利拉鲁肽注射液治疗2型糖尿病合并肥胖/超重男性患者的临床研究

Clinical trial of liraglutide injection in the treatment of type 2 diabetes mellitus with obesity/overweight male patients

目的观察利拉鲁肽注射液治疗2型糖尿病(T2DM)合并肥胖/超重男性患者的临床疗效及其血清雌激素水平的变化。方法将40例T2DM合并肥胖/超重男性患者随机分为对照组和试验组,每组20例。对照组在服用原降糖药物的基础上,根据血糖水平进行剂量调整;试验组予以利拉鲁肽起初剂量0.6 mg,1周后增量至1.2 mg,最大剂量1.8 mg·d^(-1),每天进行皮下注射。2组患者均治疗24周。比较2组患者的临床疗效、胰岛功能、血清雌二醇水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为95.00%(19例/20例)和75.00%(15例/20例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的糖化血红蛋白分别为(5.90±1.40)%和(7.10±1.20)%,胰岛素抵抗指数分别为(2.61±1.33)和(3.80±0.77),胰岛β细胞功能指数分别为(50.62±12.14)%和(31.88±7.66)%,雌二醇分别为(49.75±12.11)和(69.66±11.29)pg·mL^(-1),差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有恶心,对照组的药物不良反应主要有腹泻和腹胀。试验组和对照组的总药物不良反应发生率分别为17.50%和25.00%,差异无统计学意义(P>0.05)。结论利拉鲁肽注射液治疗T2DM合并肥胖/超重男性患者的临床疗效确切,其能有效改善T2DM患者糖代谢和胰岛素敏感性,同时降低雌二醇水平,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of liraglutide injection in the treatment of type 2 diabetes mellitus（ T2DM）with obesity/overweight male patients and the changes of serum estrogen. Methods A total of 40 patients with T2DM and obesity/overweight were randomly divided into control and treatment groups with 20 cases per group. On the basis of taking proactive hypoglycemic drugs,the dose of control group was adjusted according to the level of blood glucose level. Treatment group was given the initial dose of liraglutide 0. 6 mg,subcutaneously,and the increment to 1. 2 mg after 1 weeks,the maximum dose of 1. 8 mg subcutaneously daily. Two groups were treated for 24 weeks. The clinical efficacy,islet function,serum estradiol level and adverse drug reactions were compared between two groups. Results After treatment,the total effective rates in treatment group and control group were 95. 00%（ 19 cases/20 cases） and 75. 00%（ 15 cases/20 cases） with significant difference（ P〈0. 05）. After treatment,the main indexes of treatment and control groups were compared： glycated hemoglobin were（ 5. 90 ± 1. 40） % and（ 7. 10 ± 1. 20） %,homeostasis model assessment-insulin resistance were（ 2. 61 ± 1. 33） and（ 3. 80 ± 0. 77）,homeostasis model assessment-β were（ 50. 62 ± 12. 14） % and（ 31. 88 ± 7. 66） %,estradiol were（ 49. 75 ± 12. 11） and（ 69. 66 ± 11. 29） pg·mL^-1,the differences were statistically significant（ all P〈0. 05）. The adverse drug reactions of treatment group were nausea,which in control group were diarrhea and abdominal distention. The total incidences of adverse drug reactions in treatment and control groups were 17. 50% and 25. 00% without significant difference（ P〉0. 05）. Conclusion Liraglutide injection has a definite clinical efficacy for the male patients with T2DM and obesity/overweight,which can effectively improve the T2DM patients＇ glucose metabolism and insulin sensitivity,and decrease the levels of estradiol,without increasing the incidence of adverse drug reactions.