评估英国二级护理中开具利伐沙班治疗和预防深静脉血栓形成和肺栓塞的患者出血发生率：一项观察性队列研究。
Evaluation of the incidence of bleeding in patients prescribed rivaroxaban for the treatment and prevention of deep vein thrombosis and pulmonary embolism in UK secondary care: an observational cohort study.
机构信息
Drug Safety Research Unit, Southampton, UK
University of Portsmouth, Portsmouth, UK.
出版信息
BMJ Open. 2020 Nov 3;10(11):e038102. doi: 10.1136/bmjopen-2020-038102.
OBJECTIVES
To evaluate the short-term (12 weeks) safety and utilisation of rivaroxaban prescribed to new-user adult patients for the treatment of deep vein thrombosis and pulmonary embolism and for the prevention of recurrent deep vein thrombosis and pulmonary embolism in a secondary care setting in England and Wales.
DESIGN
An observational cohort study using the technique of Specialist Cohort Event Monitoring.
SETTING
The Rivaroxaban Observational Safety Evaluation study was conducted across 87 participating National Health Service secondary care trusts in England and Wales.
PARTICIPANTS
1532 patients treated with rivaroxaban for the prevention and treatment of deep vein thrombosis/pulmonary embolism from September 2013 to January 2016.
INTERVENTIONS
Non-interventional postauthorisation safety study of rivaroxaban. PRIMARY AND SECONDARY OUTCOME MEASURES: (1) Risk of major bleeding in gastrointestinal, intracranial, and urogenital sites and (2) risk of all major and clinically relevant non-major bleeds.
RESULTS
Of a total of 4846 patients enrolled in the study from September 2013 to January 2016, 1532 were treated with rivaroxaban for the prevention and treatment of deep vein thrombosis/pulmonary embolism. The median age of the deep vein thrombosis/pulmonary embolism cohort was 63 years, and 54.6% were men. The risk of major bleeding within the gastrointestinal, urogenital and intracranial primary sites was 0.7% (n=11), 0.3% (n=5) and 0.1% (n=1), respectively. The risk of major bleeding in all sites was 1.5% (n=23) at a rate of 8.3 events per 100 patient-years.
CONCLUSIONS
In terms of the primary outcome risk of major bleeding in gastrointestinal, intracranial and urogenital sites, the risk estimates in the population using rivaroxaban for deep vein thrombosis/pulmonary embolism were low (<1%) and consistent with the risk estimated from clinical trial data and in routine clinical practice.
TRIAL REGISTRATION NUMBERS
ClinicalTrials.gov Registry (NCT01871194); ENCePP Registry (EUPAS3979).
目的
评估利伐沙班在英格兰和威尔士的二级保健环境中新使用的成年患者中，用于治疗深静脉血栓形成和肺栓塞以及预防深静脉血栓形成和肺栓塞复发的短期（12 周）安全性和利用情况。
设计
使用专家队列事件监测技术的观察性队列研究。
设置
利伐沙班观察性安全性评估研究在英格兰和威尔士的 87 个参与的国家卫生服务二级保健信托中进行。
参与者
2013 年 9 月至 2016 年 1 月期间，1532 名患者接受利伐沙班预防和治疗深静脉血栓形成/肺栓塞。
干预措施
利伐沙班的非干预性上市后安全性研究。
主要和次要结果测量
（1）胃肠道、颅内和泌尿生殖道部位的大出血风险，以及（2）所有大出血和临床上相关的非大出血风险。
结果
在 2013 年 9 月至 2016 年 1 月期间，共有 4846 名患者参加了这项研究，其中 1532 名患者接受利伐沙班预防和治疗深静脉血栓形成/肺栓塞。深静脉血栓形成/肺栓塞队列的中位年龄为 63 岁，54.6%为男性。胃肠道、泌尿生殖道和颅内主要部位的大出血风险分别为 0.7%（n=11）、0.3%（n=5）和 0.1%（n=1）。所有部位大出血的风险为 1.5%（n=23），发生率为每 100 患者年 8.3 例事件。
结论
就主要结局胃肠道、颅内和泌尿生殖道部位的大出血风险而言，使用利伐沙班治疗深静脉血栓形成/肺栓塞的人群中的风险估计值较低（<1%），与临床试验数据和常规临床实践中的风险估计值一致。
试验注册
ClinicalTrials.gov 注册（NCT01871194）；ENCePP 注册（EUPAS3979）。
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