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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 efficacy and safety of sibutramine hydrochloride capsules in Chinese patients with simple obesity. Methods A multicenter, open-ended study was conducted in 481 subjects aged 18-65 years and body mass index> 25 kg / m2 for a 24-week clinical period: sibutramine hydrochloride Capsule 10 mg. Results After 24 weeks of diet control and drug treatment, the number of completed cases was 429, the rate of exfoliation was 10.6% and the rate of elimination was 0.21%. The average body weight of the subjects decreased from 78 kg ± 12 kg to 73 kg ± 12 kg (6.5% decrease, significant difference, P <0.0001); mean body mass index decreased from 29 kg / m2 ± 3 kg / m2 to 27 kg / m2 ± 3 kg / m2, the difference was significant (P <0.0001); the indexes of significant decrease were waist circumference, hip circumference, systolic pressure and diastolic pressure; ± 8 beats / min to 77 beats / min ± 7 beats / min (P <0.05). The biochemical indexes of uric acid and fasting insulin decreased significantly, and the density of high density lipoprotein increased significantly. The incidence of various adverse events was 35.14%, mainly including dry mouth (21.41%), constipation (8.32%), dizziness (2.70%) and poor sleep (2.49%). Conclusion sibutramine hydrochloride capsules with low calorie diet have a significant weight loss effect, and can alleviate the relevant indicators in the metabolic syndrome. Most of its adverse events are mild and can tolerate. Sibutramine hydrochloride capsules is a safe and effective clinical diet pills.