NEJM:塞来昔布心血管安全性不比萘普生或布洛芬差

2016-11-14 xing.T MedSci原创

由此可见,给予中等剂量的塞来昔布治疗其心血管安全性并不于布洛芬或萘普生。

相比于非选择性非甾体类抗炎药,选择性非甾体类抗炎药塞来昔布的心血管安全性仍不确定。近日,顶级医学期刊NEJM上发表了一篇针对这一问题的研究文章。

研究者招募了需要用非甾体类抗炎药治疗而且增加心血管疾病风险的骨关节炎和类风湿关节炎患者,将其随机分组,分别接受塞来昔布、布洛芬或萘普生治疗。本试验的目的是评估塞来昔布在心血管死亡(包括出血性死亡)、非致死性心肌梗死或非致死性卒中主要复合终点的非劣效性。非劣效性要求具有低于1.12的风险比,以及在意向治疗人群中97.5%可信上限低于1.33,在完成治疗人群中低于1.40。同时,也比较了胃肠道和肾脏预后。

该研究共纳入了24,081例患者,随机分为塞来昔布组(平均[±SD ]每日剂量为209±37mg)、萘普生组(852±103mg)或布洛芬组(2045±246mg),平均治疗时间为20.3±16个月,平均随访时间为34.1±13.4个月。


在试验过程中,68.8%的患者停止服用研究药物,27.4%的患者失访。在意向治疗分析中,发生主要终点事件的患者在塞来昔布组有188例(2.3%)、在萘普生组有201例(2.5%)以及在布洛芬组有218例(2.7%)(塞来昔布 vs.萘普生的危险比为0.93;95%可信区间为0.76-1.13;塞来昔布 vs.布洛芬的危险比为0.85;95%可信区间为0.70-1.04;两次非劣效性比较均有P<0.001)。

在完成治疗分析发生主要终点事件的患者在塞来昔布组有134例(1.7%)、在萘普生组有144例(1.8%)以及在布洛芬组有155例(1.9%)(塞来昔布vs.萘普生的危险比为0.90;95%可信区间为0.71-1.15;塞来昔布vs.布洛芬的危险比为0.81;95%可信区间为0.65-1.02;两次非劣效性比较均有P<0.001)。

塞来昔布组的胃肠道事件的风险比萘普生组(P=0.01)或布洛芬组(P=0.002)要显著降低;塞来昔布组的肾脏事件的风险比布洛芬组要显著降低(P=0.004),但与萘普生组比较并没有显著降低(P=0.19)。

由此可见,给予中等剂量的塞来昔布治疗其心血管安全性并不低于布洛芬或萘普生。

原始出处:

Steven E. Nissen, et al.Cardiovascular Safety of Celecoxib, Naproxen, or Ibuprofen for Arthritis. NEJM. November 13, 2016. DOI:10.1056/NEJMoa1611593

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    2016-11-15 yibei
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    2016-11-15 1dd8c52fm63(暂无匿称)

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