Kalodiki E P, Hoppensteadt D A, Nicolaides A N, Fareed J, Gill K, Regan F, al-Kutoubi A, Cunningham D A, Birch R, Harris N, Hunt D, Johnson J, Marx C
Irvine Laboratory for Cardiovascular Investigation & Research, Academic Surgical Unit, St Mary's Hospital Medical School, London, UK.
Int Angiol. 1996 Jun;15(2):162-8.
Seventy-eight patients having elective total hip replacement were randomised into 3 groups A) control; B) low molecular weight heparin: (enoxaparin 40 mg once daily) and C) enoxaparin (40 mg once daily) plus graduated elastic compression (TEDR stockings) for 8-12 days. All patients had a preoperative perfusion lung scan and chest X-Ray and a postoperative perfusion/ventilation scan together with bilateral ascending venography on days 8-12. A blood sample was taken preoperatively, on the 1st, 3rd and 5th postoperative day and at the end of the study. The control group received placebo injections. The venograms and V/Q scans were reported blindly by an independent panel of three and one radiologists respectively. An independent panel of assessors stopped entry in the control group when a total of 45 patients were admitted according to Ethics Committee directives. The study continued with groups B and C. The incidence of DVT (including isolated asymptomatic calf thrombi) was as follows: Group A (n = 14) 93%; Group B (n = 32) 38%; Group C (n = 32) 25% (chi 2; p < 0.001 for group A versus B or C). The incidence of proximal DVT was: Group A 57%; group B 28%; group C 13% (chi 2; p = 0.057 for group A versus B and p < 0.005 for group A versus C). The incidence of silent pulmonary embolism (PE) (new defect on V/Q scan) was 28% (8 out of 29) in patients with and 5% (2 out of 43) in patients without DVT (chi 2; p < 0.02). The combination of high TAT and low anti-Xa activity on the 1st postoperative day identified a high risk group of patients who had a 56% incidence of proximal DVT on the 8th to 12th postoperative day. Further studies are needed to confirm the suggested increased efficacy in prophylaxis by the combination of LMWH and GEC as compared with LMWH alone.
78例择期行全髋关节置换术的患者被随机分为3组:A组为对照组;B组为低分子量肝素组(依诺肝素40mg,每日1次);C组为依诺肝素(40mg,每日1次)加阶梯式弹力袜压迫组(TEDR弹力袜),持续8 - 12天。所有患者术前均行肺灌注扫描和胸部X线检查,术后第8 - 12天行肺灌注/通气扫描及双侧下肢静脉造影。术前、术后第1天、第3天、第5天及研究结束时采集血样。对照组接受安慰剂注射。静脉造影和V/Q扫描分别由3名独立专家和1名放射科医生进行盲法报告。根据伦理委员会的指示,当共纳入45例患者时,独立评估小组停止对照组的入组。研究继续在B组和C组进行。深静脉血栓形成(DVT,包括孤立的无症状小腿血栓)的发生率如下:A组(n = 14)为93%;B组(n = 32)为38%;C组(n = 32)为25%(χ²检验;A组与B组或C组比较,p < 0.001)。近端DVT的发生率为:A组57%;B组28%;C组13%(χ²检验;A组与B组比较,p = 0.057;A组与C组比较,p < 0.005)。无症状肺栓塞(PE,V/Q扫描出现新的缺损)的发生率在有DVT的患者中为28%(29例中有8例),在无DVT的患者中为5%(43例中有2例)(χ²检验;p < 0.02)。术后第1天高凝血酶 - 抗凝血酶复合物(TAT)和低抗Xa活性的联合情况确定了一组高危患者,这些患者在术后第8至12天近端DVT的发生率为56%。需要进一步研究以证实与单独使用低分子量肝素相比,低分子量肝素与阶梯式弹力袜压迫联合预防的疗效是否提高。