中药辨证组方联合苯那普利对慢性肾炎CKD3期的肾保护作用——317例多中心、前瞻、双盲、随机对照试验  

Renal Protective Effects of Traditional Chinese Medcine formula combined with benazepril for Patients with Chronic Kidney Disease Stage 3: A Multi-center,Prospective,Double-blinded,Randomized Controlled Trials of 317 cases

作　　者：王永钧[1] 何立群[2] 孙伟[3] 鲁盈[4] 王小琴[5] 张佩青[6] 魏连波[7] 曹式丽[8] 杨霓芝[9] 马红珍[10] 高菁[11] 李平[12] 陶筱娟[13] 袁发焕[14] 李靖[11] 姚晨[15] 刘旭生[9] 

机构地区：[1]浙江中医药大学广兴医院(杭州市中医院),浙江杭州310007 [2]上海中医药大学曙光医院,上海200021 [3]江苏省中医院,江苏南京210029 [4]浙江省立同德医院,浙江杭州310053 [5]湖北省中医院,湖北武汉430061 [6]黑龙江省中医研究院,黑龙江哈尔滨150036 [7]南方医科大学珠江医院,广东广州510280 [8]天津中医药大学第一附属医院,天津300193 [9]广东省中医院,广东广州510120 [10]浙江省中医院,浙江杭州310006 [11]北京中医药大学东直门医院,北京100007 [12]北京中日友好医院,北京100029 [13]杭州市红十字会医院,浙江杭州310007 [14]第三军医大学新桥医院,重庆400037 [15]北京大学第一医院统计室,北京100034

出　　处：《中华中医药学刊》2015年第3期522-526,共5页Chinese Archives of Traditional Chinese Medicine

基　　金：国家"十一五"科技支撑计划项目(2006BAI04A07)

摘　　要：目的:观察中药辨证组方联合苯那普利对慢性肾小球肾炎(CGN)CKD3期患者的肾保护作用与安全性。方法:对入组人群中符合方案集(Per-protocol.PP)的317例患者,观察中西药组(160例,基础治疗+中药辨证颗粒剂+苯那普利片10 mg/d)和西药组(157例,基础治疗+中药颗粒模拟剂+苯那普利片10 mg/d)治疗前后症状、证侯积分值、临床综合疗效及尿蛋白定量/24 h(Upr/24 h)、尿蛋白/肌酐比值(Upr/Cr)、血肌酐(Scr)、尿素氮(Bun)、尿酸(UA)、钾(K+)、估测肾小球滤过率(e GFR)、CKD分期和安全性。疗程24周。结果:治后两组的症状、证侯积分值均较基线时明显改善(P<0.01),但以中西药组为优(P<0.05)。西药组治后尿蛋白减少(P>0.05),血肌酐反增高(P<0.01),其中31例(19.7%)增幅>30%,8例(5.10%)增幅>50%;e GFR降低,其中27例(17.2%)由CKD3期进展至CKD4期,而减轻至2期者仅11例(7.00%)。中西药组则尿蛋白显著减少(P<0.05),Scr降低(P<0.01),e GFR提高(P<0.01),由CKD3期进展至4期者12例(7.50%),而减轻至2期者达27例(16.90%)。临床综合疗效亦优于西药组(P<0.05)。药物不良反应两组差异无显著性(P>0.05)。结论:中药辨证组方联合苯那普利10 mg/d治疗CGN-CKD3期患者24周,较之单用苯那普利的对照组能更好地减少尿蛋白,保护肾功能,延缓病情进展。Objective： To investigate the efficacy and safety of combination of Chinese medical formula by differentiation of symptoms and signs and benazepril on patients with chronic kidney disease stage 3. Methods： This is a prospective,double blinded,randomized,controlled trial enrolling a total of 317 patients in per- protocol data set assigned to Traditional Chinese medicine combined with western medicine group（ TCMW group,160 cases,general therapy ＋ Chinese medical formula ＋ benazepril 10 mg / d） or western medicine group（ WM group,157 cases,general therapy ＋ Chinese medical formula placebo ＋ benazepril 10 mg / d）. At baseline and week 24,clinical symptoms,score of Chinese patterns and syndromes,clinical therapeautic effects,24 h proteinuria,ratio of urinary albumin versus creatinine,serum creatinine,urea nitrogen,uric acid,potassium,evaluated glomerular filtration rate（ e GFR）,stage of chronic kidney disease and safety were assessed. Patients were followed up for 24 weeks. Results： Symptoms and score of Chinese patterns and syndromes were both significantly improved in the two groups at week 24 compared with baseline（ P〈 0. 01）,whereas those in the TCMW group were improved better. In the WM group,proteinuria was decreased（ P〈 0. 05） while serum creatinine was increased（ P〈 0. 01）,serum creatinine in 31 cases（ 19. 7%） were increased 30%,8 cases（ 5. 1%）were increased 50%. e GFR in the WM group was decreased,27 cases（ 17. 2%） progressed from CKD stage 3 to stage4,only 11 cases（ 7. 00%） were improved to CKD stage 2. In the TCMW group,proteinuria（ P〈 0. 05） and serum creatinine（ P〈 0. 01） was significantly decreased,e GFR was increased（ P〈 0. 01）,12 cases（ 7. 50%） developed to CKD stage 4,27 cases（ 16. 90%） were improved to CKD stage 2. Clinical therapeautic effects in the TCMW group were also better than those in the WM group（ P〈 0. 05）. No significant difference was found in the adverse effects between the two groups（ P〈 0. 0

关 键 词：慢性肾小球肾炎 慢性肾脏病3期 中西医结合 

分 类 号：R692.3[医药卫生—泌尿科学]