胰激肽原酶联合厄贝沙坦治疗老年2型糖尿病肾病患者的临床研究

Clinical trial of pancreatic kallidinogenase combined with irbesartan in the treatment of elderly patients with type 2 diabetic nephropathy

目的探究胰激肽原酶肠溶片联合厄贝沙坦片治疗老年2型糖尿病肾病(DN)患者的临床疗效及其对微血管病变和血清水平的影响。方法选取老年2型DN患者为研究对象,将患者随机分为对照组与试验组,对照组给予厄贝沙坦片150 mg,每天1次;试验组在对照组治疗的基础上给予胰激肽原酶肠溶片240 U,每天3次,2组患者均治疗12周。对比2组患者的临床疗效、治疗前后肾功能指标[血肌酸酐(SCr)、尿素氮(BUN)、尿蛋白排泄率(UAER)]、血流动力学指标[纤维蛋白原(FIB)、全血黏度、血细胞比容(HCT)]、微血管病变指标[血管内皮生长因子(VEGF)、人可溶性细胞间黏附分子-1(sICAM-1)]、B超检测指标[肾门处主动脉最大流速(V_(max))、舒张末最低流速(V_(min))及阻力指数(RI)]水平及药物不良反应发生情况。结果对照组和试验组均入组48例。治疗后,对照组和试验组的总有效率分别为85.42%和97.92%,血SCr分别为(90.47±18.14)和(80.28±12.04)μmol·L^(-1),BUN分别为(7.24±1.34)和(6.54±1.21)mmol·L^(-1),UAER分别为(36.17±6.07)和(31.04±5.21)μg·min^(-1),FIB分别为(4.32±0.59)和(3.95±0.48)g·L^(-1),全血黏度分别为(7.38±1.15)和(6.81±0.98)mPa·s,HCT分别为(38.63±7.01)%和(36.17±6.48)%,VEGF分别为(254.18±45.59)和(212.14±40.48)pg·mL^(-1),sICAM-1分别为(336.40±61.57)和(295.30±58.46)μg·L^(-1),肾门处主动脉Vmax分别为(72.58±3.60)和(74.98±3.78)cm·s^(-1),Vmin分别为(22.48±3.14)和(24.83±3.63)cm·s^(-1),RI分别为0.73±0.06和0.68±0.07。对照组的上述指标与试验组比较,在统计学上差异均有统计学意义(均P<0.05)。对照组和试验组的总药物不良反应发生率分别为4.17%(2例/48例)和8.33%(4例/48例),在统计学上差异无统计学意义(P>0.05)。结论胰激肽原酶肠溶片联合厄贝沙坦片可有效改善老年2型DN患者肾功能,改善血液流动情况及延缓微血管病变情况,提高疗效,安全有效。

Objective To explore the efficacy of pancreatic kallidinogenase enteric-coated tablet combined with irbesartan tablet in the treatment of elderly patients with type 2 diabetic nephropathy(DN).Methods Elderly patients with type 2 DN were selected as the research subjects,and were randomized into control group and treatment group.The control group was given 150 mg of irbesartan tablets once a day,while the treatment group was given 240 U of pancreatic kallidinogenase enteric-coated tablets three times a day on the basis of the control group.The clinical efficacy,renal function indicators[serum creatinine(SCr),blood urea nitrogen(BUN),urinary albumin excretion rate(UAER)],hemodynamic indicators[fibrinogen(FIB),whole blood viscosity,hematocrit(HCT)],microvascular lesion indicators[vascular endothelial growth factor(VEGF),soluble intercellular adhesion molecule-1(s ICAM-1)],B-ultrasound detection indicators[maximum aortic flow velocity(V_(max)),minimum diastolic flow velocity(V_(min)),resistance index(RI)at the renal hilum]before and after treatment and adverse drug reactions were compared between both groups.Results After treatment,the total effective rates in control group and treatment group were 85.42%and 97.92;SCr levels were(90.47±18.14)and(80.28±12.04)μmol·L^(-1);BUN levels were(7.24±1.34)and(6.54±1.21)mmol·L^(-1);UAER levels were(36.17±6.07)and(31.04±5.21)μg·min^(-1);FIB levels were(4.32±0.59)and(3.95±0.48)g·L^(-1);whole blood viscosity values were(7.38±1.15)and(6.81±0.98)m Pa·s;HCT levels were(38.63±7.01)%and(36.17±6.48)%;VEGF levels were(254.18±45.59)and(212.14±40.48)pg·m L^(-1);human s ICAM-1levels were(336.40±61.57)and(295.30±58.46)μg·L^(-1);the V_(max)of renal artery were(72.58±3.60)and(74.98±3.78)cm·s^(-1);the V_(min)values were(22.48±3.14)and(24.83±3.63)cm·s^(-1);the RI values were0.73±0.06 and 0.68±0.07,respectively.There were statistical differences in the above indicators between control group and treatment group(all P<0.05).The total incidence eares of adverse drug reactions in control group and treatment group were 4.17%(2 cases/48 cases)and 8.33%(4 cases/48 cases)respectively(P>0.05).Conclusion Pancreatic kallidinogenase enteric-coated tablet combined with irbesartan tablet can effectively improve the renal function of elderly patients with type 2 DN,improve the blood flow and delay microvascular lesion,and enhance the efficacy,therefore it is safe and effective.