糖胰康改善成人隐匿性自身免疫性糖尿病胰岛β细胞功能的临床研究

Effect of Tangyikang in Improving the Function of Pancreatic Islet β Cells in Patients with Latent Autoimmune Diabetes Mellitus in Adults

目的探讨糖胰康对成人隐匿性自身免疫性糖尿病(latent autoimmune diabetes mellitus in adults,LADA)胰岛β细胞功能的改善作用与机制。方法将74例LADA患者随机分为两组,治疗组37例采用糖胰康(由红参10g黄芪30g麦冬15g知母10g黄连15g栀子10g虎杖10g红花10g牡丹皮10g组成)水煎剂口服加胰岛素治疗;对照组37例采用单纯胰岛素治疗;疗程均为3个月。观察两组治疗前后糖化血红蛋白(HbA1c)、胰岛β细胞功能指标(△CP2h/△BS2h)、血清γ干扰素(IFN-γ)和白细胞介素-4(IL-4)的变化。结果两组各指标均较治疗前改善。两组治疗后HbA1c比较,差异无统计学意义(t=0.441,P=0.660);△CP2h/△BS2h治疗组(0.258±0.106)较对照组(0.168±0.054)改善明显(t=4.626,P<0.01);胰岛素用量治疗组少于对照组(t=-4.169,P<0.01);协方差分析排除两组胰岛素用量不同的影响,治疗组较对照组IL-4升高(F=24.217,P<0.01),IFN-γ下降(F=14.198,P<0.01)。结论糖胰康有改善LADA患者胰岛β细胞功能的作用,其机制与调节细胞免疫,纠正Th1/Th2亚群失衡有关。

Objective To investigate the effect and mechanism of Tangyikang （TYK） for improving pancreatic islet β cell function in patients with latent autoimmune diabetes mellitus in adults （LADA）. Methods Seventyfour LADA patients were randomly assigned to two groups. The 37 patients in the treatment group were treated with TYK decoction （one dose consisted of red ginseng 10 g, milkvetch root 30 g, lilyturf root 15 g, wild weed 10 g, coptis root 15 g, cape-jasmine fruit 10 g, giant knotweed rhizome 10 g, safflower 10 g and moutan bark 10 g） combined with insulin therapy, and the 37 in the control group treated with insulin therapy alone, and the course for all was 3 months. Changes of glycosylated hemoglobin, index of pancreatic islet β-cell function （ G CP2h/A BS2h） , serum interferon-γ （IFN-γ） and interleukin- 4 （IL-4） were observed before and after treatment. Results All the above-mentioned indexes were improved after treatment in both groups, the post-treatment data showed significant difference between groups in △ CP2h/△ BS2h （0. 258 ± 0. 106 vs 0. 168 ± 0. 054, higher in the treatment group, t = 4. 626,P 〈 0. 01 ） , but with insignificant difference in glycosylated hemoglobin （t = 0. 441, P = 0. 660）. Besides, the dosage of insulin used in the treatment group was less than that in the control group （t = - 4. 169, P 〈 0.01） ; covariance analysis showed, through excluding impact of different dosages insulin used, IL- 4 level was higher （F = 24. 217, P 〈0.01 ） and IFN-γ level was lower （ F = 14. 198, P 〈0.01 ） in the treatment group than those in the control group. Conclusions TYK could improve the function of islet β-cell, its possible mechanism is related with the regulation on cell immunity and the correction of T-lymphocyte subsets （Th1/Th2 ratio） imbalance.