Goel D P, Buckley R, deVries G, Abelseth G, Ni A, Gray R
Department of Orthopaedics, University of Calgary, 3330 Hospital Drive NW, Calgary, Alberta T2N 4N1, Canada.
J Bone Joint Surg Br. 2009 Mar;91(3):388-94. doi: 10.1302/0301-620X.91B3.20820.
The incidence of deep-vein thrombosis and the need for thromboprophylaxis following isolated trauma below the knee is uncertain. We have investigated this with a prospective randomised double-blind controlled trial using low molecular weight heparin with saline injection as placebo in patients aged between 18 and 75 years who had sustained an isolated fracture below the knee which required operative fixation. All patients had surgery within 48 hours of injury and were randomised to receive either the placebo or low molecular weight heparin for 14 days, after which they underwent bilateral lower limb venography, interpreted by three independent radiologists. Further follow-up was undertaken at two, six, eight and 12 weeks. A total of 238 patients fulfilled all the inclusion criteria, with 127 in the low molecular weight heparin group and 111 in the placebo group, all of whom underwent bilateral venography. There was no statistically significant difference in the incidence of deep-vein thrombosis between those patients treated with low molecular weight heparin or the placebo (p = 0.22). The number of deep-vein thromboses in the two groups was 11 (8.7%) and 14 (12.6%), respectively. Age and the type of fracture were significantly associated with the rate of deep-vein thrombosis (p = 0.001 and p = 0.009, respectively) but gender, comorbidities and the body mass index were not. The overall incidence of deep-vein thrombosis in this series was 11%. There was no clinical or statistical significant reduction in the incidence of deep-vein thrombosis with the use of thromboprophylaxis. However, we accept that owing to a cessation of funding, recruitment to this trial had to be ended prior to establishing the necessary sample size. Our results cannot, therefore, categorically exclude the possibility that low molecular weight heparin treatment could be beneficial. We recommend a further multicentre trial be undertaken to resolve this matter.
膝部以下单纯创伤后深静脉血栓形成的发生率以及进行血栓预防的必要性尚不确定。我们进行了一项前瞻性随机双盲对照试验，对年龄在18至75岁之间、因膝部以下单纯骨折需手术固定的患者，使用低分子量肝素并以注射生理盐水作为安慰剂进行研究。所有患者在受伤后48小时内接受手术，并随机分为两组，分别接受安慰剂或低分子量肝素治疗14天，之后接受双侧下肢静脉造影，由三名独立的放射科医生进行解读。在两周、六周、八周和十二周时进行进一步随访。共有238名患者符合所有纳入标准，其中低分子量肝素组127例，安慰剂组111例，所有患者均接受了双侧静脉造影。接受低分子量肝素治疗的患者与接受安慰剂治疗的患者相比，深静脉血栓形成的发生率无统计学显著差异（p = 0.22）。两组深静脉血栓形成的病例数分别为11例（8.7%）和14例（12.6%）。年龄和骨折类型与深静脉血栓形成的发生率显著相关（分别为p = 0.001和p = 0.009），但性别、合并症和体重指数与之无关。本系列研究中深静脉血栓形成的总体发生率为11%。使用血栓预防措施并未使深静脉血栓形成的发生率在临床或统计学上显著降低。然而，我们承认由于资金停止，本试验在达到必要样本量之前不得不停止招募。因此，我们的结果不能绝对排除低分子量肝素治疗可能有益的可能性。我们建议进行进一步的多中心试验以解决这一问题。
