糖尿病肾病肾功能不全防治优化方案的有效性和安全性研究  

Study on Effectiveness and Safety of Optimum Program for Prevention and Treatment of Renal Insufficiency of Diabetic Nephropathy

作　　者：张丽芬[1] 赵进喜[1] 吕仁和[1] 杨洪涛[2] 曹式丽[2] 黄学民[3] 张淑娥[3] 马建伟[4] 徐丽梅[4] 朱章志[5] 刘敏[5] 周春华[6] 杨君[6] 亓鲁光[7] 李朝敏[7] 冯兴中[8] 姜敏[8] 程益春[9] 郭宝荣[9] 

机构地区：[1]北京中医药大学东直门医院肾病内分泌科,北京市东城区海运仓5号100700 [2]天津中医药大学第一附属医院 [3]北京大学第一医院 [4]中国人民解放军空军总医院 [5]广州中医药大学第一附属医院 [6]中国人民解放军海军总医院 [7]成都中医药大学附属医院 [8]北京铁路总医院 [9]山东中医药大学附属医院

出　　处：《中医杂志》2006年第10期755-758,共4页Journal of Traditional Chinese Medicine

基　　金：国家"十五"科技攻关计划课题(2001BA701A13c)

摘　　要：目的:优化糖尿病肾病(DN)肾功能不全防治方案,评价中医辨证论治方案保护肾功能的作用和安全性。方法:采用随机、单盲、平行对照和多中心临床研究方法,将入选的221例DN肾功能不全患者随机分入中医辨证论治方案组(A组)、氯沙坦治疗方案组(B组)和中医辨证论治加氯沙坦治疗方案组(C组),疗程3个月。结果:治疗3个月末与基线差值比较,A组血清肌酐清除率(Ccr)升高幅度高于B组(P<0.05),血清肌酐(SCr)下降幅度高于B组(P<0.01)和C组(P<0.05);3组尿素氮(BUN)和24小时尿蛋白定量组间差值比较差异无显著性意义(P均>0.05);安全性指标显示,3个月末各组患者血清谷氨酸氨基转移酶(ALT)、心电图及肝、胆、脾、胰B超检查与基线差异均无显著性意义(P均>0.05),各组之间差异亦无显著性意义(P均>0.05)。结论:建立在饮食、降糖、对症治疗基础上的中医辨证论治方案在改善肾功能方面具有较好的疗效和安全性,在升高Ccr和降低SCr方面优于氯沙坦方案。Objective：To optimize the program for prevention and treatment of renal insufficiency of diabetic nephropathy （DN） and to evaluate the effectiveness and safety of the program of TCM treatment based on syndrome differentiation for protection of renal function. Methods ：With method of randomized ,blind ,controlled and multi-central clinical study, 221 cases of renal insufficiency of DN were divided into group A （TCM treatment based on syndrome differentiation group） ,group B （Losartan group） and group C （TCM treatment plus Losartan treatment group）. The treatment course was 3 months. Results：After treatment.the increasing amplitude of serum creatimine clearance rate （Ccr） in group A was higher than in group B （P〈0.05）, and the decreasing amplitude of serum creatimine （SCr） in group A was higher than in group B （P〈0.01） and C （P〈0. 05）;There was no significant difference in blood urea nitrogen （BUN） and 24-hour urinary protein among the 3 groups（P〉0.05）. After treatment of 3 months,serum alanine aminotransferase（ALT）,electrocardiogram （ECG） and B-ultrasonic examination results of the liver, gallbladder, spleen and pancreas did not have significant change（P〈0.05） with on significant difference among the 3 groups （P〉 0.05）. Conclusion：The TCM treatment program in addition to diet regulation,decreasing blood sugar and expectant treatment is effective and safe in improving renal function,and the program is better than Losartan in increasing Ccr and decreasing SCr.

关 键 词：糖尿病肾病/中医药疗法 肾功能衰竭/预防和控制 

分 类 号：R259[医药卫生—中西医结合]