Farhan Ahmed, Bukhari Maliha, Umar Junaid, Raza Mudassar Ali
Department of General Medicine, Pakistan Institute of Medical Sciences (PIMS), Islamabad, Pakistan.
Department of Radiology, Pakistan Institute of Medical Sciences (PIMS), Islamabad, Pakistan.
J Coll Physicians Surg Pak. 2019 Sep;29(9):814-818. doi: 10.29271/jcpsp.2019.09.814.
To evaluate the efficacy of oral rivaroxaban compared to warfarin in patients with deep vein thrombosis (DVT).
Open label randomized controlled study.
Department of General Medicine, Pakistan Institute of Medical Sciences (PIMS), Islamabad from January 2016 to January 2018.
Patients of both genders between 18 and 60 years of age with Doppler ultrasound-confirmed DVT were included in the study. Pregnant patients and those with advanced liver, renal disease, those with a previous history of DVT, malignancy, with a platelets count of less than 50000/ul were excluded from the study. Rivaroxaban was given in a dose of 15 mg twice daily for 21 days followed by 20 mg once daily. Patients in the warfarin group were given heparin for 3 to 5 days followed by warfarin for 3 to 6 months. The primary efficacy outcome was patency of the vessel at 3 and 6 months of treatment. The principal safety outcomes were major and minor bleeding during the study period.
A total of 151 patients with acute symptomatic deep vein thrombosis were enrolled in the study. Half of the patients were given warfarin and the other half rivaroxaban for 6 months. At three months, there were no significant differences observed in vessel patency in the rivaroxaban group (22.4%) as compared to warfarin group (26.7%) but after 6 months of therapy, vessel patency was significantly more in the rivaroxaban group. Adverse events did not show any significant differences Conclusion: Rivaroxaban had an efficacy superior to warfarin in terms of vessel patency after six months of therapy but adverse events were similar in both the groups.
评估口服利伐沙班与华法林相比，在深静脉血栓形成（DVT）患者中的疗效。
开放标签随机对照研究。
2016年1月至2018年1月，位于伊斯兰堡的巴基斯坦医学科学研究所（PIMS）普通内科。
纳入年龄在18至60岁之间、经多普勒超声确诊为DVT的男女患者。孕妇以及患有晚期肝脏、肾脏疾病、既往有DVT病史、恶性肿瘤、血小板计数低于50000/ul的患者被排除在研究之外。利伐沙班的给药剂量为每日两次，每次15毫克，共21天，之后改为每日一次，每次20毫克。华法林组患者先接受3至5天的肝素治疗，随后接受3至6个月的华法林治疗。主要疗效指标是治疗3个月和6个月时血管的通畅情况。主要安全指标是研究期间的严重和轻微出血情况。
共有151例急性症状性深静脉血栓形成患者纳入研究。一半患者接受华法林治疗，另一半接受利伐沙班治疗，为期6个月。在三个月时，利伐沙班组（22.4%）与华法林组（26.7%）相比，血管通畅情况无显著差异，但在治疗6个月后，利伐沙班组的血管通畅情况明显更好。不良事件未显示出任何显著差异。结论：在治疗6个月后，利伐沙班在血管通畅方面的疗效优于华法林，但两组的不良事件相似。
