Chest:通过 PAH 中的活动记录评估日常生活中的身体活动:来自司来帕格 (TRACE) 随机对照研究的见解

2022-09-15 刘少飞 MedSci原创

肺动脉高压 (PAH) 患者的日常生活体力活动 (DLPA) 减少会导致生活质量下降。活动记录仪能否用于评估接受司来帕格或安慰剂治疗的 PAH 患者 DLPA 的变化?

研究背景:

肺动脉高压 (PAH) 患者的日常生活体力活动 (DLPA) 减少会导致生活质量下降。

研究问题:

活动记录仪能否用于评估接受司来帕格或安慰剂治疗的 PAH 患者 DLPA 的变化?

研究设计和方法:

TRACE 是一项前瞻性、多中心、随机、安慰剂对照、双盲探索性 4 期研究,招募了 WHO II/III 级 PAH 患者,接受稳定的内皮素受体拮抗剂联合/不联合 5 型磷酸二酯酶抑制剂背景治疗。主要终点是活动记录评估的 DLPA(由加速度计记录)从基线到第 24 周的变化,包括每天花费在非久坐体力活动 (NSPA) 中的时间、每天花费在中度到剧烈体力活动 (MVPA) 中的时间,每天的活动量和每天的步数。

研究结果:

在基线时,患者 (N=108) 普遍,接受稳定的背景 PAH 治疗且疾病进展风险较低。在整个研究过程中,患者对加速度计的佩戴表现出很高的依从性。从基线到第 24 周,司来帕格和安慰剂组在 NSPA 中花费的平均每日时间增加了 1.1 分钟,减少了 16.7 分钟(治疗差异 [95% CI]:17.8 [-6.0,41.6] 分钟);司来帕格和安慰剂组在 MVPA 中花费的平均时间增加了 0.3 分钟,减少了 2.0 分钟(治疗差异 [95% CI]:2.3 [-10.8,15.4] 分钟);司来帕格和安慰剂组的平均每日步数分别减少了 0.3 和 201.9(治疗差异 [95% CI]:201.6 [-243.0,646.2])。

研究启示:

TRACE 招募了一个接受背景治疗且疾病进展风险低的流行人群。DLPA 的变化很小且变化很大,治疗组之间没有统计学上的显着差异。这项以患者为中心的研究是 PAH 的第一项随机试验,旨在获取高质量的活动记录数据并以均值/中位数和变异性来描述 DLPA,这可能会为未来研究的设计提供信息。

 

参考文献:

Howard LS, Rosenkranz S, Frantz RP, Hemnes AR, Pfister T, Hsu Schmitz SF, Skåra H, Humbert M, Preston IR. Assessing daily life physical activity by actigraphy in PAH: insights from the randomised controlled study with selexipag (TRACE). Chest. 2022 Sep 8:S0012-3692(22)03707-2. doi: 10.1016/j.chest.2022.08.2231. Epub ahead of print. PMID: 36089068.

 

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    2023-03-08 shanyongle
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    2022-12-21 amyloid
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    2023-04-03 Smile2680
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    2023-08-15 bsmagic9140
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    2022-09-16 hb2010ye

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