Weintraub M, Ginsberg G, Stein E C, Sundaresan P R, Schuster B, O'Connor P, Byrne L M
Clin Pharmacol Ther. 1986 May;39(5):501-9. doi: 10.1038/clpt.1986.87.
We added phenylpropanolamine OROS (Acutrim; Ciba-Geigy Corp.) or placebo to a physician-managed behavior modification, mild caloric restriction, and exercise weight control program. One hundred six healthy, overweight (115% to 130% ideal body weight) women participated in this 14-week double-blind clinical trial. On average, the participants who took Acutrim lost significantly more weight (X +/- SE; 6.1 +/- 0.6 kg; 8.0% +/- 0.8%) than did those taking placebo (4.3 +/- 0.7 kg; 5.5% +/- 0.8%; P less than 0.05). Those taking Actrim continued to lose weight over the Christmas holiday, while the placebo group gained weight. Fifteen participants taking placebo withdrew, three because of adverse drug reactions (ADRs). Thirteen of 53 participants in the Acutrim group left the study, two because of ADRs. Dry mouth was the most frequent complaint from participants taking Acutrim. No serious cardiovascular effects occurred. Both complaints and the number of participants reporting ADRs decreased with continued dosing. We conclude that Acutrim is a safe, modestly effective adjunct to a physician-managed, integrated weight control program.
我们将苯丙醇胺渗透泵控释片（Acutrim；汽巴 - 嘉基公司）或安慰剂添加到由医生管理的行为矫正、轻度热量限制和运动减肥计划中。106名健康的超重女性（体重为理想体重的115%至130%）参与了这项为期14周的双盲临床试验。平均而言，服用Acutrim的参与者比服用安慰剂的参与者减重明显更多（X±SE；6.1±0.6千克；8.0%±0.8%）（服用安慰剂的参与者减重为4.3±0.7千克；5.5%±0.8%；P＜0.05）。服用Acutrim的参与者在圣诞节期间持续减重，而安慰剂组体重增加。15名服用安慰剂的参与者退出，其中3人因药物不良反应退出。Acutrim组53名参与者中有13人退出研究，2人因药物不良反应退出。口干是服用Acutrim的参与者最常抱怨的问题。未出现严重心血管影响。随着持续给药，抱怨和报告药物不良反应的参与者数量均减少。我们得出结论，Acutrim是医生管理的综合减肥计划中一种安全、效果适度的辅助药物。
