Division of Nephrology, University of British Columbia, 602-1160 Burrard St, Vancouver, BC V6Z 2E8, Canada.
JAMA. 2011 Oct 19;306(15):1679-87. doi: 10.1001/jama.2011.1499.
Thrombocytopenia is not widely recognized as a potential dialyzer-related complication. Following the observation of significant thrombocytopenia among 20 patients undergoing hemodialysis in a single dialysis unit after the introduction of dialyzers sterilized by electron beam (e-beam), a larger investigation was undertaken.
To determine the prevalence and etiology of thrombocytopenia in hemodialysis populations of 2 Canadian provinces (British Columbia and Alberta).
DESIGN, SETTING, AND PARTICIPANTS: A cohort study of patients undergoing hemodialysis in British Columbia (n = 1706) and southern Alberta (n = 425) between April 1, 2009, and November 30, 2010. Retrospective analyses of historical patient, laboratory, and dialyzer data predating conversion to e-beam dialyzers were undertaken, with prospective collection of predialysis and postdialysis platelet counts before and after the change from e-beam to non-e-beam sterilized dialyzers in September 2009.
Significant thrombocytopenia, defined a priori as postdialysis treatment platelet count of less than 100 × 10(3)/μL and a postdialysis decrease in platelet count of more than 15%.
Among 1706 patients undergoing hemodialysis in British Columbia, 1411 (83%) were undergoing hemodialysis with e-beam sterilized dialyzers. Of 1706 patients, 194 (11.4%; 95% CI, 9.9%-12.9%) had postdialysis platelet counts of less than 100 × 10(3)/μL; 400 (23.4%; 95% CI, 21.5%-25.5%) had postdialysis decreases in platelet counts of more than 15%; and 123 (7.2%; 95% CI, 6.0%-8.6%) met both criteria. Among 425 patients in Alberta undergoing dialysis with polysulfone, e-beam sterilized dialyzers made by a different manufacturer, 46 (10.8%; 95% CI, 8.1%-14.3%) had platelet counts of less than 100 × 10(3)/μL; 156 (32.0%; 95% CI, 27.6%-36.7%) had decreases in platelet counts of more than 15%; and 31 (7.3%; 95% CI, 5.1%-10.3%) met both criteria. In multivariable analysis adjusting for patient and dialysis history characteristics, a significant association was observed between using an e-beam sterilized dialyzer and risk of significant thrombocytopenia (odds ratio [OR], 2.52; 95% CI, 1.20-5.29; P = .02). Compared with use of e-beam sterilized dialyzers, following the change to use of non-e-beam sterilized dialyzers, among 1784 patients, significant reductions were observed in postdialysis thrombocytopenia (120 patients [6.7%; 95% CI, 5.6%-8.0%; P < .001] had platelet counts of <100 × 10(3)/μL; 167 patients [9.4%; 95% CI, 8.1%-10.8%; P < .001] had decreases in platelet counts of >15%; and 38 patients [2.1%; 95% CI, 1.5%-2.9%; P < .001] met both criteria). Using generalized estimating equation modeling for repeated data with binary outcome, after adjusting for patient characteristics, the odds of significant thrombocytopenia were higher during the use of e-beam sterilized dialyzers than with use of non-e-beam sterilized dialyzers (OR, 3.57; 95% CI, 2.54-5.04; P < .001).
In this cohort of patients undergoing hemodialysis in 2 Canadian provinces in 2009-2010, the use of e-beam sterilized dialyzers was associated with significant thrombocytopenia following dialysis.
血小板减少症并不被广泛认为是一种潜在的透析相关并发症。在引入电子束（e-beam）消毒的透析器后，在一个透析单元中接受血液透析的 20 名患者中观察到显著的血小板减少症后，进行了更大规模的调查。
确定加拿大两个省（不列颠哥伦比亚省和艾伯塔省）血液透析人群中血小板减少症的患病率和病因。
设计、地点和参与者：这是一项对 2009 年 4 月 1 日至 2010 年 11 月 30 日期间在不列颠哥伦比亚省（n=1706）和艾伯塔省南部（n=425）接受血液透析的患者进行的队列研究。对历史患者、实验室和透析器数据进行回顾性分析，这些数据早于向 e-beam 透析器转换之前，前瞻性收集 2009 年 9 月从 e-beam 转换为非 e-beam 消毒透析器前后透析前和透析后血小板计数。
显著血小板减少症定义为透析后治疗血小板计数小于 100×103/μL，且透析后血小板计数下降超过 15%。
在 1706 名在不列颠哥伦比亚省接受血液透析的患者中，1411 名（83%）接受 e-beam 消毒透析器进行血液透析。在 1706 名患者中，194 名（11.4%；95%CI，9.9%-12.9%）透析后血小板计数小于 100×103/μL；400 名（23.4%；95%CI，21.5%-25.5%）透析后血小板计数下降超过 15%；123 名（7.2%；95%CI，6.0%-8.6%）符合这两个标准。在艾伯塔省接受聚砜透析、由不同制造商生产的 e-beam 消毒透析器的 425 名患者中，46 名（10.8%；95%CI，8.1%-14.3%）血小板计数小于 100×103/μL；156 名（32.0%；95%CI，27.6%-36.7%）血小板计数下降超过 15%；31 名（7.3%；95%CI，5.1%-10.3%）符合这两个标准。在调整患者和透析史特征的多变量分析中，使用 e-beam 消毒透析器与显著血小板减少症的风险显著相关（比值比[OR]，2.52；95%CI，1.20-5.29；P=0.02）。与使用 e-beam 消毒透析器相比，在改用非 e-beam 消毒透析器后，在 1784 名患者中，透析后血小板减少症显著减少（120 名患者[6.7%；95%CI，5.6%-8.0%；P<0.001]血小板计数小于 100×103/μL；167 名患者[9.4%；95%CI，8.1%-10.8%；P<0.001]血小板计数下降超过 15%；38 名患者[2.1%；95%CI，1.5%-2.9%；P<0.001]符合这两个标准）。使用重复数据的广义估计方程模型进行二元结果分析，调整患者特征后，与使用非 e-beam 消毒透析器相比，使用 e-beam 消毒透析器发生显著血小板减少症的几率更高（OR，3.57；95%CI，2.54-5.04；P<0.001）。
在 2009 年至 2010 年期间，在加拿大两个省的血液透析患者中，使用 e-beam 消毒透析器与透析后显著血小板减少症相关。
