de la Rubia Javier, de Arriba Felipe, Arbona Cristina, Pascual María J, Zamora Concha, Insunza Andrés, Martínez Dorleta, Paniagua Carmen, Díaz Miguel A, Sanz Miguel A
Hematology Service, University Hospital La Fe, Avda. Campanar, 21 46009 Valencia, Spain.
Haematologica. 2008 May;93(5):735-40. doi: 10.3324/haematol.12285. Epub 2008 Apr 2.
Information about the long-term follow-up and safety of granulocyte colony-stimulating factor administration to healthy donors is limited. The aims of this study were to analyze the side effects of granulocyte colony-stimulating factor administration in donors included in a Spanish Registry of hematopoietic stem cell donors and to determine the long-term outcome of these donors.
The Spanish National Donor Registry was developed to record the short- and long-term results of granulocyte colony-stimulating factor administration to mobilize peripheral blood progenitor cells in normal donors. To date, 1436 donors (771 males, 665 females) with a median age of 37 years (range, 1 to 74 years) have been registered. Granulocyte colony-stimulating factor was the only cytokine administered. A baseline investigation was performed in every donor before granulocyte colony-stimulating factor administration and follow-up investigations (controls) were planned at 4 weeks and annually thereafter for up to 5 years after the mobilization.
At least one of the scheduled controls was performed in 736 donors, while 320 donors have been followed for 2 years or more. The peripheral white blood cell count decreased significantly from 6.8 x 10(9)/L at baseline to 5.9 x 10(9)/L at 4 weeks after leukapheresis (p<0.0001) and remained at values lower than those observed premobilization until 2 years after mobilization. In contrast, hemoglobin concentration and platelet count returned to normal values within 1 year after mobilization. Bone pain (90%) and headache (33%) were the most frequently reported granulocyte colony-stimulating factor-related side effects. Five patients (0.68%) were diagnosed as having solid tumors (lung cancer in two patients and thyroid carcinoma, choroid melanoma, and colon carcinoma in one patient each) between 10 and 64 months after administration of granulocyte colony-stimulating factor. No hematologic malignancies have been reported.
The clinical side effects of granulocyte colony-stimulating factor administration in healthy donors are generally mild. Changes in blood counts were minimal and mainly affected white blood cell counts, which returned to normal values within 2 years after granulocyte-colony stimulating factor administration. No patient developed a hematologic malignancy. A larger number of donors and longer follow-up are needed to determine the safety of granulocyte colony-stimulating factor administration definitively.
关于向健康供者注射粒细胞集落刺激因子的长期随访及安全性的信息有限。本研究的目的是分析西班牙造血干细胞供者登记处中供者注射粒细胞集落刺激因子的副作用，并确定这些供者的长期预后。
西班牙国家供者登记处用于记录向正常供者注射粒细胞集落刺激因子以动员外周血祖细胞的短期和长期结果。迄今为止，已登记了1436名供者（771名男性，665名女性），中位年龄为37岁（范围1至74岁）。粒细胞集落刺激因子是唯一使用的细胞因子。在注射粒细胞集落刺激因子前对每位供者进行基线调查，并计划在动员后4周及此后每年进行随访调查（对照），直至动员后5年。
736名供者至少进行了一次计划中的对照检查，320名供者已随访2年或更长时间。外周血白细胞计数从基线时的6.8×10⁹/L显著降至白细胞分离术后4周时的5.9×¹⁰⁹/L（p<0.0001），并在动员后2年内一直维持在低于动员前观察到的值。相比之下，血红蛋白浓度和血小板计数在动员后1年内恢复到正常水平。骨痛（90%）和头痛（33%）是最常报告与粒细胞集落刺激因子相关的副作用。5名患者（0.68%）在注射粒细胞集落刺激因子后10至64个月被诊断患有实体瘤（2名患者患肺癌，1名患者分别患甲状腺癌脉络膜黑色素瘤和结肠癌）。未报告血液系统恶性肿瘤。
向健康供者注射粒细胞集落刺激因子的临床副作用一般较轻。血细胞计数变化极小，主要影响白细胞计数，白细胞计数在注射粒细胞集落刺激因子后2年内恢复到正常水平。没有患者发生血液系统恶性肿瘤。需要更多的供者和更长时间的随访来最终确定注射粒细胞集落刺激因子的安全性。
