摘要
目的评价7．5％艾考糊精腹透液用于连续性非卧床腹膜透析（CAPD）患者长时间留腹治疗中的安全性和有效性。方法选择行CAPD治疗的慢性肾衰竭患者201例，进行为期5周的前瞻性、多中心、随机、双盲和平行对照的临床研究，其中男性96例。女性105例，平均年龄（56．1±13．7）岁。来自7个中心的患者由SAS软件模拟编号，被随机分配到艾考糊精组（98例）和葡萄糖组（103例）。白天进行常规透析，夜间艾考糊精组使用7．5％艾考糊精透析液，葡萄糖组使用2．5％葡萄糖DianealPD-2或PD-4透析液。每2周随访1次，观察时间为4周。测定并计算单袋长时间留腹后的净超滤量、腹膜肌酐和尿素氮清除率，记录常规实验室检查和不良事件。结果用药4周后，与葡萄糖组相比，艾考糊精组患者单袋长时留腹后的平均净超滤量较基线增加更为明显[（342．53±25．79）ml比（73．59±24．09）ml，P〈0．01]；负超滤（长留腹超滤量≤0ml）发生率明显低于葡萄糖组；腹膜肌酐清除率均值较基线期的变化值比葡萄糖组高[（428．02±53．14）ml／12h比（-99．79±50．19）ml／12h，P〈0．01]；腹膜尿素氮清除率均值较基线期的变化值比葡萄糖组高[（306．43±53．31）ml／12h比（-116．02±51．05）ml／12h，P〈0．01]。随访4周艾考糊精组血钠、血氯和血淀粉酶明显低于基线期（P〈0．01），血胆固醇亦较基线期下降（P〈0．05）。两组不良事件发生情况相似。结论7．5％艾考糊精腹透液长时间留腹用于CAPD治疗慢性肾功能衰竭患者是安全有效的。
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 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 uhrafihration, 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 uhrafihration 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 ultra-filtration 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 effecti
出处
《中华肾脏病杂志》
CAS
CSCD
北大核心
2008年第2期80-85,共6页
Chinese Journal of Nephrology
关键词
腹膜透析
持续不卧床
透析液
超滤
艾考糊精
Peritoneal dialysis, continuous ambulatory
Dialysis solutions
Uhrafihration
Icodextrin
