西格列汀联合一日多次胰岛素治疗成人隐匿性、免疫性糖尿病的疗效和安全性

Efficacy and safety of sitagliptin combined with multiple daily insulin injections in the treatment of the patients with latent autoimmune diabetes in adults

目的:观察西格列汀联合一日多次胰岛素治疗成人隐匿性、免疫性糖尿病(latent autoimmune diabetes in adults,LADA)的临床疗效和安全性。方法:50例LADA病人随机分为胰岛素组和(胰岛素+西格列汀)组,每组25人。两组病人均先将胰岛素治疗方案改为三餐前10min皮下注射常规重组人胰岛素注射液(优泌林R);每晚22:00皮下注射甘精胰岛素注射液(来得时)剂量先不变。(胰岛素+西格列汀)组病人在此基础上加用磷酸西格列汀片100mg,po,qd。之后两组病人胰岛素的剂量根据血糖水平调整至最佳剂量,疗程12周。观察两组病人治疗前后空腹血糖(FPG)、餐后2h血糖(PPG)、每日血糖谷峰浓度均差(△TP),空腹C肽、餐后2hC肽,糖化血红蛋白(HbA1c)、HbA1c达标率,体重增加和低血糖反应。结果:治疗12周后,两组病人FPG、PPG、HbA1c和△TP均显著低于治疗前(P<0.01),(胰岛素+西格列汀)组的降低作用强于胰岛素组(P<0.05,P<0.01)。治疗后两组病人的空腹C肽和餐后2hC肽水平显著高于治疗前(P<0.05,P<0.01),(胰岛素+西格列汀)组空腹C肽和餐后2hC肽升高作用强于胰岛素组(P<0.01)。治疗后,(胰岛素+西格列汀)组发生低血糖的人数明显少于胰岛素组(P<0.05)。治疗后,胰岛素组病人体质指数(BMI)明显增加(P<0.05),而(胰岛素+西格列汀)组病人BMI增加不明显,(胰岛素+西格列汀)组BMI增加幅度显著小于胰岛素组(P<0.05)。结论:西格列汀联合一日多次胰岛素治疗LADA病人较单用胰岛素疗效更显著,安全性更高。

Objective： To observe the efficacy and safety of sitagliptin combined with multiple daily insulin injections in the treatment of the patients with latent autoimmune diabetes in adults （LADA）. Methods： Totally, 50 patients with LADA were randomly divided into the insulin group and the insulin ＋ sitagliptin group, each consisting of 25 patients. All the patients of the 2 groups received recombinant human insulin injections （Humulin R） subcutaneously 3 times daily 10 minutes before taking the meals （breakfast, lunch and supper）, in lieu of the original insulin treatment profile. Glargine insulin （Lantus） was also in- jected subcutaneously at 10 pm with the same dosage. The patients in the insulin ＋ sitagliptin group were given oral sitagliptin phosphorate once a day at a dosage of 100 rag, in addition to the above-mentioned treatment. Then, the insulin dosages for the patients of the 2 groups were adjusted to optimal levels in accordance with the glucose levels during the treatment course of 12 weeks. Close observations were made on fasting blood glucose （FPG）, postprandial 2 h blood glucose （PPG）, HbAlc, fasting C-peptide, postprandial 2 h C-peptide and average differences of troughs and peaks of blood glucose daily （APT） before and after treatment. Weight gain and hypoglycemia of all the patients were also observed. Results： Following treatment of 12 weeks, the levels of FPG, PPG, HbAlc and A TP in the patients of the 2 groups were all significantly lower than those before treatment （P〈0.05）. The decreasing effect shown in the insulin＋sitagliptin group was stronger than that of the insulin group （P〈0.05, P〈0.01）. After treatment, fasting C peptide, postprandial 2 h C-peptide levels for the patients of the 2 groups were all significantly higher than those before treatment （P〈0.05, P〈0.01）. The enhancing effect displayed in the insulin＋ sitagliptin group was stronger than that of the insulin group （P〈0.01）. After treatment, the rate of hypoglycemia in the insulin＋ sitagliptin group was significantly lower than that of the insulin group （P〈0.05）. Following treatment, the body massindex （BMI） of the insulin group was significantly increased （P〈0. 05） ,while no significant increase in the BMI could be no- ticed in the insulin＋sitagliptin group. The rate of increase in BMI for the insulin＋sitagliptin group was significantly lower than that of the insulin group （P〈0.05）. Conelusion：Sitagliptin combined with multiple daily insulin iniections in the treatment of the patients with LADA could produce better therapeutic effects and was safer,as compared with simple insulin treatment.