参乌益肾片对慢性肾脏病4-5期肾间质纤维化和微炎症状态的影响观察  

Effect of Shenwu Yishenpian on Renal Interstitial Fibrosis and Micro-inflammatory State in Chronic Kidney Disease 4-5 Stage

作　　者：王敏[1] 张立元[1] 马国平[2] 董洪民 尹晶 WANG Min;ZHANG Li-yuan;MA Guo-ping;DONG Hong-min;YIN Jing(The First People's Hospital of Lianyungang,Lianyungang 222002,China;Jiangsu Hospital of Traditional Chinese Medicine,Nanjing 210029,China;Affiliated Hospital of Jiangnan University,Wuxi 214122,China)

机构地区：[1]连云港市第一人民医院,江苏连云港222002 [2]江苏省中医院,南京210029 [3]江南大学附属医院,江苏无锡214122

出　　处：《中国实验方剂学杂志》2020年第23期125-130,共6页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：江苏省普通高校研究生科研创新计划项目(CXLX11_0745)。

摘　　要：目的:评价参乌益肾片治疗慢性肾脏病(CKD)4-5期非透析脾肾气虚证患者的疗效与安全性,及对肾间质纤维化(RIF)和微炎症状态的影响。方法:将120例患者随机按数字表法分为观察组和对照组各60例。对照组除去脱落/失访2例,完成58例,观察组脱落/失访1例、剔除1例,完成58例。两组均给予西医综合治疗。对照组口服参乌益肾片模拟药,4片/次,3次/d;观察组口服参乌益肾片,4片/次,3次/d。两组疗程均连续治疗6个月或至肾替代治疗,并随访6个月。每月测量血肌酐(SCr),并计算肾小球滤过率(eGFR);记录12个月内肾替代(透析或肾移植)情况,进展情况(CKD 4期进展至CKD 5期),减轻情况(CKD5期转为4期或4期转为3期);检测治疗前后尿素氮(BUN),血红蛋白(Hb),血浆白蛋白(ALB),尿蛋白定量(24 h Up)和血尿酸(UA)水平;进行治疗前后脾肾气虚证评分;检测治疗前后转化生长因子-β1(TGF-β1),结缔组织生长因子(CTGF),血清Klotho蛋白,肿瘤坏死因子-α(TNF-α),白细胞介素-6(IL-6),白细胞诱素-1(Lkn-1)和白细胞介素-12(IL-12)水平,并进行安全性评价。结果:治疗后3个月和6个月,两组患者SCr持续升高(P<0.01),eGFR持续下降(P<0.01);与对照组比较,观察组SCr低于同期对照组(P<0.01),eGFR高于同期对照组(P<0.01);在12个月观察期间,观察组CKD减轻率为13.79%(8/58),高于对照组的1.72%(1/58),CKD进展率为11.43%(4/35),低于对照组的31.58%(12/38)(P<0.05);观察组BUN,24h Up和UA水平均低于对照组(P<0.01),Hb和ALB水平均高于对照组(P<0.01);观察组疾病疗效优于对照组(Z=2.051,P<0.05);观察组TGF-β1,CTGF水平均低于对照组(P<0.01),Klotho水平高于对照组(P<0.01);观察组TNF-α,IL-6,Lkn-1和IL-12水平均低于对照组(P<0.01);研究期间未发现与参乌益肾片相关不良反应。结论:参乌益肾片治疗CKD4-5期非透析(脾肾气虚证)患者能延缓肾功能下降和CKD进展的速度,并能逆转部分患者肾功能进展,降低�Objective: To discuss the efficacy and safety of Shenwu Yishenpian on stage 4-5 chronic kidney disease-nondialysis(CKD)with deficiency of spleen and kidney Qi,and the effect on renal interstitial fibrosis(RIF)and microinflammation. Method: One hundred and twenty patients were randomly divided into observation group and control group. A total of 58 patients in control group completed the treatment(including 2 patients falling off or lost). And 58 patients in observation group completed the treatment(including 1 patient was falling off or lost visit,and 1 eliminated). Both groups got comprehensive treatment of western medicine.Patients in control group got simulated medicine of Shenwu Yishenpian,4 pieces/time,3 times/day. Patients in observation group got Shenwu Yishenpian,4 pieces/time,3 times/day. The treatment lasted for 6 months until the renal replacement therapy,and the 6-month follow-up was recorded. For every month,blood creatinine(SCr)was detected,and glomerular filtration rate(eGFR)were calculated. The 12-month renal replacement(dialysis or kidney transplantation),progress(CKD4 to CKD5)and mitigation(CKD5 to CKD4 or CKD4 to CKD3)were recorded. Before and after treatment,levels of urea nitrogen(BUN),hemoglobin(HB),plasma albumin(ALB),urine protein quantity(24 hUp)and blood uric acid(UA)levels were detected,deficiency of spleen kidney Qi was scored,and transforming growth factor-β1(TGF-β1),connective tissue growth factor(CTGF),serum Klotho,tumor necrosis factor-α(TNF-α),interleukin-6(IL-6),interleukin-1(Lkn-1)and interleukin-12(IL-12)were detected. And the safety was evaluated. Result: At the 3 thand 6 thafter treatment,SCr in two groups increased(P<0.01),while eGFR decreased(P<0.01). Compared with control group,SCr was less than that in control group(P<0.01),whereas eGFR was higher than that in control group(P<0.01). During 12 months of observation,the reduction rate of CKD was 13.79%(8/58),which was higher than 1.72%(1/58)in control group. The progress rate of CKD was 11.43%(4/35),which was lower than

关 键 词：慢性肾脏病 脾肾气虚证 参乌益肾片 肾间质纤维化 微炎症状态 疾病转归 

分 类 号：R289[医药卫生—方剂学] R25[医药卫生—中药学]