清浊益肾汤联合达格列净片治疗G1A2、G2A2期糖尿病肾病

Qingzhuo Yishen Decoction Combined with Dapagliflozin Tablets in Treatment ofG1A2 and G2A2 Diabetic Nephropathy

目的:观察清浊益肾汤联合达格列净片治疗G1A2、G2A2期糖尿病肾病(diabetic nephropathy,DN)的临床疗效。方法:将80例辨证为气阴两虚、痰瘀内阻证糖尿病肾病G1A2、G2A2期患者随机分为治疗组和对照组。两组均给予常规糖尿病健康教育、降糖、降压、调脂等基础治疗,降糖方案均为口服达格列净片(每片10 mg,每次1片,1次·d-1)联合其他降糖药;治疗组在对照组治疗基础上联用清浊益肾汤,每次200 mL,2次·d-1。两组疗程均为12周。比较两组患者有效率、尿蛋白-肌酐比值(urine protein-creatinine ratio,UPCR)、24小时尿蛋白定量(24-hour urinary protein quantity,24hUPT)、血肌酐(serum creatinine,Scr)、血尿素氮(blood urea nitrogen,BUN)、肾小球滤过率(glomerular filtration rate,GFR);次要指标:空腹血糖(fasting plasma glucose,FPG)、糖化血红蛋白(glycosylated hemoglobin,HbAlC)、总胆固醇(total cholesterol,TC)、三酰甘油(triglyceride,TG)、高密度脂蛋白(high density lipoprotein HDL-C)、低密度脂蛋白(low density lipoprotein,LDL-C)、视黄醇结合蛋白(retinol binding protein,RBP)、胱抑素-c(cystatin C,CYS-C)、C反应蛋白(C-reactive protein,CRP)水平。结果:①治疗组有效率为93.33%(28/30),对照组为73.33%(22/30),两组有效率比较,差异有统计学意义(P<0.05)。②治疗后,两组患者FPG均低于本组治疗前;治疗组FPG水平为(6.38±0.37)mmol·L^(-1),低于同期对照组(P<0.01)。③治疗后,两组患者HbA1c水平均低于本组治疗前;治疗组HbA1c水平为(6.61±0.35)mmol·L^(-1),低于同期对照组(P<0.01)。④治疗后,两组患者UPCR低于治疗前,治疗组UPCR为(99.95±23.80)μg·mg-1,低于同期对照组(P<0.01)。⑤治疗后,两组患者24hUPT均低于治疗前;治疗组24hUPT为(180.97±30.11)mg,低于同期对照组(P<0.01)。⑥治疗后,两组患者TG水平均低于治疗前,治疗组TG为(1.12±0.23)mmol·L^(-1),低于同期对照组(P<0.01)。⑦治疗后,两组患者LDL-C水平低于治疗前,治疗组LDL-C(1.74±0.53)mmol·L^(-1),低于同期对照组(P<0.01)。⑧两组不良反应比较,差异无统计学意义(P>0.05)。结论:清浊益肾汤联合达格列净片治疗G1A2、G2A2期DN临床疗效显著,可降低患者蛋白尿,还可降低HbAlC、血脂水平,且具有良好的安全性。

Objective:To observe the clinical efficacy of Qingzhuo Yishen Decoction combined with Dapagliflozin Tablets in the treatment of G1A2 and G2A2 diabetic nephropathy(DN).Methods:80 patients with G1A2 and G2A2 stages of DN with syndrome differentiation of Qi and Yin deficiency and internal phlegm and Blood stasis were randomly divided into treatment group and control group.Both groups were given basic treatments such as routine diabetes health education,hypoglycemic,hypotensive,and lipid-lowering treatments.The hypoglycemic regimen is all oral administration of Dapagliflozin Tablets(10 mg per tablet,1 tablet each time,1 time·d-1)combined with other hypoglycemic drugs.The treatment group was treated with Qingzhuo Yishen Decoction on the basis of the control group treatment,200 mL each time,2 times·d-1.The treatment course for both groups was 12 weeks.The effective rate,urine protein-creatinine ratio(UPCR),24-hour urine protein quantity(24hUPT),serum creatinine(Scr),blood urea nitrogen(BUN),glomerular filtration rate(GFR)were compared between the two groups.And the secondary indicators include fasting plasma glucose(FPG),glycosylated hemoglobin(HbAlC),total cholesterol(TC),triglyceride(TG),high-density lipoprotein(HDL)-C),low-density lipoprotein(LDL-C),retinol-binding protein(RBP),cystatin-c(CYS-C),C reactive protein(CRP)level.Results:①The effective rate was 93.33%(28/30)in the treatment group and 73.33%(22/30)in the control group.There was a statistically significant difference between the two groups(P<0.05).(2)After treatment,FPG in both groups was lower than before treatment in the same group.The FPG level in the treatment group was(6.38±0.37)mmol·L^(-1),which was lower than that in the control group(P<0.01).③After treatment,the levels of HbA1c in the two groups were lower than those before treatment in the same group.The level of HbA1c in the treatment group was(6.61±0.35)mmol·L^(-1),which was lower than that in the control group(P<0.01).④After treatment,the UPCR level of the two groups was lower than that before treatment.The UPCR level of the treatment group was(99.95±23.80)ug·mg-1,which was lower than that of the control group during the same period(P<0.01).⑤After treatment,the 24hUPT of the two groups was lower than that before treatment.The 24hUPT of the treatment group was(180.97±30.11)mg,which was lower than that of the control group(P<0.01).⑥After treatment,TG levels in the two groups were lower than before treatment,and TG in the treatment group was(1.12±0.23)mmol·L^(-1),which was lower than that in the control group(P<0.01).⑦After treatment,the levels of LDL-C in the two groups were lower than those before treatment.LDL-C in the treatment group(1.74±0.53)mmol·L^(-1)was lower than that in the control group(P<0.01).⑧There was no significant difference in adverse reactions between the two groups(P>0.05).Conclusion:Qingzhuo Yishen Decoction combined with Dapagliflozin Tablets has a significant clinical curative effect in the treatment of G1A2 and G2A2 stage DN,which can reduce proteinuria,HbAlC,and blood lipid levels,and has good reliability.