摘要
目的比较国产奥利司他片和进口奥利司他胶囊治疗超重和肥胖症患者的疗效及安全性。方法中国7个中心228例年龄18～65岁、BMI 24-〈40kg／m^2的受试者，在轻度低热卡饮食基础上随机双盲给予国产奥利司他片或进口奥利司他胶囊，治疗24周后评价两种奥利司他的减重疗效以及不良事件。结果经过24周的治疗，国产奥利司他组受试者体重显著降低（5．0±3．7）b，进口奥利司他组下降（4．5±3．5）kg（P=0．3922）。国产奥利司他片减重治疗后受试者收缩压、血TC、LDL—C与基线比较，P值均〈0．0001。收缩压降低（4．4±11．5）mmHg（1mmHg=0．133 kPa），血TC下降（0．54±0．79）mmol／L，LDL-C下降（0．32±0．64）mmol／L，下降幅度与进口奥利司他组相比差异无统计学意义。国产奥利司他组和进口奥利司他组不良事件发生率分别为73．7％和63．7％（组间比较P=0．1167），多为轻度脂肪排泄增多的胃肠道症状，可自行缓解。试验中未发生与药物相关的严重不良事件。结论国产奥利司他片与进口奥利司他胶囊结合轻度低热卡饮食治疗具有相同的减重疗效，并能改善部分肥胖相关疾病，安全性和耐受性好。
Objective To compare the clinical efficacy and safety of domestic orlistat and imported orlistat in Chinese overweight and obese patients. Methods In a randomized, double-blinded and positivecontrolled study, 228 adults （BMI 24 - 〈40 kg/m^2 ） evaluated at seven research centers were randomized to receive domestic orlistat or imported odistat 120 mg 3 times a day with an energy-controlled diet for 24 weeks. Results After 24 weeks, domestic orlistat treated patients got significant weight-loss （5.0 ± 3.7） kg, which was comparable with that of imported orlistat treated patients （4. 5 ± 3.5 ） kg （ P = 0. 3922 ）. Compared with the findings before treatment, there was significant decrease of systolic blood pressure （4. 4 ±11.5）mm Hg （1 mm Hg =0,133 kPa） and serum levels of TC （0.54 ±0.79） mmol/L and LDL-C （0. 32±0. 64） mmol/L in the domestic orlistat treated group （compared with levels of baseline, P 〈 0. 0001 ）. There was no significant difference between the two groups in the changes of blood pressure and lipid levels. Both groups had similar adverse event profiles, most of which were mild and transient gastrointestinal events. There were no serious adverse events in both groups. Conclusions Domestic orlistat combined with a light low-energy diet promoted significant weight loss, which was comparable with that of imported orlistat after 24 weeks of treatment. There was also improvement in blood pressure and serum levels of TC and LDL-C. Domestic orlistat was as effective and safe as imported orlistat in the treatment of obesity.
出处
《中华内科杂志》
CAS
CSCD
北大核心
2009年第10期825-829,共5页
Chinese Journal of Internal Medicine
