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目的:观察六味地黄丸加减辅助二甲双胍对2型糖尿病(Type 2Diabetes Mellitus,T2DM)患者炎性因子及血糖指标的影响。方法:选择2013年2月~2015年2月146例阴虚内热证2型糖尿病患者为研究对象,根据入院时间分为对照组和观察组各73例,对照组给予盐酸二甲双胍片口服,观察组采用六味地黄丸加减辅助二甲双胍片治疗,两组疗程均为3个月。比较两组患者血清炎性因子、血糖指标、临床疗效、药物不良反应。结果:观察组总有效率为93.15%,明显高于对照组的75.34%(x~2=8.722,P<0.05);血清肿瘤坏死因子-α(tumor necrosis factor-α,TNF-α)、白细胞介素-6(interleukin-6,IL-6)、白细胞介素-8(interleukin-8,IL-8)等炎性因子含量分别为(1.29±0.20)ng/L、(55.63±10.49)ng/L、(5.17±0.59)ng/L,均明显低于对照组(t=4.831,3.836,6.108,P<0.05);空腹血糖(Fasitng blood glucose,FBG)、餐后2小时血糖(postprandial 2hour peripheral blood glucose,2h PG)、糖化血红蛋白(Glycosylated hemoglobin A1c,Hb A1c)等血糖含量分别为(6.31±0.85)mmol/L、(6.60±0.83)mmol/L、(6.24±0.97)%,均明显低于对照组(t=6.454,10.174,6.220,P<0.05);两组患者均未出现严重药物不良反应,观察组、对照组轻微胃肠道反应发生率分别为12.33%、9.59%,比较差异无统计学意义(x2=0.280,P<0.05)。结论:六味地黄丸加减辅助二甲双胍治疗能有效减轻阴虚内热证2型糖尿病患者的炎性反应,控制血糖水平,提高治疗效果,且安全性良好。
Objective: To observe the effect of Liuweidihuang Pills on type Ⅱ diabetes mellitus (T2DM) patients with inflammatory factors and glycemic index. Methods: From February 2013 to February 2015, 146 cases of type 2 diabetes mellitus with Yin Deficiency and Heat Syndrome were divided into control group and observation group according to the time of admission. The control group was treated with metformin hydrochloride tablets orally and the observation group Liuweidihuangwan plus and minus supplementation with metformin tablets, two courses of treatment were 3 months. Serum inflammatory factors, blood glucose, clinical efficacy and adverse drug reactions were compared between the two groups. Results: The total effective rate in the observation group was 93.15%, significantly higher than that in the control group (75.34%, x 2 = 8.722, P <0.05). Serum tumor necrosis factor-α (TNF- The levels of interleukin-6 (IL-6), interleukin-8 (IL-8) and other inflammatory factors were (1.29 ± 0.20) ng / L and (55.63 ± 10.49) ng /L,(5.17 ± 0.59) ng / L, were significantly lower than the control group (t = 4.831,3.836,6.108, P <0.05); fasting blood glucose (FBG), postprandial 2hour (6.31 ± 0.85) mmol / L, (6.60 ± 0.83) mmol / L, (6.24 ± 0.97)%, respectively, both of which were significantly higher than those of peripheral blood glucose (2h PG) and glycosylated hemoglobin A1c (Hb A1c) (T = 6.454,10.174,6.220, P <0.05). No serious adverse drug reactions occurred in both groups. The incidences of mild gastrointestinal reactions in the observation group and the control group were 12.33% and 9.59%, respectively The difference was not statistically significant (x2 = 0.280, P <0.05). Conclusion: Liuweidihuangwan addition and subtraction adjunct to metformin can effectively reduce the inflammatory reaction in patients with type 2 diabetes mellitus with deficiency of internal heat, control blood sugar level, improve the therapeutic effect and have good safety.