Granulocyte Donation with GCSF

在这项研究的第一年，38名健康志愿者被积累为活跃的粒细胞供体，并捐赠了105个非格昔汀和地塞米松刺激的粒细胞分离成分。这些药物被用于14名患有严重中性粒细胞减少症和危及生命的感染的患者；最常见的受体诊断是严重再生障碍性贫血（n=7），其次是慢性肉芽肿病（n=4）、急性白血病（n=2）和非霍奇金淋巴瘤（n=1）。14名受赠者中有8人患有播散性霉菌，6人患有危及生命的细菌感染，其中2人患有耐碳青霉烯克雷伯氏肺炎。每个患者疗程中位数为5次粒细胞输注（范围1至29）。两名患者对粒细胞输注（GTX）没有反应并迅速死亡，一名患者被评估为无效，另一名患者由于HLA异体免疫和缺乏兼容的供体而无法接受持续的GTX疗程。其余12例表现稳定或临床改善，但6例后来因其潜在疾病死亡。14人中有6人出院。一名受者由于GTX产生HLA异体免疫，导致对不相关的脐带血移植产生排斥反应。

During the first year of this study, 38 healthy volunteers were accrued as active granulocyte donors and donated a total of 105 filgrastim- and dexamethasone-stimulated granulocyte apheresis components. These were administered to 14 patients with severe neutropenia and life-threatening infections; the most common recipient diagnosis was severe aplastic anemia (n=7), followed by chronic granulomatous disease (n=4), acute leukemia (n=2) and non-Hodgkins lymphoma (n=1). Eight of 14 recipients had disseminated mold and six had life-threatening bacterial infections, including two with carbapenem-resistant Klebsiella pneumonia. A median of 5 granulocyte transfusions (range 1 to 29) were administered per patient course. Two patients did not respond to the granulocyte transfusions (GTX) and died rapidly, one assessed as a futile effort, and the other unable to receive a sustained course of GTX due to HLA alloimmunization and lack of compatible donors. The remaining 12 showed stability or clinical improvement, although 6 later died due to their underlying disease. Six of 14 were discharged from hospital. One recipient developed HLA alloimmunization due to GTX, which resulted in rejection of an unrelated cord blood graft. Donors experienced mild to moderate insomnia, nightmares, irritability and jitteriness related to the dexamethasone, and myalgia, arthralgias, fatigue and flushing related to the filgrastim administration. Twelve donors underwent comprehensive eye exams for cataract detection as a baseline assessment prior to repetitive dexamethasone administration. Donor retention in the program was 100%. A mean of 7.4 liters were processed per procedure, during which 6.89 x 10e10 granulocytes (range 3.82-20.61 x 10e10) were collected in a volume of 324 mL. Granulocyte collection efficiency was only 43% using the Spectra apheresis device, with WBC differential composed of 88% granulocytes, and with a mean hematocrit of 12% and a mean red cell content of 40 mL. Areas for further study or improvement include the low granulocyte collection efficiency of the Spectra apheresis device. A comparative efficacy study of the Spectra with the manufacturer's next generation cell separator, the Spectra Optia, will be performed as part of this study within the next year. New strategies to recruit additional committed granulocyte donors will be addressed in the next year in order to increase the study accrual numbers.