阿司匹林又有“新战绩”,登上顶级期刊NEJM
2018/03/15
阿司匹林是医药史上三大经典药物之一。近日,这款“神药”登上了顶级医学期刊New England Journal of Medicine。这次,它又取得了什么“战绩”呢?


图片来源:NEJM(DOI: 10.1056/NEJMoa1712746)

2月22日,在这篇题为“Aspirin or Rivaroxaban for VTE Prophylaxis after Hip or Knee Arthroplasty”的论文中,一个针对“接受全髋关节或膝关节置换手术患者”的多中心、双盲、随机、对照临床试验证实,阿司匹林与预防术后静脉血栓栓塞(venous thromboembolism,VTE)的标准抗凝血药物rivaroxaban一样有效。

参与该研究的加拿大蒙特利尔犹太总医院的David Zukor博士说:“我们一直非常关注经历重大骨科手术的患者术后血凝块的预防。它是导致可预防性住院死亡的(preventable in-hospital death)主要原因。尽管,众所周知,rivaroxaban是有效的,但阿司匹林有很多吸引人的优点,如便宜得多、容易买到、安全性很好。

具体来说,该试验共招募了3424名患者,其中1804人接受了髋关节置换,1620人接受了膝关节置换。患者在术后5天内服用了rivaroxaban,然后被随机分配为服用阿司匹林(1707人)或继续服用rivaroxaban(1717人)。结果显示,阿司匹林组有11人发生了VTE,rivaroxaban组有12人发生了VTE。


图片来源:网络

抗凝血药物最令人担忧的并发症是出血(bleeding)。在该试验中,阿司匹林组8人(0.47%)出现了严重出血并发症,22人(1.29%)发生了临床上重要出血事件(Clinically important bleeding);rivaroxaban组5人(0.29%)出现了严重出血并发症,17人(0.99%)发生了临床上重要出血事件。两组之间无显著差异。此外,值得一提的是,所有出血事件都发生在手术部位,而不是其他可能更危险的区域,如大脑或胃肠道。

VTE权威专家Susan Kahn博士说:“这些研究结果很重要。尽管预防重大骨科手术后凝血的方案已经建立了,但我们依然希望能够为患者找到更好的选择。基于这项成果,我们看到,阿司匹林有望成为更昂贵的抗凝剂的有效替代品。”

不过,科学家们也强调,还需要额外的临床试验对阿司匹林的这一替代性进行验证。在该试验中,一组患者将只服用阿司匹林,并与服用rivaroxaban组的患者进行有效性的直接对比。

参考资料:

Aspirin prevents venous thromboembolism following major orthopedic surgeries, study finds

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  • Aspirin or Rivaroxaban for VTE Prophylaxis after Hip or Knee Arthroplasty

    Abstract BACKGROUND Clinical trials and meta-analyses have suggested that aspirin may be effective for the prevention of venous thromboembolism (proximal deep-vein thrombosis or pulmonary embolism) after total hip or total knee arthroplasty, but comparisons with direct oral anticoagulants are lacking for prophylaxis beyond hospital discharge. METHODS We performed a multicenter, double-blind, randomized, controlled trial involving patients who were undergoing total hip or knee arthroplasty. All the patients received once-daily oral rivaroxaban (10 mg) until postoperative day 5 and then were randomly assigned to continue rivaroxaban or switch to aspirin (81 mg daily) for an additional 9 days after total knee arthroplasty or for 30 days after total hip arthroplasty. Patients were followed for 90 days for symptomatic venous thromboembolism (the primary effectiveness outcome) and bleeding complications, including major or clinically relevant nonmajor bleeding (the primary safety outcome). RESULTS A total of 3424 patients (1804 undergoing total hip arthroplasty and 1620 undergoing total knee arthroplasty) were enrolled in the trial. Venous thromboembolism occurred in 11 of 1707 patients (0.64%) in the aspirin group and in 12 of 1717 patients (0.70%) in the rivaroxaban group (difference, 0.06 percentage points; 95% confidence interval [CI], −0.55 to 0.66; P<0.001 for noninferiority and P=0.84 for superiority). Major bleeding complications occurred in 8 patients (0.47%) in the aspirin group and in 5 (0.29%) in the rivaroxaban group (difference, 0.18 percentage points; 95% CI, −0.65 to 0.29; P=0.42). Clinically important bleeding occurred in 22 patients (1.29%) in the aspirin group and in 17 (0.99%) in the rivaroxaban group (difference, 0.30 percentage points; 95% CI, −1.07 to 0.47; P=0.43). CONCLUSIONS Among patients who received 5 days of rivaroxaban prophylaxis after total hip or total knee arthroplasty, extended prophylaxis with aspirin was not significantly different from rivaroxaban in the prevention of symptomatic venous thromboembolism. (Funded by the Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT01720108.)

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