Department of Clinical Sciences Lund, Neurology, Skåne University Hospital, Lund University, Lund, Sweden.
Division of Neurology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.
Neurocrit Care. 2020 Oct;33(2):516-524. doi: 10.1007/s12028-020-00916-4.
BACKGROUND/OBJECTIVE: Intracerebral hemorrhage (ICH) patients commonly have concomitant white matter lesions (WML) which may be associated with poor outcome. We studied if WML affects hematoma expansion (HE) and post-stroke functional outcome in a post hoc analysis of patients from randomized controlled trials.
In ICH patients from the clinical trials MISTIE II and CLEAR III, WML grade on diagnostic computed tomography (dCT) scan (dCT, < 24 h after ictus) was assessed using the van Swieten scale (vSS, range 0-4). The primary outcome for HE was > 33% or > 6 mL ICH volume increase from dCT to the last pre-randomization CT (< 72 h of dCT). Secondary HE outcomes were: absolute ICH expansion, > 10.4 mL total clot volume increase, and a subgroup analysis including patients with dCT < 6 h after ictus using the primary HE definition of > 33% or > 6 mL ICH volume increase. Poor functional outcome was assessed at 180 days and defined as modified Rankin Scale (mRS) ≥ 4, with ordinal mRS as a secondary endpoint.
Of 635 patients, 55% had WML grade 1-4 at dCT (median 2.2 h from ictus) and 13% had subsequent HE. WML at dCT did not increase the odds for primary or secondary HE endpoints (P ≥ 0.05) after adjustment for ICH volume, intraventricular hemorrhage volume, warfarin/INR > 1.5, ictus to dCT time in hours, age, diabetes mellitus, and thalamic ICH location. WML increased the odds for having poor functional outcome (mRS ≥ 4) in univariate analyses (vSS 4; OR 4.16; 95% CI 2.54-6.83; P < 0.001) which persisted in multivariable analyses after adjustment for HE and other outcome risk factors.
Concomitant WML does not increase the odds for HE in patients with ICH but increases the odds for poor functional outcome.
http://www.clinicaltrials.gov trial-identifiers: NCT00224770 and NCT00784134.
背景/目的：脑出血（ICH）患者常伴有伴发的脑白质病变（WML），这可能与不良预后相关。我们通过对随机对照试验患者进行事后分析，研究 WML 是否会影响血肿扩大（HE）和卒中后功能结局。
在临床试验 MISTIE II 和 CLEAR III 的 ICH 患者中，在发病后 24 小时内（dCT 后 < 24 小时），使用 van Swieten 量表（vSS，范围 0-4）评估诊断计算机断层扫描（dCT）上的 WML 分级。HE 的主要结局是 dCT 至最后一次预随机 CT 之间的血肿体积增加> 33%或> 6 毫升（dCT 后 < 72 小时）。HE 的次要结局为：绝对血肿扩大，总血栓体积增加> 10.4 毫升，以及包括 dCT 后 < 6 小时的患者的亚组分析，采用原发性 HE 定义> 33%或> 6 毫升血肿体积增加。180 天时评估不良功能结局，定义为改良 Rankin 量表（mRS）≥ 4，将有序 mRS 作为次要终点。
在 635 名患者中，55%的患者在 dCT 时有 WML 分级 1-4（发病后中位数 2.2 小时），13%的患者发生了继发性 HE。ICH 体积、脑室内出血体积、华法林/INR>1.5、发病至 dCT 时间（小时）、年龄、糖尿病和丘脑 ICH 位置校正后，WML 并未增加原发性或继发性 HE 终点的发生几率（P≥0.05）。在单变量分析中，WML 增加了不良功能结局（mRS≥4）的几率（vSS 4；OR 4.16；95%CI 2.54-6.83；P<0.001），多变量分析校正 HE 和其他结局风险因素后，该结果仍然存在。
ICH 患者伴发 WML 并不会增加 HE 的几率，但会增加不良功能结局的几率。
http://www.clinicaltrials.gov 试验识别号：NCT00224770 和 NCT00784134。
