- 作者：Payal C. Desai ; Julia E. Brittain ; Susan K. Jones ; Adam McDonald ; Douglas R. Wilson ; Rosalie Dominik ; Nigel S. Key ; Leslie V. Parise ; Kenneth I. Ataga
- 关键词：SCD ; sickle cell disease ; CD40L ; CD40 ligand ; PCA ; patient controlled analgesia ; CI ; confidence intervals
- 刊名：Thrombosis Research
- 出版年：2013
- 出版时间：September, 2013
- 年：2013
- 卷：132
- 期：3
- 页码：341-345
- 全文大小：347 K
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 ¦ÁIIb¦Â3 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¦Â0 - 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.