固肾健脾化湿汤联合厄贝沙坦片治疗糖尿病肾病脾肾两虚证临床研究

Clinical study of Gushen Jianpi Huashi Decoction combined with irbesartan in the treatment of diabetic nephropathy with spleen and kidney deficiency syndrome

目的评价固肾健脾化湿汤结合厄贝沙坦治疗DN脾肾两虚证的临床疗效。方法将符合入选标准的2018年1月-2020年9月本院97例DN患者按随机数字表法分为对照组48例和研究组49例,对照组在西医常规治疗基础上服用厄贝沙坦,研究组在对照组基础上服用固肾健脾化湿汤。2组均14 d为1个疗程,共治疗6个疗程。分别于治疗前后进行中医症状评分,采用全自动生化仪检测BUN、SCr水平,ELISA法检测血清IL-6、TNF-α、CRP水平;采用放射免疫法测定尿微量白蛋白排泄率(UAER);评价临床疗效,记录不良反应。结果研究组总有效率为91.8%(45/49)、对照组为75.0%(36/48),2组比较差异有统计学意义(χ^(2)=4.99,P=0.025)。研究组治疗后中医症状评分低于对照组(t=29.75,P<0.01),血清BUN[(4.49±0.68)mmol/L比(5.16±0.61)mmol/L,t=5.11]、SCr[(63.42±4.09)μmol/L比(69.01±4.35)μmol/L,t=6.52]水平及UAER[(72.58±5.88)μg/min比(85.63±6.49)μg/min,t=10.44]低于对照组(P<0.01),血清IL-6、CRP、TNF-α水平低于对照组(t值分别为9.44、7.24、18.08,P<0.01)。治疗期间,对照组不良反应发生率为14.6%(7/48)、研究组为16.3%(8/49),2组比较差异无统计学意义(χ^(2)=0.06,P=0.812)。结论固肾健脾化湿汤结合厄贝沙坦可有效改善DN患者的肾功能,降低炎性细胞因子水平,提高临床疗效。

Objective To evaluate the clinical efficacy of Gushen Jianpi Huashi Decoction combined with irbesartan in the treatment of spleen and kidney deficiency syndrome of diabetic nephropathy(DN).Methods According to random number table method,97 patients with DN who met the inclusion criteria and from January 2018 to September 2020 were randomly divided into two groups,48 in the control group and 49 in the study group.The control group took irbesartan on the basis of routine treatment of western medicine,and the study group took Gushen Jianpi Huashi Decoction on the basis of the control group.Both groups were treated for 14 days as a course of treatment,a total of 6 courses of treatment.Traditional Chinese Medicine(TCM)syndrome scores were performed before and after treatment,BUN and SCr levels were detected by automatic biochemical instrument,and serum IL-6,TNF-α,and CRP levels were detected by ELISA.The Urinary microalbumin excretion rate(UAER)was measured by radioimmunoassay,and the clinical efficacy was evaluated and adverse reactions were recorded.Results The total effective rate was 91.8%(45/49)in the study group and 75.0%(36/48)in the control group,and there was significant difference between the two groups(χ^(2)=4.99,P=0.025).The scores of TCM syndrome in the study group was significantly lower than that of the control group(t=29.75,P<0.01).After treatment,the serum BUN[(4.49±0.68)mmol/L vs.(5.16±0.61)mmol/L,t=5.11],SCr[(63.42±4.09)μmol/L vs.(69.01±4.35)μmol/L,t=6.52]and UAER[(72.58±5.88)μg/min vs.(85.63±6.49)μg/min,t=10.44]in the study group were significantly lower than those in the control group(P<0.01),the serum IL-6,CRP and TNF-αlevels in the study group were significantly lower than those in the control group(t values were 9.44,7.24 and 18.08,respectively,P<0.01).During the treatment,the incidence of adverse reactions was 14.6%(7/48)in the control group and 16.3%(8/49)in the study group,but there was no significant difference between two groups(χ^(2)=0.06,P=0.812).Conclusion The Gushen Jianpi Huashi Decoction combined with irbesartan can improve the renal function of DN patients,reduce the level of inflammatory cytokines and improve the clinical effect.