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一次性使用与重复使用纤维素透析器对临床参数及生物相容性指标的影响。

Impact of single use versus reuse of cellulose dialyzers on clinical parameters and indices of biocompatibility.

作者信息

Pereira B J, Natov S N, Sundaram S, Schmid C H, Trabelsi F R, Strom J A, King A J

机构信息

Division of Nephrology, New England Medical Center Hospital, Boston, MA 02111, USA.

出版信息

J Am Soc Nephrol. 1996 Jun;7(6):861-70. doi: 10.1681/ASN.V76861.

Abstract

Hemodialysis with reprocessed dialyzers has been associated with an increased mortality in patients on chronic dialysis, but the causes for this increased mortality have not been identified thus far. The aim of this study was to compare the qualitative and/or quantitative differences in activation of cellular and plasma elements, intradialytic signs and symptoms, adequacy of dialysis, and serum biochemistry and hematology in patients dialyzed with new or reprocessed cellulose dialyzers. This study measured the plasma levels and production of interleukin-1 receptor antagonist (IL-1Ra) by peripheral blood mononuclear cells (PBMC), indices of cytokine synthesis; plasma C3a levels, an index of complement activation; plasma levels of lipopolysaccharide binding protein (LBP), an acute phase reactant; and plasma levels of bactericidal-permeability increasing factor (BPI), a neutrophil primary granule protein, in 37 patients on chronic hemodialysis with glutaraldehyde and bleach-reprocessed cellulose dialyzers after random assignment to 12 wk of dialysis with new (single use) or reprocessed (reuse) cellulose dialyzers. These indices were studied before dialysis, 15 min after the start of dialysis, and at the conclusion of dialysis in both groups. Intradialytic clinical symptoms and signs, urea reduction ratios, monthly blood chemistry, and hematology were also studied during the 12-wk period. Before randomization, clinical and laboratory characteristics and IL-1Ra production by PBMC were similar in the two groups. During the 12-wk study, the mean number of dialyzer reuses was 7 +/- 1 in the reuse group and there were no breaks in protocol in the single-use group. At the end of the study, plasma levels of IL-1Ra, cell content and production of IL-1Ra by unstimulated, endotoxin-stimulated, and lgG-stimulated PBMC among patients assigned to reuse were not significantly different from those in the single-use group either before dialysis, at 15 min, or at the conclusion of dialysis. Similarly, plasma levels of C3a, LBP, and BPl were not significantly different between groups at any of the three time points. During the 12-wk study, none of the patients in either arm of the study experienced chills, rigors, or fever, and there were no differences in the number of episodes of symptomatic hypotension in patients on reused dialyzers (11 +/- 3) compared with patients on single-use dialyzers (8 +/- 2). The mean monthly urea reduction ratio during the 3 months of the study was 63 +/- 2% and 65 +/- 2% for reuse and single-use dialyzers, respectively (not significant). Similarly, the hematocrit, white blood cell count, serum calcium, phosphorus, cholesterol, triglycerides, total protein, and albumin levels were also not significantly different between the two groups at the end of the 12-wk study period. These results suggest that the reprocessing of cellulose dialyzers with glutaraldehyde and bleach does not affect indices of blocompatibility, intradialytic symptoms and signs, adequacy of dialysis, or serum biochemistry and hematology.

摘要

使用再处理透析器进行血液透析与慢性透析患者死亡率增加有关,但迄今为止尚未确定死亡率增加的原因。本研究的目的是比较使用新的或再处理的纤维素透析器进行透析的患者在细胞和血浆成分激活、透析期间的体征和症状、透析充分性以及血清生物化学和血液学方面的定性和/或定量差异。本研究测量了37例慢性血液透析患者外周血单个核细胞(PBMC)产生的白细胞介素-1受体拮抗剂(IL-1Ra)的血浆水平和产量、细胞因子合成指标;血浆C3a水平,补体激活指标;血浆脂多糖结合蛋白(LBP)水平,一种急性期反应物;以及杀菌通透性增加因子(BPI)的血浆水平,一种中性粒细胞主要颗粒蛋白,这些患者被随机分配使用新的(一次性使用)或再处理的(重复使用)纤维素透析器进行12周的透析。在透析前、透析开始后15分钟和两组透析结束时研究了这些指标。在12周期间还研究了透析期间的临床症状和体征、尿素清除率、每月血液化学和血液学。在随机分组前,两组患者的临床和实验室特征以及PBMC产生的IL-1Ra相似。在12周的研究中,重复使用组透析器的平均重复使用次数为7±1次,一次性使用组未违反方案。在研究结束时,分配到重复使用组的患者在透析前、15分钟或透析结束时,未刺激的、内毒素刺激的和IgG刺激的PBMC产生的IL-1Ra的血浆水平、细胞含量和产量与一次性使用组相比无显著差异。同样,在三个时间点的任何一个时间点,两组之间的C3a、LBP和BPl血浆水平均无显著差异。在12周的研究中,研究的任何一组患者均未出现寒战、寒战或发热,与使用一次性透析器的患者(8±2)相比,使用重复使用透析器的患者有症状性低血压发作次数(11±3)无差异。在研究的3个月期间,重复使用和一次性使用透析器的平均每月尿素清除率分别为63±2%和65±2%(无显著差异)。同样,在12周研究期结束时,两组之间的血细胞比容、白细胞计数、血清钙、磷、胆固醇、甘油三酯、总蛋白和白蛋白水平也无显著差异。这些结果表明,用戊二醛和漂白剂对纤维素透析器进行再处理不会影响生物相容性指标、透析期间的症状和体征、透析充分性或血清生物化学和血液学。

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