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目的 评价盐酸西布曲明治疗单纯性肥胖患者的有效性和安全性。方法 采用多中心、随机、双盲、安慰剂平行对照的研究方法。选择年龄 18～ 6 5岁 ,体质指数 (BMI) 2 7～ 40的单纯性肥胖患者。口服盐酸西布曲明 10mg d或安慰剂 1粒 d ,2 4周。观察体重变化及临床和常规实验室检查结果以评价药物的疗效和安全性。结果 有效病例 2 33例 ,其中对照组 113例 ,治疗组 12 0例。从第4周起盐酸西布曲明组体重降低值即大于安慰剂组 ,至 2 4周盐酸西布曲明组平均体重降低值为 (6 8± 3 1)kg,安慰剂组为 (0 48± 2 6 )kg。治疗组不良反应的发生率高于安慰剂组 ,但症状轻微 ,易于耐受。结论 盐酸西布曲明 10mg d ,治疗单纯性肥胖是有效和安全的。
Objective To evaluate the efficacy and safety of sibutramine hydrochloride in patients with simple obesity. Methods A multicenter, randomized, double-blind, placebo-controlled study was performed. Select the age 18 ~ 65 years old, body mass index (BMI) 27 ~ 40 simple obese patients. Oral sibutramine hydrochloride 10mg d or placebo 1 d, 24 weeks. Observed body weight changes and clinical and routine laboratory tests to evaluate the efficacy and safety of the drug. Results 33 cases of effective cases 2, of which 113 cases in the control group, the treatment group 120 cases. From week 4, the body weight loss in sibutramine hydrochloride group was greater than that in placebo group, and the mean body weight loss in sibutramine hydrochloride group for 24 weeks was (6 8 ± 3 1) kg and that in placebo group (0 48 ± 2 6) kg. The incidence of adverse reactions in the treatment group was higher than in the placebo group, but the symptoms were mild and easily tolerated. Conclusion sibutramine hydrochloride 10mg d, the treatment of simple obesity is effective and safe.