六味地黄丸加减联合二甲双胍辨治阴虚内热证2型糖尿病的临床研究

Research on Treating Syndrome of Endogenous Heat Due to Yin Deficiency Type 2 Diabetes Patients with Liuwei Dihuang Bolus Combined Metformin Hydrochloride Tablets

目的 :探讨六味地黄丸加减而成的中药汤剂联合盐酸二甲双胍片辨治阴虚内热证2型糖尿病患者的临床效果。方法 :选择2012年9月至2014年9月我院诊治的经中医辨证为阴虚内热证2型糖尿病患者138例为研究对象,按照随机数字表法分为对照组和观察组患者各69例,对照组患者口服盐酸二甲双胍片治疗;观察组患者则口服由六味地黄丸加减而成的中药汤剂联合盐酸二甲双胍片治疗,2周为一个疗程,连续治疗6个疗程。观察患者血糖、血脂的变化情况,检测胰岛素水平变化,观察胰岛素抵抗变化情况;计算临床有效率及不良反应发生率。结果 :两组患者血糖均受到不同程度地控制,血脂代谢有所改善,观察组患者血糖、血脂改善与对照组相比更明显,其空腹血糖(FPG)、餐后2h血糖(2h PG)、糖化血红蛋白(Hb A1C)、血脂总胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白(LDL-C)水平较治疗前及对照组患者明显下降,其有效率92.8%与对照组有效率73.9%相比降低明显,组间比较差异性显著;两组患者胰岛素抵抗与治疗前相比有所改善,空腹胰岛素(FINS)水平下降明显,观察组患者胰岛素抵抗指数(HOMA-IR)与对照组相比改善更明显,组间比较差异性显著;观察组患者不良反应率5.8%,明显低于对照组患者不良反应率18.8%,组间比较差异性显著。结论 :六味地黄丸加减而成的中药汤剂联合盐酸二甲双胍片能有效控制阴虚内热证2型糖尿病患者的血糖水平,改善其血脂代谢及胰岛素抵抗,安全性高,值得临床深入研究。

Objective To investigate the efficacy of treating syndrome of endogenous heat due to yin deficiency type 2 diabetes patients with liuwei dihuang bolus combined metformin hydrochloride tablets. Methods 138 type 2 diabetes patients were randomly divided into a control group of 69 cases and an observation group of 69 cases. Patients in the control group were treated with metformin hydrochloride tablets; while patients in the observation group were treated with liuwei dihuang bolus,2 weeks for a course, 6courses for treatment. The research was aimed at monitoring the level change of glucose and blood fat levels before and after treatment, testing the level of FINS, calculating the effective rate, and observing the incidence of adverse reactions. Results The patients’ glucose and blood fat levels were improved clearly, the degree of change in the observation group was more pronounced, the levels of FPG, 2h PG, Hb A1 C, TC, TG and LDL-C went down compared with that of before treatment and the control group,and the efficiency for patients in the observation group was 92.8%, which was higher than that of the control group 73.9%, the difference is significant; The patients’ insulin resistance was improved compared with before treatment, the level of FINS went down, and the HOMA-IR of the patients in the observation group was improved more clearly, the difference is significant; The adverse reaction rate of the patients in the observation group was 5.8%,which was lower than that of the control group18.8%, the difference is significant. Conclusion The therapy is good to control blood sugar levels in patients with type 2 diabetes, improve the blood lipid metabolism and insulin resistance, which has high safety, is worthy of clinical promotion.