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双氢麦角胺-肝素预防术后深静脉血栓形成。一项多中心试验。多中心试验委员会。

Dihydroergotamine-heparin prophylaxis of postoperative deep vein thrombosis. A multicenter trial. The Multicenter Trial Committee.

出版信息

JAMA. 1984 Jun 8;251(22):2960-6. doi: 10.1001/jama.1984.03340460038022.

Abstract

In a large, prospective, multicenter investigation of the prophylaxis of deep vein thrombosis (DVT) in patients undergoing elective abdominal, pelvic, and thoracic surgery, 880 patients were randomized into five treatment groups: those receiving (1) dihydroergotamine mesylate, 0.5 mg, plus heparin sodium, 5,000 IU; (2) dihydroergotamine mesylate, 0.5 mg, plus heparin sodium, 2,500 IU; (3) heparin sodium, 5,000 IU alone; (4) dihydroergotamine mesylate, 0.5 mg alone; or (5) placebo. Treatment was initiated preoperatively and continued twice daily for five to seven days. Daily radiofibrinogen uptake tests revealed the following DVT rates: Dihydroergotamine mesylate, 0.5 mg, plus heparin sodium, 5,000 IU, 9.4%; dihydroergotamine mesylate, 0.5 mg, plus heparin sodium, 2,500 IU, 16.8%; heparin sodium, 5,000 IU alone, 16.8%; dihydroergotamine mesylate, 0.5 mg alone, 19.4%; and placebo, 24.4%. Dihydroergotamine mesylate, 0.5 mg, plus heparin sodium, 5,000 IU, was significantly superior to all other treatments. Adverse drug experiences did not differ significantly between groups and consisted primarily of postoperative bleeding (2% to 3%), injection site hematoma (6% to 12%), and wound hematoma (1% to 3%).

摘要

在一项针对接受择期腹部、盆腔和胸部手术患者预防深静脉血栓形成(DVT)的大型前瞻性多中心研究中,880名患者被随机分为五个治疗组:接受(1)甲磺酸双氢麦角胺0.5毫克加肝素钠5000国际单位;(2)甲磺酸双氢麦角胺0.5毫克加肝素钠2500国际单位;(3)仅肝素钠5000国际单位;(4)仅甲磺酸双氢麦角胺0.5毫克;或(5)安慰剂。治疗在术前开始,每天两次,持续五至七天。每日放射性纤维蛋白原摄取试验显示以下DVT发生率:甲磺酸双氢麦角胺0.5毫克加肝素钠5000国际单位,9.4%;甲磺酸双氢麦角胺0.5毫克加肝素钠2500国际单位,16.8%;仅肝素钠5000国际单位,16.8%;仅甲磺酸双氢麦角胺0.5毫克,19.4%;安慰剂,24.4%。甲磺酸双氢麦角胺0.5毫克加肝素钠5000国际单位明显优于所有其他治疗。各治疗组之间药物不良反应无显著差异,主要包括术后出血(2%至3%)、注射部位血肿(6%至12%)和伤口血肿(1%至3%)。

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