Hämophiliezentrum, Klinik für Innere Medizin - Angiologie, Hämostaseologie und Pneumologie, Vivantes-Klinikum im Friedrichshain, Berlin, Germany.
Klinik für Pädiatrische Hämatologie und Onkologie, Campus Virchow Klinikum, Universitätsklinikum Charité Berlin, Berlin, Germany.
Thromb Res. 2014 Nov;134 Suppl 1:S16-21. doi: 10.1016/j.thromres.2013.10.014. Epub 2014 Jan 10.
The German Beriate(®) P pharmacovigilance study started in 2003 and is planned to run until December 2013.
This analysis included data from 84 haemophilia A patients treated with the high-purity, plasma-derived coagulation factor VIII concentrate Beriate(®) P. Prior to study start, 69 of the 80 patients for whom data were available had received previous treatment with Beriate(®) P (mean treatment period 7.1 ± 5.4 years). The mean study duration from the start of pharmacovigilance was 43.3 ± 30.3 months (median 43.5 months; range 0-101.9months). The most common treatment at the last visit was prophylaxis (65.7% of patients), which was most commonly administered at a frequency of three infusions/week in 47.3% of patients.
Most patients experienced up to six minor bleeds/year. For 1,311 bleeding episodes, a median of one infusion/bleed was administered (mean 2.8 ± 4.7; range 0-83). The clinical response to Beriate(®) P was rated "excellent"/"good" in 94% of 32 visits of patients with major bleeding. The clinical response for patients with minor bleeding was rated "excellent"/"good" in 98.5% of 377 visits. One clinically relevant inhibitor in a previously untreated patient was documented during the study course. There were no reports of virus transmissions suspected to be caused by Beriate(®) P prior to the study start or during the study.
These findings confirm the excellent efficacy, safety, and tolerability of Beriate(®) P in the treatment of a wide spectrum of previously untreated patients up to adult patients with haemophilia A.
德国 Beriate(®) P 药物警戒研究于 2003 年启动，计划持续至 2013 年 12 月。
本分析纳入了 84 例接受高纯度血浆源性凝血因子 VIII 浓缩物 Beriate(®) P 治疗的血友病 A 患者的数据。在研究开始前，可获得数据的 80 例患者中有 69 例曾接受过 Beriate(®) P 治疗（平均治疗期 7.1±5.4 年）。从药物警戒开始的平均研究持续时间为 43.3±30.3 个月（中位数 43.5 个月；范围 0-101.9 个月）。最后一次就诊时最常见的治疗方法是预防治疗（65.7%的患者），其中 47.3%的患者最常每周输注 3 次预防治疗。
大多数患者每年发生 1 至 6 次轻度出血。对于 1311 次出血事件，中位数为每次出血输注 1 次（平均 2.8±4.7；范围 0-83）。32 次大出血患者就诊时，临床反应评价为“极好”/“良好”的比例为 94%。377 次轻度出血患者就诊时，临床反应评价为“极好”/“良好”的比例为 98.5%。在研究过程中，记录到 1 例先前未经治疗的患者出现临床相关抑制剂。在研究开始前或研究期间，均无报告疑似由 Beriate(®) P 引起的病毒传播。
这些发现证实了 Beriate(®) P 在治疗广泛谱的未曾治疗过的患者直至成年血友病 A 患者时具有优异的疗效、安全性和耐受性。
