Patel S C, Levine S R, Tilley B C, Grotta J C, Lu M, Frankel M, Haley E C, Brott T G, Broderick J P, Horowitz S, Lyden P D, Lewandowski C A, Marler J R, Welch K M
Division of Neuroradiology, Henry Ford Hospital and Health Science Centers, 2799 W Grand Blvd, K-3, Detroit, MI 48202-2689, USA.
JAMA. 2001 Dec 12;286(22):2830-8. doi: 10.1001/jama.286.22.2830.
The prevalence and clinical significance of early ischemic changes (EICs) on baseline computed tomography (CT) scan of the head obtained within 3 hours of ischemic stroke are not established.
To determine the frequency and significance of EIC on baseline head CT scans in the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA (recombinant tissue plasminogen activator) Stroke Trial.
The original study, a randomized controlled trial, took place from January 1991 through October 1994 at 43 sites, during which CT images were obtained within 3 hours of symptom onset and prior to the initiation of rt-PA or placebo. For the current analysis, detailed reevaluation was undertaken after October 1994 of all baseline head CT scans with clinical data available pretreatment (blinded to treatment arm).
Of 624 patients enrolled in the trial, baseline CT scans were retrieved and reviewed for 616 (99%).
Frequency of EICs on baseline CT scans; association of EIC with other baseline variables; effect of EICs on deterioration at 24 hours (>/=4 points increase from the baseline National Institutes of Health Stroke Scale [NIHSS] score); clinical outcome (measured by 4 clinical scales) at 3 months, CT lesion volume at 3 months, death at 90 days; and symptomatic intracranial hemorrhage (ICH) within 36 hours of treatment.
The prevalence of EIC on baseline CT in the combined rt-PA and placebo groups was 31% (n = 194). The EIC was significantly associated with baseline NIHSS score (rho = 0.23; P<.001) and time from stroke onset to baseline CT scan (rho = 0.11; P =.007). After adjusting for baseline variables, there was no EIC x treatment interaction detected for any clinical outcome, including deterioration at 24 hours, 4 clinical scales, lesion volume, and death at 90 days (P>/=.25), implying that EIC is unlikely to affect response to rt-PA treatment. After adjusting for NIHSS score (an independent predictor of ICH), no EIC association with symptomatic ICH at 36 hours was detected in the group treated with rt-PA (P>/=.22).
Our analysis suggests that EICs are prevalent within 3 hours of stroke onset and correlate with stroke severity. However, EICs are not independently associated with increased risk of adverse outcome after rt-PA treatment. Patients treated with rt-PA did better whether or not they had EICs, suggesting that EICs on CT scan are not critical to the decision to treat otherwise eligible patients with rt-PA within 3 hours of stroke onset.
缺血性卒中发病3小时内进行的头部基线计算机断层扫描（CT）上早期缺血性改变（EICs）的发生率及临床意义尚未明确。
确定在国立神经疾病与卒中研究所（NINDS）重组组织型纤溶酶原激活剂（rt-PA）卒中试验中，头部基线CT扫描上EICs的频率及意义。
原研究为一项随机对照试验，于1991年1月至1994年10月在43个地点进行，在此期间，在症状发作3小时内且在开始rt-PA或安慰剂治疗之前获取CT图像。对于当前分析，在1994年10月之后对所有有治疗前可用临床数据的头部基线CT扫描进行了详细的重新评估（对治疗组进行盲法评估）。
在该试验纳入的624例患者中，检索并复查了616例（99%）的基线CT扫描。
基线CT扫描上EICs的频率；EIC与其他基线变量的关联；EICs对24小时病情恶化（美国国立卫生研究院卒中量表[NIHSS]评分较基线增加≥4分）的影响；3个月时的临床结局（通过4种临床量表测量）、3个月时的CT病变体积、90天时的死亡情况；以及治疗36小时内的症状性颅内出血（ICH）。
rt-PA组和安慰剂组联合的基线CT上EICs的发生率为31%（n = 194）。EIC与基线NIHSS评分显著相关（rho = 0.23；P <.001）以及与卒中发作至基线CT扫描的时间显著相关（rho = 0.11；P =.007）。在对基线变量进行校正后，未检测到EIC与治疗之间的交互作用对任何临床结局有影响，包括24小时病情恶化、4种临床量表、病变体积以及90天时的死亡情况（P≥.25），这意味着EIC不太可能影响对rt-PA治疗的反应。在对NIHSS评分（ICH的独立预测因素）进行校正后，在接受rt-PA治疗的组中未检测到EIC与36小时时症状性ICH之间的关联（P≥.22）。
我们的分析表明，EICs在卒中发作3小时内很常见，且与卒中严重程度相关。然而，EICs与rt-PA治疗后不良结局风险增加无独立关联。接受rt-PA治疗的患者无论是否有EICs情况都较好，这表明CT扫描上的EICs对于在卒中发作3小时内对其他符合条件的患者使用rt-PA进行治疗的决策并非关键因素。
