van der Poel C L, Seifried E, Schaasberg W P
Sanquin Blood Supply Foundation, Plesmanlaan 125, 1066 CX Amsterdam, the Netherlands.
Vox Sang. 2002 Nov;83(4):285-93. doi: 10.1046/j.1423-0410.2002.00239.x.
It is presently disputed whether studies indicating a higher risk of infectious diseases among paid blood donors are lessons of the past, or still hold relevance. Comparative studies published between 1968 and 2001 were assessed for a possible trend of change in the relative risk for infectious disease markers between paid and unpaid blood or plasma donors. Studies reporting that paid donors had lower risk were found, but most studies, including recent ones, continued to report that paid donors have higher rates of infectious disease markers than unpaid donors. By log-linear regression analysis of the relative risk estimates for infectious disease markers among paid and unpaid donors from 28 published data sets, evidence was not found to indicate that the difference in risk for infectious disease markers between paid donors and unpaid donors had diminished over time (P = 0.128, not significant). Paid donors are still more likely than unpaid donors to donate blood in the period during which infectious donations escape detection by blood-screening tests (the "window-period"). Therefore, paid donations have a higher risk that labile blood components (such as red blood cells and platelets) are infected. Additional safety measures for handling plasma donations, and the preparation, purification and viral-inactivation steps employed for the production of plasma derivatives, may render the difference in infectious disease marker rates in donors irrelevant for plasma products. However, not all viruses are inactivated and paid donors were repeatedly found to have higher frequencies of markers for emerging agents. In a quality system, critical steps of the process should be addressed, and selection of the donor population is one of the first steps in this process. It is advised that blood establishments present yearly reports (with complete and raw data) to authorities on the incidence and prevalence of infectious disease markers among their donors as an ongoing surveillance on the "quality" of their donor populations. Paid blood or plasma donors still have higher rates for infectious disease markers than unpaid donors.
目前存在争议的是，那些表明有偿献血者中传染病风险较高的研究是过去的经验教训，还是仍然具有现实意义。对1968年至2001年间发表的比较研究进行了评估，以探讨有偿和无偿献血者或血浆捐献者之间传染病标志物相对风险的可能变化趋势。虽然发现了一些报告称有偿捐献者风险较低的研究，但包括近期研究在内的大多数研究仍继续报告称，有偿捐献者的传染病标志物发生率高于无偿捐献者。通过对28个已发表数据集中有偿和无偿捐献者传染病标志物相对风险估计值进行对数线性回归分析，未发现有证据表明有偿捐献者和无偿捐献者之间传染病标志物风险的差异随时间而减小（P = 0.128，无统计学意义）。在血液筛查检测无法检测到感染性捐献的时期（“窗口期”），有偿捐献者比无偿捐献者更有可能献血。因此，有偿捐献的不稳定血液成分（如红细胞和血小板）被感染的风险更高。处理血浆捐献的额外安全措施，以及血浆衍生物生产中采用的制备、纯化和病毒灭活步骤，可能使捐献者中传染病标志物发生率的差异与血浆产品无关。然而，并非所有病毒都能被灭活，而且反复发现有偿捐献者中新兴病原体标志物的频率更高。在质量体系中，应关注该过程的关键步骤，而捐献者群体的选择是该过程的首要步骤之一。建议血液机构每年向当局提交关于其捐献者中传染病标志物发生率和流行率的报告（包括完整和原始数据），作为对其捐献者群体“质量”的持续监测。有偿献血者或血浆捐献者的传染病标志物发生率仍然高于无偿捐献者。
