College of Pharmacy, Fujian Medical University, Fuzhou, China.
Pharmacy, Fujian Medical University Union Hospital, Fuzhou, China.
BMJ Open. 2019 Sep 5;9(9):e031730. doi: 10.1136/bmjopen-2019-031730.
Warfarin is widely used in the world as oral anticoagulant, but it is difficult to manage patients after medication due to its narrow treatment window and individualised differences. Therefore, every region uses network means to carry out online anticoagulant therapy services. The purpose of this paper is to compare monitoring results and randomised controlled studies of the complications of warfarin treated by offline or online management in a Chinese population.
This is a randomised controlled, multicentre clinical trial. Taking the Union Hospital Affiliated to Fujian Medical University as the main centre, a randomised controlled study of several subcentres around China produced a nationally representative sample. 496 participants who took warfarin will be recruited and then randomly divided into two groups at a ratio of 1:1. We will collect data on patient characteristics, diagnosis, treatment, hospitalisation results and later complications.
The study was approved by the Ethics Committee of the Union Hospital Affiliated to Fujian Medical University. All cooperative hospitals have been approved by the Central Ethics Committee. The results of the survey will be disseminated in future peer review documents and will provide the basis for a management model for patients in China taking warfarin.
ChiCTR1900021920.
华法林作为一种口服抗凝剂，在世界范围内广泛应用，但由于其治疗窗较窄和个体差异较大，用药后患者的管理较为困难。因此，各地区均采用网络手段开展在线抗凝治疗服务。本文旨在比较华法林在线管理和离线管理在中国人群中的监测结果和随机对照研究结果，探讨其并发症。
这是一项随机对照、多中心临床试验。以福建医科大学附属协和医院为主要中心，结合全国多个分中心开展随机对照研究，产生具有全国代表性的样本。纳入服用华法林的 496 名参与者，按 1:1 的比例随机分为两组。我们将收集患者特征、诊断、治疗、住院结果和后期并发症等数据。
该研究已获得福建医科大学附属协和医院伦理委员会的批准。所有合作医院均已获得中央伦理委员会的批准。调查结果将在未来的同行评审文件中公布，并为中国服用华法林的患者管理模式提供依据。
ChiCTR1900021920。
