滋肾健脾化瘀片对早期糖尿病肾病气阴两虚夹瘀证患者的疗效观察

Clinical Observation of Zishen Jianpi Huayu Tablets for Treatment of Early Diabetic Kidney Disease of Qi and Yin Deficiency Complicated with Blood Stasis Type

【目的】观察滋肾健脾化瘀片对早期糖尿病肾病(DKD)气阴两虚夹瘀证患者的临床疗效。【方法】将77例早期DKD气阴两虚夹瘀证患者随机分为对照组38例和干预组39例。在基础治疗的同时,干预组予以滋肾健脾化瘀片治疗,对照组予以匹配的安慰剂治疗,疗程为12周。观察2组患者治疗前后中医证候积分、肾功能指标[尿微量白蛋白/肌酐比值(ACR)、内生肌酐清除率(Ccr)、血肌酐(SCr)、血尿素氮(BUN)、胱抑素C(Cys-C)]及血压[收缩压(SBP)、舒张压(DBP)]、血糖[空腹血糖(FBG)、糖化血红蛋白(HbA1c)]、血脂[胆固醇(TC)、甘油三酯(TG)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)]等指标的变化情况,评价2组患者的临床疗效。【结果】(1)治疗12周后,干预组的总有效率为87.18%(34/39),对照组为42.11%(16/38),干预组的疗效明显优于对照组(P<0.05)。(2)治疗后,2组患者的中医证候积分均较治疗前明显降低(P<0.05),且干预组对中医证候积分的降低作用明显优于对照组(P<0.05)。(3)治疗后,干预组的ACR、Ccr及Cys-C水平较治疗前明显改善(P<0.05),而对照组的各项肾功能指标均无显著性改善(P>0.05);组间比较,干预组对ACR、Ccr及Cys-C水平的改善作用明显优于对照组(P<0.05)。(4)治疗后,干预组的FBG、HbA1c、TC、TG及LDL-C水平均较治疗前明显改善(P<0.05),而对照组的各项血糖、血压及血脂指标均无显著性改善(P>0.05);组间比较,干预组对FBG、HbA1c、TC、TG及LDL-C水平的改善作用明显优于对照组(P<0.05)。【结论】滋肾健脾化瘀片治疗早期DKD气阴两虚夹瘀证患者的疗效确切,可以有效降低患者的中医证候积分,改善肾功能,调节糖脂代谢。

Objective To evaluate the clinical effect of Zishen Jianpi Huayu Tablets on early diabetic kidney disease of qi and yin deficiency complicated with blood stasis type.Methods Seventy-seven cases of early diabetic kidney disease of qi and yin deficiency complicated with blood stasis type were randomly divided into control group(38 cases)and intervention group(39 cases).The two groups were all given fundamental treatment,and additionally,the intervention group was given oral use of Zishen Jianpi Huayu Tablets and the control group was matched with placebo treatment for 12 weeks.Before and after treatment,we monitored the outcomes of the traditional Chinese medicine(TCM)syndrome scores,renal function parameters of urine albumin-to-creatinine ratio(ACR),endogenous creatinine clearance rate(Ccr),serum creatinine(SCr),blood urea nitrogen(BUN)and cystatin C(Cys-C),blood pressure such as systolic blood pressure(SBP)and diastolic blood pressure(DBP),blood glucose levels of fasting blood glucose(FBG)and glycosylated hemoglobin A1c(HbA1c),and blood lipid levels of total cholesterol(TC),triglyceride(TG),high-density lipoprotein cholesterol(HDL-C)and low-density lipoprotein cholesterol(LDL-C)in the two groups.After treatment,the clinical efficacy in the two groups was evaluated. Results(1)After treatment for 12 weeks,the total effective rate in the intervention groupwas 87.18%(34/39)and that in the control group was 42.11%(16/38), and the difference was statisticallysignificant,indicating that the clinical efficacy of the intervention group was superior to that of the control group(P<0.05).(2)After treatment,the TCM syndrome scores in the two groups were decreased in comparison withthose before treatment(P<0.05),and the decrease in the intervention group was superior to that of the controlgroup(P<0.05).(3)After treatment, ACR, Ccr and Cys-C levels in the intervention group were markedlyimproved as compared with those before treatment(P<0.05), while the renal function indexes in the controlgroup showed no obvious changes(P>0.05). The intergroup comparison showed that the intervention group hadstronger effect on improving ACR,Ccr and Cys-C levels than the control group(P < 0.05).(4)After treatment,FBG,HbA1c,TC,TG and LDL-C in the intervention group were markedly improved as compared with thosebefore treatment(P<0.05),while the blood glucose,blood pressure and blood lipid indexes in the control groupshowed no obvious changes(P>0.05). The intergroup comparison showed that the intervention group had strongereffect on improving FBG,HbA1c,TC,TG and LDL-C than the control group(P < 0.05). Conclusion ZishenJianpi Huayu Tablets exert certain effect for the treatment of early diabetic kidney disease of qi and yin deficiencycomplicated with blood stasis type. The tablets are effective on increasing TCM syndrome scores,improving renalfunction and regulating the metabolism of glucose and lipid.