatty liver disease
Author:
Shira Zelber–Sagi, Muriel Webb, Yoav Lurie, Moshe Santo, Moshe Leshno, Laurence Blendis, Zamir Halpern,Ran Oren, Ada Kessler, Eli Brazowsky.
Author information：
Shira Zelber–Sagi, Muriel Webb, Yoav Lurie, Moshe Santo, Moshe Leshno, Laurence Blendis, Zamir Halpern,Ran Oren : The Liver Unit, Department of Gastroenterology, Tel Aviv Sourasky Medical Center and the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
Ada Kessler : Department of Radiology, Tel Aviv Sourasky Medical Center and the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
Eli Brazowsky : Department of Pathology, Tel Aviv Sourasky Medical Center and the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
Quote From: Clinical Gastroenterology and Hepatology 2006; 4:639-644
【ABSTRACT】
Background & Aims: Few controlled studies have addressed the issue of effective medical treatment for nonalcoholic fatty liver disease (NAFLD). We herein assessed the effect of orlistat in patients with NAFLD.
Methods: We performed a randomized, double-blind, placebo-controlled study on 52 patients with NAFLD diagnosed by ultrasound (US) and confirmed by liver biopsy (40 patients). The patients were randomized to receive either orlistat (120 mg 3 times daily for 6 months) or placebo. All patients participated in an identical behavioral weight loss program. All patients underwent monthly evaluation by abdominal US; liver enzyme levels, lipid profiles, insulin levels, and anthropometric parameters were monitored, and all patients underwent nutritional follow-up evaluation. Twenty-two patients underwent a second liver biopsy examination at the end of the study.
Results: Fifty-two patients were recruited and 44 (mean age, 47.7 y; mean body mass index, 33) completed the study. Serum glucose and insulin levels (P < .03) were significantly higher in the orlistat group, which also presented a higher degree of fibrosis. Body mass index was reduced significantly in each group, with a nonsignificant difference between the groups. Serum alanine transaminase (ALT) levels decreased significantly in both groups, with an almost 2-fold reduction in the orlistat group (48% vs 26.4%). There was a statistically significant reversal of fatty liver by US only in the orlistat group (P < .05).
Conclusions: Orlistat improves serum ALT levels and steatosis on US in NAFLD patients, beyond its effect on weight reduction.