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利拉鲁肽治疗青少年肥胖症患者的随机对照试验
A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity


Aaron S. Kelly ... 妇产科和儿科 • 2020.05.28
相关阅读
• 利拉鲁肽对2型糖尿病有效 • 利拉鲁肽治疗儿童和青少年2型糖尿病患者 • 利拉鲁肽治疗青少年肥胖的临床试验

摘要


背景

肥胖症是一种慢性疾病,而儿童肥胖症患者的可选治疗方案有限。利拉鲁肽可能对青少年肥胖症患者的体重管理有帮助。

 

方法

在这项随机、双盲试验(包括56周的治疗期和26周的随访期)中,我们纳入了单纯生活方式干预措施效果不佳的青少年(12~<18岁)肥胖症患者。我们以1∶1的比例将参与者随机分组,两组分别在生活方式干预措施的基础上接受利拉鲁肽(3.0 mg)或安慰剂每日1次皮下注射。主要终点是第56周的体质指数(BMI,体重[kg]除以[身高{m }的平方])的标准差评分相对于基线的变化。

 

结果

共计125例参与者被分配至利拉鲁肽组,126例被分配至安慰剂组。在第56周时BMI标准差评分相对于基线的变化方面,利拉鲁肽优于安慰剂(估计差异,-0.22;95%置信区间[CI],-0.37~-0.08;P=0.002)。利拉鲁肽组113例参与者中51例和安慰剂组105例参与者中20例的BMI降幅≥5%(估计百分比,43.3% vs. 18.7%),两组分别有33例和9例参与者的BMI降幅≥10%(估计百分比,26.1% vs. 8.1%)。利拉鲁肽组的BMI(估计差异,-4.64个百分点)和体重(估计差异,-4.50 kg[绝对变化]和-5.01个百分点[相对变化])降幅超过安慰剂组。停止治疗后,利拉鲁肽组的BMI标准差评分增幅超过安慰剂组(估计差异,0.15;95% CI,0.07~0.23)。利拉鲁肽组发生胃肠道不良事件(81/125[64.8%] vs. 46/126[36.5%])和导致停止试验治疗的不良事件(13[10.4%] vs. 0)的参与者人数超过安慰剂组。两组中发生严重不良事件的参与者均很少(3[2.4%] vs. 5[4.0%])。利拉鲁肽组发生了1例自杀,研究者判定与试验治疗不太可能相关。

 

结论

在青少年肥胖症患者中,与安慰剂+生活方式干预措施相比,利拉鲁肽(3.0 mg)+生活方式干预措施使BMI标准差评分有显著较大幅下降(由诺和诺德公司资助,NN8022-4180在ClinicalTrials.gov注册号为NCT02918279)。





作者信息

Aaron S. Kelly, Ph.D., Pernille Auerbach, M.D., Ph.D., Margarita Barrientos-Perez, M.D., Inge Gies, M.D., Ph.D., Paula M. Hale, M.D., Claude Marcus, M.D., Ph.D., Lucy D. Mastrandrea, M.D., Ph.D., Nandana Prabhu, M.Sc., and Silva Arslanian, M.D. for the NN8022-4180 Trial Investigators*
From the Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis (A.S.K.); Novo Nordisk, Søborg, Denmark (P.A.); Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); the Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Plainsboro, NJ (P.M.H.); the Division of Pediatrics, Department of Clinical Science Intervention and Technology, Karolinska Institutet, Stockholm (C.M.); the Division of Pediatric Endocrinology and Diabetes, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY (L.D.M.); Novo Nordisk, Bengaluru, India (N.P.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children’s Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).Address reprint requests to Dr. Kelly at the Center for Pediatric Obesity Medicine, University of Minnesota, 717 Delaware St. SE, Rm. 370E, Minneapolis, MN 55414, or at kelly105@umn.edu. *A complete list of the NN8022-4180 trial investigators is provided in the Supplementary Appendix, available at NEJM.org.

 

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