盐酸西布曲明胶囊治疗单纯性肥胖症的疗效和安全性的再评价

A multicenter and open study on efficacy and safety of sibutramine in obese subjects

目的 对中国单纯性肥胖症患者服用盐酸西布曲明胶囊的疗效和安全性进行再评价。方法 采用多中心、开放的方法对481例年龄在18-65岁、体重指数>25 kg/m2的受试者进行为期24周的临床观察:低热卡饮食的同时每日口服盐酸西布曲明胶囊10 mg。结果 24周的饮食控制和药物治疗后,完成病例数为429例,脱落率10.6％,剔除率0.21％。受试者的平均体重由原来的78kg±12 kg降低至了73 kg±12 kg(下降百分比为6.5％,差异有显著意义,P<0.0001);平均体重指数从原来的29 kg/m2±3 kg/m2降至27 kg/m2±3 kg/m2,差异有显著意义(P<0.0001);同时显著性下降的指标有腰围、臀围、收缩压和舒张压;平均心率从76次/min±8次/min升高至77次/min±7次/min(P<0.05);生化指标中尿酸和空腹胰岛素显著下降,高密度脂蛋白显著上升。各种不良事件发生率为35.14％,主要为口干(21.41％),便秘(8.32％),头晕(2.70％),睡眠欠佳(2.49％)。结论 盐酸西布曲明胶囊配合低热卡饮食有显著的减重疗效,并能缓解代谢综合征中的相关指标。其不良事件大多轻微,且能耐受。盐酸西布曲明胶囊是一种安全有效的临床减肥药。

Objective To evaluate the clinical efficacy and safety of sibutramine ( Qumei, produced by Fuling Pharmaceutical Factory affiliated to Taiji Group) in obese subjects. Methods The clinical data of 481 obese subjects, with the BMI > 25 kg/m , aged 18 - 65, in 8 centers treated by sibutramine 10 mg everyday with a low calorie diet for 24 weeks were collected and analyzed. Results After 24 weeks, study was completed on 429 out of the 481 subjects with a loss-to -follow-up rate of 10. 6% and a rejection rate of 0. 21%. The average BMI 24 weeks after the study was 28 kg/m2 ± 3 kg/m2, significantly lower than that before the study ( 29 kg/m2 ± 3 kg/m2) , and the average weight 24 weeks after the study was 73 kg ± 12 kg, significantly lower than that before the study (78 kg ± 12 kg) , both P < 0. 0001. So were the other indexes such as waist circumference, hip circumference, systolic blood pressure, diastolic blood pressure, uric acid, and fasting insulin. The level of high-density lipoprotein was significantly increased. The average heart rate increased from 76 time/min ± 8 time/min to 77 time/min ± 7 time/min ( P < 0. 05). The incidence of adverse events was 35.14%, manifested by thirst (21.41%), constipation (8.32%), dizziness (2.70%) and poor sleeping (2. 49% ). Seven subjects were lost in the end because of adverse events. Conclusion Sibutramine of the dosage of 10 mg/day is an effective and safe therapy for weight reduction in obese subjects. Most adverse events of sibutramine are mild and tolerable.