作者：
Shira Zelber–Sagi, Muriel Webb, Yoav Lurie, Moshe Santo, Moshe Leshno, Laurence Blendis, Zamir Halpern,Ran Oren, Ada Kessler, Eli Brazowsky.
作者單位：
Shira Zelber–Sagi, Muriel Webb, Yoav Lurie, Moshe Santo, Moshe Leshno, Laurence Blendis, Zamir Halpern,Ran Oren : 以色列特拉維夫大學(xué)-特拉維夫醫(yī)療中心-肝臟胃腸科；
Ada Kessler : 以色列特拉維夫大學(xué)-特拉維夫醫(yī)療中心-放射科；
Eli Brazowsky : 以色列特拉維夫大學(xué)-特拉維夫醫(yī)學(xué)中心-病理學(xué)科。
【摘自】臨床胃腸病學(xué)和肝病學(xué)雜志 2006年第4期:639-644
【摘要】
背景和目的：有不多的研究對如何有效治療非酒精性脂肪肝進(jìn)行了相應(yīng)的論述。在這里，我們主要評估奧利司他對非酒精性脂肪肝的療效。
方法：通過隨機(jī)、雙盲、安慰劑對照等方法對52例非酒精性脂肪肝患者進(jìn)行研究，其中52例患者通過超聲檢驗(yàn)，其中40例患者通過肝活檢進(jìn)行確認(rèn)。這些患者被隨機(jī)分配服用奧利司他6個(gè)月(120mg,每日3次)或安慰劑。除此以外，所有的患者參與相同的減肥計(jì)劃，每個(gè)月所有患者都要檢查腹部超聲、肝酶水平、血脂水平、胰島素水平以及人體體格參數(shù)等，所有患者接受營養(yǎng)后續(xù)評估。22名患者在結(jié)束后接受肝活檢檢查。
結(jié)果：52名招募的患者中，44名（平均年齡47.7歲，平均BMI指數(shù)為33）的患者完成了研究。其中奧利司他組中，血糖、血脂水平更為顯著，同時(shí)肝纖維化水平也有一定的升高。兩組中BMI指數(shù)均顯著降低，但兩組間無明顯差異。兩組中血漿谷丙轉(zhuǎn)氨酶均顯著降低，但奧利司他組較對照組降低了近2倍(48%vs26.4%)。只有奧利司他組在統(tǒng)計(jì)學(xué)上有顯著逆轉(zhuǎn)脂肪肝的作用。
結(jié)論：根據(jù)超聲波診斷結(jié)果分析，奧利司他除了能夠減少非酒精脂肪肝患者的體重以外，還能夠改善其血漿中的ALT濃度水平。
【文獻(xiàn)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.