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目的:观察益气补肾方在糖尿病肾病IV期中脾肾气虚证的治疗疗效,探讨其作用可能参与机制。方法:将64例符合糖尿病肾病IV期脾肾气虚证患者随机分为益气补肾方加替米沙坦片联合治疗组及替米沙坦片对照组,评价治疗效果,观察治疗前后24 h尿蛋白定量、血浆白蛋白(Alb)、血肌酐(Scr)、内生肌酐清除率(Ccr)、超敏C反应蛋白(hs CRP)、血清同型半胱氨酸(hcy)等指标变化。结果:治疗组无论西医临床疗效,中医临床疗效均较对照组更为理想(P<0.01或P<0.05);两组24 h尿蛋白定量均下降,血浆白蛋白均升高,对照组治疗前后比较差异明显(P<0.05),治疗组治疗前后差异非常明显(P<0.01),与对照组比较差异明显(P<0.05);两组治疗后肾功能指标变化,血肌酐指标虽无明显差异(P>0.05),但对照组Ccr短期内则有下降趋势(P<0.05);治疗前后2组血糖及糖化血红蛋白无明显变化(P>0.05);治疗后治疗组血清Hcy、hs CRP均显著下降(P<0.01);对照组hcy指标无明显变化,hs-CRP指标下降(P<0.05),治疗组较对照组hs-CRP和hcy改善非常显著(P<0.01)。结论:联合应用益气补肾方及血管紧张素Ⅱ受体拮抗剂治疗DNIV期脾肾气虚证能明显提高临床疗效,其作用机制可能与抑制DN患者炎症反应,改善血管内皮功能受损有关。
Objective: To observe the therapeutic effect of Yiqi Bushen Recipe in the stage Ⅳ of diabetic nephropathy on spleen and kidney qi deficiency syndrome, and to explore the possible mechanism involved. Methods: Sixty-four cases of diabetic nephropathy patients with stage IV of spleen and kidney qi deficiency were randomly divided into two groups: the combination therapy of nourishing kidney and decoction plus telmisartan tablets and the control group of telmisartan tablets. The therapeutic effect was evaluated and the urine of 24 h before and after treatment (Alb), serum creatinine (Scr), Ccr, hs CRP, hcy and other indexes were analyzed. Results: The clinical curative effect of TCM was better than that of the control group (P <0.01 or P <0.05), no matter the clinical curative effect of western medicine was observed in the treatment group. The urinary protein excretion of 24 h in both groups decreased and the plasma albumin increased. (P <0.05). There was significant difference between before and after treatment in the treatment group (P <0.01), and the difference was significant compared with the control group (P <0.05). There was no significant difference in the changes of renal function index and serum creatinine between the two groups (P> 0.05), but there was a trend of decrease in Ccr in the control group (P <0.05). There was no significant change in blood glucose and HbA1c before and after treatment (P> 0.05) (P <0.01). There was no significant change of hcy index and hs-CRP index in the control group (P <0.05). The improvement of hs-CRP and hcy in the treatment group was significantly improved (P <0.01). Conclusion: The combination of Yiqi Bu Shen Decoction and angiotensin Ⅱ receptor antagonist in the treatment of spleen-kidney-qi deficiency syndrome with DNIV can obviously improve the clinical curative effect, which may be related to the inhibition of inflammatory reaction and improvement of vascular endothelial dysfunction in DN patients.