组织纤溶酶原激活剂（tPA）治疗急性缺血性卒中的比较疗效和安全性：随机对照试验的系统评价和网络荟萃分析。

IF 2 4区医学 Q3 NEUROSCIENCES

Journal of Stroke & Cerebrovascular Diseases Pub Date : 2025-01-09 DOI:10.1016/j.jstrokecerebrovasdis.2025.108230

Sufyan Shahid MBBS , Humza Saeed MBBS , Minahil Iqbal MBBS , Ayesha Batool MBBS , Muhammad Bilal Masood MBBS , Muhammad Husnain Ahmad MD , Aqeeb Ur Rehman MD , Muhammad Aemaz Ur Rehman MD , Fahd Sultan MD

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引用次数: 0

摘要

背景：静脉注射阿替普酶（ALT）是治疗急性缺血性卒中（AIS）的标准疗法。然而，最近对其他组织纤溶酶原激活剂（tPA）（如替奈替普酶（TNK）和再替普酶）与阿替普酶进行比较的试验得出了相互矛盾的结果。因此，有必要进行网络荟萃分析，比较各种 tPA 对 AIS 患者的疗效和安全性：我们检索了MEDLINE、Embase和CENTRAL（截止到2024年9月15日），以寻找在AIS患者中比较TNK或再普酶（任何剂量）与ALT（0.9 mg/kg）的随机对照试验（RCT）。采用风险比（RR）和 95% CI 对每项比较进行了频数网络荟萃分析，并对治疗进行了 P 值排序。分析使用 R 软件 4.2.3.结果：共纳入 16 项研究数据（9259 名患者，62.1% 为男性）。Reteplase 18+18 mg能显著改善极佳的功能恢复（mRS 0-1）（RR：1.13；pConclusion：Reteplase 18+18 mg和TNK 0.25 mg/kg与ALT相比，疗效更高，安全性相当。需要进行更大规模的试验，以进一步探索这些药物作为 ALT 替代品的可能性。

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Comparative efficacy and safety of tissue plasminogen activators (tPA) in acute ischemic stroke: A systematic review and network meta-analysis of randomized controlled trials

Background

Intravenous alteplase (ALT) is the standard treatment for acute ischemic stroke (AIS). However, recent trials comparing other tissue plasminogen activators (tPAs) like tenecteplase (TNK) and reteplase with ALT have yielded conflicting results. This necessitated a network meta-analysis to compare the efficacy and safety of various tPAs in AIS patients.

Methods

We searched MEDLINE, Embase, and CENTRAL (until September 15, 2024) for randomized controlled trials (RCTs) comparing TNK or reteplase (any dose) with ALT (0.9 mg/kg) in AIS patients. A frequentist network meta-analysis was performed using risk ratio (RR) and 95 % CI for each comparison, and P-scores ranked treatments. Analyses were done using R Software 4.4.1.

Results

Sixteen RCTs (9259 patients, 62.1 % males) were included. Reteplase 18+18 mg significantly improved excellent functional recovery (mRS 0-1) (RR: 1.13; p < 0.01) and independent ambulation (mRS 0-2) at 3 months (RR: 1.07; p < 0.01) compared to ALT. The 0.25 mg/kg TNK group also showed improved functional recovery (mRS 0-1) (RR: 1.06; p < 0.01). For safety, 0.1 mg/kg TNK was associated with a higher incidence of symptomatic intracranial hemorrhage (s-ICH) (RR: 7.27; p < 0.01). No significant differences in ICH or all-cause mortality were found between ALT and other treatments. Reteplase 18+18 mg ranked highest for functional recovery (P-score=0.9638) and ambulation (P-score=0.9749), while ALT ranked highest for s-ICH (P-score=0.8060). No significant differences were observed between reteplase and TNK.

Conclusion

Reteplase 18+18 mg and TNK 0.25 mg/kg demonstrated higher efficacy and comparable safety to ALT. Larger trials are needed to further explore these agents as alternatives to ALT.

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来源期刊

Journal of Stroke & Cerebrovascular Diseases Medicine-Surgery

CiteScore

5.00

自引率

4.00%

发文量

583

审稿时长

62 days

期刊介绍： The Journal of Stroke & Cerebrovascular Diseases publishes original papers on basic and clinical science related to the fields of stroke and cerebrovascular diseases. The Journal also features review articles, controversies, methods and technical notes, selected case reports and other original articles of special nature. Its editorial mission is to focus on prevention and repair of cerebrovascular disease. Clinical papers emphasize medical and surgical aspects of stroke, clinical trials and design, epidemiology, stroke care delivery systems and outcomes, imaging sciences and rehabilitation of stroke. The Journal will be of special interest to specialists involved in caring for patients with cerebrovascular disease, including neurologists, neurosurgeons and cardiologists.