Duffy R, Tomashek K, Spangenberg M, Spry L, Dwyer D, Safranek T J, Ying C, Portesi D, Divan H, Kobrenski J, Arduino M, Tokars J, Jarvis W
Hospital Infections Program and National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.
Kidney Int. 2000 Apr;57(4):1668-74. doi: 10.1046/j.1523-1755.2000.00011.x.
Hemolysis associated with hemodialysis is rare. The most frequent causes of hemodialysis-associated hemolysis are chemical contamination, heat, or mechanical injury of erythrocytes from occluded or kinked hemodialysis blood lines. When patients in three states developed hemolysis while undergoing hemodialysis between May 13 and 23, 1998, an investigation was initiated.
A case-patient was defined as any patient at healthcare facilities A (Nebraska), B (Maryland), or C (Massachusetts) during May 13 through 23, 1998 (epidemic period), who had hemolysis diagnosed > or =48 hours after undergoing hemodialysis. To identify case-patients and to determine background rates, the medical records of patients from facilities A, B, and C who were undergoing hemodialysis during the epidemic and pre-epidemic (that is, May 5 through 19, 1998) periods were reviewed. Experiments simulating hemodialysis with the same lot numbers of hemodialysis blood tubing cartridge sets used on case- and control-patients were conducted.
The rates of hemolysis among patients at facilities A, B, and C were significantly higher during the epidemic than the pre-epidemic period (13 out of 118 vs. 0 out of 118, P < 0.001; 12 out of 298 vs. 0 out of 298, P = 0.001; and 5 out of 62 vs. 0/65, P = 0.03, respectively). All case-patients had hemolysis. Twenty (66%) had hypertension. Eighteen (60%) had abdominal pain, and 10 (36%) were admitted to an intensive care unit. There were two deaths. The only commonality among the three outbreaks was the use of the same lot of disposable hemodialysis blood tubing from one manufacturer. Examination of the implicated hemodialysis blood tubing cartridge sets revealed narrowing of an aperture through which blood was pumped before entering the dialyzers. In vitro experiments with the hemodialysis blood tubing revealed that hemolysis was caused by increased pressure on erythrocytes as they passed through the partially occluded hemodialysis blood tubing.
Our investigation traced the multiple hemolysis outbreaks to partially occluded hemodialysis blood tubing produced by a single manufacturer. On May 25, 1998, the manufacturer issued a voluntary nationwide recall of the implicated lots of hemodialysis blood tubing cartridge sets.
与血液透析相关的溶血很少见。血液透析相关溶血最常见的原因是化学污染、热或因血液透析血路堵塞或扭结导致红细胞受到机械损伤。1998年5月13日至23日期间，三个州的患者在进行血液透析时出现溶血，于是展开了一项调查。
病例患者定义为1998年5月13日至23日（流行期）期间在医疗机构A（内布拉斯加州）、B（马里兰州）或C（马萨诸塞州）接受血液透析且在透析后≥48小时被诊断出溶血的任何患者。为了识别病例患者并确定背景发生率，对在流行期和流行前期（即1998年5月5日至19日）期间在A、B、C医疗机构接受血液透析的患者的病历进行了审查。使用与病例患者和对照患者相同批号的血液透析血路管套装进行了模拟血液透析的实验。
A、B、C医疗机构患者的溶血发生率在流行期显著高于流行前期（118例中有13例 vs. 118例中0例，P<0.001；298例中有12例 vs. 298例中0例，P = 0.001；62例中有5例 vs. 65例中0例，P = 0.03）。所有病例患者均出现溶血。20例（66%）患有高血压。18例（60%）有腹痛，10例（36%）被收入重症监护病房。有2例死亡。三次疫情中唯一的共同点是使用了来自同一制造商的同一批次一次性血液透析血路管。对涉及的血液透析血路管套装进行检查发现，在血液进入透析器之前，血液泵送所通过的一个孔径变窄。对血液透析血路管进行的体外实验表明，溶血是由于红细胞在通过部分堵塞的血液透析血路管时所受压力增加所致。
我们的调查将多次溶血疫情追溯到由单一制造商生产的部分堵塞的血液透析血路管。1998年5月25日，该制造商自愿在全国范围内召回涉及批次的血液透析血路管套装。
