作者：
Chanoine JP, Hampl S, Jensen C, Boldrin M, Hauptman J.
作者單位：
Chanoine JP, 醫(yī)學博士: 加拿大溫哥華哥倫比亞兒童醫(yī)院內(nèi)分泌和糖尿病科；
Hampl S, 醫(yī)學博士: 美國密蘇里州·堪薩斯城·兒童慈愛醫(yī)院；
Jensen C, 醫(yī)學博士: 美國德克薩斯州·休斯敦·貝勒醫(yī)學院醫(yī)學系；;
Boldrin M,碩士, Hauptman,醫(yī)學博士: 美國新澤西州羅氏制藥公司.
【摘自】美國醫(yī)學協(xié)會雜志 2005年第293期: 2873-83
【摘要】
背景：兒童和青少年超重和肥胖的患病率正在迅速增長。在這些人口中，單一的行為療法在提供意義的、持續(xù)的減重方面具有其局限性，其次，藥物治療沒有被廣泛的研究。
目地：確認奧利司他對肥胖青少年的有效性和安全性。
設計、設置和患者：持續(xù)54周的多中心、隨機、雙盲試驗，研究539名肥胖青少年(12—16歲，BMI≥30)，研究在位于美國和加拿大的32個醫(yī)療中心展開。
干預：在539名的受試者中，357名受試者接受持續(xù)一年的奧利司他治療(120mg，每日三次)，其余182名則接受安慰劑治療，同時兩組均接受溫和的低熱量飲食(脂肪含量為30%)，鍛煉和行為干預。
主要觀察指標：BMI的變化；腰和臀圍的變化、體重減輕、脂肪含量測量，口服葡萄糖對血糖和血脂的影響等；
結(jié)果：到第12周時兩組的BMI水平均有所下降。之后奧利司他組保持穩(wěn)定，但安慰劑組則超過基線增長。在研究尾期，奧利司他組的BMI降低了0.55，而安慰劑組則增加了0.31。奧利司他組中有26.5%的受試者減少了5%以上的BMI，而安慰劑組只有15.7%。奧利司他組中有13.3%的受試者減少了約10%以上的BMI，而安慰劑組只有4.5%。研究結(jié)束后，奧利司他組的體重增長了0.53kg，安慰劑組增長了3.14kg。雙能x射線吸收儀表示這種差異主要是在于脂肪含量的變化。奧利司他組中腰圍減少了1.33cm，而安慰劑組中則增長了0.12cm。奧利司他組中輕度的胃腸道反應發(fā)生率為9%~50%之間，安慰劑組為1%~13%。
結(jié)論：與運動、飲食、生活習慣相結(jié)合，與安慰劑相比較，奧利司他對青少年肥胖患者體重的改善更加顯著。在這些使用奧利司他1年的青少年人群中盡管出現(xiàn)了胃腸道不良反應，但未見其它不安全事件。
【文獻原文】
Effect of orlistat on weight and body composition in obese adolescents: a randomized controlled trial.
Author:
Chanoine JP, Hampl S, Jensen C, Boldrin M, Hauptman J.
Author Affiliations:
Chanoine JP, MD, PhD: Endocrinology and Diabetes Unit, British Columbia Children’s Hospital, Vancouver;
Hampl S, MD, FAAP: Children’s Mercy Hospitals and Clinics, Kansas City, Mo;
Jensen C, MD: Department of Medicine, Baylor College of Medicine, Houston, Tex;
Boldrin M,MS, Hauptman,MD: JHoffmann-La Roche Inc, Nutley, NJ.
Quote From: The Journal of the American Medical Association. 2005; 293:2873-83
【ABSTRACT】
Context：The prevalence of overweight and obesity in children and adolescents is increasing rapidly. In this population, behavioral therapy alone has had limited success in providing meaningful, sustained weight reduction, and pharmacological treatment has not been extensively studied.
Objective：To determine the efficacy and safety of orlistat in weight management of adolescents.
Design, Setting, and Patients： Multicenter, 54-week (August 2000-October 2002), randomized, double-blind study of 539 obese adolescents (aged 12-16 years; body mass index [BMI] ≥2 units above the 95th percentile) at 32 centers in the United States and Canada.
Interventions：A 120-mg dose of orlistat (n = 357) or placebo (n=182) 3 times daily for 1 year, plus a mildly hypocaloric diet (30% fat calories), exercise, and behavioral therapy.
Main Outcome Measures ：Change in BMI; secondary measures included changes in waist and hip circumference, weight loss, lipid measurements, and glucose and insulin responses to oral glucose challenge.
Results：There was a decrease in BMI in both treatment groups up to week 12, thereafter stabilizing with orlistat but increasing beyond baseline with placebo. At the end of the study, BMI had decreased by 0.55 with orlistat but increased by 0.31 with placebo (P = .001). Compared with 15.7% of the placebo group, 26.5% of participants taking orlistat had a 5% or higher decrease in BMI (P = .005); 4.5% and 13.3%, respectively, had a 10% or higher decrease in BMI (P = .002). At study end, weight had increased 0.53 kg with orlistat and 3.14 kg with placebo (P<.001). Dual-energy x-ray absorptiometry showed that this difference was explained by changes in fat mass. Waist circumference decreased in the orlistat group but increased in the placebo group (–1.33 cm vs +0.12 cm; P<.05). Generally mild to moderate gastrointestinal tract adverse events occurred in 9% to 50% of the orlistat group and in 1% to 13% of the placebo group.
Conclusions：In combination with diet, exercise, and behavioral modification, orlistat statistically significantly improved weight management in obese adolescents compared with placebo. The use of orlistat for 1 year in this adolescent population did not raise major safety issues although gastrointestinal adverse events were more common in the orlistat group.