目的:2期临床试验的数据表明,与目前的抗血栓治疗相比,因子XI抑制剂可能表现出更有利的疗效/安全性。本系统综述的目的是分析从这些研究中获得的可用证据。
方法:在PubMed,科克伦图书馆,Scopus,EMBASE数据库,和临床试验注册平台进行临床试验和Cochrane中央对照注册。根据PRISMA声明,报告了结果。
结果:共有18项针对多种情况的已完成或正在进行的临床试验,包括心房颤动,中风,心肌梗塞,静脉血栓栓塞,已确定。分析了来自8项研究的证据,并有可用的结果。因子XI抑制剂的2期研究,总的来说,显示出可接受的疗效和安全性。利益-风险平衡,在减少全膝关节置换术患者的静脉血栓栓塞方面,更有利。对于这种情况,与依诺肝素相比,因子XI抑制剂显示血栓形成并发症的总发生率降低了50%,出血率降低了60%。涉及心房颤动患者的研究结果适度,中风,观察心肌梗死。
结论:因子XI抑制剂在抗血栓治疗和预防方面提供了新的前景。正在进行的3期研究将有助于确定最合适的药物和适应症。
OBJECTIVE: Data from phase 2 clinical trials suggest that factor XI inhibitors may exhibit a more favorable efficacy/safety profile compared to current antithrombotic therapies. The aim of this systematic review is to analyze the available evidence derived from these studies.
METHODS: A literature search in the PubMed, Cochrane Library, Scopus, EMBASE databases, and clinical trial registration platforms Clinical Trials and Cochrane Central Register of Controlled was conducted. In accordance with the PRISMA statement, results were reported.
RESULTS: A total of 18 completed or ongoing clinical trials addressing multiple scenarios, including atrial fibrillation, stroke, myocardial infarction, and venous thromboembolism, were identified. Evidence from 8 studies with available results was analyzed. Phase 2 studies with factor XI inhibitors, overall, demonstrated an acceptable efficacy and safety profile. The benefit-risk balance, in terms of reducing venous thromboembolism in patients undergoing total knee arthroplasty, was more favorable. For this scenario, factor XI inhibitors showed a 50% reduction in the overall rate of thrombotic complications and a 60% reduction in the rate of bleeding compared to enoxaparin. Modest results in studies involving patients with atrial fibrillation, stroke, and myocardial infarction were observed.
CONCLUSIONS: Factor XI inhibitors offer new prospects in antithrombotic treatment and prophylaxis. Ongoing phase 3 studies will help define the most suitable drugs and indications.