维格列汀与α-糖苷酶抑制剂治疗2型糖尿病的随机对照临床试验

A randomized controlled clinical trials for the treatment of type 2 diabetes by vildagliptin and alpha-glucosidase inhibitor

目的:评估维格列汀与α-糖苷酶抑制剂联合治疗2型糖尿病的疗效和对患者体重、肝肾功能的影响。方法:选择294例使用α-糖苷酶抑制剂治疗至少2个月但血糖控制不佳的2型糖尿病患者,随机分组,分别给予维格列汀或者安慰剂,并于服药前及服药后12周检测患者空腹血糖(fasting blood glucose,FBG)、餐后血糖(postprandial glucose,PPG)、糖化血红蛋白(glycated hemoglobin,Hb A1c)、体重、肝肾功能等,比较相关指标前后的变化并评估两组间的差异性。结果:试验过程中,维格列汀组2例患者出现低血糖症状,1例出现腹泻症状且3 d后自行缓解,共14例退出;安慰剂组1例患者出现低血糖症状,共12例退出。治疗12周后,维格列汀组患者Hb A1c水平由(8.99±1.881)%降至(7.32±1.414)%,该组患者FBG,PPG水平均较治疗前有所下降,但空腹胰岛素水平升高,差异均有统计学意义;安慰剂组患者各检测指标的差异均无统计学意义。两组治疗后均未见体重的变化有统计学意义,但维格列汀组体重下降水平大于安慰剂组。治疗后,维格列汀组FBG,PPG,Hb A1c,ALT,AST水平下降,空腹胰岛素水平升高,且与安慰剂组相比,其治疗前后的差异有统计学意义。结论:维格列汀与α-糖苷酶抑制剂联合使用可有效降低FBG,PPG,Hb A1c,升高空腹胰岛素水平,并可能导致转氨酶水平降低,体重增加的风险可相媲于安慰剂。总之,从安全性和有效性两方面考虑,维格列汀与α-糖苷酶抑制剂联合是一种可供选择的降糖治疗方案。

Objectives： To assess the efficacy of vildagliptin plus alpha-glucosidase inhibitor combination therapy in patients with type 2 diabetes mellitus and its influence on body weight and hepatorenal function. Methods： All of the 294 cases of type II diabetic patients with poor glycemic control after alphα-glucosidase inhibitor treatment for at least two months were selected and randomized into two groups to use vildagliptin or placebo on the basis of alpha-glucosidase inhibitor. The body weight,fasting blood glucose（ FBG）,postprandial glucose（ PPG）,glycated hemoglobin（ Hb A1c）,blood lipid,and hepatorenal function were tested at baseline and 12 weeks after the trial. The relevant indicators were compared,and the differences were evaluated between the two groups. Results： During the trial,there were two patients had symptoms of hypoglycemia,one patient had diarrhea and were alleviated after 3 days in vildagliptin group,with a total of 14 people quited. While one patient of placebo group had symptoms of hypoglycemia,and a total of 12 people quitted. After 12 weeks,the Hb A1 c of vildagliptin group decreased from（ 8. 99 ± 1. 881） % to（ 7. 32 ± 1. 414） %,FBG and PPG declined and fasting insulin increased with significant difference. The changes of all measurements of placebo group were not significant. There was nosignificant difference in body weight,despite the degree of decline of weight was larger in vildagliptin group than that of placebo group. After the treatment,the FBG,PPG,Hb A1 c,ALT and AST levels of vildagliptin group dropped,while the fasting insulin increased,with statistically significant difference compared with the placebo group. Conclusions： Togather with alphα-glycosidase inhibitor,vildagliptin can reduce FBG,PPG,and Hb A1 c and rise fasting insulin effectively,with a decrease of aminotransferace. Morever,vildagliptin has a small possibility of increasing body weight,which is comparable to placebo. In a word,from the perspective of safety and effectiveness,vildagliptin plus alpha-glucosidase inhibitor combination therapy can be considered as a good choice.