水陆二仙丹合抵挡汤加减治疗早期糖尿病肾病的前瞻性研究

Prospective Study on Modified Shuilu Erxian Pills andDidang Decoction in the Treatment of Early Diabetic Nephropathy

目的:评价水陆二仙丹合抵挡汤加减治疗早期糖尿病肾病(diabetic nephropathy,DN)的疗效。方法:将早期DN患者102例根据随访期间的暴露因素(是否服用水陆二仙丹合抵挡汤加减治疗)分为无暴露组和暴露组,无暴露组服用水陆二仙丹合抵挡汤加减治疗时间<4周,低暴露组为4~8周,高暴露组为8~16周。观察水陆二仙丹合抵挡汤加减治疗与终点事件(DNⅢ期进展到临床蛋白尿期)及次要结局指标[临床症状、空腹血糖(fasting blood glucose,FBG)、餐后2 h血糖(2-hour postprandial blood glucose,2 h PG)、总胆固醇(total cholesterol,TC)、甘油三酯(triglyceride,TG)、低密度脂蛋白(low density lipopro-tein cholesterol,LDL-C)、尿微量白蛋白排泄率(urinary albumin excretion rate,UAER)、24 h尿蛋白定量(24-hour urinary protein quantity,24 h UPQ)、血肌酐(serum creatinine,SCr)、尿素氮(blood urea nitrogen,BUN)]的关系。结果:不同暴露水平终点事件发生率比较差异无统计学意义(P>0.05);低、高暴露组患者腰膝酸软、倦怠乏力、口干、夜尿多症状较无暴露组改善明显(P<0.05);低、高暴露组FBG、TG、UAER、24 h UPQ、SCr均降低(P<0.05),且高暴露组FBG、TG、UAER、SCr降低更明显(P<0.05),而PPG、LDL、BUN低、高暴露组比较差异无统计学意义(P>0.05)。结论:在综合治疗基础上服用水陆二仙丹合抵挡汤加减4~16周可明显缓解早期DN患者临床症状,降低FBG、TG、UAER、SCr水平。

Objective: To assess clinical efficacy of Shuilu Erxian pills joined with modified Didang decoction(SDD) in the treatment of early diabetic nephropathy(DN). Methods: All 102 early DN patients were divided into non-exposure group and exposure group according to the exposure factor during the follow-up period(whether the patients were treated with Shuilu Erxian pills and modified SDD), non-exposure group took Shuilu Erxian pills joined with modified Didang decoction, therapeutic time less than four weeks, four to eight weeks in low exposure group, eight to 16 weeks in high exposure group. To observe the correlation between treatment and end point events(progression from DN stage Ⅲ to clinical proteinuria) and secondary outcome measures(clinical symptoms, FBG, 2 h PG, TC, TG, LDL-C, UAER, 24 h UPQ, SCr and BUN). Results: The difference had no statistical meaning in the incidence of endpoint events at different exposure levels(P>0.05);the improvements of the symptoms including soreness of waist and knees, fatigue, dry mouth, nocturia in low and high exposure group were more notable compared with these of non-exposure group(P<0.05);FBG, TG, UAER, 24 h UPQ and SCr lowered in low and high exposure group(P<0.05), FBG, TG, UAER and SCr of high exposure group reduced remarkably(P<0.05), while the difference had no statistical menaing in PPG, LDL and BUN between low and high exposure group(P>0.05). Conclusion: On the foundation of comprehensive therapy, the administration of Shuilu Erxian pills joined with modified SDD for four to 16 weeks could notably relieve clinical symptoms in early DN patients and lower the levels of FBG, TG, UAER and SCr.