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替奈普酶与链激酶在发展中国家心肌梗死治疗中疗效与安全性的系统评价

A Systematic Review of the Efficacy and Safety of Tenecteplase Versus Streptokinase in the Management of Myocardial Infarction in Developing Countries.

作者信息

Muoghalu Chioma G, Ekong Ndianabasi, Wyns William, Ofoegbu Cosmas C, Newell Micheal, Ebirim Danvictor A, Alex-Ojei Sandra T

机构信息

Department of Medicine, University of Galway, Galway, IRL.

Department of Medicine, Medical Center, Akwa Ibom State College of Education, Afaha Nsit, NGA.

出版信息

Cureus. 2023 Aug 25;15(8):e44125. doi: 10.7759/cureus.44125. eCollection 2023 Aug.

Abstract

Myocardial infarction (MI) is a significant cause of morbidity and mortality in low- and middle-income countries. Fibrinolytic agents and percutaneous coronary intervention (PCI) are the main approaches for the recanalization and reperfusion of the myocardium following MI. Many studies have shown that PCI is superior to thrombolytics due to better outcomes and decreased mortality. Nevertheless, PCI's mortality gain over thrombolysis decreases as the time between presentation and PCI procedure increases. Furthermore, PCI is not widely available in most developing countries; thus, it cannot be delivered promptly. Most patients in developing countries cannot afford the cost of PCI. Thus, thrombolytic therapy remains essential to managing MI in developing countries and should not be disregarded. Tenecteplase (TNK) and streptokinase (SK) are the two most widely used fibrinolytics in managing MI in underdeveloped nations. Despite their widespread availability, comparative studies on them have been inconclusive. This study aims to review the available literature on the effectiveness and safety of TNK versus SK in managing MI in resource-poor nations. The study is reported according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) extension and analyzed according to Cochrane guidelines on synthesis without meta-analysis. A comprehensive literature search for studies comparing TNK and STK was conducted on EMBASE, Cochrane Library, Web of Science, CINAHL, Scopus, Google Scholar, and Ovid version of MEDLINE databases. A reference list of the eligible articles and systematic reviews was also screened. A narrative synthesis of the available data was done by representing the data on the effect direction plot, followed by vote counting. Of the 2284 references retrieved from the databases, only 17 studies met the inclusion criteria and were selected for final analysis. The study suggested that TNK is more effective in complete ST-segment resolution (80% vs 10% on the effect direction plot) and symptom relief (80% vs 20%) than SK. SK and TNK were comparable in achieving successful fibrinolysis (50% vs 50%). For the safety parameters, TNK is associated with a lesser risk of major bleeding than SK (88.9% vs 11.1%) and minor bleeding (25% vs 75%). SK was linked with a higher risk of hypotension/shock (77.8% vs 11.1%) and anaphylaxis/allergy (100% vs 0%). Long-term mortality was higher in the SK arm (100% vs 0%). In-hospital mortality is comparable between the two agents (37.5% vs 37.5%). There is conflicting evidence regarding other safety and efficacy endpoints. Compared to SK, TNK results in better complete ST-segment resolution and symptom relief. A higher risk of long-term mortality, increased risk of major and minor bleeding, hypotension, and allergy/anaphylaxis was observed in patients who received SK. Both agents were comparable in terms of in-hospital mortality and successful fibrinolysis. Controversy exists regarding which agent is linked with increased risk of 30-35-day mortality benefit and stroke. Randomized controlled trials (RCTs) with large sample sizes are needed to establish TNK vs SK superiority in efficacy and safety. The long-term duration of follow-up of the mortality rate of the two agents is also essential, as most patients in these regions cannot afford the recommended PCI post-fibrinolysis.

摘要

心肌梗死(MI)是低收入和中等收入国家发病和死亡的重要原因。纤维蛋白溶解剂和经皮冠状动脉介入治疗(PCI)是心肌梗死后心肌再通和再灌注的主要方法。许多研究表明,由于更好的治疗效果和降低的死亡率,PCI优于溶栓治疗。然而,随着就诊与PCI手术之间时间的增加,PCI相对于溶栓治疗的死亡率获益会降低。此外,PCI在大多数发展中国家并不普遍;因此,无法及时实施。发展中国家的大多数患者负担不起PCI的费用。因此,溶栓治疗对于发展中国家的心肌梗死管理仍然至关重要,不应被忽视。替奈普酶(TNK)和链激酶(SK)是欠发达国家治疗心肌梗死最广泛使用的两种纤维蛋白溶解剂。尽管它们广泛可得,但关于它们的比较研究尚无定论。本研究旨在回顾关于TNK与SK在资源匮乏国家治疗心肌梗死的有效性和安全性的现有文献。该研究按照系统评价和荟萃分析的首选报告项目(PRISMA)扩展版进行报告,并根据Cochrane非荟萃分析的综合指南进行分析。在EMBASE、Cochrane图书馆、科学网、CINAHL、Scopus、谷歌学术和Ovid版MEDLINE数据库中对比较TNK和STK的研究进行了全面的文献检索。还筛选了符合条件的文章和系统评价的参考文献列表。通过在效应方向图上呈现数据,然后进行投票计数,对现有数据进行了叙述性综合分析。从数据库中检索到的2284篇参考文献中,只有17项研究符合纳入标准并被选入最终分析。该研究表明,在完全ST段恢复(效应方向图上为80%对10%)和症状缓解(80%对20%)方面,TNK比SK更有效。在实现成功溶栓方面,SK和TNK相当(50%对50%)。对于安全参数,TNK与严重出血风险低于SK(分别为88.9%对11.1%)和轻微出血风险低于SK(25%对75%)相关。SK与更高的低血压/休克风险(77.8%对11.1%)和过敏反应/过敏风险(100%对0%)相关。SK组的长期死亡率更高(100%对0%)。两种药物的住院死亡率相当(37.5%对37.5%)。关于其他安全性和有效性终点存在相互矛盾的证据。与SK相比,TNK能带来更好的完全ST段恢复和症状缓解。接受SK治疗的患者观察到更高的长期死亡率风险、严重和轻微出血风险增加、低血压以及过敏/过敏反应风险增加。两种药物在住院死亡率和成功溶栓方面相当。关于哪种药物与30 - 35天死亡率获益和中风风险增加相关存在争议。需要大样本量的随机对照试验(RCT)来确定TNK与SK在疗效和安全性方面的优势。对两种药物死亡率的长期随访持续时间也很重要,因为这些地区的大多数患者负担不起溶栓后推荐的PCI费用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c9a5/10518219/74fe71ce0604/cureus-0015-00000044125-i01.jpg

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