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聚乙二醇干扰素α-2b治疗真性红细胞增多症

[Ropeginterferon alfa-2 b for the therapy of polycythemia vera].

作者信息

Červinek Libor

出版信息

Vnitr Lek. 2020 Spring;66(5):309-313.

Abstract

Interferon alfa (IFNα) has been used in the treatment of myeloproliferative disorders for more than 30 years. IFNα has been shown to induce clinical, hematological, molecular, and histopathological remission, but its toxicity has remained a limitation of its more widespread use. The development of pegylated forms with a better tolerance has brought new options for patients. Phase III clinical trials, ropeginterferonα versus hydroxyurea: PROUD-PV and CONTINUATION-PV, have shown long-term superiority in the efficacy and safety when comparing ropeginterferon alfa-2 b with hydroxyurea. Therapeutic use of interferons is a necessary part of the treatment regimen in younger at-risk patients in the first line, but until now, no SPC of a non-pegylated or pegylated interferon included treatment of patients with polycythemia vera. Ropeginterferon alfa-2 b (Besremi®) is the first and only one to have obtained registration and is available in the European Union as well as the Czech Republic for the treatment of patients with polycythemia vera without symptomatic splenomegaly.

摘要

干扰素α(IFNα)用于治疗骨髓增殖性疾病已有30多年。IFNα已被证明可诱导临床、血液学、分子和组织病理学缓解,但其毒性仍然限制了其更广泛的应用。耐受性更好的聚乙二醇化形式的开发为患者带来了新的选择。III期临床试验,聚乙二醇化干扰素α-2b与羟基脲对比:PROUD-PV和CONTINUATION-PV,在比较聚乙二醇化干扰素α-2b与羟基脲时显示出长期的疗效和安全性优势。对于一线有风险的年轻患者,干扰素的治疗性使用是治疗方案的必要组成部分,但到目前为止,非聚乙二醇化或聚乙二醇化干扰素的药品说明书均未包括真性红细胞增多症患者的治疗。聚乙二醇化干扰素α-2b(Besremi®)是首个也是唯一一个获得注册的药物,在欧盟以及捷克共和国可用于治疗无症状脾肿大的真性红细胞增多症患者。

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