Jia Juan, Xue Shi-Min, Xu Ning
Department of Respiratory Medicine.
Department of Critical Medicine, Yulin No. 2 Hospital, Yulin, Shaanxi, China.
Medicine (Baltimore). 2019 Apr;98(16):e15224. doi: 10.1097/MD.0000000000015224.
Previous clinical trials have addressed that rivaroxaban is effective for the treatment of patients with pulmonary embolism (PE). This study will systematically assess its efficacy and safety for PE.
We will carry out this study by searching the following electronic databases from inception to March 1, 2019 without language restrictions: Cochrane Library, EMBASE, PUBMED, Web of Science, Cumulative Index to Nursing and Allied Health Literature, Allied and Complementary Medicine Database, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure. In addition, we will also search clinical trial registries, dissertations, and conference abstracts to avoid any missing potential studies. All randomized controlled trials of rivaroxaban for patients with PE will be fully considered. Two researchers will independently perform literature selection, data collection, and methodological quality assessment. If it is appropriate, outcome data will be pooled by using a fixed-effect model or random-effect model, and meta-analysis will be considered for operation.
All efficacy and safety of rivaroxaban for PE will be assessed through all primary and secondary outcomes. The primary outcomes are all-cause mortality and major bleeding. The secondary outcomes are recurrent venous thromboembolism, duration of hospital stay, quality of life, patient satisfaction, and adverse events.
The findings of this study will summarize updated evidence on the efficacy and safety of rivaroxaban for patients with PE.
It is not necessary to inquire ethical approval for this study, because it will not analyze any individual patient data. The results of this study will be published through peer-reviewed journals.
PROSPERO CRD42019126095.
既往临床试验已证实利伐沙班对治疗肺栓塞(PE)患者有效。本研究将系统评估其治疗PE的疗效和安全性。
我们将通过检索以下电子数据库进行本研究,检索时间从建库至2019年3月1日,无语言限制:考克兰图书馆、EMBASE、PubMed、科学引文索引、护理学与健康照护领域累积索引、补充与替代医学数据库、中国生物医学文献数据库和中国知网。此外,我们还将检索临床试验注册库、学位论文和会议摘要,以避免遗漏任何潜在研究。所有关于利伐沙班治疗PE患者的随机对照试验都将被充分考虑。两名研究人员将独立进行文献筛选、数据收集和方法学质量评估。如果合适,将使用固定效应模型或随机效应模型合并结局数据,并考虑进行荟萃分析。
利伐沙班治疗PE的所有疗效和安全性将通过所有主要和次要结局进行评估。主要结局是全因死亡率和大出血。次要结局是复发性静脉血栓栓塞、住院时间、生活质量、患者满意度和不良事件。
本研究结果将总结利伐沙班治疗PE患者疗效和安全性的最新证据。
本研究无需伦理批准,因为它不会分析任何个体患者数据。本研究结果将通过同行评审期刊发表。
国际前瞻性系统评价注册库CRD42019126095。