Centre for Evidence-Based Practice, Belgian Red Cross, Mechelen, Belgium; Department of Public Health and Primary Care, Leuven Institute for Healthcare Policy, Leuven, Belgium.
Donor Health, Sanquin Research, Amsterdam, the Netherlands; Department of Public and Occupational Health and the Amsterdam Public Health (APH) Research Institute, Amsterdam UMC, Amsterdam, The Netherlands.
Transfus Med Rev. 2024 Oct;38(4):150851. doi: 10.1016/j.tmrv.2024.150851. Epub 2024 Aug 21.
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), 2 clinical trial registries (ICTRP and clinicaltrials.gov), and the PROSPERO database were searched. Four observational and 2 experimental studies were included. 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 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. 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 needed. We should expedite such studies to support recommendations, as conclusive evidence confirming or refuting the safety of maximum allowed donation frequencies is lacking. Donor protection is essential, given that healthy donors receive no direct medical benefit from donating plasma.
大多数用于制造血浆衍生药物产品（PDMPs）的血浆，如白蛋白、免疫球蛋白（Ig）和凝血因子，都是通过血浆分离术从来源血浆中获得的，其中大部分来自美国（US）。尽管 PDMPs 的需求持续增长，但仍不清楚高频血浆分离术（如美国允许的每周两次的血浆捐献）是否会对捐献者造成任何（长期）不良健康影响。为了研究不损害供体健康的情况下可以捐献血浆的频率，本次系统评价探讨了血浆捐献频率对健康血浆供体心血管健康、蛋白质耗竭和不良事件的影响。我们提出了以下研究问题：血浆分离术的频率（干预）对健康供体（人群）的安全性或健康（结果）有什么影响？我们检索了 6 个数据库（PubMed、Embase、Web of Science、CINAHL、Cochrane 图书馆和 Transfusion Evidence Library）、2 个临床试验注册处（ICTRP 和 clinicaltrials.gov）和 PROSPERO 数据库。纳入了 4 项观察性研究和 2 项实验研究。结果表明，非常高频捐献（每周两次）可能导致铁蛋白水平出现临床相关下降，并使 IgG 水平降至 6 g/l 以下的较低阈值以下。然而，证据的确定性为低到非常低，由于健康供体效应和纳入研究的方法学限制，难以得出确凿的结论。为了确定一个安全的阈值捐献频率，使对供体的任何可能有害影响最小化，需要更多高质量的前瞻性队列研究和实验研究。我们应该加快进行这些研究，以支持相关建议，因为目前缺乏确凿的证据来证实或反驳最大允许捐献频率的安全性。考虑到健康供体从捐献血浆中无法获得直接的医疗获益，因此保护供体至关重要。
