达肝素与布洛芬治疗浅静脉血栓性静脉炎的随机试验。
A randomized trial of dalteparin compared with ibuprofen for the treatment of superficial thrombophlebitis.
机构信息
Vascular Medicine, Cardiovascular section, University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, USA.
出版信息
J Thromb Haemost. 2012 May;10(5):833-9. doi: 10.1111/j.1538-7836.2012.04669.x.
BACKGROUND
Superficial thrombophlebitis can produce pain and result in a deep vein thrombosis (DVT) if not treated. Conservative therapies including prescription of non-steroidal anti-inflammatory drugs (NSAID) and heat have been standard care. Recently, studies have been published reporting efficacy and safety of low-molecular-weight heparin for the treatment of superficial thrombophlebitis. However, there are few comparative trials to conservative therapy. We studied the effectiveness and safety of treatment with dalteparin compared with ibuprofen in patients with confirmed superficial thrombophlebitis.
METHODS
Consecutive patients were randomized to receive daily dalteparin vs. ibuprofen three times daily for up to 14 days. The primary outcome measure was the incidence of extension of thrombus or new symptomatic venous thromboembolism during the 14-day and 3-month follow-up period. The secondary outcome was a reduction in pain. The outcome measure of safety was the incidence of major and minor bleeding.
RESULTS
Of 302 consecutive patients screened, 72 were enrolled. Four patients receiving ibuprofen compared with no patients receiving dalteparin had thrombus extension at 14 days (P = 0.05), however, there was no difference in thrombus extension at 3 months. Both treatments significantly reduced pain. There were no episodes of major or minor bleeding during the treatment period.
CONCLUSIONS
Dalteparin is superior to the NSAID ibuprofen in preventing extension of superficial thrombophlebitis during the 14-day treatment period with similar relief of pain and no increase in bleeding. However, questions concerning the optimal treatment duration should be explored in future trials.
背景
如果不进行治疗，浅静脉血栓形成会引起疼痛，并导致深静脉血栓形成（DVT）。包括开具非甾体抗炎药（NSAID）和热敷在内的保守治疗一直是标准治疗方法。最近，有研究报告了低分子量肝素治疗浅静脉血栓形成的疗效和安全性。然而，与保守疗法相比，比较试验较少。我们研究了达肝素与布洛芬治疗确诊的浅静脉血栓形成患者的疗效和安全性。
方法
连续患者被随机分配接受达肝素每日治疗或布洛芬每日 3 次治疗，最长 14 天。主要终点是在 14 天和 3 个月随访期间血栓延伸或新出现有症状的静脉血栓栓塞的发生率。次要终点是疼痛缓解。安全性结局指标是主要和次要出血的发生率。
结果
在筛选的 302 例连续患者中，有 72 例入组。与接受达肝素治疗的患者相比，接受布洛芬治疗的 4 例患者在 14 天时出现血栓延伸（P=0.05），但在 3 个月时无差异。两种治疗均显著减轻疼痛。在治疗期间均无大出血或小出血事件。
结论
在 14 天的治疗期间，达肝素在预防浅静脉血栓形成延伸方面优于 NSAID 布洛芬，且疼痛缓解相似，出血无增加。然而，未来的试验应该探讨最佳治疗持续时间的问题。
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