苁归益肾胶囊干预早期糖尿病肾脏病循证评价及对血清IL-6、TNF-α、TGF-β1的影响  

Evidence-based evaluation of the intervention of Conggui Yishen Capsules in early diabetic nephropathy and the effects on serum IL-6,TNF-αand TGF-β1

作　　者：阮诺冰 李金菊 林逸轩 王帆竞 方朝晖 RUAN Nuo-bing;LI Jin-ju;LIN Yi-xuan;WANG Fan-jing;FANG Zhao-hui(First Clinical College of Anhui University of Traditional Chinese Medicine,Hefei Anhui,230038,China;Institute of Chinese Medicine against Diabetes,Anhui Academy of Chinese Medicine,Hefei Anhui,230031,China;FirstAffiliated Hospital of Anhui University of Traditional Chinese Medicine,Hefei Anhui,230031,China)

机构地区：[1]安徽中医药大学第一临床医学院,安徽合肥230038 [2]安徽省中医药科学院中医药防治糖尿病研究所,安徽合肥230031 [3]安徽中医药大学第一附属医院,安徽合肥230031

出　　处：《时珍国医国药》2023年第10期2444-2447,共4页Lishizhen Medicine and Materia Medica Research

基　　金：国家自然科学基金(82174153,81573944,81774286);国家重点研发计划“战略性国际科技创新合作”重点专项(2020YFE0201800);国家重点研发计划“中医药现代化研究”重点专项(2018YFC1704202);国家中医临床研究基地业务建设第二批科研专项(JDZX2015123);方朝晖安徽省名中医工作室(2019-8-515);国家中医药管理局中医药重点学科(20091221);国家中医药管理局中医药行业科研专项(201007004);第五批省“特支计划”人才项目(20190028);安徽省中医药领军人才及培养对象项目(20190027);安徽省高校协同创新项目(GXXT-2020-025)。

摘　　要：目的探讨苁归益肾胶囊干预早期糖尿病肾脏病(Diabetic kidney disease,DKD)肾虚血瘀证患者临床疗效。方法共纳入80例早期DKD且为肾虚血瘀证的患者,随机分为2组,均开展糖尿病健康教育、饮食运动疗法、制定个体化降糖方案及口服厄贝沙坦片(50mg/次,qd),治疗组在对照组基础上额外服用苁归益肾胶囊(5粒/次,0.4g/粒,tid),试验周期为12周。评价试验前后两组患者的中医证候积分、空腹血糖(FPG)、餐后两小时血糖(2hPG)、糖化血红蛋白(HbA1c)、尿素氮(BUN)、血肌酐(Scr)、尿微量白蛋白/尿肌酐(ACR)、血清白介素6(IL-6)、肿瘤坏死因子α(TNF-α)、转化生长因子β1(TGF-β1)的变化情况。结果治疗组总有效率明显高于对照组(P<0.05)。治疗后两组的中医证候积分、FPG、2hPG、HbA1c、BUN、Scr、ACR、IL-6、TNF-α、TGF-β1水平均明显降低(P<0.05)。治疗组中医证候积分、FPG、2hPG、BUN、Scr、ACR、IL-6、TNF-α、TGF-β1水平较对照组低(P<0.05)。结论苁归益肾胶囊作用于早期DKD肾虚血瘀证患者疗效确切,能改善糖代谢紊乱及肾功能水平,减轻炎症反应,抑制促纤维化因子。Objective To investigate the clinical efficacy of Conggui Yishen Capsules in patients with early diabetic kidney dis-ease(DKD)with evidence of kidney deficiency and blood stasis.Methods A total of 80 patients with early DKD and evidence of kidney deficiency and blood stasis were randomly divided into 2 groups,both of whom were provided with diabetes health educa-tion,diet and exercise therapy,individualized glucose-lowering regimen and oral Irbesartan tablets(150 mg/dose,qd),while the treatment group was given additional Conggui Yishen Capsules(5 capsules/dose,0.4 g/capsule,tid)in addition to the con-trol group.Before and after the trial,we evaluated the changes of TCM syndrome score,fasting blood glucose(FPG),two-hour postprandial blood glucose(2hPG),glycosylated hemoglobin(HbA1c),urea nitrogen(BUN),blood creatinine(Scr),urinary microalbumin/urinary creatinine(ACR),serum interleukin 6(IL-6),tumor necrosis factorα(TNF-α),transforming growth factorβ1(TGF-β1).Results The total effective rate of the treatment group was significantly higher than that of the control group(P<0.05).The levels of TCM symptom score,FPG,2hPG,HbA1c,BUN,Scr,ACR,IL-6,TNF-α,and TGF-β1 were significantly lower in both groups after treatment(P<0.05).The levels of TCM symptom score,FPG,2hPG,BUN,Scr,ACR,IL-6,TNF-α,and TGF-β1 were lower in the treatment group than in the control group(P<0.05).Conclusion Conggui Yish-en Capsules are effective in patients with early DKD with kidney deficiency and blood stasis,improving glucose metabolism disor-der and kidney function level,reducing inflammatory response and inhibiting pro-fibrotic factors.

关 键 词：苁归益肾胶囊 早期糖尿病肾脏病 IL-6 TNF-α TGF-Β1 

分 类 号：R285.5[医药卫生—中药学]