DiSerio F J, Sasahara A A
Am J Surg. 1985 Oct 8;150(4A):25-32.
DVT involving the lower extremities is a frequent (25-40 percent of patients) complication of major thoracic, abdominal, and pelvic surgery in patients beyond the age of 40 years. Herein, we have reported a recently completed large prospective, randomized multicenter investigation of the prophylaxis of postoperative DVT in the United States. A total of 880 patients were randomized into five treatment groups: 0.5 mg of dihydroergotamine plus 5,000 IU of heparin (DHE/H5,000), 0.5 mg of dihydroergotamine plus 2,500 IU of heparin (DHE/H2,500), 5,000 IU of heparin alone (H5,000), 0.5 mg of dihydroergotamine alone (DHE), or placebo. Administration was by the subcutaneous route, using the anterior abdominal wall on a twice daily schedule. Treatment was initiated preoperatively and continued twice daily for 5 days. Daily radiofibrinogen uptake tests revealed the following DVT rates: DHE/H5,000 9.4 percent, DHE/H2,500 16.8 percent, H5,000 16.8 percent, DHE 19.4 percent, and placebo 24.4 percent. DHE/H5,000 was significantly superior (p less than 0.05) to all other treatments in this respect. Adverse drug experiences did not differ significantly between groups and consisted primarily of postoperative bleeding (2 to 3 percent of patients), injection site hematoma (6 to 12 percent of patients), and wound hematoma (1 to 3 percent of patients).
下肢深静脉血栓形成是40岁以上患者进行胸、腹和盆腔大手术常见的（发生率为25% - 40%）并发症。在此，我们报告了美国一项近期完成的关于术后深静脉血栓形成预防的大型前瞻性随机多中心研究。共有880例患者被随机分为五个治疗组：0.5毫克双氢麦角胺加5000国际单位肝素（DHE/H5,000）、0.5毫克双氢麦角胺加2500国际单位肝素（DHE/H2,500）、仅用5000国际单位肝素（H5,000）、仅用0.5毫克双氢麦角胺（DHE）或安慰剂。给药途径为皮下注射，注射部位为前腹壁，每日两次。术前开始治疗，持续每日两次，共5天。每日放射性纤维蛋白原摄取试验显示深静脉血栓形成率如下：DHE/H5,000组为9.4%，DHE/H2,500组为16.8%，H5,000组为16.8%，DHE组为19.4%，安慰剂组为24.4%。在这方面，DHE/H5,000组显著优于所有其他治疗组（p小于0.05）。各治疗组间药物不良反应无显著差异，主要包括术后出血（占患者的2% - 3%）、注射部位血肿（占患者的6% - 12%）和伤口血肿（占患者的1% - 3%）。
