直接口服抗凝剂治疗脑静脉血栓形成：系统评价方案。
Direct oral anticoagulants in treatment of cerebral venous thrombosis: a systematic review protocol.
机构信息
Department of Medicine, University of Ottawa and The Ottawa Hospital Research Institute, 1053 Carling Avenue, Ottawa, ON, K1Y 4E9, Canada.
出版信息
Syst Rev. 2019 Apr 18;8(1):99. doi: 10.1186/s13643-019-1022-8.
BACKGROUND AND PURPOSE
Cerebral venous thrombosis causes disability from venous infarct and hemorrhage and potential mortality. Anticoagulation improves survival and disability outcomes, yet direct oral anticoagulants are currently not indicated in cerebral venous thrombosis due to lack of evidence, despite being on the market for nearly a decade. This systematic review will collate evidence of reported safety and efficacy of direct oral anticoagulant therapy in cerebral venous thrombosis.
METHODS
A search strategy was developed with a research librarian and registered on a protocol database (PROSPERO CRD42017078398). All published studies from MEDLINE and EMBASE up to February 2019 containing patients diagnosed with cerebral venous thrombosis who were treated with a direct oral anticoagulant (dabigatran, rivaroxaban, apixaban, or edoxaban) will be included. A risk of bias analysis will be performed to evaluate quality of studies overall.
DISCUSSION
Current guidelines in the treatment of cerebral vein thrombosis dating back to 2011 from the American Heart Association/American Stroke Association endorse the utility of anticoagulation for the treatment of cerebral vein thrombosis; however, they did not support the use of direct oral anticoagulants. Updated guidelines from the European Stroke Organization, endorsed by the European Academy of Neurology in 2017, also refute utilization of direct oral anticoagulants due to a lack of evidence. There have been nearly 10 years of experience with direct oral anticoagulants in the treatment of venous thrombosis and prevention of stroke in patients with atrial fibrillation, with purported efficacy and safety in comparison with heparins and vitamin K antagonists. Our goal is to undertake a systematic review to assess the effectiveness and safety of direct oral anticoagulants in patients with cerebral vein thrombosis to help guide clinical decision-making for patients unable to take heparins or vitamin K antagonists and to direct future studies to contribute further to an area of certain evidence-based needs.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42017078398.
背景与目的
脑静脉血栓形成可导致静脉梗死和出血，并导致潜在的死亡。抗凝治疗可改善生存和残疾结局，但由于缺乏证据，尽管直接口服抗凝剂已上市近十年，目前仍不适用于脑静脉血栓形成。本系统评价将汇总报告的脑静脉血栓形成中直接口服抗凝剂治疗安全性和疗效的证据。
方法
与研究图书馆员共同制定了检索策略，并在方案数据库（PROSPERO CRD42017078398）中进行了注册。纳入了截至 2019 年 2 月发表于 MEDLINE 和 EMBASE 的所有包含接受直接口服抗凝剂（达比加群、利伐沙班、阿哌沙班或依度沙班）治疗的脑静脉血栓形成患者的研究。将进行风险偏倚分析，以评估总体研究质量。
讨论
美国心脏协会/美国中风协会 2011 年发布的脑静脉血栓形成治疗指南支持抗凝治疗脑静脉血栓形成的应用；然而，它们不支持使用直接口服抗凝剂。2017 年，欧洲卒中组织更新的指南得到了欧洲神经病学学会的认可，也因缺乏证据而反对使用直接口服抗凝剂。直接口服抗凝剂在治疗静脉血栓形成和预防房颤患者中风方面已有近 10 年的经验，与肝素和维生素 K 拮抗剂相比，据称具有疗效和安全性。我们的目标是进行系统评价，评估直接口服抗凝剂在脑静脉血栓形成患者中的有效性和安全性，以帮助为不能使用肝素或维生素 K 拮抗剂的患者做出临床决策，并指导未来的研究为这一具有明确循证需求的领域做出进一步贡献。
系统评价注册
PROSPERO CRD42017078398。
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