中医辨证联合氯沙坦钾治疗肝肾阴虚型重症IgA肾病的前瞻性多中心临床研究  

Treatment of Severe IgA Nephropathy Patients with Liver and Kidney Yin Deficiency Syndrome by Traditional Chinese Medicine Syndrome Differentiation Combinated with Losartan Potassium: A Prospective and Multicentered Clinical Study

作　　者：王杰[1] 张昕贤[1] 陈晓农 路建饶 王朝晖 胡静 高雅婵 徐虹[4] 沈茜[4] 蒋更如 顾颖莉 何立群[1] WANG Jie;ZHANG Xinxian;CHEN Xiaonong;LU Jianrao;WANG Zhaohui;HU Jing;GAO Yachan;XU Hong;SHEN Qian;JIANG Gengru;GU Yingli;HE Liqun(Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai,200021;Ruijin Hospital,Shanghai Jiaotong University;Seventh People's Hospital Affilated to Shanghai University of Traditional Chinese Medicine;Children^Hospital of Fudan University;Xinhua Hospital,Shanghai Jiaotong University)

机构地区：[1]上海中医药大学附属曙光医院,上海市200021 [2]上海交通大学附属瑞金医院 [3]上海中医药大学附属第七人民医院 [4]复旦大学附属儿科医院 [5]上海交通大学附属新华医院

出　　处：《中医杂志》2019年第22期1929-1934,共6页Journal of Traditional Chinese Medicine

基　　金：上海市科学技术委员会重大项目(15401970300)

摘　　要：目的观察中医辨证联合氯沙坦钾对肝肾阴虚型重症IgA肾病的临床疗效及安全性。方法采用前瞻性多中心随机对照方法,于2016年9月至2018年8月5个中心共纳入156例患者,随机分为治疗组(补益肝肾颗粒剂和氯沙坦钾片治疗)和对照组(补益肝肾颗粒剂模拟剂和氯沙坦钾片治疗)各78例。每8周测定患者24小时尿蛋白定量(24hUpro)、尿微量白蛋白/肌酐(MA/Cr)、血肌酐(SCr)、血尿素氮(BUN)、血白蛋白(Alb)、肾小球滤过率(e GFR)、血红蛋白(Hb),同时进行中医证候评分,共观察24周,评价中医证候疗效及临床疗效。结果治疗组临床疗效总有效率为70.67%,高于对照组的38.57%(P<0.01)。治疗组中医证候疗效总有效率88.00%,高于对照组的45.72%(P<0.01)。与治疗前比较,治疗组治疗8、16、24周24hUPro、MA/Cr、SCr、BUN明显下降,eGFR明显升高(P<0.05或P<0.01);对照组治疗24周24hUPro、SCr、BUN均下降(P<0.05),且治疗组治疗24周24hUPro、MA/Cr、SCr、BUN明显低于对照组,eGFR明显高于对照组(P<0.05)。结论中医辨证联合氯沙坦钾能够有效降低肝肾阴虚型重症IgA肾病患者24hUPro、MA/Cr、BUN、SCr水平,提高患者eGFR,改善患者的肾功能,延缓IgA肾病的进展。Objective To evaluate the efficacy and safety of syndrome differentiation-based treatment with traditional Chinese medicine(TCM)and losartan potassium in treating severe IgA nephropathy with liver and kidney yin deficiency syndrome.Methods A prospective multicentered randomize-controlled trial was conducted.A total of156 patients from 5 centers were enrolled from September 2016 to August 2018.They were randomly divided into a treatment group treated with Buyi Ganshen Granules(补益肝肾颗粒)and Losartan Potassium Tablets and a control group treated with Buyi Ganshen Granules simulant and Losartan Potassium Tablets),with 78 cases in each group.24-hour urinary protein quantity(24 hUpro),urinary microalbumin/creatinine(MA/Cr),serum creatinine(SCr),blood urea nitrogen(BUN),serum albumin(Alb)and glomerular filtration rate(eGFR),Hemoglobin(Hb)were detected every 8 weeks.Traditional Chinese medicine(TCM)syndrome scores were determined,for a total of 24 weeks.The efficacy of TCM syndromes and clinical efficacy were evaluated.Results The total effective rate of the treatment group was 70.67%,which was higher than 38.57%of the control group(P<0.01).The total effective rate of TCM syndromes in the treatment group was 88.00%,which was higher than 45.72%in the control group(P<0.01).Compared with before treatment,24 hUPro,MA/Cr,SCr and BUN were significantly decreased and eGFR was significantly increased in the treatment group at 8,16 and 24 weeks(P<0.05 or P<0.01).The control group had a decrease in 24 hUPro,SCr and BUN at 24 weeks of treatment(P<0.05).24 hUPro,MA/Cr,SCr,BUN in the treatment group was significantly lower than those of the control group at 24 weeks of treatment,and eGFR was significantly higher than that of the control group(P<0.05).Conclusion Combination of TCM syndrome differentiation and losartan potassium could effectively reduce 24 hUPro,MA/Cr,BUN,SCr levels,increase eGFR in patients with severe IgA nephropathy of liver and kidney yin deficiency syndrome,and could improve renal function and delay the

关 键 词：重症IgA肾病 中西医结合疗法 肝肾阴虚证 氯沙坦钾片 

分 类 号：R73[医药卫生—肿瘤]