Kundrapu Sirisha, Datla Sireesha, Griffin Vanessa, Maitta Robert W
Department of Pathology, University Hospitals Cleveland Medical Center, Cleveland, Ohio.
Department of Pathology, Division of Transfusion Medicine, Case Western Reserve University School of Medicine, Cleveland, OH.
J Clin Apher. 2019 Oct;34(5):528-536. doi: 10.1002/jca.21706. Epub 2019 Apr 5.
Apheresis can be associated with adverse events (AEs). Available studies published on apheresis-associated AEs lack uniformity of data. Unfortunately, there is no common database in the United States (US) to report apheresis-associated AEs. We evaluated our institutional incidence of apheresis-associated AEs and compared it with published literature.
We conducted a 10-year retrospective study of apheresis procedures and associated AEs at our facility, a tertiary academic medical center, from 2007 to 2016. Concurrently, a literature search was conducted on AEs associated with apheresis procedures. Twenty-eight studies including data from US and other countries' facilities were analyzed.
The overall AE incidence was 6.9% (396/5684 procedures). Frequency of AEs associated with therapeutic plasma exchange (TPE) was higher (8.5%, P < .0001) compared to other apheresis procedures. Significant correlation between number of TPE and AEs (Spearman rho [r ] = 0.7, P = .002) was encountered. Furthermore, there was a significant decrease over time of moderate and severe AEs (r = -0.64, P = .04 and r = -0.83, P = .003 respectively). Comparison of our institutional AEs (6.9%) to data from other countries (9.8%) and US (22.6%) indicated a significant difference (P < .0001).
Overall our incidence of AEs was significantly lower than current published literature. Incidence of AEs published in other countries is significantly lower than US rates. Differences in incidence of AEs emphasize need for uniform reporting and stratification of AEs and development of a common database to report AEs. Therefore, we propose a grading rationale in order to standardize reporting of AEs.
单采术可能与不良事件（AE）相关。已发表的关于单采术相关不良事件的现有研究缺乏数据的一致性。不幸的是，美国没有用于报告单采术相关不良事件的通用数据库。我们评估了我们机构中单采术相关不良事件的发生率，并将其与已发表的文献进行比较。
我们对2007年至2016年期间在我们的机构（一家三级学术医疗中心）进行的单采术程序及相关不良事件进行了为期10年的回顾性研究。同时，对与单采术程序相关的不良事件进行了文献检索。分析了包括来自美国和其他国家机构数据的28项研究。
总体不良事件发生率为6.9%（396/5684例程序）。与治疗性血浆置换（TPE）相关的不良事件发生率（8.5%，P <.0001）高于其他单采术程序。发现TPE次数与不良事件之间存在显著相关性（斯皮尔曼等级相关系数[r]=0.7，P = 0.002）。此外，中度和重度不良事件随时间显著减少（r分别为-0.64，P = 0.04和r = -0.83，P = 0.003）。将我们机构的不良事件发生率（6.9%）与其他国家（9.8%）和美国（22.6%）的数据进行比较，显示出显著差异（P <.0001）。
总体而言，我们的不良事件发生率显著低于当前已发表的文献。其他国家发表的不良事件发生率显著低于美国。不良事件发生率的差异强调了对不良事件进行统一报告和分层以及开发用于报告不良事件的通用数据库的必要性。因此，我们提出了一个分级原理，以便对不良事件的报告进行标准化。
