摘要
目的 对奥利司他 (orlistat;商品名 :赛尼可 )在中国超重和肥胖症患者中的临床疗效及安全性进行评价。方法 中国 6个中心 44 4例年龄 18～ 6 5岁 ,体重指数 2 5～ 40kg/m2 的患者 ,在轻度低热卡饮食的同时按 2 :1的比例随机双盲给予奥利司他 (2 96例 )或安慰剂 (148例 )。结果经过 2 4周的治疗 ,奥利司他组患者的体重降低〔(6 .1± 3.6 )kg ,(x±s) ,下同〕显著大于安慰剂组的下降 (3.0± 3.5 )kg(P <0 .0 0 1)。与安慰剂组相比 ,奥利司他更能显著降低肥胖伴高脂血症患者的血胆固醇水平及低密度脂蛋白胆固醇水平 (P <0 .0 1) ;显著降低肥胖伴高血糖患者的空腹血糖、餐后 2小时血糖、HbA1c水平 ;并能显著降低肥胖合并高血压患者的舒张压 (12 .5± 7.8)mmHg(P <0 .0 5或P<0 .0 1)。奥利司他治疗组胃肠道不良事件的发生率为 85 .1%,但是这些胃肠道症状多为轻度 ,可自行缓解。除此之外的不良事件发生率两组间差异无显著性 ,试验中未发生与药物相关的严重不良事件。结论 奥利司他结合轻度低热卡饮食控制治疗可显著促进肥胖患者的体重降低 ,并改善部分与肥胖相关疾病的危险因素 ,且安全性和耐受性好。
Objective To evaluate the clinical efficacy and safety of orlistat in Chinese overweight and obese patients. Methods In six research centers, 444 overweight and obese patients (body mass index 25～40 kg/m 2) were divided into orlistat group (296 patients) and placebo group (148 patients) with a low-energy diet for 24 weeks by a randomized, double-blinded, placebo-controlled study. Results For intent-to-treat analysis, 286 orlistat-treated and 142 placebo-treated subjects were evaluated. After 24 weeks, orlistat-treated patients lost more weight 〔(6.1±3.6)kg,( x ±s)〕 than placebo-treated patients did (3.0±3.5)kg (P<0.001). Orlistat-treated patients showed significant decreases in serum levels of total cholesterol, low density lipoprotein-cholesterol, fasting glucose, postprandial glucose and HbA 1c in comparison with placebo-treated patients (P<0.05 or P<0.01). After treatment, diastolic blood pressure in orlistat-treated patients was significantly reduced than that in placebo-treated patients (P<0.05). Both groups had similar adverse-event profiles, except the gastrointestinal events, which happened in 85.1% orlistat-treated patients and were mostly mild and transient. There were no serious adverse events relative to orlistat. Conclusion Orlistat in conjunction with a low-energy diet induces more weight loss of obese patients than placebo does in 24-week treatment. There is also an improvement in most serum lipid, glucose and blood pressure parameters. Orlistat is well tolerated and offers a new approach for treating obesity.
出处
《中华内分泌代谢杂志》
CAS
CSCD
北大核心
2001年第6期383-387,共5页
Chinese Journal of Endocrinology and Metabolism
