1 The Royal Melbourne Hospital, Melbourne, Australia. 2 Canadian Blood Services, Ottowa, ONT, Canada. 3 Europdonor Foundation, Leiden, The Netherlands. 4 Singapore General Hospital and Duke-NUS Graduate Medical School, College Road, Singapore. 5 Cell Therapy Services, Finnish Red Cross Blood Service and Helsinki University Central Hospital, Finland. 6 National Marrow Donor Program, Minneapolis, MN. 7 DKMS German Bone Marrow Donor Center, Köln, Germany. 8 Center for International Blood and Marrow Transplant Research, Milwaukee, MN. 9 Schneider Children's Medical Center of Israel, Petach Tikva, Israel.
Transplantation. 2016 Jun;100(6):1329-31. doi: 10.1097/TP.0000000000001223.
More than 12 000 volunteer unrelated hematopoietic stem cell donations are undertaken annually, and the World Marrow Donor Association established an expert committee to examine all reports of adverse events affecting donors globally, eventually making such reporting a necessary part of World Marrow Donor Association accreditation. The committee evaluates and responds to reported events in a nonpunitive confidential process designed to alert the community of rare events which might be missed by local follow-up. Each report is evaluated by the committee for imputability (causal link between the donation and the adverse event) and compared with that submitted by the reporting registry. In 2014, there were 50 reports received from 16 different registries in 15 countries. There were 16 reports of malignancies arising in donors including 3 hematologic malignancies. All but 2 of the 16 occurred more than a year after donation. There were 4 reports of autoimmune phenomena in donors all occurring more than a year postdonation. Of the 30 remaining events, 6 were allergic, 4 cardiac, 3 gastrointestinal, 2 infections, 2 pulmonary, and 13 miscellaneous. Causation was assessed differently to the reporting registry in 17 events with 6 thought to be less likely causally linked to the donation and 10 more likely with 1 requiring more information. Volunteer unrelated hematopoietic stem cell donation is a safe and effective altruistic contribution to the treatment of patients with life-threatening hematologic disorders. A decade of detailed examination of adverse donor events has contributed to the safety of these donations.
每年有超过 12000 例志愿者无关造血干细胞捐献，世界骨髓捐献者协会成立了一个专家委员会，审查全球影响供者的所有不良事件报告，最终使这种报告成为世界骨髓捐献者协会认证的必要部分。该委员会以非惩罚性保密程序评估和回应报告的事件，旨在提醒社区注意可能被当地随访遗漏的罕见事件。委员会对每一份报告进行可归因性评估（捐献与不良事件之间的因果关系），并与报告登记处提交的报告进行比较。2014 年，来自 15 个国家的 16 个不同登记处收到了 50 份报告。在供者中报告了 16 例恶性肿瘤，包括 3 例血液恶性肿瘤。除 2 例外，其余 16 例均发生在捐献后一年以上。供者中有 4 例自身免疫现象报告，均发生在捐献后一年以上。在其余 30 例事件中，6 例为过敏，4 例为心脏，3 例为胃肠道，2 例为感染，2 例为肺部，13 例为其他。17 例事件的因果关系评估与报告登记处不同，其中 6 例被认为与捐献的因果关系较小，10 例更有可能，其中 1 例需要更多信息。志愿者无关造血干细胞捐献是对危及生命的血液系统疾病患者治疗的一种安全有效的利他主义贡献。十年来对不良供者事件的详细检查有助于这些捐献的安全性。
