全脑CT灌注成像指导静脉溶栓的有效性和安全性评价

Intravenous thrombolysis directed by whole-brain computed tomographic perfusion：a case-control study

目的 本研究旨在探讨全脑CT灌注成像（CTP）指导缺血性卒中静脉溶栓的有效性和安全性.方法 前瞻性收集2011年4月至2013年4月就诊于宣武医院的急性卒中病例资料,其中65例按既定CTP或时间窗标准（3.0 h和3.0～4.5 h）入选的静脉溶栓病例被纳入了分析.主要终点指标为发病14 d的日常生活能力评分和严重不良事件发生率.次要指标包括：再灌注率及血管再通率,神经功能改善比例,脑出血发生率和时间指标.统计学方法主要采用t检验、Mann-Whitney U检验和Pearson Chi-Square检验比较对应变量之间的差异.结果 CTP和时间窗标准分别入选了25和40例静脉溶栓病例,两组基线资料中非时间变量差异无统计学意义.CTP组的发病时间（265 min）较3 h亚组（160 min）明显延长,而较3.0～4.5 h亚组（251 min）无明显延长.CTP组的转诊比例明显高于时间窗标准组（52.0%比25.0%,P=0.03）,亚组分析提示CTP组转诊比例仅显著高于3 h亚组（52.0%比7.7%,P=0.02）,而与3.0～4.5 h亚组比较差异无统计学意义.主要终点指标中,近期良好预后和严重不良事件发生率的组间比较差异无统计学意义;次要疗效指标中,CTP标准组血管再通率较3.0～4.5 h亚组有增加趋势（52.0%比37.0%,P=0.28）.CTP早期排除了20例未能被平扫CT识别的大面积梗死.结论 全脑CTP可能较时间窗标准更安全和有效地指导静脉溶栓.其可在不增加时间延误的基础上,较平扫CT更敏感地识别大面积梗死,尤其适用于发病时间超过3 h的病例.

Objective To explore the efficacy and safety of intravenous thrombolysis （IVT） directed by whole-brain computed tomographic perfusion （CTP）. Methods A total of 65 patients with acute ischemic stroke at our hospital during the period of April 2011 to April 2013, selected in accordance with the established CTP or Trw standard （0 to 3.0 h and 3.0 to 4. 5 h） for IVT were included for analysis. The primary endpoint events were Barthel index （BI） and the rate of serious adverse events at 14 days post-onset. The latter included mortality and symptomatic intracerebral hemorrhage （ICH）. And secondary indicators included the incidence of reperfusion, recanalization, ICH and neurological improvement at Day 14, as well as time indicators, such as onset-to-door time （ODT）, door-to-treatment time （DTT） and onset-to-treatment time （OTT）. Statistical calculations for continuous variables were compared with t or Mann-Whitney U test. And other comparisons were made with Pearson Chi-square or Fisher＇s exact test. Results Twenty-five and 40 cases with acute ischemic stroke were enrolled according to CTP or Trw standard for IVT respectively. Baseline characteristics, including age, gender, risk factors, blood pressure, blood sugar, National Institute of Health stroke scale （NIHSS） and drug dose showed no significant difference among groups. DTT and OTT in CTP group were significantly longer than those of the 0 to 3.0 h subgroup, while similar with those of the 3.0 to 4. 5 h subgroup. Interestingly, consistent with a significant higher rate of transferring for consultation in the CTP group comparing with the TTW group （52. 0% vs 25. 0%, P = 0. 03 ）, the rate was also significantly higher than the 0 to 3. 0 h subgroup （52. 0% vs 7.7%, P =0. 02）, but not significantly higher than the 3.0 to 4. 5 subgroup. Both primary endpoint events and secondary outcome measures among three groups showed no significant differences. As for secondary outcome measures, CTP group had a higher recanalization than the 3.0 to 4. 5 h subgroup （52.0% vs 37. 0%, P = 0. 28） and there was a trend toward significance. CTP excluded 58 cases, including 20 proved cases of malignant infarction on magnetic resonance imaging. Conclusion CTP is able to select reasonable candidates for IVT in an extended time window with effectiveness and safety comparable to Trw standard. Furthermore, it is quicker and more sensitive than Trw standard in detecting malignant infarction.