盐酸西布曲明胶囊治疗单纯性肥胖症的临床疗效和安全性

Clinical curative effect and safety research in treatment of the simple obesity with sibutrimine hydrochloride capsule

目的 :评价盐酸西布曲明胶囊治疗单纯性肥胖症的疗效及安全性 ,并比较盐酸西布曲明和安慰剂对食欲和静息代谢率的影响。方法 :采用双盲、随机、安慰剂平行对照研究 ,97例单纯性肥胖患者随机分成试验组 4 8例 (男 14例 ,女 3 4例 ) ,年龄( 3 6± 10 ) y;对照组 4 9例 (男 7例 ,女 4 2例 ) ,年龄 ( 3 5± 11) y。试验组和对照组病例在 2 wk的筛选期后分别予盐酸西布曲明或安慰剂 10 mg,po,qd,疗程 2 4 wk。结果 :试验组治疗后体重下降 ( 7.1± 4 .2 ) kg,下降率为 ( 8.9± 5 .3 ) % ,总有效率为 75 % ,不良反应发生率为 2 4 .5 % ;而对照组分别为 ( 1.7± 2 .8) kg,( 2 .2± 3 .4 ) % ,18.4 %和 8%。 2组病例的上述各项比较均有统计学差异 ( P<0 .0 5 )。患者依从性良好。结论 :盐酸西布曲明胶囊是治疗单纯性肥胖症的有效药物 。

AIM: To evaluate the curative effect and safety on the simple obesity that was cured by sibutrimine hydrochloride capsule and compare it with the placebo in the influences on the appetite and the resting metabolic rate. METHODS: A double blind,random and placebo control method was used. Ninety seven fat patients were divided into 2 groups. In the test group 48 patients (M14, F34), age (36±10) y were treated with sibutrimine hydrochloride 10 mg, qd, po , for 24 wk. In the control group 49 patients (M 7, F 42), age (35±11) y were treated with the placebo 10 mg, qd, po , for 24 wk. The compliance of all patients was good. RESULTS: In the test group the weight descent value, the weight descent rate, the total effective rate and the occurrence rate of adverse drug reactions were (7 1±4 2) kg, (8 9±5 3)%, 75% and 24 5%,respectively. In the control group the weight descent value,the weight descent rate,the total effective rate and the occurrence rate of adverse drug reactions were (1 7±2 8) kg, (2 2±3 4)%,18 4% and 8%, respectively. There were significant differences between the test group and the control group in above each side ( P <0 05). CONCLUSION: The sibutrimine hydrochloride capsule is an effective drug for curing the simple obesity. The adverse drug reactions level is comparatively light.