木丹颗粒联合晚睡前注射中效胰岛素治疗以黎明现象为频发症状的2型糖尿病的疗效及对胰岛α和β细胞功能的影响

Effect of Mudan Granules combined with intermediate-acting insulin injection at night before sleeping on type 2 diabetes with frequent symptoms of “dawn phenomenon” and its effect on islet α and β cell function

目的观察木丹颗粒联合晚睡前注射中效胰岛素治疗以黎明现象为频发症状的2型糖尿病的疗效及对胰岛α和β细胞功能的影响。方法将87例黎明现象为频发症状的2型糖尿病患者按照随机数字表分为观察组45例及对照组42例,对照组给予睡前注射中效胰岛素治疗,观察组在对照组基础上联合木丹颗粒治疗,2组疗程均为12周。评估2组治疗前及治疗12周后糖化血红蛋白(HbA1c)和治疗4周、8周、12周后空腹血糖(FPG)水平,通过持续葡萄糖监测(CGM)测定平均血糖值(MBG)、血糖标准差(SDBG)及黎明现象发生率,检测2组治疗前后胰岛α细胞功能(AUCGln0~8min)和胰岛β细胞(HOMA-β、AUCIns0~10min)情况,同时记录用药后不良反应。结果2组治疗4周、8周、12周后FPG、MBG、SDBG及治疗12周后的HbA1c均较治疗前显著降低(P均<0.05),且观察组治疗后FPG、MBG、SDBG、HbA1c均显著低于对照组(P均<0.05)。观察组治疗4周、8周、12周后和对照组治疗8周、12周后的AUCGln0~8min和HOMA-β、AUCIns0~10min水平均较治疗前显著改善(P均<0.05),观察组各时间点上述指标改善情况均显著优于对照组(P均<0.05)。2组治疗4周、8周、12周后的黎明现象发生率均较治疗前显著降低(P均<0.05),且观察组以上时间点的发生率均显著低于对照组(P均<0.05)。2组不良反应发生率比较差异无统计学意义(P>0.05)。结论木丹颗粒联合晚睡前注射中效胰岛素可有效控制以黎明现象为频发症状的2型糖尿病患者血糖,降低黎明现象发生率,并有利于改善胰岛α和β细胞功能,且安全性高,值得临床推广应用。

Objective It is to observe the effect of Mudan granules combined with mid-night injection of intermediate-acting insulin on type 2 diabetes with frequent symptoms of “dawn phenomenon” and its effect on islet α and β cell function. Methods Eighty-seven patients with type 2 diabetes who had frequent symptoms of “dawn phenomenon” were randomly divided into observation group (45 cases) and control group (42 cases). The control group was given pre-sleep injection of intermediate-acting insulin, the observation group was treated with Mudan granules on the basis of the control group, both groups were treated for 12 weeks. The levels of glucose hemoglobin (HbA1c) before treatment and after treatment for 12 weeks, and that of fasting blood glucose (FPG) after treatment for 4 weeks, 8 weeks, and 12 weeks were evaluated, mean blood glucose (MBG), blood glucose standard deviation (SDBG) and and the incidence of “dawn phenomenon” were measured by continuous glucose monitoring (CGM). The islet α cell function (AUC Gln 0~8 min ) and islet β cells (HOMA-β, AUC Ins 0~10 min ) were detected before and after treatment, and adverse reactions after drug administration were recorded. Results The levels of FPG, MBG, SDBG after treatment for 4 weeks, 8 weeks and 12 weeks and HbA1c after treatment for 12 weeks were significantly lower than those before treatment ( P <0.05), and FPG, MBG, SDBG and HbA1c were significantly lower in the observation group than the control group ( P <0.05). The levels of AUC Gln 0~8 min and HOMA-β, AUC Ins 0~10 min in the observation group after 4 weeks, 8 weeks, 12 weeks of treatment in the observation group and after 8 weeks and 12 weeks of treatment in the control group were significantly improved compared with those before treatment ( P <0.05), the improvement of the above indicators at each time point in the observation group was significantly better than that of the control group ( P <0.05). The incidence of “dawn phenomenon” in the 2 groups after 4 weeks, 8 weeks, and 12 weeks of treatment was significantly lower than that before treatment ( P <0.05), and the incidence rate in the observation group was significantly lower than that in the control group ( P <0.05). There was no significant difference in the incidence of adverse reactions between the two groups ( P >0.05). Conclusion Mudan granule combined with mid-night injection of intermediate-acting insulin can effectively control the blood glucose of patients with type 2 diabetes with frequent symptoms of “dawn phenomenon”, reduce the incidence of “dawn phenomenon”, and improve the function of islet α and β cells with good safety, it is worthy of clinical application.