Bupropion SR enhances weight loss: A 48-week double-blind, placebo-controlled trial
Bupropion SR enhances weight loss: A 48-week double-blind, placebo-controlled trial
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DOI：
10.1038/oby.2002.86
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发表时间：
2002-07-01
期刊：
影响因子：
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通讯作者：
O'Neil, PM
中科院分区：
文献类型：
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作者：
Anderson, JW;Greenway, FL;O'Neil, PM
目的：严格检验安非他酮缓释片对减肥的功效。研究方法和程序：这项为期 24 周的多中心、双盲、安慰剂对照研究将肥胖成人随机分配至安慰剂、安非他酮缓释片 300 或 400 毫克/天。向受试者提供限制能量饮食、代餐和运动方面的建议。在 24 周的延长期中，安慰剂受试者以双盲方式随机接受安非他酮 SR 300 或 400 mg/d。 结果：在 327 名受试者中，227 名完成了 24 周； 192 完成了 48 周。对于完成 24 周的受试者，安慰剂、安非他酮 SR 300 和 400 mg/d 的初始体重下降百分比分别为 5.0%、7.2% 和 10.1%。与安慰剂相比，安非他酮 SR 300 和 400 mg/d 的净体重损失分别为 2.2% (p = 0.0468) 和 5.1% (p < 0.0001)。安慰剂、安非他酮 SR 300 和 400 mg/d 组中，体重减轻超过或等于初始体重 5% 的受试者百分比分别为 46%、59% 和 83%（p 与安慰剂 < 0.0001）；对于安慰剂、安非他酮 SR 300 和 400 mg/d，大于或等于 10% 的体重减轻分别为 20%、33% 和 46%（p 与安慰剂 = 0.0008）。 24 周时，停药、脉搏和血压的变化与安慰剂相比没有显着差异。完成 48 周的受试者服用安非他酮 SR 300 和 400 mg/d 后，初始体重平均下降分别为 7.5% 和 8.6%。 讨论：安非他酮 SR 300 和 400 mg/d 对肥胖成人的耐受性良好，与 24 周体重减轻 7.2% 和 10.1% 相关，并在 48 周时持续体重减轻。
Objective: To critically examine the efficacy of bupropion SR for weight loss.Research Methods and Procedures: This 24-week multicenter, double-blind, placebo-controlled study randomized obese adults to placebo, bupropion SR 300, or 400 mg/d. Subjects were counseled on energy-restricted diets, meal replacements, and exercise. During a 24-week extension, placebo subjects were randomized to bupropion SR 300 or 400 mg/d in a double-blinded manner.Results: Of 327 subjects enrolled, 227 completed 24 weeks; 192 completed 48 weeks. Percentage losses of initial body weight for subjects completing 24 weeks were 5.0%, 7.2%, and 10.1% for placebo, bupropion SR 300, and 400 mg/d, respectively. Compared with placebo, net weight losses were 2.2% (p = 0.0468) and 5.1% (p < 0.0001) for bupropion SR 300 and 400 mg/d, respectively. The percentages of subjects who lost greater than or equal to5% of initial body weight were 46%, 59%, and 83% (p vs. placebo < 0.0001) for placebo, bupropion SR 300, and 400 mg/d, respectively; weight losses of greater than or equal to10% were 20%, 33%, and 46% (p vs. placebo = 0.0008) for placebo, bupropion SR 300, and 400 mg/d, respectively. Withdrawals, changes in pulse and blood pressure did not differ significantly from placebo at 24 weeks. Subjects who completed 48 weeks maintained mean losses of initial body weight of 7.5% and 8.6% for bupropion SR 300 and 400 mg/d, respectively.Discussion: Bupropion SR 300 and 400 mg/d were well-tolerated by obese adults and were associated with a 24-week weight loss of 7.2% and 10.1% and sustained weight losses at 48 weeks.