亲缘与非亲缘供者造血干细胞动员和采集的安全性比较

本研究对捐献骨髓及外周造血干细胞的健康亲缘供者及只捐献外周造血干细胞的非亲缘供者，在造血干细胞动员和采集的安全性方面进行比较。对2005年9月至2006年8月在北京大学人民医院血液病研究所提供异基因造血干细胞的亲缘供者100例及2003年11月至2007年12月在中国造血干细胞捐献者资料库北京管理中心登记的非血缘供者71例，在造血干细胞动员、采集及采集后1、3、6个月及每年进行了评估。对血常规指标、不良反应等进行观察记录，并对随访期间的长期不良反应及生活质量进行了问卷调查。结果显示：亲缘供者提供的骨髓＋外周血干细胞总MNC剂量为6．70（4．11—12．23）×10^8／kg，总CD34^＋细胞剂量为3．40（1．61—13．57）×10^6／kg：非亲缘供者提供的外周血干细胞总MNC剂量为6．69（3．35-11．48）×10^8／kg，总CD34^＋细胞剂量为3．50（1．15—11．60）×10^6／kg。动员时的常见副作用为骨痛，在亲缘供者的发生率为47％，在非亲缘供者的发生率为43．7％，两组之间无显著性差异；采集时的常见副作用为感觉异常（口唇和四肢），在亲缘供者的发生率为25％，在非亲缘供者的发生率为29．6％，两组之间无显著性差异；所有供者对副作用皆可耐受，没有供者因为不能耐受而中断采集。亲缘供者由于骨髓和外周血的采集，其血红蛋白水平低于非亲缘供者（125．8±20．2）g／L vs（143．2±20．1）g／L]（P〈0．05）。非亲缘供者由于外周干细胞采集多为2次，其血小板计数低于亲缘供者（126．2±57．2）×10^9／L vs（162．4±72．9）×10^9／L]（P〈0．05）。在长期随访中，亲缘供者与非亲缘供者的血常规检查结果比较无显著性差异，无长期的不良反应，健康状况良好。结论：亲缘与非亲缘供者进行造血干细胞采集都是安全可行的。术前进行完备的检查，术中仔细操作、严密观察，及术后长期随访对于供者的安全有重要的意义。

Safety Comparison of Mobilization and Collection of Hematopoietic Stem Cells between Related and Unrelated Donors

The study was aimed to compare the safety of hematopoietic stem cell mobilization and collection in related donors providing bone marrow and peripheral blood stem cells and in unrelated donors providing peripheral blood stem cells only. 100 related donors from September 2005 to August 2006 at Institute of Hematology ＆ People Hospital, Peking University, and 71 unrelated donors from November 2003 to December 2007 in Data Bank of Chinese Hematopoi- etic Stem Cell Donor Beijing Management Center, were observed in process of bone marrow and peripheral blood stem cell mobilization, collection, and follow-up. The change of hematologic parameters （white blood cell count, platelet count and hemoglobin level） and the side effects were recorded and evaluated on months 1, 3 and 6 as well as annually ,after PBSC donation. During follow-up, long-term side effects and life quality were investigated by questionnaires. The results showed that the total MNC count of bone marrow and PBSC from related donors was 6.70（4.11 - 12.23） × 10^8/ kg, and the total CD34^＋ cell count was 3.40（ 1.61 - 13.57） × 10^6/kg; the total MNC count of PBSC from unrelated donors was 6. 69 （3.35-11.48） ×108/kg, and the total CD34^＋ cell count was 3. 50 （1.15-11.60） ×106/kg. The main side effect of mobilization was bone pain, reported in 47.0% of the related donors and in 43.7% of unrelated ones, the main side effect of collection was paresthesia, reported in 25.0% of the related donors and in 29.6% of unrelated ones, there was no significant difference on side effects between related and unrelated donors during mobilization and collection of hematopoietic stem cells, all donors could endure these side effects, and no donor discontinued G-CSF administration because of side effects. After collection, the hemoglobin level of related donors was lower than that of unrelated donors （ 125.8 ±20.2）g/L vs （ 143.2 ±20.1 ）g/L] （p 〈0.05） because of bone morrow and peripheral blood collection, and the platelet count of unrelated donors were lower than that of related donors （ 126.2 ± 57.2 ） × 10^9/L vs （162.4 ± 72. 9） ×10^9/L] （p 〈 0.05 ） because of more than two times of collection. There was no significant difference on hematologic parameters between two groups during long-term follow-up, and the majority of the donors reported were in good or very good health. It is concluded that the donation proved from related and unrelated donors is safe to mobilize hematopoietic stem cells for allogeneic transplantation. Long-term monitoring of healthy PBSC donors remains important to guarantee the safety standards of bone marrow and peripheral blood stem cell mobilization and collection, including comprehensive medical examination before mobilization and collection, careful manupulation during collection, long term follow up after collection and so on.