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

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.