BACKGROUNDA multi-center large scale study is needed to confirm the efficacy and safety of domestic peritoneal dialysis (PD) solutions. Some researchers believe that 6 L/d is enough for adequate dialysis, but there is no multi-center prospective study on Chinese population to confirm this. In this study, we evaluated the efficacy and safety of domestic PD solution (Changfu) and its difference between 6 L and 8 L dosage.

METHODSAdult PD patients who had taken PD therapy for at least one month were selected and divided into four groups according to two dialysis solution brands and two dialysis dosages, i.e., 6 L dose with Changfu dialysis solution, 6 L dose with Baxter dialysis solution, 8 L dose with Changfu dialysis solution, and 8 L dose with Baxter dialysis solution. After 48 weeks, the changes of primary and secondary efficacy indices were compared between different types and different dosages. We also analyzed the changes of safety indices.

RESULTSChanges of Kt/V from baseline to 48 weeks between Changfu and Baxter showed no statistical differences; so did those of creatinine clearance rate (Ccr). Normalized protein catabolic rate (nPCR) from baseline to 48 weeks between Changfu and Baxter showed no statistical differences; so did those of net ultrafiltration volume (nUF) and estimated glomerular filtration rate (eGFR). Changes of nPCR from baseline to 48 weeks between 6 L and 8 L showed no statistical differences; so did those of nUF and eGFR. The decline of Kt/V from baseline to 48 weeks in 6 L group was more than that in 8 L group. Change of Ccr was similar. During the 48-week period, the mean Kt/V was above 1.7/w, and mean Ccr was above 50 L×1.73 m(-2)×w(-1). More adverse events were found in Changfu group before Changfu Corporation commenced technology optimization, and the statistical differences disappeared after that.

CONCLUSIONSThe domestic PD solution (Changfu) was proven to be as effective as Baxter dialysis solution. During 48-week period, a dosage of 6 L/d was enough for these patients to reach adequate PD. Clinical study promotes technological optimization, further helps to improve the safety indices of the medical products.

Adolescent ; Adult ; Aged ; Dialysis Solutions ; therapeutic use ; Female ; Humans ; Male ; Middle Aged ; Peritoneal Dialysis ; methods ; Young Adult

In a prospective randomized controlled study, the efficacy and safety of a continuous ambulatory peritoneal dialysis (CAPD) technique has been evaluated using one icodextrin-containing and two glucose-containing dialysates a day. Eighty incident CAPD patients were randomized to two groups; GLU group continuously using four glucose-containing dialysates (n=39) and ICO group using one icodextrin-containing and two glucose-containing dialysates (n=41). Variables related to residual renal function (RRF), metabolic and fluid control, dialysis adequacy, and dialysate effluent cancer antigen 125 (CA125) and interleukin 6 (IL-6) levels were measured. The GLU group showed a significant decrease in mean renal urea and creatinine clearance (-Delta1.2+/-2.9 mL/min/1.73 m2, P=0.027) and urine volume (-Delta363.6+/-543.0 mL/day, P=0.001) during 12 months, but the ICO group did not (-Delta0.5+/-2.7 mL/min/1.73 m2, P=0.266; -Delta108.6+/-543.3 mL/day, P=0.246). Peritoneal glucose absorption and dialysate calorie load were significantly lower in the ICO group than the GLU group. The dialysate CA125 and IL-6 levels were significantly higher in the ICO group than the GLU group. Dialysis adequacy, beta2-microglobulin clearance and blood pressure did not differ between the two groups. The CAPD technique using one icodextrin-containing and two glucose-containing dialysates tends to better preserve RRF and is more biocompatible, with similar dialysis adequacy compared to that using four glucose-containing dialysates in incident CAPD patients. [Clincal Trial Registry, ISRCTN23727549]
Adult ; Aged ; CA-125 Antigen/analysis ; Creatinine/urine ; Dialysis Solutions/*therapeutic use ; Female ; Glomerular Filtration Rate ; Glucans/*therapeutic use ; Glucose/*therapeutic use ; Humans ; Interleukin-6/analysis ; Kidney/physiopathology ; Kidney Failure, Chronic/*therapy ; Male ; Membrane Proteins/analysis ; Middle Aged ; Peritoneal Dialysis ; Peritoneal Dialysis, Continuous Ambulatory ; Urea/urine

