Abstract: OBJECTIVE To study the clinical curative effect of Qigui Yishen decoction in the treatment of patients with chronic kidney diseases of spleen and kidney deficiency.METHODS Patients with chronic kidney diseases met the diagnosis criteria were divided into two groups. Both groups were given the high quality low protein， low salt， low fat， low phosphorus diet， and also given basic treatments such as correcting water and electrolyte disorders， acidosis， anemia， lowering blood pressure， anticoagulation and regulating lipid. On the basis of this， the treatment group was also given Qigui Yishen decoction orally. Objective indexes including kidney function，serum plasminogen activator inhibitor-1 (PAI-1)， transforming growth factor-β1 (TGF-β1) and changes of TCM syndrome scores were observed after four weeks. RESULTS After the treatment， TCM syndrome scores in two groups decreased significantly compared with pre-treatment (P<0.05~0.01)， and the treatment group was better than the control group (P<0.05~0.01). PAI-1， ALB/Cr， TGF-β1 and IL-6 levels in two groups decreased significantly after treatment (P<0.05~0.01)， and the treatment group was better the control group (P<0.05~0.01). CONCLUSIONS Qigui Yishen decoction has definite curative effect on protecting renal function and alleviating the progress of renal fibrosis， and its therapeutic effect may be related to the improvement of blood coagulation and endothelial cell function.