The Clinical Usefulness of Peritoneal Dialysis Fluids with Neutral pH and Low Glucose Degradation Product Concentration: An Open Randomized Prospective Trial
The Clinical Usefulness of Peritoneal Dialysis Fluids with Neutral pH and Low Glucose Degradation Product Concentration: An Open Randomized Prospective Trial
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中性 pH 值和低葡萄糖降解产物浓度的腹膜透析液的临床用途：一项开放随机前瞻性试验
DOI：
10.1177/089686080802800214
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发表时间：
2008
影响因子：
2.8
通讯作者：
Ho Yung Lee
中科院分区：
文献类型：
--
作者：
H. Choi;D. K. Kim;Tae Hee Lee;S. Moon;S. Han;Jung Eun Lee;B. Kim;H. Park;K. Choi;S. Ha;Dae Suk Han;Ho Yung Lee
背景长期腹膜透析（PD）与使用生物不相容的常规腹膜透析液（PDF）时腹膜的各种结构和功能变化有关。在这项研究中，我们观察了接受传统PDF治疗的患者，然后改用具有中性pH值和低浓度葡萄糖降解产物（GDP）的新型生物相容性PDF，以研究这种变化是否会导致腹膜恶化的停滞或逆转。方法在一项开放标签、随机前瞻性试验中，比较了104例患者中常规PDF和具有中性pH和极低浓度GDP的生物相容性PDF的临床效果。在基线、4、8和12个月时采集血液和流出液透析液样本，进行腹膜平衡试验和充分性评价。目标变量为透析液/血浆（D/P）肌酐比值、腹膜超滤、残余肾功能、透析充分性指数和流出液癌抗原125（CA 125）。结果两组D/P肌酐值差异无统计学意义。在所有随访时间，低GDP PDF组的腹膜超滤量均显著高于传统PDF组（4个月：9.1 ± 4.3 vs 6.0 ± 3.0; 8个月：8.3 ± 3.4 vs 6.0 ± 3.0; 12个月：8.9 ± 3.3 vs 6.1 ± 3.3 mL/g葡萄糖/天; p < 0.05）。低GDP PDF组4个月时腹膜Kt/V尿素值和每周总Kt/V尿素值显著高于常规PDF组。残余肾功能无统计学显著性。在所有随访访视中，低GDP PDF组的流出液CA 125水平显著较高（4个月：37.8 ± 20.8 vs 22.0 ± 9.5; 8个月：41.2 ± 20.3 vs 25.9 ± 11.3; 12个月：40.4 ± 21.4 vs 28.6 ± 13.0 U/mL; p < 0.05）。在无尿患者中，低GDP PDF治疗患者在4个月、8个月和12个月时的腹膜超滤、4个月和8个月时的每周总Kt/V以及所有随访访视时的CA 125水平均显著高于常规PDF治疗患者。然而，在无尿患者中，低GDP PDF组和常规PDF组的D/P肌酐无显著差异。结论中性pH值、低GDP浓度的生物相容性腹膜透析滤过器有助于改善腹膜透析患者的腹膜超滤，提高腹膜透析液CA 125水平，CA 125水平可作为腹膜完整性的指标。
Background Long-term peritoneal dialysis (PD) is associated with the development of various structural and functional changes to the peritoneal membrane when bioincompatible conventional peritoneal dialysis fluids (PDFs) are used. In this study, we looked at patients that were treated with conventional PDFs and then changed to novel biocompatible PDFs with a neutral pH and a low concentration of glucose degradation products (GDPs) to investigate whether this change could result in the arrest or reversal of peritoneal membrane deterioration. Methods In an open label, randomized prospective trial, the clinical effects of conventional PDFs and biocompatible PDFs with neutral pH and very low concentration of GDPs were compared in 104 patients equally divided between both study PDFs. Blood and effluent dialysate samples, peritoneal equilibration tests, and adequacy evaluation were undertaken at baseline, 4, 8, and 12 months. The target variables were the ratio of dialysate-to-plasma (D/P) creatinine, peritoneal ultrafiltration, residual renal function, dialysis adequacy indices, and effluent cancer antigen 125 (CA125). Results D/P creatinine values were not different in the two groups. Peritoneal ultrafiltration was significantly higher in the low-GDP PDF group than in the conventional PDF group at all follow-up times (4 months: 9.1 ± 4.3 vs 6.0 ± 3.0; 8 months: 8.3 ± 3.4 vs 6.0 ± 3.0; 12 months: 8.9 ± 3.3 vs 6.1 ± 3.3 mL/g dextrose/day; p < 0.05). Peritoneal Kt/V urea values and total weekly Kt/V urea values at 4 months were significantly higher in the low-GDP PDF group than in the conventional PDF group. Residual renal function was not statistically significant. Effluent CA125 levels were significantly higher in the low-GDP PDF group at all follow-up visits (4 months: 37.8 ± 20.8 vs 22.0 ± 9.5; 8 months: 41.2 ± 20.3 vs 25.9 ± 11.3; 12 months: 40.4 ± 21.4 vs 28.6 ± 13.0 U/mL; p < 0.05). Among anuric patients, peritoneal ultrafiltration at 4, 8, and 12 months, total weekly Kt/V at 4 and 8 months, and CA125 levels at all follow-up visits were significantly higher in patients treated with low-GDP PDF than those treated with conventional PDF. However, among anuric patients, D/P creatinine showed no significant differences between the low-GDP PDF group and the conventional PDF group. Conclusion The use of biocompatible PDFs with neutral pH and low GDP concentration can contribute to improvement of peritoneal ultrafiltration and peritoneal effluent CA125 level, an indicator of peritoneal membrane integrity in PD patients.