Balancing donor health and plasma collection: a systematic review of the impact of plasmapheresis frequency

Tine D'aes, Katja van den Hurk, Natalie Schroyens, Susan Mikkelsen, Pieter Severijns, Emmy De Buck, Peter O'Leary, Pierre Tiberghien, Veerle Compernolle, Christian Erikstrup, Hans Van Remoortel
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Abstract

Most plasma used for manufacturing plasma-derived medicinal products (PDMPs) such as albumin, immunoglobulin (Ig), and clotting factors is obtained from source plasma collected via plasmapheresis, the majority of which is contributed by the United States (US). While the demand for PDMPs continues to rise, it remains unclear whether high-frequency plasmapheresis, such as the twice-weekly plasma donation allowed in the US, may have any (long-term) adverse health effects on the donor. To investigate the frequency at which plasma can be donated without harm to the donor, the current systematic review explores the impact of plasma donation frequency on cardiovascular health, protein depletion, and adverse events in healthy plasma donors. We asked the following research question: What is the impact of plasmapheresis frequency (Intervention) on the safety or health (Outcome) of healthy donors (Population)? Six databases (PubMed, Embase, Web of Science, CINAHL, the Cochrane Library, and Transfusion Evidence Library), two clinical trial registries (ICTRP and clinicaltrials.gov), and the PROSPERO database were searched. Four observational and two experimental studies were included, and one ongoing randomized controlled trial was identified. The results showed that very high-frequency donation (twice per week) may result in a clinically relevant decrease in ferritin and bring IgG levels below the EDQM-defined lower threshold of 6 g/l. However, the evidence is of low to very low certainty, and solid conclusions are hindered by the healthy donor effect and methodological limitations of the included studies. In order to determine a safe threshold donation frequency that minimizes any possible harmful effect on the donor, more high-quality prospective cohort studies and experimental studies are thus needed. In the meantime, we argue for a precautionary approach and suggest that a sustainable and stable plasma supply may better rely on a large number of voluntary donors donating at a lower frequency (up to two donations per month), rather than on a small number of donors donating at a high frequency.
平衡捐赠者健康与血浆采集:对血浆置换频率影响的系统性审查
用于生产白蛋白、免疫球蛋白 (Ig) 和凝血因子等血浆衍生医药产品 (PDMP) 的血浆大多来自通过血浆置换术收集的源血浆,其中大部分来自美国。虽然对 PDMP 的需求持续上升,但高频率的血浆置换(如美国允许的每周两次血浆捐献)是否会对捐献者的健康产生任何(长期)不良影响仍不清楚。为了调查捐献血浆不会对捐献者造成伤害的频率,本系统综述探讨了血浆捐献频率对健康血浆捐献者的心血管健康、蛋白质耗竭和不良事件的影响。我们提出了以下研究问题:血浆捐献频率(干预)对健康捐献者(人群)的安全或健康(结果)有什么影响?我们检索了六个数据库(PubMed、Embase、Web of Science、CINAHL、Cochrane Library 和 Transfusion Evidence Library)、两个临床试验登记处(ICTRP 和 clinicaltrials.gov)以及 PROSPERO 数据库。其中包括四项观察性研究和两项实验性研究,并确定了一项正在进行的随机对照试验。结果显示,非常高频率的捐献(每周两次)可能会导致铁蛋白的临床相关性下降,并使 IgG 水平低于 EDQM 定义的 6 克/升的较低阈值。然而,这些证据的确定性较低或很低,而且由于健康捐献者效应和所纳入研究的方法限制,无法得出可靠的结论。因此,为了确定一个安全的捐献频率阈值,将可能对捐献者造成的有害影响降至最低,需要进行更多高质量的前瞻性队列研究和实验研究。与此同时,我们主张采取预防措施,并建议可持续和稳定的血浆供应最好依靠大量自愿捐献者以较低频率(每月最多两次)捐献,而不是少数捐献者以较高频率捐献。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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