Norris Susan L, Zhang Xuanping, Avenell Alison, Gregg Edward, Schmid Christopher H, Kim Curi, Lau Joseph
Division of Diabetes Translation, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, GA 30341, USA.
Arch Intern Med. 2004 Jul 12;164(13):1395-404. doi: 10.1001/archinte.164.13.1395.
Obesity is closely related to type 2 diabetes mellitus, and weight reduction is an important part of the care delivered to obese persons with diabetes. The objective of this review was to assess the efficacy of pharmacotherapy for weight loss in adults with type 2 diabetes.
A systematic review of the literature was performed, and studies were included if pharmacotherapy was used as the primary strategy for weight loss among adults with type 2 diabetes. Published and unpublished studies with any design were included. A random effects model was used to combine outcomes from randomized controlled trials.
Sufficient data for the meta-analysis were available for fluoxetine, orlistat, and sibutramine. Fourteen randomized, placebo-controlled trials were included in the review, with a total of 2231 patients. Pharmacotherapy produced modest reductions in weight for fluoxetine (3.4 kg [95% confidence interval (CI), 1.7-5.2 kg] at 8-16 weeks of follow-up; 5.1 kg [95% CI, 3.3-6.9 kg] at 24-30 weeks; and 5.8 kg [ 95% CI, 0.8-10.8 kg] at 52 weeks); orlistat (2.6 kg [95% CI, 2.1-3.2 kg] [2.6% loss] at 52 weeks); and sibutramine (4.5 kg [95% CI, 1.8-7.2 kg] [3.3% loss] at up to 26 weeks). Glycated hemoglobin was also modestly reduced: fluoxetine (1.0% [95% CI, 0.4%-1.5%] at 8-16 weeks; 1.0% [95% 0.6%-1.4%] at 24-30 weeks; and 1.8% [95% CI, -0.2%-3.8%] at 52 weeks); orlistat (0.4% [95% CI, 0.3%-0.5%]); and sibutramine (0.7% [95% CI, -0.5%-1.9%]). Gastrointestinal adverse effects were common with orlistat; tremor, somnolence, and sweating with fluoxetine; and palpitations with sibutramine.
Fluoxetine, orlistat, and sibutramine can achieve statistically significant weight loss over 26 to 52 weeks. However, the magnitude of weight loss was modest, and the long-term health benefits and safety remain unclear. Interventions that combine pharmacologic therapy with intensive behavioral interventions may be more effective but need additional research.
肥胖与2型糖尿病密切相关，体重减轻是糖尿病肥胖患者护理的重要组成部分。本综述的目的是评估药物治疗对2型糖尿病成年患者体重减轻的疗效。
对文献进行系统综述，纳入将药物治疗作为2型糖尿病成年患者体重减轻主要策略的研究。纳入任何设计的已发表和未发表研究。采用随机效应模型合并随机对照试验的结果。
有足够的数据可用于对氟西汀、奥利司他和西布曲明进行荟萃分析。该综述纳入了14项随机、安慰剂对照试验，共2231例患者。药物治疗使体重适度减轻：氟西汀（随访8 - 16周时减轻3.4 kg[95%置信区间(CI)，1.7 - 5.2 kg]；24 - 30周时减轻5.1 kg[95% CI，3.3 - 6.9 kg]；52周时减轻5.8 kg[95% CI，0.8 - 10.8 kg]）；奥利司他（52周时减轻2.6 kg[95% CI，2.1 - 3.2 kg][减重2.6%]）；西布曲明（长达26周时减轻4.5 kg[95% CI，1.8 - 7.2 kg][减重3.3%]）。糖化血红蛋白也适度降低：氟西汀（8 - 16周时降低1.0%[95% CI，0.4% - 1.5%]；24 - 30周时降低1.0%[95% CI，0.6% - 1.4%]；52周时降低1.8%[95% CI， - 0.2% - 3.8%]）；奥利司他（降低0.4%[95% CI，0.3% - 0.5%]）；西布曲明（降低0.7%[95% CI, - 0.5% - 1.9%]）。奥利司他常见胃肠道不良反应；氟西汀常见震颤、嗜睡和出汗；西布曲明常见心悸。
氟西汀、奥利司他和西布曲明在26至52周内可实现具有统计学意义的体重减轻。然而，体重减轻幅度不大，长期健康益处和安全性仍不明确。将药物治疗与强化行为干预相结合的干预措施可能更有效，但需要更多研究。
