芪蛭益肾胶囊治疗早期糖尿病肾病的多中心前瞻性临床观察  

A Multi-center Prospective Clinical Study of on Qizhi Yishen Capsule in the Treatment of Diabetic Kidney Disease

作　　者：姜晨[1] 杨洪涛[1] 宋立群[2] 王小琴[3] 张守琳[4] 王世东[5] 徐旭东[6] JIANG Chen;YANG Hongtao;SONG Liqun(First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion,Tianjin,300193)

机构地区：[1]天津中医药大学第一附属医院,国家中医针灸临床医学研究中心,天津300384 [2]黑龙江中医药大学附属第一医院,哈尔滨150006 [3]湖北省中医院,武汉430061 [4]长春中医药大学附属医院,长春130021 [5]北京中医药大学东直门医院,北京100700 [6]上海瑞金医院集团闵行医院,上海201100

出　　处：《中国中西医结合肾病杂志》2024年第7期591-595,共5页Chinese Journal of Integrated Traditional and Western Nephrology

摘　　要：目的:评价芪蛭益肾胶囊治疗糖尿病肾病(DKD)(气阴两虚型)的临床疗效与安全性。方法:采取多中心、区组随机、双盲、安慰剂对照前瞻性研究方法,选取2013年04月—2014年11月全国11所医院478例受试者。采用随机编码表法将患者分为试验组和对照组。试验组口服芪蛭益肾胶囊(1次5粒,1日3次),对照组口服芪蛭益肾胶囊模拟剂(1次5粒,1日3次),共治疗24周,以24 h尿白蛋白排泄率(UAER)作为主要观察指标,并观察24 h尿蛋白定量、肾功能、中医证候评分及不良事件发生情况。结果:治疗后两组UAER均有不同程度下降,但治疗12周、24周后试验组显著低于对照组(P<0.05,P<0.01)。试验组与对照组的UAER下降率在12周末分别为35.81%vs 20.36%(P<0.05),24周后分别为46.08%vs 27.28%(P<0.01),试验组UAER下降率优于对照组。观察结束时试验组UAER较基线下降超过50%的患者比例较对照组多(P<0.05),分别为120(46.51%)vs 30(31.58%)。治疗后试验组24 h尿蛋白定量90.00 mg显著低于对照组131.68 mg(P<0.01)。治疗24周后试验组中医证候疗效为84.5%,显著优于对照组45.26%(P<0.01)。但两组的肾小球滤过率差异无统计学意义(P>0.05),治疗期间两组不良事件发生率差异无统计学意义(P>0.05)。结论:芪蛭益肾胶囊能有效控制DKD(气阴两虚型)尿蛋白,临床使用安全。Objective:To evaluate the clinical efficacy and safety of Qizhi Yishen capsule in the treatment of diabetic kidney disease(Qi and Yin deficiency type).Methods:478 patients from 11 hospitals were randomly divided into experimental group and control group by random coding table method.The treatment period was 24 weeks.The experimental group received Qizhi Yishen Capsule simulator orally(5 capsules per time,3 times a day),and the control group received Qizhi Yishen Capsule simulator orally(5 capsules per time,3 times a day).The treatment lasted 24 weeks.The 24 h urinary albumin excretion rate(UAER)was taken as the main therapeutic index.24 h urine protein,serum creatinine,glomerular filtration rate,traditional Chinese medicine syndrome score and occurrence of adverse events were also assessed.Results:UAER in both the treatment group and the control group was decreased.However,the UAER was significantly lower in the treatment group than in the control group 12 weeks and 24 weeks after treatment.The reduction ratio of UAER in The treatment group and in the control group were 35.81%vs 20.36%(P<0.05)and 46.08%vs 27.28%(P<0.01),while the individuals had a more than 50%decreased UAER were 90(34.88%)vs 25(26.32%)(P<0.05)and 120(46.51%)vs 30(31.58%)(P<0.05)12 weeks and 24 weeks after treatment respectively.The 24 h urinary protein quantification in the treatment group and in the control group was 90.00 mg vs 131.68 mg(P<0.01)24 weeks after treatment.The effective rate of TCM syndrome was 84.50%vs 45.26%(P<0.01)between the two groups 24 weeks after treatment.There was no significant difference in the change of glomerular filtration rate between the two groups(P>0.05)24 weeks after treatment.There was no no significant difference of adverse events between the two groups(P>0.05)during the study.Conclusion:Qizhi Yishen capsule is has good efficacy effective and safety in the treatment of diabetic kidney disease nephropathy(qi-Yin deficiency type).

关 键 词：芪蛭益肾胶囊 糖尿病肾病 气阴两虚 中药 

分 类 号：R259[医药卫生—中西医结合] R277.5[医药卫生—中医内科学]