Romiplostim or Standard of Care in Patients with Immune Thrombocytopenia.
Romiplostim or Standard of Care in Patients with Immune Thrombocytopenia.
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DOI：
10.1056/nejmoa1002625
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发表时间：
2010-11-11
影响因子：
158.5
通讯作者：
Berger, Dietmar P.
中科院分区：
文献类型：
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作者：
Kuter, David J.;Rummel, Mathias;Berger, Dietmar P.
背景资料：Romiplostim，血小板生成素模拟物，增加血小板计数免疫性血小板减少症患者，很少有不良反应。方法：在这个开放标签，52周的研究，我们随机分配234例成人免疫性血小板减少症患者，谁没有接受脾切除术，接受标准的护理（77例）或每周皮下注射romiplostim（157例）。主要终点是治疗失败和脾切除术的发生率。次要终点包括血小板应答率（在任何预定的访视中血小板计数>50 × 10（sup 9）/L）、安全性结果和生活质量。结果：罗米司亭组的血小板应答率是标准治疗组的2.3倍（95%可信区间[CI]，2.0 - 2.6; P
Background: Romiplostim, a thrombopoietin mimetic, increases platelet counts in patients with immune thrombocytopenia, with few adverse effects.Methods: In this open-label, 52-week study, we randomly assigned 234 adult patients with immune thrombocytopenia, who had not undergone splenectomy, to receive the standard of care (77 patients) or weekly subcutaneous injections of romiplostim (157 patients). Primary end points were incidences of treatment failure and splenectomy. Secondary end points included the rate of a platelet response (a platelet count >50 x 10(sup 9) per liter at any scheduled visit), safety outcomes, and the quality of life.Results: The rate of a platelet response in the romiplostim group was 2.3 times that in the standard-of-care group (95% confidence interval [CI], 2.0 to 2.6; P