Weighing the risks of G-CSF administration, leukopheresis, and standard marrow harvest: Ethical and safety considerations for normal pediatric hematopoietic cell donors
Weighing the risks of G-CSF administration, leukopheresis, and standard marrow harvest: Ethical and safety considerations for normal pediatric hematopoietic cell donors
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DOI：
10.1002/pbc.20708
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发表时间：
2006-04-01
影响因子：
3.2
通讯作者：
Nelson, RM
中科院分区：
文献类型：
--
作者：
Pulsipher, MA;Nagler, A;Nelson, RM
背景资料：粒细胞集落刺激因子（G-CSF）用于采集大多数成人和较小但占显著百分比的儿科正常供体收获物中的造血细胞。G-CSF管理和leukopheresis的短期和长期的风险是没有很好地理解在pediatric population.Procedure：文献综述，包括观察从IBMTR，NMDP，EBMT，德国供体注册，和authors' work.Results：GCSF引起暂时的不适，在少数年轻的捐助者。G-CSF的罕见严重副作用尚未在儿童中报道。迄今为止，在成人供体中未检测到短期使用G-CSF后血液学恶性肿瘤的增加，也未报告儿童中的病例。报道的儿童白细胞去除术的并发症是罕见和轻微的，但< 20公斤的供体可能暴露于同种异体血液制品。儿科老年捐赠者在同意或同意捐赠程序风险的能力方面差异很大。在决定哪些捐赠程序适合未成年人时，必须考虑到关键的法规和道德要求。虽然短期给予G-CSF和白细胞去除术在用于辅助从正常儿科供体收集造血细胞移植物时似乎是安全有效的程序，增加或取代标准骨髓捐赠的一种或两种程序的机构必须决定捐赠者是否应被视为研究对象，如果是，新程序是否比最小风险略有增加。由于这些手术在许多儿科中心进行，因此针对供体安全性的全面研究可能有助于澄清罕见不良事件的风险。
Background: Granulocyte colony stimulating factor (G-CSF) is used for collection of hematopoietic cells in most adult and a smaller but significant percentage of pediatric normal donor harvests. Short and long-term risks of G-CSF administration and leukopheresis are not well understood in the pediatric population.Procedure: Literature review including observations from the IBMTR, NMDP, EBMT, German Donor Registry, and the authors' work.Results: GCSF causes temporary discomfort in a minority of younger donors. Rare serious side effects of G-CSF have yet to be reported in children. To date, an increase in hematological malignancies after short-term G-CSF use has not been detected in adult donors and no cases have been reported in children. Reported complications of leukopheresis in children are rare and minor, but donors < 20 kg may be exposed to allogeneic blood products. Pediatric aged donors vary widely in their ability to assent or consent to the risks of a donation procedure. There are key regulations and ethical imperitives, which must be addressed in deciding which donation procedures are appropriate for minors.Conclusions: While short term administration of G-CSF and leukopheresis appear to be safe and effective procedures when used to assist in collection of a hematopoietic cell graft from a normal pediatric donor, institutions adding or substituting one or both of these procedures for standard marrow donation must decide whether the donor should be considered a research subject, and if so, whether the new procedures are a minor increase over minimal risk. Because these procedures are being performed on and off study at many pediatric centers, a comprehensive study addressing donor safety could help clarify risks of rare adverse events.