Objective: To explore the effectiveness and safety of direct oral anticoagulant rivaroxaban and low molecular weight heparin (LMWH) in the treatment of tumor patients with venous thromboembolism (VTE). Methods: A retrospective analysis was conducted on 296 patients diagnosed with tumor associated VTE in the Shanghai Pulmonary Thromboembolism Database from December 2020 to September 2022. Patients were grouped according to the prescription of anticoagulant drugs. Thirteen baseline variables [age, gender, smoking history, physical state (PS) score, tumor type, tumor stage, tumor treatment method, hemoglobin, platelets, D-dimer, creatinine, alanine aminotransferase, and VTE site] were matched. After matching, 100 cases were assigned to rivaroxaban group, including 64 males and 36 females, aged [M (Q1, Q3)] 70 (62,74) years old; There were 100 cases in the LMWH group, including 69 males and 31 females, aged 68 (60,73) years old. Kaplan-Meier method was used to plot survival curves. The differences between the rivaroxaban group and LMWH group in 6-month cumulative VTE recurrence rate, clinically significant bleeding rate, and all-cause mortality rate were analysed using log-rank test. Results: There were no statistically significant differences between the rivaroxaban group and the LMWH group in the 6-month cumulative VTE recurrence rate [13.5% (95%CI: 6.4%-20.1%) vs 7.5% (95%CI: 2.0%-12.7%), P=0.171], bleeding incidence rate [9.2% (95%CI: 3.3%-14.8%) vs 6.2% (95%CI: 1.3%-10.9%), P=0.438] and all-cause mortality rate [8.0% (95%CI: 2.5%-13.2%) vs 10.0% (95%CI: 3.9%-15.7%), P=0.602]. Conclusion: The anticoagulant efficacy and safety of rivaroxaban and LMWH are comparable in tumor patients with VTE.
目的： 探讨直接口服抗凝药利伐沙班与低分子肝素（LMWH）治疗肿瘤合并静脉血栓栓塞（VTE）的有效性与安全性。 方法： 回顾性分析2020年12月至2022年9月在上海市肺栓塞专病队列数据库中诊断为肿瘤合并VTE 296例患者资料。根据抗凝治疗的药物选择分组，通过对13个基线变量［年龄、性别、吸烟史、体力状态（PS）评分、肿瘤类型、肿瘤分期、肿瘤治疗方式、血红蛋白、血小板、D二聚体、肌酐、丙氨酸转氨酶和VTE部位］匹配。匹配后得到利伐沙班组100例，其中男64例，女36例，年龄［M（Q1，Q3）］为70（62，74）岁；LMWH组100例，其中男69例，女31例，年龄为68（60，73）岁。采用Kaplan-Meier法绘制生存曲线；log-rank检验比较两组6个月VTE累积复发率、抗凝后出血率及全因死亡率的差异。 结果： 利伐沙班组和LMWH组6个月VTE累积复发率（95%CI）差异无统计学意义［13.5%（6.4%~20.1%）比7.5%（2.0%~12.7%），P=0.171］；抗凝后出血发生率（95%CI）差异无统计学意义［9.2%（3.3%~14.8%）比6.2%（1.3%~10.9%），P=0.438］；全因死亡率（95%CI）差异无统计学意义［8.0%（2.5%~13.2%）比10.0%（3.9%~15.7%），P=0.602］。 结论： 在肿瘤合并VTE患者的治疗中，利伐沙班和LMWH的抗凝疗效和安全性相当。.