Drent M L, van der Veen E A
Department of Endocrinology, Free University Hospital, Amsterdam, The Netherlands.
Int J Obes Relat Metab Disord. 1993 Apr;17(4):241-4.
Orlistat (Ro 18-0647) is an inhibitor of gastric, carboxylester and pancreatic lipase and specifically reduces the absorption of dietary fat due to the inhibition of triglyceride hydrolysis. Orlistat can be used for the treatment of obesity. Of 52 healthy obese patients entering a four-week single-blind run-in period with diet (500 kcal-reduced, containing 30% of calories in the form of fat) and placebo three times a day, 44 patients showed compliance to the diet by reducing their body weight by 0.5-4 kg from screening. These patients were randomized for a 12-week double-blind, parallel group, placebo-controlled treatment period with diet and 50 mg Orlistat or placebo three times a day. Complete data were available for 39 patients, 20 on Orlistat (3 men, 17 women; mean weight 85.5 +/- 12.1 kg; mean body mass index 30.6 +/- 3.7 kg/m2) and 19 on placebo (3 men, 16 women; mean weight 81.9 +/- 7.9 kg; mean body mass index 30.0 +/- 2.6 kg/m2. Total weight loss after randomization was 4.3 +/- 3.4 kg in the Orlistat group and 2.1 +/- 2.8 kg in the placebo group (P = 0.025, analysis of variance with repeated measurements; 95% confidence interval for the weight loss difference 0.2-4.2 kg). Gastrointestinal side effects were seen in the Orlistat group, but in most patients the symptoms were mild or transient. One patient dropped out because of faecal incontinence. No effect was seen on vitamin A levels, but vitamin E levels became lower in the Orlistat group (P < 0.05, paired t test).(ABSTRACT TRUNCATED AT 250 WORDS)
奥利司他（Ro 18 - 0647）是一种胃、羧酸酯酶和胰脂肪酶抑制剂，通过抑制甘油三酯水解，特异性地减少膳食脂肪的吸收。奥利司他可用于治疗肥胖症。52名健康肥胖患者进入为期四周的单盲导入期，期间采用饮食控制（热量减少500千卡，脂肪形式的热量占30%）并每日三次服用安慰剂，其中44名患者通过从筛查时起体重减轻0.5 - 4千克表明对饮食控制依从。这些患者被随机分为两组，进入为期12周的双盲、平行组、安慰剂对照治疗期，一组采用饮食控制并每日三次服用50毫克奥利司他，另一组服用安慰剂。39名患者有完整数据，20名服用奥利司他（3名男性，17名女性；平均体重85.5±12.1千克；平均体重指数30.6±3.7千克/平方米），19名服用安慰剂（3名男性，16名女性；平均体重81.9±7.9千克；平均体重指数30.0±2.6千克/平方米）。随机分组后，奥利司他组总体重减轻4.3±3.4千克，安慰剂组为2.1±2.8千克（P = 0.025，重复测量方差分析；体重减轻差异的95%置信区间为0.2 - 4.2千克）。奥利司他组出现胃肠道副作用，但大多数患者症状轻微或短暂。一名患者因大便失禁退出。对维生素A水平无影响，但奥利司他组维生素E水平降低（P < 0.05，配对t检验）。（摘要截短于250字）
