摘要
目的探索沙格列汀对二甲双胍单药治疗血糖控制不佳2型糖尿病患者的安全性及有效性。方法选择2015年1月—2016年12月在该院内分泌科门诊及住院的糖尿病患者252例。将入选患者按照1:1的比例随机分配至沙格列汀组或者阿卡波糖组。两组患者均继续维持二甲双胍治疗,沙格列汀组患者在原降糖方案的基础上加用沙格列汀片5 mg/d,1次/d;阿卡波糖组加用阿卡波糖50 mg,3次/d。随访观察期24周。每4周随访1次。观察两组患者治疗前后的FPG、2 h PG、Hb A1c的变化,并记录随访期间药物相关不良事件发生情况。比较上述指标的在两组的变化。结果 (1)沙格列汀组与阿卡波糖组治疗后FPG、2 h PG较该组治疗前均有明显降低(P<0.05);与阿卡波糖组治疗后相比,沙格列汀组2 h PG显著下降,差异有统计学意义(P<0.05);(2)干预24周后,沙格列汀组与阿卡波糖组各组Hb Alc均有降低(P<0.05);与阿卡波糖组相比,沙格列汀组Hb Alc下降幅度更大(P<0.05);沙格列汀组Hb A1c达标率为48.82%显著高于阿卡波糖组的35.20%,差异有统计学意义(P<0.05)。(3)随访期间,阿卡波糖组胃肠道异常发生率高于沙格列汀组(16.80%vs 3.94%,P<0.05);沙格列汀组与阿卡波糖组的低血糖事件和因不良事件而终止者相比较差异无统计学意义(7.09%vs 6.40%、5.51%vs 4.80%,P>0.05)。结论对于二甲双胍单药治疗血糖不达标的2型糖尿病患者,加用沙格列汀可有效降糖,提高糖化血红蛋白达标率,且不增加低血糖和胃肠道反应风险。
Objective This paper tries to assess the efficacy and safety of saxagliptin on patients with type 2 diabetes with inadequate glyeemic control of mefformin. Methods 252 patients with type 2 diabetes in this hospital from January 2015 to December 2016 were enrolled in the study. Patients were randomly assigned to the saxagliptin group and acarbose group at a 1：1 ratio. The patients in the two groups were treated with metformin, and the patients in the saxagliptin group were treated with saxagliptin tablets 5 mg per day and one time a day. The acarbose group was treated with acarbose 50 mg, 3 times a day. Follow-up observation period lasted for 24 weeks, with one follow-up in every 4 weeks. The changes of FPG, 2 hPG and HbAle before and after treatment were observed and the incidence of drug-related adverse events during the follow-up was recorded. The changes of the above indicators in the two groups were compared. Results （1）The levels of FPG and 2 hPG in the saxagliptin group and acarbose group after treatment significantly decreased compared with that before the treatment （P〈0.05）. the 2 hPG level of the saxagliptin group decreased more obviously than that of the acabose group after treatment （P〈0.05）. （2）After 24 weeks of intervention, the levels of HbAlc in the two groups were significantly decreased （P〈0.05）, and that of the saxagliptin group decreased more than that of the aearbose group （P〈0.05）, the HbAlc level of the aaxagliptin group was 48.82%, signifieantly higher than the acarbose group of 35.20% and the difference was statistically significant （P〈0.05）. （3）During the follow-up period, the incidence of gastrointestinal abnormalities in the acarbose group was higher than that in the saxagliptin group （16.80% vs 3.94%, P〈0.05）; There was no significant difference between the two groups in incidences of hypoglycemia and other adverse events （7.09% vs 6.40%, 5.51% vs 4.80%, P〉0.05）. Conclusion For patients with type 2 diabetes of inadequately control
出处
《糖尿病新世界》
2017年第10期103-105,共3页
Diabetes New World Magazine
