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

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. 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.