摘要
目的:探讨肾康宁胶囊对显性糖尿病肾病(DKD)脾肾气虚证患者的临床疗效及对血清核转录因子-κB(NF-κB),转化生长因子-β_1(TGF-β_1)和血小板源性生长因子(PDGF)水平的影响。方法:将138例患者采用区组随机,按数字表法分为对照组和观察组各69例。对照组口服替米沙坦片,1片/d,和口服阿托伐他汀钙片,10 mg·d^(-1)。观察组西药使用同对照组,并服用肾康宁胶囊,4粒/次,3次/d。两组疗程均为连续治疗24周或至Ⅴ期,并进行24周随访。记录治疗期和随访期病情进展至Ⅴ期的患者数量,或肌酐(SCr)翻版倍等终点事件发生情况;检测治疗前后空腹血糖(FBG),糖化血红蛋白(Hb Alc),尿素氮(BUN),血肌酐(SCr),血红蛋白(Hb),血浆白蛋白(ALB),24 h尿蛋白定量(24 h Upr),胆固醇(TC),甘油三酯(TG),高密度脂蛋白胆固醇(HDL-C)和低密度脂蛋白胆固醇(LDL-C)检测;进行治疗前后脾肾气虚证评分;检测治疗前后TGF-β_1,NF-κB和PDGF水平。结果:观察组临床疗效有效率为78.26%,对照组为57.97%,观察组高于对照组(χ~2=6.539,P<0.05);观察组中医证候评分有效率为85.51%,对照组为65.22%,观察组中医证候评分高于对照组(χ~2=7.649,P<0.01);观察组终点事件发生率为15.94%,对照组为33.33%,观察组终点事件发生率低于对照组(χ~2=5.619,P<0.05);治疗后观察组Hb Alc,24 h Upr,BUN和SCr水平均低于对照组(P<0.01);治疗后观察组Hb,ALB和HDL-C水平均高于对照组(P<0.01),LDL-C水平低于对照组(P<0.01),TC和TG组间比较差异无统计学意义;治疗后观察组TGF-β_1,NF-κB和PDG水平均低于对照组(P<0.01)。结论:在西医常规治疗的基础上,采用肾康宁胶囊内服治疗DKDⅣ期患者,能改善脾肾气虚证症状、减轻蛋白尿,能调节糖、脂代谢,改善患者营养状况,从而降低终点事件的发生率,对DKD病情起到延缓作用,其作用机制可能通过下调血清TGF-β_1,PDGF,NF-κB等细胞因子来实现的。
Objective： To discuss the clinical efficacy of Shenkangning capsules in treating diabetic nephropathy（Qi deficiency of spleen and kidney） and investigate their effects on levels of transforming growth factor-β1（TGF-β1）,nuclear transcription factor-κB（NF-κB） and platelet-derived growth factor（PDGF）.Method： Altogether one hundred and thirty-eight patients were randomly divided into control group（69 cases） and observation group（69 cases） by random number table. Patients in control group orally took telmisartan tablets,1 tablet/day,atorvastatin calcium tablets,10 mg/day. Based on the treatment in control group,patients in observation group added Shenkangning capsules,4 capsules/time,3 times/day. The treatment course was24 weeks for both groups,with a follow-up of 24 weeks. The number of patients entering Stage V,or the endpoint events such as serum creatinine（SCr） doubling were recorded during treatment period and follow-up period. The levels of fasting blood-glucose（FBG）,glycosylated hemoglobin（Hb Alc）,urea nitrogen（BUN）,serum creatinine（SCr）,hemoglobin（Hb）,plasma-albumin（ALB）,urine protein quantitation at 24 hours（24 h Upr）,cholesterol（TC）,triglyceride（TG）,high density lipoprotein cholesterol（HDL-C） and low density lipoprotein cholesterol（LDL-C） were detected before and after treatment. The scores of qi deficiency of spleen and kidney were graded. And levels of TGF-β1,NF-κB and PDGF were detected both before and after treatment. Result： The total effective rate of clinical efficacy was 78. 26% in observation group,higher than 57. 97% in control group（χ~2= 6. 539,P〈0. 05）. The effective rate of traditional Chinese medicine（TCM） symptoms was 85. 51% in observation group,higher than 65. 22% in control group（χ~2= 7. 649,P〈0.01）. The incidence of endpoint events was 15. 94% in observation group,lower than 33. 33% in control group（χ~2= 5. 619,P〈0. 05）. Levels of Hb Alc,24 h Upr,BUN,Scr and LDL-C in observation gro
作者
陈司汉
柳尧
曾炎
阮凤
CHEN Si-han LIU Yao ZENG Yan RUAN Feng(Leshan Vocational Technical Institute, Leshan 614000, China Yunnan Hospital of Traditional Chinese Medicine （TCM） , Kunming 650011, China TCM Hospital Affiliated to Southwest Medical University, Luzhou 646000, China)
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2017年第10期183-188,共6页
Chinese Journal of Experimental Traditional Medical Formulae
基金
四川省教育厅科研基金项目(2014SC-04606)
乐山职业技术学院2013年科研基金项目(KY2013002)
关键词
糖尿病肾病Ⅳ期
肾康宁胶囊
终点事件
核转录因子
转化生长因子-Β1
血小板源生长因子
diabetic nephropathy Ⅳ
Shenkangning capsules
endpoint events
transcription factor
transforming growth factor-β1
platelet-derived growth factor
