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首页> 外文期刊>Blood coagulation & fibrinolysis: an international journal in haemostasis and thrombosis >Inhibitors incidence rate in Czech previously untreated patients with haemophilia A has not increased since introduction of recombinant factor VIII treatment in 2003
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Inhibitors incidence rate in Czech previously untreated patients with haemophilia A has not increased since introduction of recombinant factor VIII treatment in 2003

机译：自2003年采用重组VIII因子治疗以来，捷克以前未经治疗的A型血友病患者的抑制剂发生率并未增加

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Our objective was to assess the incidence of inhibitors development in Czech Republic since the introduction of recombinant factor VIII (rFVIII) and to look for the factors potentially influencing this parameter. It is to be expected that inhibitors risk may be increased after the introduction of recombinant products. Data of Czech National Haemophilia Programme registry entered from 2003 till 2013 were analysed. Both annual and absolute incidences of newly developed inhibitors in previously untreated patients (PUPs) were calculated. Bleeding and treatment data were also extracted, and association to the treatment regimen and development of inhibitors were analysed. Within the given period, we commenced 45 PUPs with haemophilia A on rFVIII and treated them for 137 treatment-years. Twenty-two of the PUPs had severe haemophilia A, being treated for 88 treatment-years. Treatment strategy for them was prophylaxis. Other PUPs were treated on demand. Median annual bleeding rate was 5 for boys with severe haemophilia, 3 for moderate haemophilia and 1 for mild form of the disease. No inhibitors developed in PUPs with moderate/mild haemophilia A. Annual inhibitor incidence rate in PUPs with severe haemophilia A treated with rFVIII was 56.8 per 1000 treatment-years. Absolute incidence was 22.7% (5/22). All inhibitors appeared within the first 50 exposure days. Comparing rFVIII-treated group with the control group treated under same/similar conditions with plasma-derived FVIII during the same follow-up period, we were not able to find significant difference in inhibitor development between these two groups. Our results support the finding that use of rFVIII is not a proven risk factor for inhibitor development in patients with haemophilia A.
机译：我们的目标是评估自引入重组因子VIII（rFVIII）以来捷克共和国抑制剂发展的发生率，并寻找可能影响该参数的因素。预期引入重组产物后抑制剂风险可能会增加。分析了2003年至2013年输入的捷克国家血友病计划注册数据。计算了以前未治疗的患者（PUPs）中新开发的抑制剂的年发生率和绝对发生率。还提取出血和治疗数据，并分析与治疗方案和抑制剂发展的关系。在给定的时间段内，我们开始用rFVIII进行45例AUP血友病的PUP治疗，治疗了137个治疗年。 22个PUP患有严重的A型血友病，接受了88年的治疗。他们的治疗策略是预防。其他PUP按需处理。重度血友病男孩的年中位数出血率为5，中度血友病为3，轻度疾病为1。在患有中度/轻度A型血友病的PUP中没有开发抑制剂。用rFVIII治疗的患有严重血友病A的PUP中的年抑制剂发生率为每1000个治疗年56.8。绝对发生率为22.7％（5/22）。所有抑制剂均在暴露的前50天内出现。在相同的随访期间，将rFVIII治疗组与对照组在相同/相似条件下用血浆衍生的FVIII治疗，我们在两组之间在抑制剂开发方面没有发现显着差异。我们的结果支持以下发现：使用rFVIII并不是A型血友病患者抑制剂形成的公认危险因素。

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