Cairella M, Cairella G, Graziani P, Mirante M G, Taghva A R
Servizio Speciale di Dietologia, Università degli Studi di Roma La Sapienza.
Clin Ter. 1992 Mar;140(3):235-8.
The object of the present research was to study the effect of dexfenfluramine (d-F) and placebo (P) on compliance with dietary treatment, especially as far as changes in kcal and macronutrient intake are concerned. A double-blind study d-F vs P was performed in 36 obese females, age range 20-59 years (mean 37.22 +/- 12.41), with a mean BMI of 33.95 +/- 5.36, suffering from obesity due to overeating without complications: Outpatient control every 30 days. The study protocol provided for a 14-month double-blind treatment with daily administration of either P (2 capsules) or d-F (two 15 mg capsules). Dietary prescription of 1200 kcal (5016 kJ) was given 15 days before enrollment (T/0) and during this period enrollment criteria were checked prior to randomization. Dietary intake was checked by a three-day recall (one working day, one half-holiday and one full holiday) in basal conditions and after 6-12 and 14 months. Administration of d-F and P brought about changes in alimentary behaviour in obese patients according to the dietary regime prescribed. In our patients, no highly significant differences between d-F and P were observed; however, the effect of P on macronutrient intake (carbohydrates, lipids and proteins) tended to peter out around the 12th month. Treatment with d-F reduced the consumption of simple carbohydrates, animal fats but not of animal proteins.
本研究的目的是研究右旋芬氟拉明(d-F)和安慰剂(P)对饮食治疗依从性的影响,特别是在千卡和常量营养素摄入量变化方面。对36名年龄在20至59岁(平均37.22±12.41)、平均BMI为33.95±5.36、因暴饮暴食导致肥胖且无并发症的肥胖女性进行了d-F与P的双盲研究:每30天门诊复查一次。研究方案规定进行为期14个月的双盲治疗,每天服用P(2粒胶囊)或d-F(两粒15毫克胶囊)。在入组前15天(T/0)给出1200千卡(5016千焦)的饮食处方,在此期间,在随机分组前检查入组标准。通过在基础条件下以及6个月、12个月和14个月后进行的三日饮食回顾(一个工作日、一个半日假期和一个整日假期)来检查饮食摄入量。根据规定的饮食方案,服用d-F和P会使肥胖患者的饮食行为发生变化。在我们的患者中,未观察到d-F和P之间有高度显著差异;然而,P对常量营养素摄入量(碳水化合物、脂质和蛋白质)的影响在第12个月左右趋于消失。用d-F治疗可减少简单碳水化合物、动物脂肪的摄入量,但不会减少动物蛋白的摄入量。