Department of Neurology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.
Brain Behav. 2019 Oct;9(10):e01398. doi: 10.1002/brb3.1398. Epub 2019 Sep 18.
Approximately, half of the acute stroke patients with minor symptoms were excluded from thrombolysis in some randomized controlled trials (RCTs). There is little evidence on treating minor strokes with rt-PA. Here, we performed a systematic review and meta-analysis to assess the safety and efficacy of thrombolysis in these patients.
PubMed, Embase, Web of Science, and Cochrane Library were searched in July 2018. All available RCTs and retrospective comparative studies that compared thrombolysis with nonthrombolysis' for acute minor stroke (NIHSS ≤ 5) with quantitative outcomes were included.
Ten studies, including a total of 4,333 patients, were identified. The risk of intracranial hemorrhage (ICH) was higher in the rt-PA group as compared with that in the non-rt-PA group (3.8% vs. 0.6%; p = .0001). However, there is no significant difference in the rate of mortality between the two groups (p = .96). The pooled rate of a good outcome in 90 days was 67.8% in those with rt-PA and 63.3% in those without rt-PA (p = .07). Heterogeneity was 43% between the studies (p = .08). After adjusting for the heterogeneity, thrombolysis was associated with good outcome (68.3% vs. 63.0%, OR 1.47; 95% CI 1.14-1.89; p = .003). In post hoc analyses, including only RCTs, the pooled rate of good outcome had no significant differences between the two groups (86.6% vs. 85.7%, 95% CI 0.44-3.17, p = .74; 87.4% vs. 91.9%, 95% CI 0.35-1.41, p = .32; before and after adjusting separately).
Although thrombolysis might increase the risk of ICH based on existing studies, patients with acute minor ischemic stroke could still benefit from thrombolysis at 3 months from the onset.
在一些随机对照试验(RCT)中,约有一半症状较轻的急性脑卒中患者被排除在溶栓治疗之外。目前,对于使用 rt-PA 治疗轻度脑卒中的疗效和安全性证据较少。因此,我们进行了一项系统评价和荟萃分析,以评估这些患者溶栓治疗的安全性和有效性。
我们于 2018 年 7 月检索了 PubMed、Embase、Web of Science 和 Cochrane Library 数据库。纳入所有比较急性轻度脑卒中(NIHSS≤5)患者溶栓与非溶栓治疗(rt-PA 组与非 rt-PA 组)并报告定量结局的 RCT 和回顾性对照研究。
共纳入 10 项研究,共计 4333 例患者。与非 rt-PA 组相比,rt-PA 组颅内出血(ICH)的风险更高(3.8% vs. 0.6%;p=0.0001)。但两组死亡率差异无统计学意义(p=0.96)。rt-PA 组 90 天良好结局的累积发生率为 67.8%,非 rt-PA 组为 63.3%(p=0.07)。研究之间存在 43%的异质性(p=0.08)。调整异质性后,溶栓治疗与良好结局相关(68.3% vs. 63.0%,OR 1.47;95% CI 1.14-1.89;p=0.003)。在事后分析中,包括仅 RCT 时,两组间的良好结局发生率差异无统计学意义(86.6% vs. 85.7%,95% CI 0.44-3.17,p=0.74;87.4% vs. 91.9%,95% CI 0.35-1.41,p=0.32;分别调整前后)。
尽管现有研究表明溶栓治疗可能会增加 ICH 的风险,但发病 3 个月内的急性轻度缺血性脑卒中患者仍可能从溶栓治疗中获益。