Romiplostim:回顾其在免疫血小板减少使用。
文章的细节
-
引用
复制到剪贴板 -
基廷通用
Romiplostim:回顾其在免疫血小板减少使用。
药。2012年2月12日,72 (3):415 - 35。doi: 10.2165 / 11208260-000000000-00000。
- PubMed ID
-
22316355 (在PubMed]
- 文摘
-
Romiplostim (Nplate (R))是一个Fc-peptide融合蛋白(peptibody)作为促血小板生成素受体激动剂;它没有和内源性促血小板生成素氨基酸序列的同源性。本文综述的临床疗效和耐受性皮下romiplostim成人免疫血小板减少症(ITP),以及总结其药理特性。12或24周的治疗的疗效与皮下romiplostim ITP患者与安慰剂比较三个随机、双盲、多中心、III期试验。两个24周试验,耐久的血小板反应率(主要终点)明显高于romiplostim比安慰剂splenectomized和nonsplenectomized病人。此外,大多数romiplostim接受者能够停止或减少并发ITP的治疗,和romiplostim改善健康相关的生活质量(HR-QOL)。在为期12周的审判在splenectomized或nonsplenectomized日本ITP患者,中位数的周数与血小板反应(主要终点)明显高于romiplostim比安慰剂。两个扩展研究(romiplostim治疗的持续时间中位数为78和100周)表明,长期治疗romiplostim维护ITP患者的血小板计数在目标范围内。在一项随机、非盲、多中心、52周,希望审判阶段,romiplostim是更有效的比标准的医疗保健的nonsplenectomized ITP患者至少收到一个在ITP治疗。显著减少患者接受romiplostim与所需的医疗保健经验治疗失败或标准的脾切除术(co-primary端点),从基线和临床上有意义的改进与romiplostim HR-QOL分数被认为。 Subcutaneous romiplostim was generally well tolerated in patients with ITP; in short-term trials, the majority of adverse events were of mild to moderate severity and appeared to be related to the underlying thrombocytopenia. The incidence of bleeding events of at least grade 3 severity did not significantly differ between romiplostim and placebo recipients, and was significantly lower with romiplostim than with the medical standard of care. Romiplostim did not appear to be associated with an increased risk of haematological malignancies or an increased risk of thrombotic events. Although binding antibodies against romiplostim or thrombopoietin developed in some romiplostim recipients, with neutralizing antibodies to romiplostim detected in two romiplostim recipients, antibodies cross reacting to thrombopoietin have not been detected. Romiplostim was associated with modest increases in bone marrow reticulin in some patients with ITP; reductions in reticulin were usually seen when romiplostim was discontinued. In conclusion, subcutaneous romiplostim is a valuable agent for use in patients with refractory chronic ITP.
beplay体育安全吗DrugBank数据引用了这篇文章
- 药物