Berkowitz Robert I, Wadden Thomas A, Tershakovec Andrew M, Cronquist Joanna L
Department of Psychiatry, Weight and Eating Disorders Program, University of Pennsylvania School of Medicine, Philadelphia 19104-3309, USA.
JAMA. 2003 Apr 9;289(14):1805-12. doi: 10.1001/jama.289.14.1805.
Adolescent obesity is becoming a national public health problem. Weight-loss medications including sibutramine facilitate weight control in adults and could be used with obese adolescents in combination with behavior therapy (BT).
To examine whether increased weight loss in obese adolescents is induced when sibutramine is added to a family-based, behavioral weight control program.
DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind, placebo-controlled trial consisting of 82 adolescents aged 13 to 17 years with a body mass index (BMI) of 32 to 44 conducted from March 1999 to August 2002 at a university-based clinic for 6 months, followed by open-label treatment during months 7 to 12.
For the first 6 months, participants received either BT and sibutramine or BT and placebo. From months 7 to 12, all participants received sibutramine in open-label treatment.
Percentage change in BMI; systolic and diastolic blood pressure and pulse; and hunger.
In intention-to-treat analysis at month 6, participants in the BT and sibutramine group lost a mean (SD) of 7.8 kg (6.3 kg) and had an 8.5% (6.8%) reduction in BMI, which was significantly more than weight loss of 3.2 kg (6.1 kg) and reduction in BMI of 4.0% (5.4%) in the BT and placebo group. Significantly greater reductions in hunger (P =.002) also were reported by participants who received BT and sibutramine. From months 7 to 12, adolescents initially treated with sibutramine gained 0.8 kg (10.5 kg) with continued use of the medication, whereas those who switched from placebo to sibutramine lost an additional 1.3 kg (5.4 kg). Medication dose was reduced (n = 23) or discontinued (n = 10) to manage increases in blood pressure, pulse rate, or other symptoms.
The addition of sibutramine to a comprehensive behavioral program induced significantly more weight loss than did BT and placebo. Until more extensive safety and efficacy data are available, medications for weight loss should be used only on an experimental basis in adolescents and children.
青少年肥胖正成为一个全国性的公共卫生问题。包括西布曲明在内的减肥药物有助于成年人控制体重，可与行为疗法（BT）联合用于肥胖青少年。
研究在以家庭为基础的行为体重控制计划中加入西布曲明是否能使肥胖青少年体重进一步减轻。
设计、地点和参与者：1999年3月至2002年8月在一家大学诊所进行的随机、双盲、安慰剂对照试验，共82名13至17岁的青少年，体重指数（BMI）为32至44，为期6个月，随后在第7至12个月进行开放标签治疗。
在最初的6个月里，参与者接受行为疗法加西布曲明或行为疗法加安慰剂。从第7至12个月，所有参与者接受开放标签治疗的西布曲明。
BMI的变化百分比；收缩压、舒张压和脉搏；以及饥饿感。
在第6个月的意向性分析中，行为疗法加西布曲明组的参与者平均（标准差）体重减轻7.8 kg（6.3 kg），BMI降低8.5%（6.8%），显著多于行为疗法加安慰剂组的体重减轻3.2 kg（6.1 kg）和BMI降低4.0%（5.4%）。接受行为疗法加西布曲明的参与者报告饥饿感也显著降低（P = 0.002）。从第7至12个月，最初接受西布曲明治疗的青少年在继续使用该药物后体重增加0.8 kg（10.5 kg），而从安慰剂转换为西布曲明的青少年又额外减轻了1.3 kg（5.4 kg）。为控制血压、脉搏率或其他症状，减少了药物剂量（n = 2３）或停药（n = 10）。
在综合行为计划中加入西布曲明比行为疗法加安慰剂能显著减轻更多体重。在获得更广泛的安全性和有效性数据之前，减肥药物在青少年和儿童中应仅用于实验目的。
