疏血通注射液联合贝那普利治疗糖尿病肾病Ⅲ期、Ⅳ期临床研究

Clinical Research of Shuxuetong Injection and Benazepril Treatment of Patients with Diabetic Nephropathy Ⅲ,Ⅳ Period

目的:探讨疏血通注射液联合贝那普利对糖尿病肾病(diabetic nephropathy,DN)Ⅲ期、Ⅳ期患者的临床疗效及对C反应蛋白(C-reactive prote,hs-CRP)、胱抑素(Cystatin C,Cys C)的影响。方法:134例DN患者按随机数字表法分为对照组和治疗组。对照组65例采用贝那普利治疗,治疗组69例在对照组基础上加用疏血通注射液治疗。两组均以3个月为1个疗程。观察临床疗效,治疗前、治疗后4周、8周、12周24小时尿蛋白排泄率(24 hUPE),hs-CRP、Cys C、空腹血糖(FPG),血清总胆固醇(TC),血清三酰甘油(TG),餐后2小时血糖(2 hPG)。结果:①治疗组有效率为95.6%,对照组有效率为84.6%,两组比较,差异有统计学意义(χ2=4.654,P<0.05)。②治疗前两组24 hUPE排泄率(132.1±20.7,128.0±23.5)比较,在统计学上无差异(P>0.05)。两组24 hUPE水平与随着治疗时间延长而不断降低,治疗后12周为最低。治疗后4周两组24 hUPE水平(92.3±16.5,99.4±21.6)比较,差异无统计学意义(P>0.05)。治疗后8周(56.4±10.2,77.2±11.4)、12周(47.8±8.3,61.3±7.4),治疗组24 hUPE排泄率显著低于对照组,差异有统计学意义(P<0.05)。③治疗组与对照组治疗前、后hs-CRP[(8.6±0.1,3.7±0.2),(8.6±0.3,6.2±0.5)]、Cys C[(1.4±0.2,1.0±0.3),(1.4±0.4,1.2±0.6)],FPG[(7.7±0.3,6.2±0.4),(7.6±0.5,6.7±0.7)],TC[(6.8±0.4,4.1±0.6),(6.6±0.4,5.9±0.5)],TG[(1.8±0.5,1.2±0.4),(1.8±0.6,1.5±0.3)],2 hPG[(16.5±0.6,8.5±0.5),(16.6±0.2,11.3±0.2)]水平治疗后与治疗前比较,均显著降低,差异有统计学意义(P<0.05)。治疗后治疗组与对照组比较hs-CRP、CysC、FPG、TC、TG、2 hPG水平,均显著降低,差异有统计学意义(P<0.05)。结论:疏血通注射液联合贝那普利治疗DN,可降低2 hUPE,提高临床疗效,降低hs-CRP、Cys C及血糖血脂水平,疗效显著。

Objective： To explore the influence of of Shuxuetong injection and benazepril on clinical curative effect of patients with diabetic nephropathy（DN） Ⅲ,Ⅳ period and c-reactive protein and Cystatin C.Methods： 134 cases of patients with DN were randomly divided into the control group of 65 cases and the treatment group of 69 cases.The control group was given benazepril.The treatment group was treated with Shuxuetong injection on the basis of the control group.Three months as one course of treatment of the two groups.Observed overall curative effect,24 h urinary protein excretion rate（24 hUPER）,hs-CRP,Cys C,FPG（fasting plasma glucose）,TC（serum total cholesterol）,TG（serum triglyceride）,2 hPG（2 hours blood glucose after a meal） before and after treatment for 4 weeks,8 weeks,and 12 weeks.Results： ① The effective rate of the treatment group was 95.6%,and the rate of the control group was 84.6%,comparisons of the two groups showed that the difference was statistically significant（χ2= 4.654,P 0.05）.Comparisons of the 24h UPER in the two groups（132.1 ± 20.7,128.0 ± 23.5） showed that there was no difference in statistics（P 0.05）.Two groups of the levels of 24 hUPER in the two groups reduced constantly as the treatment time extension,and 12 weeks after treatment to the lowest.Comparison of The levels of 24 hUPER in the two groups after treatment of 4 weeks（92.3 ± 16.5,99.4 ± 21.6） showed that there was no statistical difference（P 0.05）.8 weeks after treatment,the levels of 24 h UPER in the two groups were（56.4 ± 10.2） and（77.2 ± 11.4） respectively,and 12 weeks after treatment those of（47.8 ± 8.3） and（61.3 ± 7.4） separately,and 24 hUPER of the treatment group was significantly lower than that of the control group,and the difference had statistical significance（P 0.05）.③The treatment group and the control group,before and after treatment of hs-CRP[（8.6 ± 0.1,3.7 ± 0.2）,（8.6 ± 0.3,6.2 ± 0.5） ],CysC[（1.4 ± 0.2,1.0 ± 0.3）,（1.4 ± 0.4,1.2 ± 0.6） ],FPG[（7.7 ± 0.3,6.2 ± 0.4）,（7.6 ± 0.5,6.7 ± 0.7） ],TC[（6.8 ± 0.4,4.1 ± 0.6）,（6.6 ± 0.4,5.9 ± 0.5） ],TG[（1.8 ± 0.5,1.2 ± 0.4）,（1.8 ± 0.6,1.5 ± 0.3） ]and 2 h PG[（16.5 ± 0.6,8.5 ± 0.5）,（16.6 ± 0.2,11.3 ± 0.2） ].The levels after treatment were all significant lower than the levels before treatment,and the difference had statistical significance（P 0.05）.after treatment,levels of hs-CRP,CysC,FPG,TC,TG and 2hPG in the treatment group were all decreased compared with the levels before treatment,and the difference was statistical significance（P 0.05）.Conclusion： Shuxuetong injection combined with benazepril treatment of patients with diabetic nephropathy can reduce the 24 h urinary protein,improve the clinical curative effect,reduce c-reactive protein（hs-CRP） and Cystatin C（Cys C） and the levels of glucose and lipid,and curative effect is exact.