Granulocyte Donation with GCSF

在这项研究的第一年，38名健康志愿者被累积为活跃的粒细胞捐献者，总共捐献了105份非格列汀和地塞米松刺激的粒细胞采集组件。14例严重中性粒细胞减少和危及生命的感染患者接受了这些治疗；最常见的受者诊断为严重再生障碍性贫血(n=7)，其次是慢性肉芽肿性疾病(n=4)、急性白血病(n=2)和非霍奇金淋巴瘤(n=1)。14名受者中有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人患有碳青霉烯耐药肺炎克雷伯菌。平均每个病程接受5次粒细胞输注(范围为1至29次)。两名患者对粒细胞输注(GTX)无反应并迅速死亡，一名患者被评估为徒劳，另一名患者由于人类白细胞抗原(HLA)异基因免疫和缺乏相容的供者而无法接受持续疗程的GTX。其余12人病情稳定或临床好转，但有6人后来因基础疾病死亡。14人中有6人已出院。1例受者发生了GTX引起的人类白细胞抗原同种异体免疫反应，导致非亲缘脐血移植排斥反应。 捐赠者经历了与地塞米松有关的轻至中度失眠、噩梦、易怒和紧张，以及与非格司替用药有关的肌肉疼痛、关节痛、疲劳和潮红。在重复使用地塞米松之前，12名捐献者接受了全面的白内障检测眼科检查，作为基线评估。供者在该计划中的保留率为100%。 平均每次处理7.4L，其间采集6.89×10e10粒细胞(范围3.82~20.61×10e10)，体积324毫升。Spectra采集仪的粒细胞采集率仅为43%，WBC差异由88%的粒细胞组成，平均红细胞压积为12%，平均红细胞含量为40mL。 需要进一步研究或改进的领域包括Spectra分离设备的粒细胞采集效率较低。一项Spectra与制造商的下一代细胞分离器Spectra Optia的比较功效研究将在明年作为这项研究的一部分进行。明年将提出招募更多承诺的粒细胞捐献者的新战略，以增加研究的应计数字。

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.