Sasahara A A, Koppenhagen K, Häring R, Welzel D, Wolf H
Br J Surg. 1986 Sep;73(9):697-700. doi: 10.1002/bjs.1800730906.
In a prospective, double-blind investigation of the prophylaxis of deep vein thrombosis (DVT) in patients undergoing elective major abdominal surgery, 269 patients were randomized into two groups. One hundred and thirty-two patients received a fixed combination of heparin sodium 5000 units plus dihydroergotamine mesylate 0.5 mg (H/DHE) twice a day and 137 patients received a fixed combination of low molecular weight heparin 1500 units plus dihydroergotamine mesylate 0.5 mg (LMWH/DHE) once a day as well as one injection of placebo per day. Treatment was initiated 2 h pre-operatively in both groups and continued for 7-10 days. The frequency of DVT determined by the 125I-labelled fibrinogen uptake test and phlebography was 10.3 per cent in patients receiving H/DHE and 10.4 per cent in those receiving LMWH/DHE. DVT of the femoral vein was detected in four patients of the H/DHE group and in none of the LMWH/DHE group. Intra- and postoperative blood loss did not differ significantly between both groups. Also no difference in the development of wound haematoma and injection site haematoma was found. While intra-operative volume substitution was comparable in both groups, significantly more patients under H/DHE prophylaxis received volume substitution during the postoperative phase. These results show that once-daily prophylaxis with the combination of low molecular weight heparin and dihydroergotamine is equally as effective and as safe as the twice-daily regimen using a combination of unfractionated heparin and dihydroergotamine in patients undergoing elective, major abdominal surgery. The advantages of the once-daily regimen of LMWH/DHE include greater patient acceptance, less nursing time and greater cost effectiveness, provided the new combination can be sold at a cost which maintains this advantage.
在一项针对择期进行大型腹部手术患者预防深静脉血栓形成(DVT)的前瞻性双盲研究中,269例患者被随机分为两组。132例患者接受肝素钠5000单位加甲磺酸双氢麦角胺0.5毫克(H/DHE)的固定组合,每日两次;137例患者接受低分子量肝素1500单位加甲磺酸双氢麦角胺0.5毫克(LMWH/DHE)的固定组合,每日一次,以及每日一次安慰剂注射。两组均在术前2小时开始治疗,并持续7 - 10天。通过125I标记的纤维蛋白原摄取试验和静脉造影确定的DVT发生率,接受H/DHE的患者为10.3%,接受LMWH/DHE的患者为10.4%。H/DHE组有4例患者检测到股静脉DVT,而LMWH/DHE组未检测到。两组术中和术后失血量无显著差异。伤口血肿和注射部位血肿的发生情况也未发现差异。虽然两组术中的容量替代相当,但接受H/DHE预防的患者术后接受容量替代的人数明显更多。这些结果表明,在择期进行大型腹部手术的患者中,低分子量肝素和双氢麦角胺联合每日一次预防与普通肝素和双氢麦角胺联合每日两次预防同样有效且安全。LMWH/DHE每日一次方案的优点包括患者接受度更高、护理时间更少以及成本效益更高,前提是新组合能够以保持这一优势的成本出售。