健脾益肾通络胶囊联合坎地沙坦酯治疗糖尿病肾病临床研究

Clinical study of Jianpi-Yishen-Tongluo capsules combined with candesartan cilexetil in the treatment of diabetic nephropathy

目的评价健脾益肾通络胶囊联合坎地沙坦酯治疗DN的疗效。方法将2015年1月-2018年12月本院符合入选标准的82例患者,采用随机数字表法分为2组,每组41例。对照组口服坎地沙坦酯,研究组在对照组基础上加用健脾益肾通络胶囊。2组均治疗1个月。采用全自动生化分析仪检测24 h尿蛋白定量、SCr及BUN,采用ELISA法检测血清内脂素、HbAlc、IL-6、TNF-α水平;观察治疗期间的不良反应,评价临床疗效。结果研究组总有效率为97.6%(40/41)、对照组为85.4%(35/41),2组比较差异有统计学意义(χ^2=3.905,P=0.048)。治疗后,研究组尿液中24 h尿蛋白定量[(64.35±6.39)mg比(96.32±8.74)mg,t=18.908]、SCr[(86.84±9.30)μmol/L比(124.34±13.11)μmol/L,t=14.939]、BUN[(5.41±0.59)mmol/L比(7.58±0.71)mmol/L,t=15.052]水平低于对照组(P<0.01);血清内脂素、HbAlc水平低于对照组(t值分别为10.595、13.140,P值均<0.01);血清IL-6、TNF-α水平均低于对照组(t值分别为10.071、6.969,P值均<0.01)。治疗期间,对照组不良反应发生率为12.2%(5/41)、研究组为4.9%(2/41),2组比较差异无统计学意义(χ^2=1.406,P=0.236)。结论健脾益肾通络胶囊联合坎地沙坦酯可有效改善DN患者的肾功能,减轻炎症反应,提高临床疗效。

Objective To evaluate the effect of Jianpi-Yishen-Tongluo capsules combined with candesartan cilexetil in the treatment of diabetic nephropathy(DN).Methods According to the random table method,82 patients who met the inclusion criteria in our hospital from January 2015 to December 2018 were divided into two groups,41 in each group.The control group was treated with candesartan cilexetil,while the research group was treated with Jianpi-Yishen-Tongluo capsules based on the control group.Both groups were treated for 1 month.Then,the 24-hour urinary protein quantity(24 hPro)in urine,serum creatinine(SCr),blood urea nitrogen(BUN)were measured by automatic biochemical analyzer.The serum levels of visfatin(VF),glycosylated hemoglobin(HbAlc),interleukin-6(IL-6),tumor necrosis factor-α(TNF-α)were measured by ELISA.The adverse reaction during the treatment was observed and the clinical effect was evaluated.Results The total effective rate of the research group was 97.6%(40/41),and 85.4%(35/41)of the control group,the difference between the two groups was statistically significant(χ2=3.905,P=0.048).After the treatment,the 24 hPro(64.35±6.39 mg vs.96.32±8.74 mg,t=18.908)in urine,SCr(86.84±9.30mmol/L vs.124.34±13.11mmol/L,t=14.939),BUN(5.41±0.59 mmol/L vs.7.58±0.71 mmol/L,t=15.052)in the research group were significantly lower than those of the control group(P<0.01).The levels of VF and HbAlc in the research group were significantly lower than those of the control group(t values were 10.595 and 13.140,respectively,all Ps<0.01),the serum levels of IL-6 and TNF-αwere significantly lower than those of the control group(t values were 10.071 and 6.969,respectively,all Ps<0.01).During the treatment,the incidence of adverse reactions was 12.2%(5/41)in the control group and 4.9%(2/41)in the research group,with no significant difference between the two groups(χ2=1.406,P=0.236).Conclusions The Jianpi-Yishen-Tongluo capsules combined with candesartan cilexetil can improve the renal function of DN patients,reduce the inflammatory reaction and improve the clinical effect.