糖肾方联合贝前列素钠影响糖尿病肾病患者炎症因子及安全性的临床观察

Clinical Effect of Tangshen Prescription Combined with Beraprost Sodium on Inflammatory Factors and Safety of Treatment of Diabetic Kidney Disease

目的:观察糖肾方联合贝前列素钠对糖尿病肾病患者(DKD)炎症因子的影响及安全性。方法:单纯应用糖肾方(中药组)、贝前列素钠(西药组)与两者联合应用(合用组)进行随机平行对照研究,观察各组患者给药前后临床疗效、中医证候积分、空腹血糖(FBG)、尿蛋白排泄率(UAER)及相关炎性细胞因子转化生长因子(TGF)-β1,肿瘤坏死因子(TNF)-α及白细胞介素(IL)-18等的变化。结果:与治疗前比较,各组治疗后各项指标均降低;与西药组比较,中药组患者FBG水平明显降低(P<0.05);与中药组比较,西药组患者IL-18水平明显降低(P<0.05);与中药组、西药组比较,合用组患者临床总有效率升高(P<0.05),合用组患者的肾气虚相关症状(腰膝酸软、口干不欲饮)积分,FBG水平,UAER水平以及炎症因子水平均明显降低(P<0.05);与西药组比较,合用组患者脾气虚相关症状(纳差乏力、肢体浮肿)积分明显降低(P<0.05)。3组患者研究过程中均未发现严重不良反应。结论:糖肾方与贝前列素钠联用,可提高降低患者尿蛋白,改善炎症状态的作用,对临床期DKD有较好的治疗效果。

Objective： To observe the effect of Tangshen prescription combined with beraprost sodium on inflammatory factors and safety of patients with diabetic kidney disease （ DKD）. Method ： The randomized parallel control study was carried on among three groups, which were the traditional Chinese medicine （TCM） group （Tangshen prescription） , the western medicine group （beraprost sodium） and the combined group （combination of the two medicines）. Clinical curative effect, symptom score, fasting blood glucose （FBG）, urinary albumin excretion rate （UAER）, and relevant inflammatory factors, such as interleukin （IL）-18, tumor necrosis factor （TNF）-a and transforming growth factor （TGF）-/31 were observed before and after the administration. Result： After treatment, all of the indexes in each group were significantly reduced, compared with before treatment.Compared with western medicine group, the level of FBG in TCM group was significantly lower, with statistically significant differences （P 〈 0.05）. The level of IL-18 in western medicine group was lower than that of traditional Chinese medicine group, with statistically significant differences （P 〈 0.05）. Compared with group, the total clinical efficiency of combined group increased, with statistically significant differences （ P 〈 0.05 ） ; and it was also increased in combined group, compared with western medicine group, with statistically significant differences （P 〈 0.01 ）. In improving the deficiency of spleen Qi （ soreness and weakness of waist and knees and thirst without desire to drink） , and reducing the levels of FBG, UAER and inflammatory factors, the combined group was superior to both group and western medicine group, with statistically significant differences （P 〈 0.05 ）. In releasing the deficiency of spleen Qi （fatigue, anorexia and swollen limbs）, combined group was superior to western medicine group, with statistically significant differences （P 〈 0.05 ）. No serious adverse reaction was found in three groups. Conclusion： Tangshen prescription combined with beraprost sodium could enhance the effect of reducing proteinuria and inflammation, with a better effect in treatment of DKD at the clinical stage.