Department of Pharmacy, The Affiliated Changzhou No. 2 People's Hospital of Nanjing Medical University, Changzhou, China.
Department of Pharmaceutics, College of Pharmaceutical Sciences, Soochow University, Suzhou, China.
Eur J Clin Pharmacol. 2020 Apr;76(4):475-481. doi: 10.1007/s00228-019-02817-8. Epub 2020 Jan 3.
The safety and efficacy of tirofiban for patients with acute ischemic stroke (AIS) remains controversial. We therefore conducted a systematic review and meta-analysis.
We searched PubMed, EMBASE, Cochrane Library, Web of Science, and related international clinical trials registries through March 31, 2019, using the terms "tirofiban" and "stroke". All apparently unconfounded randomized controlled trials (RCTs) and cohort studies with two arms comparing treatment with and without tirofiban for AIS were included in this review. Primary outcomes included symptomatic intracranial hemorrhage (sICH), fatal ICH, mortality, and modified Rankin Scale (mRS 0-2) at 3 months.
Seventeen studies including 2914 AIS patients were identified. Pooled results showed that tirofiban treatment in AIS did not increase the risk of sICH (OR, 0.95; 95% CI, 0.71-1.28; p = 0.75) or mortality (OR, 0.80; 95% CI; 0.64-1.02; p = 0.07). However, fatal ICH increased significantly in the tirofiban treatment group (OR, 2.84; 95% CI, 1.38-5.85; p = 0.005), and subgroup analysis showed that tirofiban via intra-arterial (IA) administration was associated with increased risk of fatal ICH (OR, 2.90; 95% CI, 1.12-7.55; p = 0.03), while intravenous (IV) administration was not (OR, 2.75; 95% CI, 0.92-8.20; p = 0.07). In addition, tirofiban showed no obvious improvement in functional outcome (mRS 0-2) (OR, 1.29; 95% CI, 0.97-1.71; p = 0.08).
Tirofiban seems to be safe in systemic treatment and may represent a potential choice for management of AIS. However, intra-arterial administration requires further adequately controlled studies in order to develop an appropriate protocol, similar to that in cardiology.
替罗非班治疗急性缺血性脑卒中（AIS）的安全性和疗效仍存在争议。因此，我们进行了一项系统评价和荟萃分析。
我们检索了 PubMed、EMBASE、Cochrane 图书馆、Web of Science 以及相关的国际临床试验注册处，检索词为“替罗非班”和“stroke”。本综述纳入了所有明显无混杂的随机对照试验（RCT）和双臂比较替罗非班治疗与不治疗 AIS 的队列研究。主要结局包括症状性颅内出血（sICH）、致命性颅内出血（ICH）、死亡率和 3 个月时改良 Rankin 量表（mRS）0-2 分。
共纳入 17 项研究，包括 2914 例 AIS 患者。汇总结果显示，替罗非班治疗 AIS 并未增加 sICH 的风险（OR，0.95；95%CI，0.71-1.28；p=0.75）或死亡率（OR，0.80；95%CI；0.64-1.02；p=0.07）。然而，替罗非班组致命性 ICH 显著增加（OR，2.84；95%CI，1.38-5.85；p=0.005），亚组分析显示，替罗非班经动脉内（IA）给药与致命性 ICH 风险增加相关（OR，2.90；95%CI，1.12-7.55；p=0.03），而静脉内（IV）给药则不然（OR，2.75；95%CI，0.92-8.20；p=0.07）。此外，替罗非班在功能结局（mRS 0-2）方面无明显改善（OR，1.29；95%CI，0.97-1.71；p=0.08）。
替罗非班在系统性治疗中似乎是安全的，可能是 AIS 治疗的潜在选择。然而，IA 给药需要进一步进行充分对照研究，以制定适当的方案，类似于心脏病学中的方案。
