Lancet Respir Med:法国研究中心报道BPA与riociguat在不可手术的CTEPH患者中的疗效和安全性。

2022-08-09 刘少飞 MedSci原创

目前还缺乏比较这些治疗方法的随机对照试验。我们旨在评估BPA与riociguat在不可手术的CTEPH患者中的疗效和安全性。

riociguat和球囊肺血管成形术(BPA)是无法手术的慢性血栓栓塞性肺动脉高压(CTEPH)的治疗方案。然而,目前还缺乏比较这些治疗方法的随机对照试验。我们旨在评估BPA与riociguat在不可手术的CTEPH患者中的疗效和安全性。

研究方法:

在这项3期、多中心、开放标签、平行分组、随机对照试验中,我们在23个法国肺动脉高压专业中心进行了试验,招募了18-80岁新诊断的、不能手术的CTEPH患者和肺血管阻力超过320达因/厘米5的治疗无效的患者。通过网络随机系统将患者随机分配(1:1)到BPA或riociguat,采用分组随机(2或4名患者为一组),不分层。主要终点是第26周时肺血管阻力的变化,以有意治疗人群中基线肺血管阻力的百分比表示。对所有接受了至少一剂riociguat或至少一次BPA治疗的患者进行了安全性分析。完成RACE试验的患者继续进行为期26周的辅助随访,在此期间,肺血管阻力超过320dyn·s/cm5的有症状的患者可从BPA后加用riociguatriociguat后加用BPA获益。这项试验已在ClinicalTrials.gov注册,编号为NCT02634203,并已完成。

研究结果:

2016年1月19日至2019年1月18日期间,105名患者被随机分配到riociguat(n=53)或BPA(n=52)。在第26周,BPA组的几何平均肺血管阻力降至基线肺血管阻力的39-9%(95% CI 36-2-44-0),riociguat组为基线肺血管阻力的66-7%(60-5-73-5)(几何平均值之比为0-60,95% CI 0-52-0-69;P<0-0001)。BPA组52名患者中有22人(42%)发生了治疗相关的严重不良事件,riociguat组53名患者中有5人(9%)。最常见的治疗相关严重不良事件是BPA组的肺部损伤(52名患者中的18人[35%])和riociguat组的严重低血压伴晕厥(53名患者中的2人[4%])。没有发生与治疗有关的死亡。在第52周,接受一线riociguat或一线BPA治疗的患者的肺血管阻力有类似的降低(几何平均值之比为0-91,95%CI为0-79-1-04)。与BPA相关的严重不良事件的发生率在用riociguat预处理的患者中较低(36名患者中的5名[14%]与52名患者中的22名[42%])。

 

启示:

在第26周,BPA的肺血管阻力降低比riociguat更明显,但BPA的治疗相关严重不良事件更常见。在随访研究中,与接受BPA作为一线治疗的患者相比,用riociguat进行预处理的患者中,发现BPA相关的严重不良事件较少,这说明对无法手术的CTEPH患者采用多模式治疗方法可能会有好处。需要进一步的研究来探讨在不可手术的CTEPH患者中结合一种或两种药物和BPA进行序贯治疗的效果。

 

 

参考文献:

Jaïs X, Brenot P, Bouvaist H, Jevnikar M, Canuet M, Chabanne C, Chaouat A, Cottin V, De Groote P, Favrolt N, Horeau-Langlard D, Magro P, Savale L, Prévot G, Renard S, Sitbon O, Parent F, Trésorier R, Tromeur C, Piedvache C, Grimaldi L, Fadel E, Montani D, Humbert M, Simonneau G. Balloon pulmonary angioplasty versus riociguat for the treatment of inoperable chronic thromboembolic pulmonary hypertension (RACE): a multicentre, phase 3, open-label, randomised controlled trial and ancillary follow-up study. Lancet Respir Med. 2022 Aug 1:S2213-2600(22)00214-4. doi: 10.1016/S2213-2600(22)00214-4. Epub ahead of print. PMID: 35926542.

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    2022-09-08 zhlpower
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    2022-10-11 howi
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    2022-08-08 neurowu
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    2022-08-06 younei

    lancet上果然牛,感谢梅斯更新及时

    0

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