【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。更多还原

【Abstract】 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. 05). Conclusion: Chinese medicine formula by differentiation of symptoms and signs combined with benazepril 10 mg / d can reduced proteinuria and protect renal function more significantly to retard the deterioration renal function compared with the benazeril group.更多还原