van Rhenen Dick, Gulliksson Hans, Cazenave Jean-Pierre, Pamphilon Derwood, Ljungman Per, Klüter Harald, Vermeij Hans, Kappers-Klunne Mies, de Greef Georgine, Laforet Michel, Lioure Bruno, Davis Kathryn, Marblie Stephane, Mayaudon Veronique, Flament Jocelyne, Conlan Maureen, Lin Lily, Metzel Peyton, Buchholz Don, Corash Laurence
Sanquin Blood Bank South West Region, Rotterdam, The Netherlands.
Blood. 2003 Mar 15;101(6):2426-33. doi: 10.1182/blood-2002-03-0932. Epub 2002 Nov 27.
A nucleic acid-targeted photochemical treatment (PCT) using amotosalen HCl (S-59) and ultraviolet A (UVA) light was developed to inactivate viruses, bacteria, protozoa, and leukocytes in platelet components. We conducted a controlled, randomized, double-blinded trial in thrombocytopenic patients requiring repeated platelet transfusions for up to 56 days of support to evaluate the therapeutic efficacy and safety of platelet components prepared with the buffy coat method using this pathogen inactivation process. A total of 103 patients received one or more transfusions of either PCT test (311 transfusions) or conventional reference (256 transfusions) pooled, leukoreduced platelet components stored for up to 5 days before transfusion. More than 50% of the PCT platelet components were stored for 4 to 5 days prior to transfusion. The mean 1-hour corrected count increment for up to the first 8 test and reference transfusions was not statistically significantly different between treatment groups (13,100 +/- 5400 vs 14,900 +/- 6200, P =.11). By longitudinal regression analysis for all transfusions, equal doses of test and reference components did not differ significantly with respect to the 1-hour (95% confidence interval [CI], -3.1 to 6.1 x 10(9)/L, P =.53) and 24-hour (95% CI, -1.3 to 6.5 x 10(9)/L, P =.19) posttransfusion platelet count. Platelet transfusion dose, pretransfusion storage duration, and patient size were significant covariates (P <.001) for posttransfusion platelet counts. Clinical hemostasis, hemorrhagic adverse events, and overall adverse events were not different between the treatment groups. Platelet components prepared with PCT offer the potential to further improve the safety of platelet transfusion using technology compatible with current methods to prepare buffy coat platelet components.
开发了一种使用盐酸氨甲环酸（S-59）和紫外线A（UVA）光的核酸靶向光化学疗法（PCT），以灭活血小板成分中的病毒、细菌、原生动物和白细胞。我们对需要反复输注血小板长达56天以提供支持的血小板减少症患者进行了一项对照、随机、双盲试验，以评估使用这种病原体灭活过程通过白膜层法制备的血小板成分的治疗效果和安全性。共有103名患者接受了一次或多次输注PCT测试（311次输注）或传统对照（256次输注）的汇集、白细胞滤除的血小板成分，这些成分在输血前最多储存5天。超过50%的PCT血小板成分在输血前储存4至5天。在前8次测试和对照输注中，治疗组之间的平均1小时校正计数增加值在统计学上无显著差异（13,100±5400对14,900±6200，P = 0.11）。通过对所有输注进行纵向回归分析，等剂量的测试和对照成分在输血后1小时（95%置信区间[CI]，-3.1至6.1×10⁹/L，P = 0.53）和24小时（95%CI，-1.3至6.5×10⁹/L，P = 0.19）的血小板计数方面无显著差异。血小板输注剂量、输血前储存时间和患者体型是输血后血小板计数的显著协变量（P < 0.001）。治疗组之间的临床止血、出血不良事件和总体不良事件无差异。使用PCT制备的血小板成分有可能利用与当前制备白膜层血小板成分的方法兼容的技术进一步提高血小板输血的安全性。
