奥利司他胶囊联合二甲双胍片治疗肥胖型2型糖尿病患者的临床研究

Clinical trial of orlistat capsules combined with metformin tablets in the treatment of obese type 2 diabetes mellitus

目的观察奥利司他胶囊联合二甲双胍片治疗肥胖型2型糖尿病的临床疗效及安全性。方法将89例肥胖型2型糖尿病患者随机分成对照组44例和试验组45例。对照组给予盐酸二甲双胍片每次0.5 g,tid,随餐口服;试验组在对照组的治疗基础上,给予奥利司他胶囊每次0.12 g,tid,随餐服用。2组患者均治疗12周。比较2组患者的体重指数(BMI)、胰岛β细胞功能指数(HOMA-β)、胰岛素抵抗指数(HOMA-IR),以及药物不良反应的发生情况。结果治疗后,试验组和对照组的BMI分别为(27.03±1.64)和(28.02±0.83)kg·m-2,HOMA-β分别为(67.59±12.67)和(53.67±10.01),HOMA-IR分别为(2.31±0.17)和(2.56±0.25),差异均有统计学意义(均P<0.05)。试验组发生的药物不良反应主要有头痛、低血糖、腹泻和胃肠胀气,对照组发生的药物不良反应主要有低血糖、头痛和腹泻。试验组和对照组的总药物不良反应发生率分别为11.11%和18.18%,差异无统计学意义(P>0.05)。结论奥利司他胶囊联合二甲双胍片治疗肥胖型2型糖尿病患者不仅可以明显减轻患者体重,还可以改善患者胰岛功能,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of orlistat capsules combined with metformin tablets in the treatment of obese type 2 diabetes mellitus(T2 DM).Methods Eight-nine obese T2 DM patients were randomly divided into control group(n=44 cases) and treatment group(n=45 cases).Control group was given oral metformin hydrochloride tablets at meal time, 0.5 g per time,tid.Treatment group was given oral orlistat capsules at meal time, 0.12 g per time,tid, on the basis of control group.Two groups were treated for 12 weeks.The body mass index(BMI),Homeostasis model assessment-β(HOMA-β) and Homeostasis model assessment of insulin resistance(HOMA-IR),and adverse drug reactions were compared between two groups.Results After treatment,the main indexes of treatment and control groups were compared: BMI were(27.03±1.64) and(28.02±0.83)kg·m-2,HOMA-β were(67.59±12.67) and(53.67±10.01),HOMA-IR were(2.31±0.17) and(2.56±0.25), with significant differences(all P<0.05).The adverse drug reactions of treatment group were headache, hypoglycemia, diarrhea and flatulence,while those in the control group were hypoglycemia,headache and diarrhea.The incidences of total adverse drug reactions in treatment group and control group were 11.11% and 18.18% without significant difference(P>0.05).Conclusion Orlistat capsules combined with metformin tablets in treatment of patients with obese T2 DM can not only significantly reduce weight,but also improve islet function,without increasing incidence of adverse drug reactions.