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使用双病毒灭活和朊病毒减少的溶剂/去污剂新鲜冰冻血浆进行血浆置换治疗血栓性微血管病的疗效和安全性:法国单中心的首例经验。

Efficacy and safety of plasma exchange using a double viral inactivated and prion reduced solvent/detergent fresh frozen plasma for the treatment of thrombotic microangiopathy: The first French experience in a single center.

作者信息

Poullin Pascale, Delmotte Nicolas, Sanderson Frederick, Roche Manon, Gensollen Sophie

机构信息

Service d'Hémaphérèse, Hôpital de La Conception, Assistance Publique-Hôpitaux de Marseille, Marseille, France; Centre de Référence Constitutif des Microangiopathies Thrombotiques, France.

Pharmacie Usage Intérieur, Hôpital de la Conception, Assistance Publique-Hôpitaux de Marseille, Marseille, France.

出版信息

Transfus Apher Sci. 2020 Feb;59(1):102587. doi: 10.1016/j.transci.2019.07.002. Epub 2019 Jul 9.

DOI:10.1016/j.transci.2019.07.002
PMID:31331708
Abstract

BACKGROUND

Octaplas LG® is the first plasma with marketing authorisation, available in France only since February 2016. This is a double viral inactivated and prion reduced solvent/detergent fresh frozen plasma. Clinical data on Octaplas LG® use in thrombotic microangiopathy (TMA) remains very limited. In May 2017, we were the first hospital in France to benefit of this new plasma product now dispensed by hospital pharmacies. We present a prospective review of all therapeutic plasma exchange (TPE) procedures for TMA patients in our hospital to evaluate the new delivery circuit, the efficacy and the adverse events (AE) related to this plasma.

STUDY DESIGN AND METHODS

We prospectively reviewed 166 TPE procedures where Octaplas LG® was used as replacement fluid in 15 consecutive TMA patients required TPE in our hospital from May 2017 until December 2018.

RESULTS

The total replacement plasma volume administered was 763 L (3818 units) with a median on 32 L (range 6-157) per episode. Remission was achieved in all cases after a median of 7 TPE per patient's episode. No exacerbation nor relapse were noted. One patient presented a grade 1 citrate reaction, and another patient an allergic reaction. We deplored pulmonary embolism in 2 patients.

CONCLUSION

In our experience OctaplasLG® was well-tolerated and was effective at inducing a full clinical remission. Although two PE were noted, the relationship to OctaplasLG® in unclear. The new dispensing circuit through the hospital pharmacy has proven to be safe and efficient.

摘要

背景

Octaplas LG®是首个获得上市许可的血浆产品,自2016年2月起仅在法国有售。这是一种双重病毒灭活且朊病毒减少的溶剂/去污剂新鲜冷冻血浆。关于Octaplas LG®用于血栓性微血管病(TMA)的临床数据仍然非常有限。2017年5月,我们是法国第一家受益于这种现由医院药房配发的新型血浆产品的医院。我们对我院TMA患者的所有治疗性血浆置换(TPE)程序进行了前瞻性回顾,以评估新的输注回路、该血浆的疗效和不良事件(AE)。

研究设计与方法

我们前瞻性回顾了166例TPE程序,其中从2017年5月至2018年12月,在我院15例连续需要TPE的TMA患者中使用Octaplas LG®作为置换液。

结果

总共输注的置换血浆量为763升(3818单位),每次输注的中位数为32升(范围6 - 157升)。每位患者每次发作平均进行7次TPE后,所有病例均实现缓解。未观察到病情加重或复发。1例患者出现1级枸橼酸盐反应,另1例患者出现过敏反应。我们对2例患者发生肺栓塞感到遗憾。

结论

根据我们的经验,OctaplasLG®耐受性良好,能有效诱导完全临床缓解。尽管注意到2例肺栓塞,但与OctaplasLG®的关系尚不清楚。通过医院药房的新配发回路已被证明是安全有效的。

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