Koller M, Schoch U, Buchmann P, Largiadèr F, von Felten A, Frick P G
Thromb Haemost. 1986 Dec 15;56(3):243-6.
In two randomized double-blind studies perioperative bleeding complications and thromboembolic events were assessed in 189 patients (pts) undergoing elective visceral surgery after subcutaneous administration of a low molecular weight (LMW) heparin fragment (KABI fragment 2165) or unfractionated (UF) heparin. The first study comparing 1 X 7'500 anti-factor Xa IU LMW heparin daily with 2 X 5'000 IU UF heparin was interrupted because of excessive bleeding complications (LMW heparin: 11/23 pts, UF heparin: 2/20 pts, p less than 0.01). In the second study (146 pts) the dose of LMW heparin was reduced to 1 X 2'500 anti-factor Xa IU. Bleeding complications (LMW heparin: 14.9%, UF heparin: 15.3%) and thromboembolic events (LMW heparin: 2.86%, UF heparin: 2.94%) were equal among the two groups. 2'500 anti-factor Xa IU/day of this LMW heparin fragment, corresponding to 15 mg/day, is the lowest dose of a LMW heparin used in a randomized clinical trial and was found to be a safe and efficient regimen in perioperative thrombosis prophylaxis. An advantage of LMW heparin over UF heparin is its once daily administration.
在两项随机双盲研究中，对189例接受择期内脏手术的患者皮下注射低分子量（LMW）肝素片段（KABI片段2165）或普通肝素（UF）后，评估围手术期出血并发症和血栓栓塞事件。第一项研究比较每日1×7500抗Xa因子国际单位的低分子量肝素与每日2×5000国际单位的普通肝素，因出血并发症过多而中断（低分子量肝素组：11/23例患者，普通肝素组：2/20例患者，p<0.01）。在第二项研究（146例患者）中，低分子量肝素的剂量降至1×2500抗Xa因子国际单位。两组之间的出血并发症（低分子量肝素组：14.9%，普通肝素组：15.3%）和血栓栓塞事件（低分子量肝素组：2.86%，普通肝素组：2.94%）相当。这种低分子量肝素片段每日2500抗Xa因子国际单位，相当于每日15毫克，是随机临床试验中使用的低分子量肝素的最低剂量，被发现是围手术期预防血栓形成的一种安全有效的方案。低分子量肝素相对于普通肝素的一个优点是其每日一次给药。
