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 progression of IgA nephropathy.
作者
王杰
张昕贤
陈晓农
路建饶
王朝晖
胡静
高雅婵
徐虹
沈茜
蒋更如
顾颖莉
何立群
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)
出处
《中医杂志》
CSCD
北大核心
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)
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
severe IgA nephropathy(IgAN)
treatment of the integrative traditional Chinese medicine and western medicine
liver and kidney yin deficiency syndrome
losartan potassium