二地消渴方治疗2型糖尿病肾病早期蛋白尿的临床观察

Clinical Observation on the Treatment of Proteinuria in the Early Stage of Diabetic Kidney Disease by Erdi Xiaoke Formula

目的观察二地消渴方治疗2型糖尿病肾病早期(G1-3A1-2期)蛋白尿的临床疗效与安全性。方法将100例2型糖尿病肾病早期气阴两虚兼内热证患者随机分为试验组和对照组。对照组给予西医常规治疗,试验组在对照组的基础上联合口服二地消渴方治疗,疗程均为12周,观察两组患者治疗前后尿微量白蛋白与尿肌酐比值(UACR)、估算肾小球滤过率(eGFR)、血糖、血压、血脂和中医证候积分的变化,评价两组临床疗效及安全性。结果治疗后,试验组UACR低于治疗前(P<0.05),试验组低于对照组(P<0.05),两组eGFR治疗前后比较,差异无统计学意义(P>0.05)。治疗后,两组糖化血红蛋白(HbA1c)均降低(P<0.05),空腹血糖(FBG)、血压、总胆固醇(TC)、低密度脂蛋白胆固醇(LDL-C)治疗前后比较,差异无统计学意义(P>0.05)。两组中医证候积分均降低(P<0.05),试验组低于对照组(P<0.01)。试验组总有效率高于对照组(P<0.05)。两组治疗过程中血常规和肝功能未见明显异常,且均未出现明显不良反应。结论二地消渴方结合西医常规治疗较单纯西医常规治疗在降低蛋白尿水平和改善中医临床证候方面具有较好的临床疗效,安全性良好,该临床疗效可能不依赖血压和糖脂代谢的改善。

Objective To observe the clinical effect and safety of Erdi Xiaoke formula with the effect of“invigorating qi and nourishing yin and clearing heat”on proteinuria in the carly stage of type 2 diabetic kidney disease(T2DKD)(C1-3A1-2 stage).Methods 100 patients with deficiency of qi and yin combined with internal heat at early stage of T2DKD were randomLy divided into TCM group and control group,with 50 cases in each group.The control group was given conventional Wester medi-cine treatment,and the Chinese medicine group was combined with Erdi Xiaoke formula on the basis of the control group.The course of treatment was 12 weeks.The changes of urinary microal bumin to urinary creatinine ratio(UACR),estimated glomerular filtration rate(eGFR),blood glucose,blood pressure,blood lipid and TCM syndrome score before and after T2DKD treatment in both groups were observed.The clinical efficacy and safety of the two groups were evaluated.Results:UACR of early T2DKD patients in TCM group decreased significantly after treatment compared with that before treatment(P<0.05).The decrease of UACR before and after treatment(AUACR)in TCM group was significantly higher than that in control group(P<0.01),while there was no statistical significance between the two groups before and after eGFRtreatment.After treatment,the glycosylated he-moglobin(HbAle)of the two groups was significantly decreased compared with that before treatment(P<0.05),while the fast-ing blood glucose(FBG),blood pressure,total cholesterol(TC)and low density lipoprotein cholesterol(LDL-C)of the two groups were not statistically significant.TCMsyndrome scores of early T2DKD patients in both groups were significantly lower than before treatment(P<0.05),and the improvement of TCM syndrome scores in the TCM group was significantly better than that in the control group(P<0.01).The total effective rate was 30.0%in the control group and 81.2%in the Chinese medi-cine group,which was significantly better than that in the control group(P<0.01).There were no obvious abnormalities in blood routine and liver function and no obvious adverse reactions in both groups during the treatment of early T2DKD.Conclusion Erdi Xiaoke formula combined with conventional wester medicine treatment has better clinical efficacy and safety than conventional Western medicine treatment alone in reducing proteinuria level and improving TCM clinical syndrome of patients with early T2DKD.The clinical efficacy may not depend on the improvement of blood pressure and glucose and lipid metabolism.