Ann Neurol-强化降压,的确有利于改善急性脑出血

2021-07-07 Freeman MedSci原创

强化降压,的确有利于改善急性脑出血

血肿扩大(HE)是急性脑内出血(ICH)不良后果的决定因素,也是临床试验的一个引人注目的目标。虽然血流动力学和止血疗法似乎可以减轻血肿,但在III期试验中证明其疗效具有挑战性。

目前作为生物标志物结果的HE评估包括中心趋势的比较(中位数和平均值)和固定二分法阈值的分析。然而,将连续变量还原为二分法结果,有可能放弃有关特定疗法的生物效应的大量信息,并可能导致检测候选疗法和感兴趣的结果之间关系的能力下降。

将连续变量减少到多分法结果,可以减少信息损失,提高治疗效果终点的信息性。例如,一种止血剂可能会在所有患者中适度减少血栓,但二分法的测量方法将只在减少血栓产生阈值转变的一小部分患者中检测到这种效果。使用二分法HE分析的研究有可能错过了针对HE的疗法的真正生物效应。

藉此,渥太华大学的Vignan Yogendrakumar等人,对血肿体积变化的分布进行更细化的评估可能会更好地评估有关治疗的生物效应,并可能支持重新审视以前的 "中性 "治疗方案,以便进一步研究。他们通过提出了一个 "血肿转移 "分析模型,作为ICH治疗评估的策略,并利用以前发表的临床试验数据来说明这一方法。

他们利用急性脑出血抗高血压治疗II(ATACH-2)试验的数据,对强化降压的反应进行了HE转变分析,根据
a)先前建立的HE定义,
b)血肿体积变化的百分位/绝对四分位数,
c)24小时随访血肿体积的四分位数,产生了多分位的层。使用cox模型探讨了血压治疗和血肿转变之间的关系。

主要分析人群包括863名患者。他们发现,在两个治疗组中,约有三分之一的患者没有出现血肿。

使用三分法的HE分层,≥33%的最高分层显示,随机接受强化治疗者的血肿增长减少5.8%(aOR:0.77[95%CI:0.60-0.99])。

使用血肿体积变化的百分位数四分法,在接受强化治疗的患者中,减少血肿增长的有利转变:aOR:0.73(0.57-0.93)。同样,在24小时随访血肿体积的四分法分析中,最高层(>21.9 mL)的转变最为明显。

这个研究的重要意义在于,发现了强化降压可优先缓解高容量血肿风险患者的生长。高血压的转移分析模型(shift analysis model)提供了对特定疗法的生物效应的额外解释,并可能成为在未来研究中评估止血剂的一种额外方式。

原文出处:
Yogendrakumar V, Ramsay T, Menon BK, Qureshi AI, Saver JL, Dowlatshahi D. Hematoma Expansion Shift Analysis to Assess Acute Intracerebral Hemorrhage Treatments. Neurology. 2021 Jun 18:10.1212/WNL.0000000000012393. doi: 10.1212/WNL.0000000000012393. Epub ahead of print. PMID: 34144995.

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    2022-02-28 yinhl1978
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    2021-07-23 ms4000000408264698

    xiexie

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    2021-07-07 言西早

    加强公共卫生预防

    0

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