| To investigate the efficacy and safety of Chinese medical formula by symptom differentiation and signs on patients with chronic Stage 3 kidney disease. Methods:This is a prospective, double blinded, randomized, controlled trial enrolling a total of 315 patients in per-protocol data set assigned to traditional Chinese medicine group (TCM group, 158 cases) or western medicine (benazepril) group (WM group, 157 cases). TCM group received general therapy, benazepril placebo and Chinese medical formula according to the four Chinese medicine patterns including qi yin/xue deficiency patterns, blood stasis in the kidney patterns, wind-dampness interfering in the kidney patterns, endoretention of damp heat patterns. WM group received 10 mg/d of benazepril, placebo of Chinese medicine formula and general therapy. Finally, 24 h proteinuria, ratio of urinary albumin versus creatinine, serum creatinine, urea nitrogen, uric acid, potassium, evaluated glomerular filtration rate (eGFR), stage of chronic kidney disease, score of Chinese patterns and syndromes, evaluation of composite effects and safety were assessed. Patients were followed up for 24 weeks. Results: In TCM group, serum creatinine was decreased while eGFR was increased at week 24 as compared with baseline (P<0.05-0.01) with little side effects, whereas proteinuria was increased a bit compared with baseline. In WM group, proteinuria was decreased (P>0.05), whereas serum creatinine was increased (P<0.01) as compared with baseline. Of the WM group, serum creatinine in 31 cases (19.7%) increased >30%, 8 cases (5.10%) increased >50%. eGFR was decreased with 27 (17.2%) cases developed CKD Stage 4 from Stage 3.Conclusion: Chinese medicine formula by differentiation of symptoms and signs had renal protective effects independent of reducing proteinuria with safety. |
