Stroke Center and Department of Neurology, Geffen School of Medicine, University of California, Los Angeles, CA, USA.
Stroke. 2010 May;41(5):932-7. doi: 10.1161/STROKEAHA.109.574335. Epub 2010 Apr 1.
Although intra-arterial (IA) fibrinolysis for acute ischemic stroke has been clinically available for many years, it is not a therapy approved by the US Food and Drug Administration. Single, randomized, clinical trials (RCTs) have suggested beneficial effects, but no single RCT has demonstrated that IA fibrinolysis yields increases in both good (modified Rankin Scale score 0 to 2) and excellent (modified Rankin Scale score 0 to 1) outcomes when compared with the control group. Relatively few participants and inadequate statistical power in single RCTs may have contributed to this difficulty. Method- We performed a systematic literature search to identified RCTs of IA fibrinolysis in acute ischemic stroke. Multiple outcomes were analyzed, with emphasis on good and excellent outcomes at 90 days or at trial end point.
The systematic search identified 5 RCTs with 395 participants comparing IA fibrinolysis and control. IA fibrinolysis was associated with increased good (odds ratio=2.05; 95% CI, 1.33 to 3.14; P=0.001) and excellent (odds ratio=2.14; 95% CI, 1.31 to 3.51; P=0.003) outcomes. For additional end points, IA fibrinolysis was associated with increased frequencies of minimal neurologic deficit (National Institutes of Health Stroke Scale score 0 to 1), minimal impairment of activities of daily living (Barthel Index 90 to 100 or 95 to 100), and recanalization. IA fibrinolysis was associated with increased radiological and symptomatic intracerebral hemorrhage. However, there was no difference in mortality between groups.
Formal meta-analysis suggests that IA fibrinolysis substantially increases recanalization rates and good and excellent clinical outcomes in acute ischemic stroke. Increased hemorrhage frequencies are not associated with any increase in mortality.
尽管动脉内（IA）溶栓治疗急性缺血性脑卒中已在临床上应用多年，但它并未获得美国食品和药物管理局的批准。单次、随机对照临床试验（RCT）表明其具有有益效果，但尚无单一 RCT 证明与对照组相比，IA 溶栓可增加良好（改良 Rankin 量表评分 0 至 2）和优秀（改良 Rankin 量表评分 0 至 1）结局的比例。这可能与单次 RCT 中相对较少的参与者和统计效能不足有关。方法-我们进行了系统的文献检索，以确定急性缺血性脑卒中的 IA 溶栓 RCT。分析了多个结局，重点关注 90 天或试验终点时的良好和优秀结局。
系统搜索确定了 5 项 RCT，共纳入 395 名患者，比较了 IA 溶栓与对照组。IA 溶栓与良好结局（优势比=2.05；95%置信区间，1.33 至 3.14；P=0.001）和优秀结局（优势比=2.14；95%置信区间，1.31 至 3.51；P=0.003）的增加相关。对于其他结局，IA 溶栓与轻微神经功能缺损（NIHSS 评分 0 至 1）、日常生活活动能力轻度受损（Barthel 指数 90 至 100 或 95 至 100）和再通的频率增加相关。IA 溶栓与影像学和症状性颅内出血的增加相关。然而，两组间的死亡率无差异。
正式的荟萃分析表明，IA 溶栓可显著增加急性缺血性脑卒中的再通率以及良好和优秀的临床结局。增加的出血频率与死亡率的增加无关。
