Survival Analysis Of Integrated TCM TheraPy On Non-Dialysis Chronic Kidney Disease Patients

Background:Clinical observations and exPeriments have a clue imPlying that Integrated TCM TheraPy has short-term effectiveness on CKD Patients. In order to have an long-term evaluation on this theraPy, we Planned to have a long-term follow-uP and survival analysis.Object:To evaluate the long-term effective on Integrated TCM Therapy in the management of non-dialysis CKD Patients and relevant risk factors.Methods:We included CKD Patients who admitted to nePhroPathy in Patients Department, Guangdong Provincial Hospital (Integrated TCM group) and who began regular follow-uP in Renal Clinic, Peking University Third Hospital (Western medicine grouP) during January and March,2007. And we record their data including start time, or sensor time, or endPoint time (time to death, begin dialysis, transPlantation, or double serum creatinine) and other risk factor including serum creatinine level, BUN,24h urine protein, serum cholesterol level, ALB, serum Phosphate and calcium level etc. Then we estimate the median survival time of integrated TCM grouP and Western medicine grouP and comPare survival time of these two group via Log-Rank methods to evaluate the long-term effect of integrated TCM therapy. COX-regression model is applied to analysis risk factors and protest factor of integrated TCM therapy.Results: 1.194 Chinese CKD Patients were included in our study. The log-rank test revealed that there were significant difference in median survival time among CKD stage 3,4,5 patients (P<0.001). In subgroup analysis, there was no significant difference in survival time between integrated TCM group and Western Medicine group in CKD stage 3 and 5 (P=0.304,P=0.727).However, significant difference was found in CKD stage 4 between these two group (P=0.049). Further analysis revealed there was no significant difference in non-diabetes CKD stage 4 patient(P=0.180)2. A multivariate Cox's proportional hazards regression analysis via Enter methods indicated that risk factors relate to endpoint event(death, begin dialysis, transplantation or double serum creatinine level) in patients who received integrated TCM therapy were age, diabetes, anemia, high cholesterol level, hyperparathyroidism, CKD stage (b>0,RR>1),while female was a protest factor (b<0, RR<1). Via step forward LR methods, results indicated CKD stage and low albumin level were risk factors relate to end points events. In a certain CKD stage, patients with low albumin level were 2.63 times easier to get endpoint events compared to whom without low albumin level. For patient with low albumin level, the incidence of endpoint event increase 211% with CKD stage increase 1 stage.Cone lusions:1. ComPared to Western Medicine, integrated TCM theraPy could slow down CKD stage 4 Progression and endpoint events(death, begin dialysis, transplantation or double serum creatinine level) occurred.2. Risk factors relate to endpoint event(death, begin dialysis, transplantation or double serum creatinine level) in patients who received integrated TCM therapy were age, diabetes, anemia, high cholesterol level, hyperparathyroidism, CKD stage and low albumin level.3. Prognosis Index for patients who received integrated TCM therapy=2.63 X low albumin level (yes=1, no=0)+3.11×CKD stage, the high of prognosis index, the earlier the endpoint events occurred.4. ComPared to Western Medicine, integrated TCM therapy could not slow down CKD stage 3and 5 progression and endpoint events(death, begin dialysis, transplantation or double serum creatinine level) occurred. 5. Further study are needed to evaluate whether integrated TCM therapy could slow down progression of patients in non-diabetes CKD stage 4.