黄葵胶囊联合氨氯地平治疗早期糖尿病肾脏疾病的疗效

Effect of Huangkui capsule combined with amlodipine on early diabetic kidney disease

目的探讨黄葵胶囊联合氨氯地平治疗早期糖尿病肾脏疾病(DKD)的临床疗效以及其对患者肾脏血流动力学和血清内皮素-1(ET-1)、转化生长因子β1(TGF-β1)、肿瘤坏死因子α(TNF-α)水平的影响。方法前瞻性选取2017年5月至2019年12月河北省眼科医院收治的123例早期DKD患者,采用随机数字表法将其随机分成观察组(n=62)与对照组(n=61)。对照组口服苯磺酸氨氯地平片治疗,观察组在此基础上口服黄葵胶囊治疗,疗程均为12周。比较2组患者临床疗效。观察治疗前和治疗12周后2组患者肾功能相关指标[血清尿素氮(BUN)、肌酐(Cr)含量及24 h尿蛋白定量、预估肾小球滤过率(eGFR)]、双侧肾动脉血流动力学参数[收缩期峰值流速(VS)、舒张末期流速(VD)和阻力指数(RI)]及血清ET-1、TGF-β1、TNF-α水平的变化情况,并进行统计分析。比较2组患者不良反应发生率。结果观察组总有效率为91.9%(57/62),较对照组[78.7%(48/61)]显著升高,差异有统计学意义(P<0.05)。治疗12周后,2组患者血清BUN、Cr水平和24 h尿蛋白定量均显著低于治疗前,eGFR值显著高于治疗前(P<0.05),且观察组肾功能相关指标较对照组改善更显著,差异有统计学意义(P<0.05)。治疗12周后,2组患者双侧肾动脉VS、VD均显著高于治疗前,RI值显著低于治疗前(P<0.05),且观察组双侧肾动脉血流动力学参数较对照组改善更显著,差异有统计学意义(P<0.05)。治疗12周后,2组患者血清ET-1、TGF-β1和TNF-α含量均低于治疗前(P<0.05),且观察组血清ET-1、TGF-β1和TNF-α水平较对照组降低更显著,差异有统计学意义(P<0.05)。观察组不良反应发生率为4.8%(3/62),较对照组[3.3%(2/61)]差异无统计学意义(P>0.05)。结论黄葵胶囊联合氨氯地平可能通过进一步改善肾脏血流动力学状态及下调血清ET-1、TGF-β1、TNF-α表达水平的途径,达到保护早期DKD患者肾脏功能的目的,其总体疗效确切,且安全性好。

Objective To explore the clinical efficacy of Huangkui capsule combined with amlodipine in the treatment of early diabetic kidney disease(DKD)and its effects on renal hemodynamics,influence on levels of serum endothelin-1(ET-1),transforming growth factor beta1(TGF-β1),tumor necrosis factor alpha(TNF-α).Methods 123 patients with early DKD from Hebei Eye Hospital May 2017 to December 2019 were randomly divided into observation group(n=62)and control oroup(n=61).The control group was treated with Amlodipine besylate tablets,and the observation group was treated with Huangkui capsule for 12 weeks.The clinical effects of the two groups were compared.The changes of serum urea nitrogen(BUN),creatinine(Cr),24-hour urinary protein,estimated glomerular filtration rate(eGFR),peak systolic velocity(VS),end-diastolic velocity(VD),resistance index(RI)and serum ET-1,TGF-β1,TNF-αwere observed before and after 12 weeks of treatment.Finally,the side reaction rates of the two groups were compared.Results The total effective rate of the observation group was 91.9%(57/62),which was significantly higher than that of the control group[78.7%(48/61)],the difference was statistically significant(P<0.05).The levels of serum BUN,Cr and 24 h urinary protein were significantly lower in the two groups after 12 weeks of treatment than those before treatment,and the levels of eGFR were significantly higher than those before treatment,the differences were statistically significant(P<0.05).Moreover,the renal function-related indicators of the observation group improved more significantly than those of the control group,and the difference was statistically significant(P<0.05).After 12 weeks of treatment,VS and VD of both renal arteries were significantly increased,and RI were significantly decreased in both groups,the differences were statistically significant(P<0.05).The hemodynamic parameters of bilateral renal arteries in the observation group improved more significantly than those in the control group,and the differences were statistically significant(P<0.05).After 12 weeks of treatment,the levels of serum ET-1,TGF-β1 and TNF-αin the two groups were lower than before treatment(P<0.05),and the levels of serum ET-1,TGF-β1 and TNF-αin the observation group were lower than those in the control group,and the difference was statistically significant(P<0.05).The side effect rate of the observation group was 4.8%(3/62),which was not statistically different from the control group[3.3%(2/61)](P>0.05).Conclusion Huangkui capsule combined with Amlodipine may protect renal function in early DKD patients by further improving the state of renal Hemodynamics and down regulating the expression levels of ET-1,TGF-β1 and TNF-α,its overall curative effect is exact,and the security is good.