沙格列汀联合胰岛素治疗2型糖尿病的疗效和安全性观察

Observation on efficacy and safety of sagliptin combined with insulin in the treatment of type 2 diabetes mellitus

目的研究沙格列汀联合胰岛素治疗2型糖尿病的疗效和安全性。方法 50例2型糖尿病患者,随机分成对照组与观察组,各25例。对照组患者使用胰岛素治疗,观察组患者使用沙格列汀联合胰岛素治疗,比较两组患者治疗前后血糖水平、体质量指数、胰岛素使用剂量及不良反应发生情况。结果观察组治疗显效20例、有效4例、无效1例,总有效率为96.00%;对照组治疗显效18例、有效3例、无效4例,总有效率为84.00%;观察组总有效率高于对照组,但差异无统计学意义(P>0.05)。治疗前,对照组空腹血糖(FPG)、餐后2 h血糖(2 h PBG)、糖化血红蛋白水平分别为(10.98±3.32)mmol/L、(18.33±3.15)mmol/L、(9.97±2.05)%,观察组空腹血糖、餐后2 h血糖、糖化血红蛋白水平分别为(11.33±3.28)mmol/L、(18.78±3.37)mmol/L、(10.02±2.02)%,比较差异无统计学意义(P>0.05);治疗后,对照组空腹血糖、餐后2 h血糖、糖化血红蛋白水平分别为(7.64±1.22)mmol/L、(9.46±1.38)mmol/L、(7.12±1.03)%,观察组空腹血糖、餐后2 h血糖、糖化血红蛋白水平分别为(6.54±0.91)mmol/L、(8.13±0.96)mmol/L、(6.48±1.02)%,两组空腹血糖、餐后2 h血糖、糖化血红蛋白水平均低于本组治疗前,且观察组空腹血糖、餐后2 h血糖、糖化血红蛋白水平均低于对照组,差异具有统计学意义(P<0.05)。治疗前,对照组胰岛素使用剂量及体质量指数分别为(39.3±13.7)U/d、(24.15±2.02)kg/m^2,观察组胰岛素使用剂量及体质量指数分别为(40.3±13.6)U/d、(24.35±3.61)kg/m^2,比较差异无统计学意义(P>0.05);治疗后,观察组胰岛素使用剂量及体质量指数分别为(26.0±12.2)U/d、(23.52±3.12)kg/m^2,均低于对照组的(46.0±16.2)U/d、(25.07±1.67)kg/m^2,差异具有统计学意义(P<0.05)。观察组不良反应发生率为16.0%,低于对照组的28.0%,但差异无统计学意义(P>0.05)。结论在胰岛素治疗基础上加用沙格列汀对2型糖尿病患者有较好的降糖效果,并能降低胰岛素使用剂量,且不会增加低血糖、体重增加等不良反应的发生。

Objective To study the efficacy and safety of sagliptin combined with insulin in the treatment of type 2 diabetes mellitus. Methods A total of 50 patients with type 2 diabetes mellitus were randomly divided into control group and observation group, with 25 cases in each group. The control group was treated with insulin, and the observation group was treated with sagliptin combined with insulin. Comparison were made on blood glucose level, body mass index before and after treatment, insulin dosage and occurrence of adverse reactions between the two groups. Results The observation group had 20 excellent cases, 4 effective cases, and 1 ineffective cases, with total effective rate as 96.00%, while the control group had 18 excellent cases, 3 effective cases and 4 ineffective cases, with total effective rate as 84.00%. The observation group had higher total effective rate than the control group, but the difference was not statistically significant (P>0.05). Before treatment, the control group had fasting plasma glucose (FPG), 2 h postprandial blood glucose (2 h PBG), glycosylated hemoglobin respectively as (10.98±3.32) mmol/L,(18.33±3.15) mmol/L and (9.97±2.05)%, which were (11.33±3.28) mmol/L,(18.78±3.37) mmol/L and (10.02±2.02)% in the observation group. Their difference was not statistically significant (P>0.05). After treatment, the control group had fasting plasma glucose, 2 h postprandial blood glucose, glycosylated hemoglobin respectively as (7.64±1.22) mmol/L,(9.46±1.38) mmol/L and (7.12±1.03)%, which were (6.54±0.91) mmol/L,(8.13±0.96) mmol/L and (6.48±1.02)% in the observation group. Both groups had lower fasting plasma glucose, 2 h postprandial blood glucose, glycosylated hemoglobin than those before treatment, and the observation group had lower fasting plasma glucose, 2 h postprandial blood glucose, glycosylated hemoglobin than the control group. Their difference was statistically significant (P<0.05). Before treatment, the control group had insulin dosage and body mass index respectively as (39.3±13.7) U/d and (24.15±2.02) kg/m^2, which were (40.3±13.6) U/d and (24.35±3.61) kg/m^2 in the observation group. Their difference was not statistically significant (P>0.05). After treatment, the observation group had lower insulin dosage and body mass index respectively as (26.0±12.2) U/d and (23.52±3.12) kg/m^2 than (46.0±16.2) U/d and (25.07±1.67) kg/m^2 in the control group. Their difference was statistically significant (P<0.05). The observation group had lower incidence of adverse reactions as 16.0% than 28.0% in the control group, but the difference was not statistically significant (P>0.05). Conclusion On the basis of insulin therapy, sagliptin has better hypoglycemic effect in type 2 diabetes mellitus patients, and can reduce insulin dosage without increasing the occurrence of adverse reactions of hypoglycemia and weight gain.