A pilot study of eptifibatide for treatment of acute pain episodes in sickle cell disease
A pilot study of eptifibatide for treatment of acute pain episodes in sickle cell disease
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DOI：
10.1016/j.thromres.2013.08.002
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发表时间：
2013-09-01
影响因子：
7.5
通讯作者：
Ataga, Kenneth I.
中科院分区：
文献类型：
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作者：
Desai, Payal C.;Brittain, Julia E.;Ataga, Kenneth I.
引言：血小板活化对镰状细胞病（SCD）发病机制的作用仍不确定。我们评估了依替巴肽（一种α IIb β 3受体的合成肽抑制剂）在SCD患者急性疼痛发作中的安全性和有效性。材料和方法：在这项单中心、双盲、安慰剂对照试验中，符合条件的SCD急性疼痛发作患者以2：1的比例随机接受依替巴肽或安慰剂治疗。13名患者（SS - 10，S β（0）-2，SC - 1）随机接受依替巴肽（N = 9; 6名女性;中位年龄~ 25岁）或安慰剂（N = 4; 3名女性;中位年龄~ 31岁）。在意向治疗分析中，依替巴肽组或安慰剂组均未发生大出血事件（差异点估计值：0.00，95% CI;-0.604，0.372）。依替巴肽组有1例轻微出血事件（任何出血的点估计差异：0.11，95% CI：-0.502，0.494）。治疗组间血小板减少患者比例无显著差异（差异点估计值：0. 11，95% CI：-0. 587，0.495）。出院的中位时间，危机解决的中位时间或中位总阿片类药物use.Conclusions：在这项小型研究中，依替巴肽似乎是安全的，但没有改善危机解决或出院的时间。需要进行有把握度的研究来评价依替巴肽在SCD中的安全性和有效性。Clinicaltrials.gov标识符：NCT 00834899。(C)2013爱思唯尔有限公司保留所有权利。
Introduction: The contribution of platelet activation to the pathogenesis of sickle cell disease (SCD) remains uncertain. We evaluated the safety and efficacy of eptifibatide, a synthetic peptide inhibitor of the alpha IIb beta 3 receptor, in SCD patients during acute painful episodes.Materials and Methods: In this single site, double-blind, placebo-controlled trial, eligible patients with SCD admitted for acute painful episodes were randomized to receive eptifibatide or placebo at a ratio of 2:1.Results: Thirteen patients (SS - 10, S beta(0) - 2, SC - 1) were randomized to receive either eptifibatide (N = 9; 6 females; median age -25 years) or placebo (N = 4; 3 females; median age -31 years). In the intent-to-treat analysis, there were no major bleeding episodes in either the eptifibatide or placebo arms (point estimate of difference: 0.00, 95% CI; -0.604, 0.372). There was one minor bleeding episode in the eptifibatide arm (point estimate of difference for any bleeding: 0.11, 95% CI: -0.502, 0.494). There was no significant difference in the proportion of patients with thrombocytopenia between the treatment groups (point estimate of difference: 0.11, 95% CI: -0.587, 0.495). There were no differences in the median times to discharge, median times to crisis resolution or the median total opioid use.Conclusions: In this small study, eptifibatide appeared to be safe, but did not improve the times to crisis resolution or hospital discharge. Adequately powered studies are required to evaluate the safety and efficacy of eptifibatide in SCD. Clinicaltrials.gov Identifier: NCT00834899. (C) 2013 Elsevier Ltd. All rights reserved.