糖肾康平方治疗早期糖尿病肾脏疾病的有效性评价及远期疗效观察  

Clinical Effectiveness and Long-term Efficacy of Tangshen Kangping Decoction in the Treatment of Early Diabetic Kidney Diasese

作　　者：李雪玲[1] 林小靖 严佳怡 朱青青 刘妮 王珏[1] 钟逸斐[1] LI Xueling;LIN Xiaojing;YAN Jiayi(Department of Nephrology,Longhua Hospital,Shanghai University of Traditional Chinese Medicine,Shanghai,200032)

机构地区：[1]上海中医药大学附属龙华医院肾内科,上海200032 [2]广东省深圳市福田区风湿病专科医院,深圳518040 [3]江苏省中医院,南京210004

出　　处：《中国中西医结合肾病杂志》2022年第6期488-491,共4页Chinese Journal of Integrated Traditional and Western Nephrology

基　　金：国家自然科学基金资助项目(No.81973772,81903978);上海市进一步加快中医药事业发展三年行动计划项目(No.ZY(2018-2020)-CCCX-2002-02);上海市中医药领军人才计划项目(No.ZY(2018-2020)-RCPY-1007);上海市临床重点专科-中医肾病科(No.shslczdzk04201)。

摘　　要：目的:观察糖肾康平方治疗早期糖尿病肾脏疾病(DKD)气阴两虚型患者的有效性、安全性及远期疗效。方法:72例早期DKD气阴两虚型患者随机分为治疗组和对照组各36例。对照组予基础治疗及口服缬沙坦胶囊80 mg/次,1次/d。治疗组在对照组基础上,口服中药汤剂糖肾康平方,1剂/d。疗程12周。观察两组随机尿微量白蛋白/尿肌酐(uACR)、血肌酐(Scr)、血尿素氮(BUN)、eGFR、尿肾损伤分子Kim-1(uKim-1)水平以及安全性指标。疗程结束后对治疗组进行2年的长期随访。结果:第一阶段的随机对照试验结果显示,治疗组总有效率及中医证候积分均显著高于对照组(P<0.05)。治疗后两组Scr、BUN、eGFR比较差异均无统计学意义(P>0.05),治疗组uKim-1低于对照组,两组比较差异有统计学意义(P<0.05)。两组不良反应发生率比较,差异无统计学意义(P>0.05)。长期随访观察发现不同观察时间之间uACR差异存在统计学意义(P<0.01),而eGFR和uKim-1差异无统计学意义(P>0.05)。结论:糖肾康平方能有效改善早期气阴两虚型DKD患者症状,降低uACR和uKim-1排泄,且未发现明显不良反应,同时具有良好的远期疗效,提示糖肾康平方可能对DKD患者肾小球和小管间质均有一定的保护作用,具体机制有待于深入研究。Objective:To observe the efficacy,safety and long-term efficacy of Tangshen Kangping prescription in the treatment of patients with early diabetic kidney disease(DKD)with deficiency of both Qi and Yin.Methods:72 early DKD patients with Qi and Yin deficiency were randomly divided into control group and treatment group,36 cases in each group.The control group received basic treatment and oral Valsartan capsule 80 mg,qd.On the basis of the control group,the treatment group was given oral Tangshen Kangping prescription,1 dose/day.The treatment course was 12 weeks.The levels of urinary microalbumin/urinary creatinine(UACR),serum creatinine(Scr),blood urea nitrogen(BUN),eGFR,urinary kidney injury molecule KIM-1 and safety indexes were observed in 2 groups.Then the treatment group was followed up for 2 years after the treatment.Results:The results of Phase I randomized controlled trial showed that the total effective rate and TCM syndrome score in the treatment group were significantly higher than those in the control group(P<0.05).After treatment,there were no significant differences in Scr,BUN and eGFR between the two groups(P>0.05).The uKim-1 in the treatment group was lower than that in the control group,and the difference between the two groups was statistically significant(P<0.05).There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05).Patients in the treatment group who completed the preliminary clinical trial were followed up for up to 2 years,and there was significant differences in UACR between different observation times(P<0.01).There was no significant difference between eGFR and uKim-1 observation time(P>0.05).Conclusion:Tangshen Kangping decoction can effectively improve the symptoms of early DKD patients with qi and Yin deficiency,reduce UACR and uKim-1 excretion,without obvious adverse reactions,and with long-term efficacy,suggesting Tangshen Kangping decoction may have a certain protective effect on both glomeruli and tubule interstitium in DKD patients,t

关 键 词：糖尿病肾脏疾病 糖肾康平方 气阴两虚 尿Kim-1 远期有效性 

分 类 号：R587.2[医药卫生—内分泌] R692.9[医药卫生—内科学]