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一项关于体重控制的双盲临床试验。单独及联合使用芬氟拉明和苯丁胺。

A double-blind clinical trial in weight control. Use of fenfluramine and phentermine alone and in combination.

作者信息

Weintraub M, Hasday J D, Mushlin A I, Lockwood D H

出版信息

Arch Intern Med. 1984 Jun;144(6):1143-8.

PMID:6375610
Abstract

We performed a double-blind, controlled clinical trial comparing phentermine resin (30 mg in the morning), fenfluramine hydrochloride (20 mg three times a day), and a combination of phentermine resin (15 mg in the morning) and fenfluramine hydrochloride (30 mg before the evening meal), and placebo. We combined low doses of the two drugs to maintain efficacy while diminishing adverse effects. Eighty-one people with simple obesity (130% to 180% of ideal body weight) participated. Individualized diets were prescribed and discussed again during the 24-week study period. Weight loss in those receiving the combination (8.4 +/- 1.1 kg; mean +/- SEM) was significantly greater than in those receiving placebo (4.4 +/- 0.9 kg; Scheff é's test) and equivalent to that of those receiving fenfluramine (7.5 +/- 1.2 kg) or phentermine (10.0 +/- 1.2 kg) alone. Adverse effects were less frequent with the combination regimen than with other active treatments. Thirty-seven participants dropped out of the study, 18 for reasons related to drug treatment. Combining fenfluramine and phentermine capitalized on their pharmacodynamic differences, resulting in equivalent weight loss, fewer adverse effects, and better appetite control.

摘要

我们进行了一项双盲对照临床试验,比较了苯丁胺树脂(早上30毫克)、盐酸芬氟拉明(每日三次,每次20毫克)、苯丁胺树脂(早上15毫克)与盐酸芬氟拉明(晚餐前30毫克)的组合以及安慰剂。我们将两种药物的低剂量联合使用,以维持疗效同时减少不良反应。81名单纯性肥胖患者(理想体重的130%至180%)参与了研究。在为期24周的研究期间,规定了个性化饮食并再次进行了讨论。接受联合用药的患者体重减轻(8.4±1.1千克;均值±标准误)显著大于接受安慰剂的患者(4.4±0.9千克;谢夫检验),且与单独接受芬氟拉明(7.5±1.2千克)或苯丁胺(10.0±1.2千克)的患者。联合用药方案的不良反应比其他活性治疗更少。37名参与者退出了研究,其中18人是因为与药物治疗相关的原因。将芬氟拉明和苯丁胺联合使用利用了它们的药效学差异,导致体重减轻相当、不良反应更少且食欲控制更好。

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