作者：Hollander PA, Elbein SC, Hirsch IB, Kelley D, McGill J, Taylor T, Weiss SR, Crockett SE, Kaplan RA, Comstock J, Lucas CP, Lodewick PA, Canovatchel W, Chung J, Hauptman J.
作者單位：美國(guó)德克薩斯州達(dá)拉斯貝勒醫(yī)療中心。
【摘自】美國(guó)糖尿病護(hù)理雜志，1998年8月第21刊第8期。
【摘要】
目的：肥胖對(duì)于2型糖尿病來(lái)說(shuō)是一個(gè)重要的風(fēng)險(xiǎn)因子，伴2型糖尿病的肥胖患者的減肥與改善血糖控制和減少心血管疾病風(fēng)險(xiǎn)因子相關(guān)，但是減肥尤其很難以限制卡路里和鍛煉去維持。這項(xiàng)研究的目的是為了發(fā)現(xiàn)奧利司他(脂肪酶抑制劑)在伴2型糖尿病肥胖患者中減重、血糖控制和血脂水平的影響。
研究設(shè)計(jì)與方法：在一項(xiàng)57周的多中心隨機(jī)雙盲安慰劑對(duì)照研究中，391名BMI在28~40范圍內(nèi)、且年齡≥18歲的伴Ⅱ型糖尿病的男女，1日3次口服奧利司他120mg或安慰劑，并伴隨中度低熱量飲食，同時(shí)臨床上口服磺酰脲類的穩(wěn)定群體。測(cè)量其體重變化，血糖控制，血脂水平和藥物耐受性。
結(jié)果：經(jīng)過(guò)1年的治療，奧利司他組較初始體重減少了6.2±0.45%，安慰劑組較初始體重減少了4.3±0.49%，且在奧利司他組中，體重減少≥5%的人數(shù)比減少≤5%的人數(shù)多兩倍。兩組中，奧利司他組和安慰機(jī)組均能顯著提升血糖控制能力，反映在糖化血紅蛋白、空腹血糖水平降低，磺酰脲類口服降糖藥劑量下降。與安慰劑組相比，奧利司他組能夠顯著改善脂質(zhì)水平，即顯著的降低總膽固醇、低密度脂蛋白、三酰甘油、載脂蛋白B。在奧利司他治療過(guò)程中，曾經(jīng)報(bào)告過(guò)中輕度和暫時(shí)的胃腸道反應(yīng)，盡管他們的協(xié)會(huì)有著極低的撤回率。脂溶性維生素水平總體上仍處于參考范圍內(nèi)，僅少數(shù)病人需要服用維生素補(bǔ)充劑。
結(jié)論：服用奧利司他對(duì)伴Ⅱ型糖尿病肥胖患者是一種有效的治療方式，奧利司他能夠顯著降低并長(zhǎng)期維持患者體重，提高患者血糖控制水平，改善患者的血脂代謝。
文獻(xiàn)原文：
Role of Orlistat in the Treatment of Obese Patients With Type 2 Diabetes: A 1-year randomized double-blind study
Author：Hollander PA, Elbein SC, Hirsch IB, Kelley D, McGill J, Taylor T, Weiss SR, Crockett SE, Kaplan RA, Comstock J, Lucas CP, Lodewick PA, Canovatchel W, Chung J, Hauptman J.
Author information：Baylor Medical Center,Dallas,Texas,USA.
Quote：Diabetes Care. 1998 Aug;21(8):1288-94
【ABSTRACT】
OBJECTIVE Obesity is an important risk factor for type 2 diabetes. Weight loss in patients with type 2 diabetes is associated with improved glycemic control and reduced cardiovascular disease risk factors, but weight loss is notably difficult to achieve and sustain with caloric restriction and exercise. The purpose of this study was to assess the impact of treatment with orlistat, a pancreatic lipase inhibitor, on weight loss, glycemic control, and serum lipid levels in obese patients with type 2 diabetes on sulfonylurea medications.
RESEARCH DESIGN AND METHODS：In a multicenter 57-week randomized double-blind placebo-controlled study, 120 mg orlistat or placebo was administered orally three times a day with a mildly hypocaloric diet to 391 obese men and women with type 2 diabetes who were aged > 18 years, had a BMI of 28–40 kg/m2, and were clinically stable on oral sulfonylureas. Changes in body weight, glycemic control, lipid levels, and drug tolerability were measured.
RESULTS：After 1 year of treatment, the orlistat group lost 6.2 ± 0.45% (mean ± SEM) of initial body weight vs. 4.3 ± 0.49% in the placebo group (P < 0.001). Twice as many patients receiving orlistat (49 vs. 23%) lost ≥ 5% of initial body weight (P < 0.001). Orlistat treatment plus diet compared with placebo plus diet was associated with significant improvement in glycemic control, as reflected in decreases in HbA1c (P < 0.001) and fasting plasma glucose (P < 0.001) and in dosage reductions of oral sulfonylurea medication (P < 0.01). Orlistat therapy also resulted in significantly greater improvements than placebo in several lipid parameters, namely, greater reductions in total cholesterol, (P < 0.001), LDL cholesterol (P < 0.001), triglycerides (P < 0.05), apolipoprotein B (P < 0.001), and the LDL-to-HDL cholesterol ratio (P < 0.001). Mild to moderate and transient gastrointestinal events were reported with orlistat therapy, although their association with study withdrawal was low. Fat-soluble vitamin levels generally remained within the reference range, and vitamin supplementation was required in only a few patients.
CONCLUSIONS：Orlistat is an effective treatment modality in obese patients with type 2 diabetes with respect to clinically meaningful weight loss and maintenance of weight loss, improved glycemic control, and improved lipid profile.
文獻(xiàn)詳情：http://www.ncbi.nlm.nih.gov/pubmed/9702435/