Dexamethasone plus oseltamivir versus dexamethasone in treatment-naive primary immune thrombocytopenia: a multicentre, randomised, open-label, phase 2 trial
Dexamethasone plus oseltamivir versus dexamethasone in treatment-naive primary immune thrombocytopenia: a multicentre, randomised, open-label, phase 2 trial
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地塞米松联合奥司他韦与地塞米松治疗初治原发性免疫性血小板减少症：一项多中心、随机、开放标签 2 期试验
DOI：
10.1016/s2352-3026(21)00030-2
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发表时间：
2021-04-01
影响因子：
24.7
通讯作者：
Hou, Ming
中科院分区：
文献类型：
--
作者：
Sun, Lu;Wang, Juan;Hou, Ming
背景原发性免疫性血小板减少症是一种自身免疫性出血性疾病。临床前报告表明，唾液酸酶抑制剂奥司他韦在治疗免疫性血小板减少症中诱导血小板应答。本研究探讨地塞米松加奥司他韦与地塞米松单独作为初始治疗原发性免疫性血小板减少症的成人患者的活动和安全性。方法本多中心，随机，开放标签，平行组，2期试验在5个三级医院在中国。符合条件的患者年龄为18岁或以上，患有新诊断的、未经治疗的原发性免疫性血小板减少症。参与者被随机分配（1：1），采用区组随机化，接受地塞米松（口服，每天40 mg，持续4天）+奥司他韦（口服，每天两次，持续10天）或地塞米松单药治疗（口服，每天40 mg，持续4天）。对治疗无反应的患者（血小板计数保持不变）
Background Primary immune thrombocytopenia is an autoimmune bleeding disorder. Preclinical reports suggest that the sialidase inhibitor oseltamivir induces a platelet response in the treatment of immune thrombocytopenia. This study investigated the activity and safety of dexamethasone plus oseltamivir versus dexamethasone alone as initial treatment in adult patients with primary immune thrombocytopenia.Methods This multicentre, randomised, open-label, parallel group, phase 2 trial was done in five tertiary medical hospitals in China. Eligible patients were aged 18 years or older with newly diagnosed, treatment-naive primary immune thrombocytopenia. Participants were randomly assigned (1:1), using block randomisation, to receive either dexamethasone (orally at 40 mg per day for 4 days) plus oseltamivir (orally at 75 mg twice a day for 10 days) or dexamethasone monotherapy (orally at 40 mg a day for 4 days). Patients who did not respond to treatment (platelet counts remained