In a prospective randomized controlled study, the efficacy and safety of a continuous ambulatory peritoneal dialysis (CAPD) technique has been evaluated using one icodextrin-containing and two glucose-containing dialysates a day. Eighty incident CAPD patients were randomized to two groups; GLU group continuously using four glucose-containing dialysates (n=39) and ICO group using one icodextrin-containing and two glucose-containing dialysates (n=41). Variables related to residual renal function (RRF), metabolic and fluid control, dialysis adequacy, and dialysate effluent cancer antigen 125 (CA125) and interleukin 6 (IL-6) levels were measured. The GLU group showed a significant decrease in mean renal urea and creatinine clearance (-Delta1.2+/-2.9 mL/min/1.73 m2, P=0.027) and urine volume (-Delta363.6+/-543.0 mL/day, P=0.001) during 12 months, but the ICO group did not (-Delta0.5+/-2.7 mL/min/1.73 m2, P=0.266; -Delta108.6+/-543.3 mL/day, P=0.246). Peritoneal glucose absorption and dialysate calorie load were significantly lower in the ICO group than the GLU group. The dialysate CA125 and IL-6 levels were significantly higher in the ICO group than the GLU group. Dialysis adequacy, beta2-microglobulin clearance and blood pressure did not differ between the two groups. The CAPD technique using one icodextrin-containing and two glucose-containing dialysates tends to better preserve RRF and is more biocompatible, with similar dialysis adequacy compared to that using four glucose-containing dialysates in incident CAPD patients. [Clincal Trial Registry, ISRCTN23727549]
Adult ; Aged ; CA-125 Antigen/analysis ; Creatinine/urine ; Dialysis Solutions/*therapeutic use ; Female ; Glomerular Filtration Rate ; Glucans/*therapeutic use ; Glucose/*therapeutic use ; Humans ; Interleukin-6/analysis ; Kidney/physiopathology ; Kidney Failure, Chronic/*therapy ; Male ; Membrane Proteins/analysis ; Middle Aged ; Peritoneal Dialysis ; Peritoneal Dialysis, Continuous Ambulatory ; Urea/urine

We undertook this study to elucidate whether baseline peritoneal membrane transport characteristics are associated with high mortality in incident automated peritoneal dialysis (APD) patients. This retrospective study includes 117 patients who started APD at Yonsei University Health System from 1996 to 2008 and had a PET within 3 months of APD initiation. High transporters were significantly older and had a higher incidence of cardiovascular disease. Patient survival for years 1, 3, and 5 were 85%, 64%, and 35% for high transporter and 94%, 81%, and 68% for non-high transporter group (P<0.01). Multivariate analysis revealed that age, diabetes, cardiovascular disease, serum albumin level, and residual renal function were independently associated with high mortality in APD patients. In contrast, high transport status was not a significant predictor for mortality in this population when the other covariates were included. Even though high transport was significantly associated with mortality in the univariate analysis, its role seemed to be influenced by other comorbid conditions. These findings suggest that the proper management of these comorbid conditions, as well as appropriate ultrafiltration by use of APD and/or icodextrin, must be considered as protective strategies to improve survival in peritoneal dialysis patients with high transport.
Adult ; Age Factors ; Aged ; Aged, 80 and over ; Automation ; Cardiovascular Diseases/complications ; Diabetes Complications ; Dialysis Solutions/therapeutic use ; Female ; Glomerular Filtration Rate ; Glucans/therapeutic use ; Glucose/therapeutic use ; Humans ; Kidney Failure, Chronic/therapy ; Male ; Middle Aged ; Multivariate Analysis ; Peritoneal Dialysis/*mortality ; Retrospective Studies ; Risk Factors ; Serum Albumin/analysis ; Survival Rate

OBJECTIVETo explore the effects of dialysate contained Chinese herbs for replenishing qi and activating blood circulation on platelet membranous glycoprotein CD62P in patients with chronic renal failure (CRF) undergoing hemodialysis.

METHODSForty patients underwent maintaining hemodialysis were randomly assigned to two groups, the Western medicated group (WMG) and the Chinese herbs group (CHG). The content of CD62P in all patients was detected by ELISA before and after hemodialysis.

RESULTSThe levels of blood urea nitrogen, creatinine, potassium, hematocrit, platelet count and carbon dioxide combining power (CO2CP) as well as the expression of CD62P after treatment were significantly changed in both groups with significant difference as compared with those before treatment (both P < 0.05). And comparison between the two groups in expression of CD62P after treatment also showed significant difference (P < 0.05). But the improvement in TCM syndrome between the two groups was insignificantly different (P > 0.05).

CONCLUSIONHemodialysis with dialysate containing Chinese herbs of replenishing qi and activating blood circulation can decrease the expression of platelet membranous glycoprotein CD62P, which may be associated with the mechanism of Chinese herbs in treating CRF.

Adult ; Blood Circulation ; Blood Platelets ; drug effects ; metabolism ; Combined Modality Therapy ; Dialysis Solutions ; Drugs, Chinese Herbal ; administration & dosage ; therapeutic use ; Enzyme-Linked Immunosorbent Assay ; Female ; Humans ; Kidney Failure, Chronic ; blood ; therapy ; Male ; Middle Aged ; P-Selectin ; blood ; Phytotherapy ; Qi ; Renal Dialysis ; methods