荷兰阿姆斯特丹药学中心Katja van den Hurk团队研究了铁蛋白引导的捐献间隔改善献血者缺铁和贫血风险的效果。相关论文于2024年6月13日发表在《柳叶刀》杂志上。

全血捐献者患缺铁和贫血的风险增加。目前的血红蛋白监测标准不足以确保维持适当的铁储备和捐献者的健康。该研究旨在确定铁蛋白引导的献血间隔对荷兰献血者健康和血液供应的影响。

在这项阶梯式楔形聚类随机试验（FIND’EM）中，荷兰的138个固定和移动捐赠中心被组织成29个地理群，这些群被随机分配到四个治疗组，其中有两个组根据协议修正案进一步各分成两个。符合条件的献血者是同意在研究中使用其剩余成分的全血献血者。在3年的时间里，每组依次从现有政策（基于血红蛋白的筛查；对照）过渡到铁蛋白引导的捐赠间隔政策。在干预组中，除了现有的血红蛋白筛查外，还对所有新捐献者和重复捐献者的每五分位捐献者进行了铁蛋白测量。

如果铁蛋白浓度为15-30 ng/mL，则将随后的捐赠间隔延长至6个月，如果低于15 ng/mL，将延长至12个月。在四个时间点对所有捐赠中心的结果进行横断面测量。主要结局是铁蛋白和血红蛋白浓度、缺铁和基于血红蛋白的延期。研究组根据性别和更年期状况评估了所有结果，主要结局的显著性由小于0.0125的p值表示。

在2017年9月11日至2020年11月27日期间，献血中心共有412888名全血捐献者，研究组对36099名捐献者的37621份献血样本进行了测量。在38个月的时间里，铁蛋白引导的捐献间隔增加了献血者的平均铁蛋白浓度（男性捐献者增加了0.18 log10 ng/mL[95%CI 0.15–0.22；p<0.0001]，绝经前女性捐献者增加了0.10 log10 ng/mL[0.06–0.15]；p<0001]，绝经后女性捐献者增加了0.17 log10 g/mL[0.12–0.21；p>0.0001]）和平均血红蛋白浓度（男性献血者增加了0.30 g/dL[95%CI 0.22–0.38；p<0.0001]，绝经前女性捐献者增加了0.12 g/dL[0.03–0.20；p＜0074]，绝经后女性捐献者增加了0.16 g/dL[0.05–0.27；p＜0044]）。

缺铁减少了36~38个月（男性捐赠者的比值比[OR]0.24[95%CI 0.18–0.31；p<0.0001]，绝经前女性捐赠者为0.49[0.37–0.64；p<0001]，绝经后女性捐赠者为0.24[0.15–0.37；p<.0001]）。在36~38个月时，男性捐献者基于血红蛋白的延期显著降低（在36~38月时OR为0.21[95%CI为0.10–0.40，p<0.0001]），但在绝经前或绝经后女性捐献者中不显著（分别为0.81[0.54–1.20；p=0.29]和0.50[95%CI 0.25–0.98；p=0.051]）。

在研究期间，铁蛋白引导的捐献间隔显著提高了血红蛋白和铁蛋白浓度，并显著减少了缺铁。男性献血者基于血红蛋白的延期间隔显著缩短，但女性献血者没有。尽管这种干预措施总体上有利于维持捐赠者体内的铁和血红蛋白浓度，但仍需要加大力度来招募和留住捐赠者。

附：英文原文

Title: Effectiveness of ferritin-guided donation intervals in whole-blood donors in the Netherlands (FIND'EM): a stepped-wedge cluster-randomised trial

Author: Amber Meulenbeld, Steven Ramondt, Maike G Sweegers, Franke A Quee, Femmeke J Prinsze, Emiel O Hoogendijk, Dorine W Swinkels, Katja van den Hurk

Issue&Volume: 2024-06-13

Abstract:

Background

Whole-blood donors are at increased risk for iron deficiency and anaemia. The current standard of haemoglobin monitoring is insufficient to ensure the maintenance of proper iron reserves and donor health. We aimed to determine the effects of ferritin-guided donation intervals for blood donor health and blood supply in the Netherlands.

Methods

In this stepped-wedge cluster-randomised trial (FIND'EM), the 138 fixed and mobile donation centres in the Netherlands are organised into 29 geographical clusters and the clusters were randomly assigned to four treatment groups, with two groups being further split into two per a protocol amendment. Eligible donors were whole-blood donors who consented for use of their leftover material in the study. Each group was sequentially crossed over from the existing policy (haemoglobin-based screening; control) to a ferritin-guided donation interval policy over a 3-year period. In the intervention groups, in addition to the existing haemoglobin screening, ferritin was measured in all new donors and at every fifth donation in repeat donors. Subsequent donation intervals were extended to 6 months if ferritin concentrations were 15–30 ng/mL and to 12 months if they were less than 15 ng/mL. Outcomes were measured cross-sectionally across all donation centres at four timepoints. Primary outcomes were ferritin and haemoglobin concentrations, iron deficiency, and haemoglobin-based deferrals. We assessed all outcomes by sex and menopausal status and significance for primary outcomes was indicated by a p value of less than 0·0125. This trial is registered in the Dutch trial registry, NTR6738, and is complete.

Findings

Between Sept 11, 2017, and Nov 27, 2020, 412888 whole-blood donors visited a donation centre, and we did measurements on samples from 37621 donations from 36099 donors. Over 38 months, ferritin-guided donation intervals increased mean ferritin concentrations (by 0·18 log10 ng/mL [95% CI 0·15–0·22; p<0·0001] in male donors, 0·10 log10 ng/mL [0·06–0·15; p<0·0001] in premenopausal female donors, and 0·17 log10 ng/mL [0·12–0·21; p<0·0001] in postmenopausal female donors) and mean haemoglobin concentrations (by 0·30 g/dL [95% CI 0·22–0·38; p<0·0001] in male donors, 0·12 g/dL [0·03–0·20; p<0·0074] in premenopausal female donors, and 0·16 g/dL [0·05–0·27; p<0·0044] in postmenopausal female donors). Iron deficiency decreased by 36–38 months (odds ratio [OR] 0·24 [95% CI 0·18–0·31; p<0·0001] for male donors, 0·49 [0·37–0·64; p<0·0001] for premenopausal female donors, and 0·24 [0·15–0·37; p<0·0001] for postmenopausal female donors). At 36–38 months, haemoglobin-based deferral decreased significantly in male donors (OR at 36–38 months 0·21 [95% CI 0·10–0·40, p<0·0001]) but not significantly in premenopausal or postmenopausal female donors (0·81 [0·54–1·20; p=0·29] and 0·50 [95% CI 0·25–0·98; p=0·051], respectively).

Interpretation

Ferritin-guided donation intervals significantly improved haemoglobin and ferritin concentrations and significantly decreased iron deficiency over the study period. Haemoglobin-based deferrals decreased significantly for male donors, but not female donors. Although this intervention is overall beneficial for maintenance of iron and haemoglobin concentrations in donors, increased efforts are needed to recruit and retain donors.

DOI: 10.1016/S0140-6736(24)01085-7

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)01085-7/abstract