中医辨证治疗慢性肾脏病蛋白尿的多中心前瞻性临床研究  

Syndrome differentiation-based treatment with traditional Chinese medicine for proteinuria in patients with chronic kidney disease:a randomized multicenter trial

作　　者：王东[1] 吴同茹[1] 谢婷婷[1] 彭文[2] 王怡[3] 袁敏[4] 米秀华 毕月萍 何立群[1,7] 

机构地区：[1]上海中医药大学附属曙光医院,上海200021 [2]上海中医药大学附属普陀医院,上海200118 [3]上海中医药大学附属岳阳中西医结合医院,上海200437 [4]复旦大学附属中山医院,上海200032 [5]上海杨浦区中医院,上海200090 [6]上海殷行社区卫生服务中心,上海200438 [7]上海市中医临床重点实验室

出　　处：《南方医科大学学报》2013年第4期502-506,共5页Journal of Southern Medical University

基　　金：国家自然科学基金(81173219);科技部中医药行业科研专项(201007005);教育部高等学校博士点专项科研基金(20093107110006);上海市科委创新行动计划项目(11DZ1973100);上海高校创新团队建设项目(第二期)~~

摘　　要：目的研究中医辨证组方联合基础治疗与氯沙坦联合基础治疗对慢性肾脏病蛋白尿的临床疗效。方法对入组人群采用多中心、前瞻性、随机、对照研究的方法,将符合方案的81例患者分为中药组(60例),按脾肾气阴两虚、脾肾气阳两虚予中医辨证组方内服;西药组(21例)予氯沙坦50 mg/d口服。总疗程24周,观察两组临床疗效。结果中药组临床总有效率93.33%,优于西药组76.20%(P<0.05);两组患者治疗后的中医证候积分值均较基线时明显改善(P<0.01或P<0.05),中药组较西药组下降更为明显(P<0.05)。中药组用药后8周血肌酐、肾小球滤过率估算值下降值以及24周血血胱抑素C和24 h尿蛋白定量、尿微量白蛋白/尿肌酐比值下降值均有统计学意义(P<0.05),而西药组无明显变化(P>0.05)。结论中医辨证组方联合基础治疗对慢性肾脏病蛋白尿在改善症状、降低证候积分值、减少尿蛋白、保护肾功能方面显示了良好的临床疗效。Objective To evaluate the clinical efficacy of syndrome differentiation-based treatment with traditional Chinese medicine（TCM） versus losartan therapy in addition to basic treatment for management of proteinuria in patients with chronic kidney disease.Methods This multicenter,randomized,and case-controlled clinical trial was conducted among 81 consecutive patients meeting the inclusion criteria.The patients were randomized consecutively to receive TCM treatments according to the syndrome patterns in TCM（spleen and kidney Qi and Yin deficiency,and spleen and kidney Qi and Yang deficiency,n=60） or oral losartan therapy（50 mg/day,n=21） in addition to the basic treatments.All the patients were followed up for 24 weeks to observe the clinical effects.Results The patients in TCM group showed a significantly higher overall response rate（93.33%） than those in losartan group（76.20%,P0.05）.The TCM score in the two groups were all decreased at week 24 as compared with baseline（P0.01 or P0.05）.The TCM scores in both groups decreased significantly after the treatments as compared with the baseline scores（P0.05）.After a 8-week-long treatment,Scr,eGFR and Cys-C,U-Pro/24 h,and MA/Cr all decreased significantly in TCM group（P0.05） but showed no significant changes in losartan group（P0.05）.Conclusion Syndrome differentiation-based TCM treatment in addition to basic treatments can produce satisfactory therapeutic effects on proteinuria in patients with chronic kidney disease by improving the clinical symptoms,reducing TCM symptom scores and proteinuria, and protecting the renal functions.

关 键 词：慢性肾脏病 蛋白尿 中医辨证组方 氯沙坦 

分 类 号：R277.5[医药卫生—中医学]