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目的观察苦碟子注射液联合坎地沙坦治疗2型糖尿病肾病的临床疗效和安全性。方法 358例2型糖尿病肾病患者随机分为试验组179例和对照组179例。对照组口服坎地沙坦8 mg,每天1次;试验组在对照组的基础上加用苦碟子注射液40 m L,每天1次。2组均治疗1个月。观察2组患者的临床疗效和治疗前后的血清干细胞因子(HGF)、转化生长因子(TGF-β_1)、胱抑素C(Cys C)、血糖及糖化血红蛋白水平变化,并观察2组患者治疗前后平均动脉压及肾功能变化及不良反应发生情况。结果治疗后,试验组的总有效率为91.62%,显著高于对照组的77.10%(P<0.05)。治疗后,试验组的HGF,Cys C和TGF-β_1显著优于对照组(P<0.05)。治疗后,试验组的血肌酸酐和尿素氮,β2-微球蛋白,尿蛋白排泄率显著优于对照组(P<0.05)。2组患者治疗期间不良反应发生率差异无统计学意义(P>0.05)。结论苦碟子注射液联合坎地沙坦治疗2型糖尿病肾病,能改善患者的HGF、TGF-β_1、Cys C水平及肾功能,临床疗效确切,且安全性高。
Objective To observe the clinical efficacy and safety of Kudiezi injection combined with candesartan in the treatment of type 2 diabetic nephropathy. Methods 358 patients with type 2 diabetic nephropathy were randomly divided into trial group (179 cases) and control group (179 cases). The control group was given candesartan 8 mg orally once daily. The experimental group was given Kudiezi injection 40 m L once a day on the basis of the control group. 2 groups were treated for 1 month. The clinical curative effect and changes of serum levels of stem cell factor (HGF), transforming growth factor (TGF-β 1), cystatin C (Cys C), blood glucose and glycosylated hemoglobin before and after treatment were observed in two groups. Mean arterial pressure and renal function changes and adverse reactions. Results After treatment, the total effective rate of the experimental group was 91.62%, which was significantly higher than that of the control group (77.10%, P <0.05). After treatment, HGF, Cys C and TGF-β 1 in the experimental group were significantly better than those in the control group (P <0.05). After treatment, the blood creatinine, urea nitrogen, β2-microglobulin and urinary protein excretion rate in the experimental group were significantly better than those in the control group (P <0.05). There was no significant difference in the incidence of adverse reactions between the two groups during treatment (P> 0.05). Conclusion Kudiezi injection combined with candesartan in the treatment of type 2 diabetic nephropathy can improve the level of HGF, TGF-β 1, Cys C and renal function in patients with definite curative effect and high safety.