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首页> 外文期刊>Prescrire international >Romiplostim: new drug. Thrombocytopenic purpura: for selected patients, with close monitoring.
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Romiplostim: new drug. Thrombocytopenic purpura: for selected patients, with close monitoring.

机译：Romiplostim：新药。血小板减少性紫癜：针对特定患者，并进行密切监测。

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There is no consensus treatment for patients with idiopathic thrombocytopenic purpura at a high risk of bleeding after failure of corticosteroids, immunoglobulins and splenectomy. Romiplostim (Nplate~o, Amgen), a recombinant analogue of thrombopoietin (a platelet growth factor), is now authorised in the European Union for use in this setting. In a randomised double-blind placebo-controlled trial in 63 splenectomised patients treated for 24 weeks, the platelet count rose to at least 50 000/mm~3 and remained at this level for 6 weeks in 38% of patients receiving romiplostin, versus none of the patients in the placebo group. However, there was no difference in the number of patients who experienced bleeding events. It is not known how long the beneficial effect of romiplostim lasts after treatment cessation. A randomised double-blind placebo-controlled trial in 62 non-splenectomised patients provided similar results. This study also failed to show how long the benefit lasted after romiplostim withdrawal. A long-term study of 142 patients (mean follow-up 69 weeks, maximum 156 weeks) suggested that romiplostim reduced the risk of bleeding. Indirect comparison with eltrombopag, another thrombopoietin receptor agonist, favours romiplostim. Romiplostim has been more thoroughly evaluated and has led to an increase in the platelet count to at least 50 000/mm~3 in more patients. As indirect comparisons provide a low level of evidence, this superiority needs to be confirmed in head-to-head trials. Rebound thrombocytopenia can sometimes occur after drug withdrawal. Follow-up is too short to reach conclusions about the potential risk of bone marrow fibrosis and cancer. About 10% of patients develop antibodies to romiplostim. The clinical consequences are not known but animal studies showed a decline in efficacy. The risk of renal adverse effects needs to be determined. In practice, romiplostim is an option when standard treatments fail to control chronic idiopathic thrombocytopenic purpura in patients who are at high risk of bleeding. Strict follow-up is needed to identify long-term risks.
机译：对于皮质类固醇，免疫球蛋白和脾切除术失败后高出血风险的特发性血小板减少性紫癜患者尚无共识性治疗方法。 Romiplostim（Nplate_o，Amgen）是一种血小板生成素（血小板生长因子）的重组类似物，现已在欧盟授权用于这种环境。在一项随机双盲安慰剂对照试验中，在接受了24周治疗的63例经脾切除术治疗的患者中，血小板计数上升至至少50000 / mm〜3，并且在38％接受romiplostin的患者中血小板计数保持在该水平6周，而没有安慰剂组的患者中。但是，经历出血事件的患者数量没有差异。尚不知道罗米洛司汀的疗效在停药后持续多长时间。一项在62例未切除脾脏的患者中进行的随机双盲安慰剂对照试验提供了相似的结果。这项研究也未能显示停用罗莫司汀后益处持续多长时间。一项针对142例患者的长期研究（平均随访69周，最大156周）表明romiplostim降低了出血的风险。与另一种血小板生成素受体激动剂Eltrombopag的间接比较有利于romiplostim。对Romiplostim进行了更彻底的评估，并导致更多患者的血小板计数增加至至少50000 / mm〜3。由于间接比较提供的证据很少，因此这种优势需要在面对面试验中得到证实。停药后有时会发生反弹性血小板减少。随访时间太短，无法得出有关骨髓纤维化和癌症的潜在风险的结论。大约10％的患者会产生针对romiplostim的抗体。临床后果尚不清楚，但动物研究显示功效下降。需要确定肾脏不良反应的风险。在实践中，当标准疗法无法控制高出血风险患者的慢性特发性血小板减少性紫癜时，romiplostim是一种选择。需要严格的跟进以确定长期风险。

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    《Prescrire international》 |2009年第104期|共1页
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