神经康复临床试验设计的基本信息：出院至急性康复设施的卒中后 90 天内全球残疾轨迹。
Essential information for neurorecovery clinical trial design: trajectory of global disability in first 90 days post-stroke in patients discharged to acute rehabilitation facilities.
机构信息
Department of Neurology, David Geffen School of Medicine, UCLA, Los Angeles, USA.
Department of Neurology, Kaiser Permanente Los Angeles Medical Center, Los Angeles, USA.
出版信息
BMC Neurol. 2023 Jun 20;23(1):239. doi: 10.1186/s12883-023-03251-1.
BACKGROUND
Many stroke recovery interventions are most beneficial when started 2-14d post-stroke, a time when patients become eligible for inpatient rehabilitation facilities (IRF) and neuroplasticity is often at its peak. Clinical trials focused on recovery need to expand the time from this plasticity to later outcome timepoints.
METHODS
The disability course of patients with acute ischemic stroke (AIS) and intracranial hemorrhage (ICH) enrolled in Field Administration of Stroke Therapy Magnesium (FAST-MAG) Trial with moderate-severe disability (modified Rankin Scale [mRS] 3-5) on post-stroke day4 who were discharged to IRF 2-14d post-stroke were analyzed.
RESULTS
Among 1422 patients, 446 (31.4%) were discharged to IRFs, including 23.6% within 2-14d and 7.8% beyond 14d. Patients with mRS 3-5 on day4 discharged to IRFs between 2-14d accounted for 21.7% (226/1041) of AIS patients and 28.9% (110/381) of ICH patients, (p < 0.001). Among these AIS patients, age was 69.8 (± 12.7), initial NIHSS median 8 (IQR 4-12), and day4 mRS = 3 in 16.4%, mRS = 4 in 50.0%, and mRS = 5 in 33.6%. Among these ICH patients, age was 62.4 (± 11.7), initial NIHSS median 9 (IQR 5-13), day 4 mRS = 3 in 9.4%, mRS = 4 in 45.3%, and mRS = 5 in 45.3% (p < 0.01 for AIS vs ICH). Between day4 to day90, mRS improved ≥ 1 levels in 72.6% of AIS patients vs 77.3% of ICH patients, p = 0.3. For AIS, mRS improved from mean 4.17 (± 0.7) to 2.84 (± 1.5); for ICH, mRS improved from mean 4.35 (± 0.7) to 2.75 (± 1.3). Patients discharged to IRF beyond day14 had less improvement on day90 mRS compared with patients discharged between 2-14d.
CONCLUSIONS
In this acute stroke cohort, nearly 1 in 4 patients with moderate-severe disability on post-stroke day4 were transferred to IRF within 2-14d post-stroke. ICH patients had nominally greater mean improvement on mRS day90 than AIS patients. This course delineation provides a roadmap for future rehabilitation intervention studies.
背景
许多中风康复干预措施在中风后 2-14 天最为有效，此时患者有资格进入住院康复机构（IRF），神经可塑性通常处于高峰期。专注于康复的临床试验需要将时间从这种可塑性扩展到后期结果时间点。
方法
对 FAST-MAG 试验中患有急性缺血性中风（AIS）和颅内出血（ICH）且残疾程度中度至重度（改良 Rankin 量表 [mRS] 3-5）的患者进行分析，这些患者在中风后第 4 天出院至 IRF，且在中风后 2-14 天内出院。
结果
在 1422 名患者中，446 名（31.4%）被送往 IRF，其中 23.6%在 2-14 天内出院，7.8%在 14 天后出院。在中风后第 4 天残疾程度为 mRS 3-5 的患者中，有 21.7%（226/1041）的 AIS 患者和 28.9%（110/381）的 ICH 患者在 2-14 天内出院至 IRF（p<0.001）。在这些 AIS 患者中，年龄为 69.8（±12.7）岁，入院 NIHSS 中位数为 8（四分位距 4-12），第 4 天 mRS=3 的占 16.4%，mRS=4 的占 50.0%，mRS=5 的占 33.6%。在这些 ICH 患者中，年龄为 62.4（±11.7）岁，入院 NIHSS 中位数为 9（四分位距 5-13），第 4 天 mRS=3 的占 9.4%，mRS=4 的占 45.3%，mRS=5 的占 45.3%（AIS 与 ICH 比较，p<0.01）。从第 4 天到第 90 天，72.6%的 AIS 患者 mRS 改善≥1 级，77.3%的 ICH 患者 mRS 改善≥1 级，p=0.3。AIS 患者 mRS 从平均 4.17（±0.7）改善至 2.84（±1.5）；ICH 患者 mRS 从平均 4.35（±0.7）改善至 2.75（±1.3）。与在 2-14 天内出院的患者相比，在第 14 天以后出院的患者在第 90 天 mRS 上的改善程度较小。
结论
在这个急性中风队列中，中风后第 4 天残疾程度中度至重度的患者中，近 1/4 在中风后 2-14 天内被转移到 IRF。ICH 患者的 mRS 在第 90 天的改善程度略高于 AIS 患者。这一病程描述为未来的康复干预研究提供了路线图。
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