艾考糊精腹透液单袋长时间留腹治疗连续性非卧床腹膜透析患者的安全性和有效性

Objective To evaluate the efficacy and safety of 7.5% icodextrin peritoneal dialysis solution for once-daily long dwell exchange in patients undergoing continuous ambulatory peritoneal dialysis (CAPD). Methods A prospective, multicenter, randomized, double blind, parallel controlled study was conducted for 5 weeks in 201 CAPD patients (96 male, 105 female) with mean age (56.1±13.7) years old. These patients were from 7 centers with 98 allocated to the icodextrin group and 103 to the dextrose group randomly. Patients in the icodextrin group were given 7.5% icodextrin and those in the dextrose group were given 2.5% Dianeal?誖PD-2 or PD-4 for the nocturnal long dwell exchange while the diurnal dialysis remained unchanged. During the 4- week treatment, patients were tested every other week for net ultrafiltration, peritoneal creatinine and urea nitrogen clearance after the long dwell. Other laboratory tests and adverse events were recorded. Results Compared to the dextrose group, the net ultrafiltration was up-regulated more significantly from the baseline in the icodextrin group (342.53±25.79) ml vs (73.59±24.09) ml, P<0.01]. Episodes of net ultrafiltration less than 0 ml in the icodextrin group were much less than those in the dextrose group. Similarly, the mean difference between groups for change from baseline for peritoneal creatinine and urea nitrogen clearance was much higher（428.02±53.14） ml/12 h vs （－99.79±50.19） ml/12 h， P<0.01； （306.43±53.31） ml/12 h vs (－116.02±51.05） ml/12 h， P<0.01， respectively] in the icodextrin group. In the icodextrin group, there was a decrease in serum sodium and chloride compared with baseline (P<0.01). Serum amylase activity decreased from (87.04±48.01) U/L to (21.59±13.58) U/L(P<0.01). Cholesterol in the icodextrin group was lower than baseline (P<0.05). There was no significant difference between two groups for the incidence and severity of adverse events. Conclusion 7.5% icodextrin is a safe and effective peritoneal dialysis solution for once-daily long dwell exchange in CAPD patients.

Efficacy and safety of 7.5% icodextrin peritoneal dialysis solution for once-daily long dwell exchange in continuous ambulatory peritoneal dialysis patients