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采用INTERCEPT血液系统™对血小板成分进行病原体灭活:一项队列研究。

Pathogen-inactivation of platelet components with the INTERCEPT Blood System ™: a cohort study.

作者信息

Infanti Laura, Stebler Christine, Job Shabahang, Ruesch Morven, Gratwohl Alois, Irsch Johannes, Lin Lily, Buser Andreas

机构信息

Blood Transfusion Center, Swiss Red Cross, Basel, Switzerland.

出版信息

Transfus Apher Sci. 2011 Oct;45(2):175-81. doi: 10.1016/j.transci.2011.07.013. Epub 2011 Aug 15.

Abstract

INTRODUCTION

INTERCEPT treatment is used to reduce platelet transfusion associated bacterial infections. Limited data are available in Switzerland.

PATIENTS AND METHODS

Patients with thrombocytopenia or thrombocyte dysfunction requiring platelet transfusions were enrolled in a prospective cohort study on safety (primary endpoint) and efficacy (secondary endpoint) of INTERCEPT treated platelets (I-PLTs). I-PLTs were produced from double-dose apheresis products. Data on safety were actively recorded for each transfusion.

RESULTS

A total of 551 I-PLT units (mean platelet dose: 2.6 ± 0.4 × 10(11)/unit) were transfused to 46 patients (mean number of platelet transfusions per patient: 12 ± 12.5). Fifty-one (9%) transfusions were associated with adverse events and 12 (2%) with acute transfusion reactions. Eleven serious adverse events were observed, none considered as related to the administration of I-PLT. Mean 1-4h and 16-24h CCIs were 10.1 ± 8.1 and 3.6 ± 6.6, respectively.

CONCLUSION

The transfusion of I-PLT was associated with a good safety profile and adequate platelet count increments at 1-4h.

摘要

引言

INTERCEPT治疗用于减少血小板输注相关的细菌感染。瑞士的相关数据有限。

患者与方法

需要输注血小板的血小板减少症或血小板功能障碍患者参与了一项关于INTERCEPT处理血小板(I-PLT)安全性(主要终点)和有效性(次要终点)的前瞻性队列研究。I-PLT由双倍剂量单采产品制备。每次输血时都主动记录安全性数据。

结果

共向46例患者输注了551个I-PLT单位(平均血小板剂量:2.6±0.4×10¹¹/单位)(每位患者平均血小板输注次数:12±12.5)。51次(9%)输血与不良事件相关,12次(2%)与急性输血反应相关。观察到11例严重不良事件,均不认为与I-PLT的输注有关。平均1 - 4小时和16 - 24小时的CCI分别为10.1±8.1和3.6±6.6。

结论

I-PLT的输注安全性良好,1 - 4小时时血小板计数有足够的增加。

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