Department of Medicine, Tung Wah Hospital, Hong Kong SAR, People's Republic of China.
Am J Kidney Dis. 2012 Dec;60(6):966-75. doi: 10.1053/j.ajkd.2012.05.018. Epub 2012 Jul 25.
The benefits of biocompatible peritoneal dialysis (PD) fluids, particularly for residual renal function (RRF), are controversial. Moreover, the clinical effects of a PD regimen consisting of different biocompatible PD fluids have not been fully established.
Prospective, randomized, controlled, open-label study.
SETTING & PARTICIPANTS: Patients with end-stage kidney disease newly started on continuous ambulatory PD therapy (N = 150).
A 12-month intervention with 3 biocompatible PD fluids (a neutral-pH, low glucose degradation product, 1.5% glucose solution; a solution with 1.1% amino acid; and a fluid with 7.5% icodextrin) or conventional PD fluid.
The primary outcome was change in RRF and daily urine volume. Secondary outcomes were peritoneal transport and inflammation markers.
RRF, daily urine volume, serum and dialysate cytokine levels.
RRF(3.24 ± 1.98 vs 2.88 ± 2.43 mL/min/1.73 m(2); P = 0.9) and rate of decline in RRF (-0.76 ± 1.77 vs -0.91 ± 1.92 mL/min/1.73 m(2) per year; P = 0.6) did not differ between the biocompatible- and conventional-PD-fluid groups. However, patients using the biocompatible PD fluids had better preservation of daily urine volume (959 ± 515 vs 798 ± 615 mL/d in the conventional group, P = 0.02 by comparison of difference in overall change by repeated-measures analysis of variance). Their dialysate-plasma creatinine ratio at 4 hours was higher at 12 months (0.78 ± 0.13 vs 0.68 ± 0.12; P = 0.01 for comparison of the difference in overall change by repeated-measures analysis of variance). They also had significantly higher serum levels of adiponectin and overnight spent dialysate levels of cancer antigen 125, adiponectin, and interleukin 6 (IL-6). No differences between the 2 groups were observed for serum C-reactive protein and IL-6 levels.
Unblinded, relatively short follow-up; no formal sample-size calculations.
Use of a combination of 3 biocompatible PD fluids for 12 months compared with conventional PD fluid did not affect RRF, but was associated with better preservation of daily urine volume. The biocompatible PD fluids also lead to changes in small-solute transport and an increase in dialysate cancer antigen 125, IL-6, adiponectin, and systemic adiponectin levels, but have no effect on systemic inflammatory response. The clinical significance of these changes, while of great interest, remains to be determined by further studies.
生物相容性腹膜透析（PD）液的益处，特别是对残余肾功能（RRF）的益处，存在争议。此外，不同生物相容性 PD 液组成的 PD 方案的临床效果尚未完全确定。
前瞻性、随机、对照、开放标签研究。
150 名新开始持续非卧床 PD 治疗的终末期肾病患者。
为期 12 个月的干预，使用 3 种生物相容性 PD 液（中性 pH、低葡萄糖降解产物、1.5%葡萄糖溶液；含 1.1%氨基酸的溶液；含 7.5%艾考糊精的溶液）或常规 PD 液。
主要结果是 RRF 和每日尿量的变化。次要结果是腹膜转运和炎症标志物。
RRF、每日尿量、血清和透析液细胞因子水平。
RRF（3.24±1.98 与 2.88±2.43 mL/min/1.73 m²；P=0.9）和 RRF 下降率（-0.76±1.77 与 -0.91±1.92 mL/min/1.73 m²/年；P=0.6）在生物相容性 PD 液组和常规 PD 液组之间无差异。然而，使用生物相容性 PD 液的患者每日尿量保存更好（959±515 与常规组 798±615 mL/d，重复测量方差分析的整体变化差异比较的 P=0.02）。12 个月时，4 小时透析液-血浆肌酐比值更高（0.78±0.13 与 0.68±0.12；重复测量方差分析的整体变化差异比较的 P=0.01）。他们的过夜透析液中还存在更高水平的癌抗原 125、脂联素和白细胞介素 6（IL-6）。两组之间血清 C 反应蛋白和 IL-6 水平无差异。
未设盲，随访时间相对较短；未进行正式的样本量计算。
与常规 PD 液相比，使用 3 种生物相容性 PD 液联合治疗 12 个月与 RRF 无关，但与每日尿量保存更好相关。生物相容性 PD 液还可改变小分子转运，并增加透析液中癌抗原 125、IL-6、脂联素和全身脂联素水平，但对全身炎症反应无影响。这些变化的临床意义虽然很有趣，但仍有待进一步研究确定。
