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NEJM:伊屈泼帕可减少慢性肝病患者血小板输注

  1. 伊屈泼帕
  2. 慢性肝病患者
  3. 血小板

来源:互联网 2012-12-19 17:50

伊屈泼帕是一种口服促血小板生成素受体激动剂。以色列Deaconess医学中心Nezam H. Afdhal博士等人的这一研究评估了伊屈泼帕治疗接受选择性侵入性治疗的血小板减少症和慢性肝病患者增加血小板计数,减少血小板输注的效果。

伊屈泼帕是一种口服促血小板生成素受体激动剂。以色列Deaconess医学中心Nezam H. Afdhal博士等人的这一研究评估了伊屈泼帕治疗接受选择性侵入性治疗的血小板减少症和慢性肝病患者增加血小板计数,减少血小板输注的效果。

研究者随机指定血小板计数少于50 000每立方毫米的292例因各种原因引起的慢性肝病患者接受伊屈泼帕治疗,剂量为75 mg每天,或安慰剂治疗,治疗共14天,之后按既定计划行选择性侵入性治疗5天。试验首要终点为侵入性治疗之前,期间及之后7天内避免血小板输注。一个重要的次要终点为在此期间发生出血(WHO 2级或更高)。

结果显示,接受伊屈泼帕治疗的145例患者中有104例避免了血小板输注(72%),与此相比,安慰剂组的147例患者则只有28例(19%) (P<0.001)。研究人员发现,伊屈泼帕治疗组和安慰剂组相比,出现WHO2级以上偶发出血事件的概率无显着性差异,分别为17%和23%。伊屈泼帕治疗组共发现6例患者出现门静脉系统血栓形成,与之相比,安慰剂组有1例,导致试验提前终止。研究者认为,伊屈泼帕治疗组和安慰剂组相比,其他不良反应事件的发生率和严重程度相似。

研究人员由此得出结论,伊屈泼帕治疗可减少接受选择性侵入性治疗的慢性肝病患者血小板输注需要,但与安慰剂组相比,伊屈泼帕会导致更多的门静脉血栓形成。(生物谷Bioon.com)

Eltrombopag before Procedures in Patients with Cirrhosis and Thrombocytopenia

Nezam H. Afdhal, M.D., Edoardo G. Giannini, M.D., Ph.D., Ghias Tayyab, M.D., Aftab Mohsin, M.D., Jin-Woo Lee, M.D., Ph.D., Angelo Andriulli, M.D., Lennox Jeffers, M.D., John McHutchison, M.D., Pei-Jer Chen, M.D., Ph.D., Kwang-Hyub Han, M.D., Fiona Campbell, B.Sc., Denise Hyde, Ph.D., Andres Brainsky, M.D., and Dickens Theodore, M.D., M.P.H. for the ELEVATE Study Group

BACKGROUND Eltrombopag is an oral thrombopoietin-receptor agonist. This study evaluated the efficacy of eltrombopag for increasing platelet counts and reducing the need for platelet transfusions in patients with thrombocytopenia and chronic liver disease who are undergoing an elective invasive procedure. METHODS We randomly assigned 292 patients with chronic liver disease of diverse causes and platelet counts of less than 50,000 per cubic millimeter to receive eltrombopag, at a dose of 75 mg daily, or placebo for 14 days before a planned elective invasive procedure that was performed within 5 days after the last dose. The primary end point was the avoidance of a platelet transfusion before, during, and up to 7 days after the procedure. A key secondary end point was the occurrence of bleeding (World Health Organization [WHO] grade 2 or higher) during this period. RESULTS A platelet transfusion was avoided in 104 of 145 patients who received eltrombopag (72%) and in 28 of 147 who received placebo (19%) (P<0.001). No significant difference between the eltrombopag and placebo groups was observed in bleeding episodes of WHO grade 2 or higher, which were reported in 17% and 23% of patients, respectively. Thrombotic events of the portal venous system were observed in 6 patients who received eltrombopag, as compared with 1 who received placebo, resulting in the early termination of the study. The incidence and severity of other adverse events were similar in the eltrombopag and placebo groups. CONCLUSIONS Eltrombopag reduced the need for platelet transfusions in patients with chronic liver disease who were undergoing elective invasive procedures, but it was associated with an increased incidence of portal-vein thrombosis, as compared with placebo. (Funded by GlaxoSmithKline; ELEVATE ClinicalTrials.gov number,NCT00678587.)

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