Scirica Benjamin M, Cannon Christopher P, Cooper Richard, Aster Richard H, Brassard Jacqueline, McCabe Carolyn H, Charlesworth Andrew, Skene Allan M, Braunwald Eugene
TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, 75 Francis st., Boston, MA 02115, USA.
J Thromb Thrombolysis. 2006 Oct;22(2):95-102. doi: 10.1007/s11239-006-8669-4.
To assess etiology and impact of thrombocytopenia in a large oral glycoprotein (GP) IIb/IIIa inhibitor trial.
Heparin is known to cause thrombocytopenia, and in some of these patients thrombosis. GP IIb/IIIa inhibitors are also associated with thrombocytopenia.
The Orbofiban in Patients with Unstable Coronary Syndromes (OPUS-TIMI 16) Trial randomized 10,392 patients with ACS to the oral GP IIb/IIIa inhibitor orbofiban or placebo. Patients were followed for a minimum of ten months. Thrombocytopenia was defined prospectively as a platelet count < 80,000.
Thrombocytopenia was rare in the OPUS-TIMI 16 trial (0.68% at Day 30 and 0.80% at 1 year), but more common in patients treated with orbofiban (0.92%) compared with those treated with placebo (0.2%), p < 0.001. Patients who developed thrombocytopenia had higher rates of death (11.6% vs. 1.7%, p < 0.001), recurrent MI (12.1% vs. 2.8%, p < 0.001), intracranial hemorrhage (2.9% vs. 0.0%, p < 0.001), and major or severe bleeding (19.0% vs. 2.0%, p < 0.001) at 30 days (with similar results at one year).
Thrombocytopenia, though uncommon, was associated with orbofiban use and an increased risk of bleeding, but also death and MI. This study provides further evidence that drugs that lead to thrombocytopenia are, in a significant proportion of patients associated with thrombotic events.
在一项大型口服糖蛋白（GP）IIb/IIIa抑制剂试验中评估血小板减少症的病因及影响。
已知肝素会导致血小板减少症，且在部分此类患者中会引发血栓形成。GP IIb/IIIa抑制剂也与血小板减少症有关。
不稳定冠状动脉综合征患者使用orbofiban的试验（OPUS-TIMI 16）将10392例急性冠状动脉综合征（ACS）患者随机分为口服GP IIb/IIIa抑制剂orbofiban组或安慰剂组。对患者进行至少10个月的随访。血小板减少症前瞻性定义为血小板计数<80,000。
在OPUS-TIMI 16试验中，血小板减少症较为罕见（第30天时为0.68%，1年时为0.80%），但与接受安慰剂治疗的患者（0.2%）相比，接受orbofiban治疗的患者中更为常见（第30天时为0.92%），p<0.001。发生血小板减少症的患者在30天时死亡（11.6%对1.7%，p<0.001）、复发性心肌梗死（12.1%对2.8%，p<0.001）、颅内出血（2.9%对0.0%，p<0.001）以及严重或大出血（19.0%对2.0%，p<0.001）的发生率更高（1年时结果相似）。
血小板减少症虽不常见，但与使用orbofiban有关，且出血风险增加，同时还与死亡和心肌梗死有关。本研究进一步证明，导致血小板减少症产生的药物在相当一部分患者中与血栓形成事件相关。
