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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 clinical effect of Liuweidihuangwan addition and subtraction of traditional Chinese medicine decoction combined with metformin hydrochloride on type 2 diabetes mellitus patients with yin deficiency and heat deficiency syndrome. Methods: From September 2012 to September 2014, 138 cases of type 2 diabetes mellitus diagnosed by TCM in our hospital were divided into control group and observation group according to random number table method, and 69 cases in each group . The patients in the control group were treated with metformin hydrochloride tablets orally. The patients in the observation group were orally treated with Chinese herbal decoction plus metformin hydrochloride, which was added or subtracted by Liuweidihuang Pill for two weeks for one course of treatment for 6 courses. Observe the changes of blood glucose and blood lipids in patients, detect the changes of insulin levels and observe the changes of insulin resistance. Calculate the clinical efficiency and the incidence of adverse reactions. Results: The blood glucose in both groups was controlled to varying degrees and the lipid metabolism was improved. The improvement of blood glucose and blood lipid in the observation group was more obvious than that in the control group. The fasting blood glucose (FPG), postprandial 2h blood glucose (2h PG) The levels of Hb A1C, TC, TG and LDL-C in patients with diabetes mellitus were significantly lower than those before treatment and those in the control group, and the effective rate was 92.8% (73.9%), the differences between the two groups were significant. Insulin resistance in both groups improved compared with that before treatment, and the level of fasting insulin (FINS) decreased significantly. The insulin resistance index (HOMA-IR) Compared with the control group, the improvement was more obvious, and there was significant difference between the two groups. The adverse reaction rate in the observation group was 5.8%, which was significantly lower than that in the control group (18.8%). There was significant difference between the two groups. Conclusion: The Liuweidihuangwan addition and subtraction of Chinese medicine decoction combined with metformin hydrochloride tablets can effectively control the type 2 diabetes patients with Yin Deficiency and Heat Syndrome to improve blood lipid metabolism and insulin resistance, which is safe and worthy of further study in clinic.