Py J-Y, Durieux S, Barnoux M, Sapey T
EFS centre-atlantique site d'Orléans, 190, rue Léon-Foucault, 45140 Saint-Jean de la Ruelle, France.
EFS centre-atlantique site de Niort, 40, avenue Charles-de-Gaulle, 79000 Niort, France.
Transfus Clin Biol. 2016 Nov;23(4):233-239. doi: 10.1016/j.tracli.2016.07.007. Epub 2016 Oct 18.
Delayed adverse reactions to blood donation occur after the donor left donation site. Their intrinsic gravity and possible complications can be increased by the fact the donor is alone. This can also increase bad memories, leading to a donation giving up. Blood transfusion centre is only aware in case of donor feedback, hence an event underrating. We choose to compare our data upon delayed adverse donor reactions with those we could find in past studies.
A first data level comes from French haemovigilance data while serious adverse reactions declaration is mandatory. But a second level can be reached using blood transfusion centre computerized data because all the donation reactions are saved whatever the gravity is. In both cases, delayed reactions are only those reported by donors. We try to make an exhaustive search of specific studies upon the real delayed reactions incidence so as to compare with our data.
There were 1957 serious adverse reactions declared in our regional haemovigilance database between 2011 and 2015: 49 % occurring during donation, 40 % after it but before donor departure, and 11 % delayed events. There were 16,050 adverse reactions recorded during the first trimester of 2016 in mainland France, with 2.7 % delayed ones. Proportion of delayed events rises when gravity rises, until 27.6 % for the most serious ones. It varies between 2.2 % and 2.7 % for vasovagal reactions, haematomas, and other local reactions, and reaches 16.2 % for other general reactions. Data found in other studies with a spontaneous donor notification are of the same kind. But four studies soliciting specifically donor notification give a dramatically higher delayed reactions incidence, with an understatement greater than three out of four. Moreover, these studies found a majority of delayed reactions, which are not included in haemovigilance like fatigue or bruising.
Occurrence of a delayed donor reaction is clearly underrated in standard haemovigilance. It remains to be seen whether it have the same impact on donor return as immediate reactions. Considering that delayed reactions are much larger, it might be interesting to take them into account in the evaluation of strategies dedicated to lower immediate reactions.
献血的延迟不良反应发生在献血者离开献血地点之后。由于献血者是独自一人,这些反应的内在严重性和可能的并发症可能会增加。这也可能会增加不愉快的记忆,导致放弃献血。输血中心只有在收到献血者反馈时才会知晓,因此存在事件低估的情况。我们选择将我们关于献血者延迟不良反应的数据与以往研究中的数据进行比较。
第一级数据来自法国血液警戒数据,而严重不良反应申报是强制性的。但第二级数据可以通过输血中心的计算机数据获得,因为所有的献血反应都会被记录下来,无论其严重程度如何。在这两种情况下,延迟反应仅指献血者报告的反应。我们试图对关于实际延迟反应发生率的具体研究进行详尽搜索,以便与我们的数据进行比较。
2011年至2015年期间,我们地区的血液警戒数据库中申报了1957例严重不良反应:49%发生在献血期间,40%发生在献血后但在献血者离开之前,11%为延迟事件。2016年第一季度,法国本土记录了16050例不良反应,其中2.7%为延迟反应。延迟事件的比例随着严重程度的增加而上升,最严重的延迟事件比例达到27.6%。血管迷走神经反应、血肿和其他局部反应的延迟事件比例在2.2%至2.7%之间,其他一般反应的延迟事件比例达到16.2%。在其他有献血者自发报告的研究中发现的数据也是如此。但四项专门征求献血者报告的研究给出的延迟反应发生率要高得多,低估程度超过四分之三。此外,这些研究发现大多数延迟反应未被纳入血液警戒,如疲劳或瘀伤。
在标准的血液警戒中,献血者延迟反应的发生率显然被低估了。它对献血者再次献血的影响是否与即时反应相同仍有待观察。考虑到延迟反应要多得多,在评估旨在降低即时反应的策略时将其考虑在内可能会很有意思。