芪丹糖肾颗粒治疗早期糖尿病肾病气虚血瘀肾亏证患者95例——双盲双模拟随机对照试验  

Oxidative Stress of Qidan Tangshen Granules (芪丹糖肾颗粒) in Treatment of 95 Patients with Early Diabetic Kidney Disease with Qi Deficiency,Blood Stasis,and Kidney Deficiency Syndrome:A Double-Blind,Double-Simulated,Randomized Controlled Trial

作　　者：张洁 丛亿蕾 吴腾飞[1] 柳琴 袁玥 崔石磊[2] 杨华[1] ZHANG Jie;CONG Yilei;WU Tengfei;LIU Qin;YUAN Yue;CUI Shilei;YANG Hua(Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai,200032;Huangdong Hospital Affiliated to Fudan University)

机构地区：[1]上海中医药大学附属龙华医院,上海市200032 [2]复旦大学附属华东医院

出　　处：《中医杂志》2025年第7期695-703,共9页Journal of Traditional Chinese Medicine

基　　金：上海市科学技术委员会项目(20Y21902500)。

摘　　要：目的观察芪丹糖肾颗粒治疗早期糖尿病肾病(DKD)气虚血瘀肾亏证的临床疗效与安全性,并探讨其作用机制。方法采用双盲双模拟方法,收集200例早期DKD气虚血瘀肾亏证患者,按照1∶1比例随机分为治疗组及对照组,每组100例。治疗组予芪丹糖肾颗粒+缬沙坦胶囊模拟剂治疗,对照组予缬沙坦胶囊+芪丹糖肾颗粒模拟剂治疗,两组均治疗12周。以随机尿白蛋白/肌酐(UACR)为主要结局指标,并比较治疗前后肾小球滤过率(eGFR)、空腹血糖(FPG)、餐后2 h血糖(PBG)、糖化血红蛋白(HbA1c)水平及中医证候评分(包括神疲乏力、面色晦暗、腰膝酸软、头胸疼痛、心烦易怒、自汗、口渴多饮、多食善饥、多尿、肢体麻木单项症状评分和中医证候总积分),检测血清8-羟基-2′-脱氧鸟苷(8-OHDG)、3-硝基酪氨酸(3-NT)、超氧化物歧化酶(SOD)水平。治疗后观察两组临床疗效和中医证候疗效,于治疗前后检测血常规、尿常规、肝功能指标,并记录试验期间不良反应的发生情况以判定安全性。结果最终完成试验患者共191例,其中治疗组95例,对照组96例。与本组治疗前比较,治疗组治疗后UACR、FBG、PBG、HbA1c水平明显下降,治疗后神疲乏力、面色晦暗、腰膝酸软、头胸疼痛、心烦易怒、自汗、口渴多饮、多尿、肢体麻木单项症状评分及中医证候总积分均显著降低(P<0.05或P<0.01)。治疗后治疗组UACR、FBG、PBG水平、中医证候总积分及除多食善饥、肢体麻木外其余各单项症状评分显著低于对照组(P<0.05或P<0.01)。随机选取40例患者(治疗组21例,对照组19例)检测氧化应激指标,两组患者治疗前后组内及组间比较,SOD、3-NT、8-OHDG水平差异均无统计学意义(P>0.05)。治疗组治疗后临床疗效总有效率为64.2%(61/95),中医证候疗效总有效率为80.0%(76/95),对照组分别为39.6%(38/96)、24.0%(23/96),治疗组均优于对照组(P<0.01)。两组治疗前后�Objective To evaluate the clinical efficacy and safety of Qidan Tangshen Granules(芪丹糖肾颗粒,QTG)in the treatment of early diabetic kidney disease(DKD)with qi deficiency,blood stasis,and kidney deficiency syndrome,and to explore its mechanism.Methods A double-blind,double-simulated method was used to enroll 200 patients with early DKD and qi deficiency,blood stasis,and kidney deficiency syndrome.Patients were randomly assigned in a 1∶1 ratio to the treatment group(100 cases)and the control group(100 cases).The treatment group received QTG plus a valsartan capsule simulant,while the control group received valsartan capsules plus a QTG simulant,both for 12 weeks.The primary outcome was the urinary albumin-to-creatinine ratio(UACR).Secondary outcomes included estimated glomerular filtration rate(eGFR),fasting blood glucose(FBG),2-hour postprandial blood glucose(PBG),glycated hemoglobin(HbA1c),and traditional Chinese medicine(TCM)syndrome scores(including individual symptom scores for fatigue,dull complexion,soreness and weakness of the waist and knees,headache and chest pain,irritability,spontaneous sweating,thirst and polydipsia,polyphagia,polyuria,numbness of the limbs,and the total TCM syndrome score).Oxidative stress markers including serum 8-hydroxy-2'-deoxyguanosine(8-OHDG),3-nitrotyrosine(3-NT),and superoxide dismutase(SOD)were also assessed.Clinical efficacy and TCM syndrome efficacy were evaluated after treatment,and routine blood tests,urinalysis,and liver function tests were conducted and adverse reaction during the tria was recorded to assess safety.Results A total of 191 patients completed the study(95 in the treatment group and 96 in the control group).The treatment group showed significant reductions in UACR,FBG,PBG,and HbA1c levels after treatment(P<0.05 or P<0.01).The single TCM symptom scores except for polyphagia and total TCM syndrome scores significantly decreased(P<0.05 or P<0.01).Compared to the control group,the treatment group had signi-ficantly lower UACR,FBG,PBG levels,and total

关 键 词：糖尿病肾病 气虚血瘀肾亏证 芪丹糖肾颗粒 尿白蛋白 肌酐 氧化应激 随机对照试验 

分 类 号：R259[医药卫生—中西医结合]