阿加曲班作为抗血小板治疗辅助用药在缺血性卒中中的疗效与安全性：更新的系统评价与荟萃分析。
完整摘要 · 中文译文
引言：急性缺血性卒中（AIS）是一种危及生命的疾病。阿加曲班可限制血栓进展并改善AIS的功能结局。本研究评估了阿加曲班联合抗血小板治疗与对照相比的疗效和安全性。 方法：检索了PubMed和Scopus。主要结局为改良Rankin量表（mRS）0-2分和复合出血；次要结局包括mRS（0-1分）、早期神经功能恶化（END）、美国国立卫生研究院卒中量表（NIHSS）评分变化、死亡率、颅内出血和器官出血。采用随机效应模型，二分类结局报告风险比（RR），连续结局报告均数差（MD），均给出95%置信区间（CI）和0.05的p值。 结果：共纳入17项研究，阿加曲班组和对照组分别共有51,703例和18,759例患者。主要结局mRS（0-2分）和复合出血在阿加曲班组与对照组之间无显著差异（分别为RR：1.03，CI：0.97-1.10，p = 0.26和RR：1.10，CI：0.98-1.23，p = 0.11）。然而，阿加曲班显著降低了END（RR：0.48，CI：0.30-0.75，p < 0.05），并有利于mRS（0-1分），RR：1.22（CI：1.01-1.48，p = 0.03）。NIHSS评分变化以及死亡率、卒中复发、颅内出血和器官出血的发生率在两组之间相当。按干预组和对照组中抗血小板药物进行的亚组分析证实，阿加曲班与DAPT联合应用时结果最为显著。而总体 汇总分析未显示出血风险增加，但仅限于随机对照试验的亚组分析显示，阿加曲班使复合出血和颅内出血显著增加。对随机对照试验来源证据的GRADE评价显示，所有结局的证据确定性为极低至高等。 结论：与单用抗血小板治疗相比，阿加曲班作为抗血小板治疗的辅助用药并未显著改善总体功能结局（mRS 0-2）或减少复合出血。然而，它似乎是安全的，并可能显著减少早期神经功能恶化（END）。
完整摘要 · 英文原文
INTRODUCTION: Acute ischemic stroke (AIS) is a life-threatening condition. Argatroban can limit thrombus progression and improve AIS's functional outcomes. This study assessed the efficacy and safety of argatroban in combination with antiplatelet therapy compared to control. METHODS: PubMed and Scopus were searched. Primary outcomes were Modified Rankin Scale (mRS) 0-2 and composite hemorrhage; secondary outcomes included mRS (0-1), early neurological deterioration (END), change in National Institutes of Health Stroke Scale (NIHSS) score, mortality, intracranial and organ hemorrhage. A random-effects model was used, with risk ratios (RRs) reported for binary outcomes, while mean differences (MDs) for continuous outcomes at 95% confidence intervals (CI) and a p-value of 0.05. RESULTS: 17 studies were included with a total of 51,703 and 18,759 patients in the argatroban and control group, respectively. The primary outcomes, mRS (0-2), and composite hemorrhage showed no significant difference between argatroban and control (RR: 1.03, CI: 0.97-1.10, p = 0.26 and RR: 1.10, CI: 0.98-1.23, p = 0.11, respectively). However, argatroban significantly reduced END (RR: 0.48, CI: 0.30-0.75, p < 0.05) and favored mRS (0-1) with RR:1.22 (CI: 1.01-1.48, p = 0.03). The change in NIHSS score and incidence of mortality, stroke recurrence, intracranial and organ hemorrhage was comparable between the two groups. Subgroup analyses by antiplatelet drug in the intervention and comparison groups confirmed that argatroban showed the most pronounced results when combined with DAPT. While the overall pooled analysis did not demonstrate increased hemorrhagic risk, subgroup analysis restricted to randomized controlled trials revealed a significant increase in composite and intracranial hemorrhage with argatroban. GRADE assessment of RCT-derived evidence indicated very low to high certainty across all outcomes. CONCLUSION: Argatroban as an adjunct to antiplatelet therapy did not significantly improve overall functional outcome (mRS 0-2) or reduce composite hemorrhage compared with antiplatelet therapy alone. However it appears safe and may reduce END significantly.