Axdorph Nygell Ulla, Sollén-Nilsson Agneta, Lundahl Joachim
Department of Clinical Immunology and Transfusion Medicine, Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden.
Department of Haematology, Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden.
J Clin Apher. 2015 Oct;30(5):265-72. doi: 10.1002/jca.21373. Epub 2014 Dec 26.
Granulocyte transfusions are given to patients with life-threatening infections, refractory to treatment. The donors are stimulated with corticosteroids ± granulocyte colony stimulating factor (G-CSF). However, data regarding the donors' safety is sparse. The objective was therefore to evaluate short- and long-term adverse events (AE) in G-CSF stimulated donors.
All consecutive granulocyte donors from 1994 to 2012 were identified through our registry. From the donation records, the number of aphereses, stimulation therapy, AE, blood values post donation, and recent status were evaluated.
One hundred fifty-four volunteer donors were mobilized for 359 collections. Age at first granulocyte donation was 43 years (median; range 19-64 years). Follow-up was 60 months (median; range 0-229 months). The dose of G-CSF per collection was 3.8 ug/kg body weight (median; range 1.6-6.0 ug/kg). Sedimentation agent was HES. Short-term AE were mild. Blood values 4 weeks post donation with minor reductions/elevations mostly resolved in later donations. Fourteen donors were excluded from the registry due to hypertension (4), diabetes (2), atrial flutter (1), breast carcinoma (1), urethral carcinoma in situ (1), MGUS (1), thrombosis (1), anaphylaxis (1), primary biliary cirrhosis (1), and unknown (1). Three donors are deceased due to diabetes, acute myocardial infarction, and unknown cause. All excluded/deceased donors except one were excluded/died at least 6 months after first granulocyte donation.
No serious short-term AE were observed. Due to the variability of diagnoses among excluded/deceased donors, we propose that it is less likely that granulocyte donations have a causative impact on these donors' exclusion or death.
粒细胞输注用于治疗危及生命且治疗难治的感染患者。供者通过皮质类固醇±粒细胞集落刺激因子(G-CSF)进行刺激。然而,关于供者安全性的数据很少。因此,本研究的目的是评估G-CSF刺激供者的短期和长期不良事件(AE)。
通过我们的登记系统识别了1994年至2012年所有连续的粒细胞供者。从捐献记录中,评估了采集次数、刺激治疗、不良事件、捐献后血液值以及近期状况。
154名志愿供者被动员进行了359次采集。首次粒细胞捐献时的年龄为43岁(中位数;范围19 - 64岁)。随访时间为60个月(中位数;范围0 - 229个月)。每次采集的G-CSF剂量为3.8μg/kg体重(中位数;范围1.6 - 6.0μg/kg)。沉降剂为羟乙基淀粉(HES)。短期不良事件较轻。捐献后4周血液值有轻微降低/升高,大多在后续捐献中恢复。14名供者因高血压(4例)、糖尿病(2例)、心房颤动(1例)、乳腺癌(1例)、原位尿道癌(1例)、意义未明的单克隆丙种球蛋白血症(MGUS,1例)、血栓形成(1例)、过敏反应(1例)、原发性胆汁性肝硬化(1例)以及不明原因(1例)被从登记系统中排除。3名供者因糖尿病、急性心肌梗死和不明原因死亡。除1名供者外,所有被排除/死亡的供者均在首次粒细胞捐献至少6个月后被排除/死亡。
未观察到严重的短期不良事件。由于被排除/死亡供者的诊断存在差异,我们认为粒细胞捐献不太可能是导致这些供者被排除或死亡的原因。