苦荞对2型糖尿病有效性和安全性的临床研究

Clinical study on the efficacy and safety of tartarian buckwheat on type 2 diabetes mellitus

目的探讨随餐冲服苦荞膳食粉对2型糖尿病患者的有效性及安全性。方法 22例2型糖尿病患者随机分为对照组与干预组,各11例。对照组继续原有糖尿病饮食及生活习惯,干预组在原有糖尿病饮食及生活习惯的基础上,于干预第4天至第10天服用苦荞膳食粉。比较两组患者干预前后动态血糖指标[24 h平均血糖水平(MBG)、血糖达标时间占比(TIR%)、高于目标血糖范围的时间占比(TAR%)、低于目标血糖范围的时间占比(TBR%)]及血糖变异性[血糖的曲线下面积(GAUC)、血糖标准差(SDBG)、平均血糖波动幅度(MAGE)]变化情况,干预10 d后降糖药物减量>50%发生情况,不良反应发生情况。结果干预后,干预组患者MBG(6.41±1.64)mmol/L、TAR%(10.98±6.28)%、GAUC(5.71±1.73)mmol/(L·h)明显低于对照组的(7.94±1.75)mmol/L、(19.62±10.03)%、(7.87±1.75)mmol/(L·h),差异具有统计学意义(P<0.05)。干预后,干预组患者TAR%(10.98±6.28)%、GAUC(5.71±1.73)mmol/(L·h)、SDBG(1.21±0.89)mmol/L、MAGE(3.12±1.49)mmol/L均低于本组干预前的(19.79±21.90)%、(7.56±2.23)mmol/(L·h)、(2.10±1.07)mmol/L、(5.21±2.22)mmol/L,差异具有统计学意义(P<0.05)。对照组降糖药物减量>50%发生率为0;干预组降糖药物减量>50%发生率为9.09%。两组患者干预10 d后降糖药物减量>50%发生率比较,差异无统计学意义(P>0.05)。对照组无发生不良反应。干预组患者发生轻度腹胀1例,症状可伴随治疗自行缓解;一过性腹泻1例,在治疗的第5天出现,次日自行好转。两组患者不良反应发生情况比较,差异无统计学意义(P>0.05)。结论苦荞能降低2型糖尿病患者24 h的整体血糖水平,改善24 h内血糖的波动,对血糖管理具有良好的调节作用。

Objective To discuss the efficacy and safety of tartarian buckwheat on type 2 diabetes mellitus.Methods A total of 22 patients with type 2 diabetes mellitus were randomly divided into control group and intervention group,with 11 cases in each group.The control group The control group continued the original diabetic diet and living habits,and the intervention group took tartarian buckwheat meal powder from the 4 th to the 10 th day of the intervention on the basis of the original diabetic diet and living habits.The dynamic blood glucose indicators[24-h mean blood glucose(MBG),time in range ratio(TIR%),time above target glucose range ratio(TAR%),time below target glucose range ratio(TBR%)],blood glucose variability[glucose area under the serum concentration curve(GAUC),standard deviation of blood glucose(SDBG),mean amplitude of glycemic excursion(MAGE)]before and after intervention,occurrence of hypoglycemic drugs reduced>50%after 10 d of intervention and occurrence of adverse reactions were compared between the two groups.Results After intervention,MBG(6.41±1.64)mmol/L,TAR%(10.98±6.28)%and GAUC(5.71±1.73)mmol/(L·h)of the intervention group were obviously lower than(7.94±1.75)mmol/L,(19.62±10.03)%and(7.87±1.75)mmol/(L·h)of the control group,and the difference was statistically significant(P<0.05).After intervention,TAR%(10.98±6.28)%,GAUC(5.71±1.73)mmol/(L·h),SDBG(1.21±0.89)mmol/L and MAGE(3.12±1.49)mmol/L of the intervention group were lower than(19.79±21.90)%,(7.56±2.23)mmol/(L·h),(2.10±1.07)mmol/L and(5.21±2.22)mmol/L before intervention,and the difference was statistically significant(P<0.05).The incidence of hypoglycemic drug reduction>50%in the control group was 0;the incidence of hypoglycemic drug reduction>50%in the intervention group was 9.09%.There was no statistically significant difference in incidence of hypoglycemic drug reduction>50%after 10 d of intervention between the two groups(P>0.05).No adverse reactions occurred in the control group;in the intervention group,1 patient developed mild abdominal distension,and the symptoms could be relieved spontaneously with treatment;1 case of transient diarrhea appeared on the 5 th day of treatment and improved by himself on the next day.There was no statistically significant difference in incidence of adverse reactions between the two groups(P>0.05).Conclusion Tartarian buckwheat can reduce the overall blood glucose level of patients with type 2 diabetes mellitus,improve the fluctuation of blood glucose,and has a good regulatory effect on blood glucose management.