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在广泛患者群体中进行冠状动脉支架植入术后噻氯匹定与氯吡格雷的随机对照研究。

Randomized comparison of ticlopidine and clopidogrel after intracoronary stent implantation in a broad patient population.

作者信息

Taniuchi M, Kurz H I, Lasala J M

机构信息

Department of Medicine, Washington University School of Medicine, Barnes-Jewish Hospital, St Louis, MO 63110, USA.

出版信息

Circulation. 2001 Jul 31;104(5):539-43. doi: 10.1161/hc3001.093435.

DOI:10.1161/hc3001.093435
PMID:11479250
Abstract

BACKGROUND

Although clopidogrel is used to prevent subacute stent thrombosis, its safety and efficacy have not been compared with ticlopidine in a randomized manner in the United States.

METHODS AND RESULTS

Patients with successful intracoronary stent implantation were randomly assigned to therapy with ticlopidine or clopidogrel. Loading doses were administered immediately after the procedure, and the drugs were prescribed for 2 weeks. One thousand sixteen patients were enrolled: 522 patients were randomly assigned to ticlopidine therapy and 494 to clopidogrel. High-risk characteristics included recent myocardial infarction in 41.4% of the cases, angiographically evident thrombus in 20.9%, and abrupt or threatened closure in 3.64%. An intravenous glycoprotein IIb/IIIa inhibitor was used in 48.2% of the cases, and thrombocytopenia occurred in 1.43% of these patients. Failure to complete 2 weeks of therapy occurred in 3.64% of the patients treated with ticlopidine and in 1.62% of the patients treated with clopidogrel (P=0.043). Within 30 days, thrombosis of the stent occurred in 1.92% of the patients in the ticlopidine group and in 2.02% of the clopidogrel group (P=0.901). A major adverse cardiac event occurred in 4.60% of patients receiving ticlopidine and in 3.85% of patients receiving clopidogrel (P=0.551).

CONCLUSIONS

Clopidogrel is better tolerated than ticlopidine during a 2-week regimen after intracoronary stent implantation. Combining either thienopyridine with an intravenous platelet IIb/IIIa inhibitor appears to be safe. When applied to a broad spectrum of patients receiving stent implantation, clopidogrel confers similar protection as ticlopidine against subacute stent thrombosis and major adverse cardiac events.

摘要

背景

尽管氯吡格雷用于预防亚急性支架血栓形成,但在美国尚未以随机方式将其安全性和疗效与噻氯匹定进行比较。

方法与结果

冠状动脉支架植入成功的患者被随机分配接受噻氯匹定或氯吡格雷治疗。负荷剂量在手术后立即给予,药物服用2周。共纳入1016例患者:522例患者被随机分配接受噻氯匹定治疗,494例接受氯吡格雷治疗。高危特征包括41.4%的病例近期发生心肌梗死,20.9%的病例血管造影显示有血栓,3.64%的病例有急性或濒临闭塞。48.2%的病例使用了静脉糖蛋白IIb/IIIa抑制剂,这些患者中有1.43%发生血小板减少。接受噻氯匹定治疗的患者中有3.64%未完成2周治疗,接受氯吡格雷治疗的患者中有1.62%未完成治疗(P = 0.043)。在30天内,噻氯匹定组1.92%的患者发生支架血栓形成,氯吡格雷组2.02%的患者发生支架血栓形成(P = 0.901)。接受噻氯匹定治疗的患者中有4.60%发生主要不良心脏事件,接受氯吡格雷治疗的患者中有3.85%发生主要不良心脏事件(P = 0.551)。

结论

冠状动脉支架植入术后2周疗程中,氯吡格雷的耐受性优于噻氯匹定。将任何一种噻吩并吡啶与静脉血小板IIb/IIIa抑制剂联合使用似乎是安全的。当应用于接受支架植入的广泛患者群体时,氯吡格雷在预防亚急性支架血栓形成和主要不良心脏事件方面与噻氯匹定具有相似的保护作用。

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