用盐酸氨甲环酸（S-59）光化学病原体灭活法制备的新鲜冰冻血浆：用于先天性凝血因子缺乏患者的输血治疗

Fresh frozen plasma prepared with amotosalen HCl (S-59) photochemical pathogen inactivation: transfusion of patients with congenital coagulation factor deficiencies.

作者信息

de Alarcon Pedro, Benjamin Richard, Dugdale Marion, Kessler Craig, Shopnick Rinah, Smith Peter, Abshire Thomas, Hambleton Julie, Matthew Prasad, Ortiz Idith, Cohen Alice, Konkle Barbara A, Streiff Michael, Lee Martin, Wages David, Corash Laurence

机构信息

Department of Pediatric Hematology, University of Virginia, Charlottesville, Virginia, USA.

出版信息

Transfusion. 2005 Aug;45(8):1362-72. doi: 10.1111/j.1537-2995.2005.00216.x.

DOI:10.1111/j.1537-2995.2005.00216.x

PMID:16078927

Abstract

BACKGROUND

Photochemical treatment (PCT) with amotosalen HCl (S-59) was developed to inactivate pathogens and white blood cells in plasma (PCT-FFP) used for transfusion support.

STUDY DESIGN AND METHODS

An open-label, multicenter trial was conducted in patients with congenital coagulation factor deficiencies (factors [F]I, FII, FV, FVII, FX, FXI, and FXIII and protein C) to measure the kinetics of specific coagulation factors, hemostatic efficacy, and safety of PCT-FFP. Posttransfusion prothrombin time (PT), partial thromboplastin time (PTT), and clinical hemostasis were evaluated before and after PCT-FFP transfusions.

RESULTS

Thirty-four patients received 107 transfusions of PCT-FFP for kinetic studies or therapeutic indications (mean dose, 12.8 +/- 8.5 mL/kg). Incremental factor recoveries ranged from 0.9 to 2.4 IU per dL per IU per kg (FII, FV, FVII, FX, FXI, and protein C). Mean pretransfusion PT (20.7 +/- 22.2 sec) corrected after PCT-FFP (13.8 +/- 2.4 sec, p < 0.001). Mean pretransfusion PTT (51.2 +/- 29.3 sec) corrected after PCT-FFP (32.0 +/- 5.1 sec, p < 0.001). Thirteen patients required 77 transfusions for therapeutic indications. PCT-FFP provided effective hemostasis and was well tolerated.

CONCLUSIONS

Replacement coagulation factors in PCT-FFP exhibited kinetics and therapeutic efficacy consistent with conventional FFP.

摘要

背景

开发了盐酸氨甲环酸（S - 59）光化学处理（PCT）以灭活用于输血支持的血浆（PCT - FFP）中的病原体和白细胞。

研究设计与方法

对先天性凝血因子缺乏症（因子[F]I、FII、FV、FVII、FX、FXI、FXIII和蛋白C）患者进行了一项开放标签、多中心试验，以测量特定凝血因子的动力学、止血效果和PCT - FFP的安全性。在输注PCT - FFP前后评估输血后的凝血酶原时间（PT）、部分凝血活酶时间（PTT）和临床止血情况。

结果

34例患者接受了107次PCT - FFP输注用于动力学研究或治疗指征（平均剂量，12.8±8.5 mL/kg）。每千克每国际单位（IU）每分升的增量因子回收率范围为0.9至2.4 IU（FII、FV、FVII、FX、FXI和蛋白C）。PCT - FFP输注后，平均输血前PT（20.7±22.2秒）得到纠正（13.8±2.4秒，p<0.001）。平均输血前PTT（51.2±29.3秒）在PCT - FFP输注后得到纠正（32.0±5.1秒，p<0.001）。13例患者因治疗指征需要77次输血。PCT - FFP提供了有效的止血，且耐受性良好。