利伐沙班预防乳腺癌导管相关血栓前瞻性 队列研究中期分析. (Chinese)

Objective To explore the efficacy and safety of Rivaroxaban in preventing catheter related thrombosis (CRT) in patients with breast cancer who are undergoing central venous catheter chemotherapy, and provide basis for making standardized prevention and treatment strategies. Methods In this research, a prospective cohort study was adopted, and breast cancer patients who received central venous catheter chemotherapy in Sanhuan Cancer Hospital during September 2020 to March 2022 were selected as a treatment group to take the rivaroxaban anticoagulation therapy with 10 mg. po. qd for one month. The control group got no preventive anticoagulation therapy. Vascular ultrasound examination was taken to confirm the occurrence of CRT, and a chi-square test was done for comparison the disparity between the groups. Logistic regression was applied to analyze the univariate and multivariate factors for the formation of CRT. Results In the research, a total of 235 patients were selected, and there were a total of 19 035 days of catheterization with 81 days of catheterization on average. While in the control group, the incidence of CRT was 28.0% (33/118), the incidence of CRT in the treatment group was 20.5% (24/117), the difference was no significant (P=0.183). Subgroup analysis results showed that the peripherally inserted central catheter (PICC) was performed in 165 cases with the CRT incidence of 18.2% (30/165) and thrombosis was mostly seen around axillary vein, accounting for 63.3%. Subclavian vein catheterization was performed in 63 cases with the CRT incidence of 39.7% (25/63), and thrombosis was mostly seen around subclavian vein, accounting for 88.0% (22/25). Implantable venous access port was implanted in 7 cases around subclavian vein and internal jugular vein with the CRT incidence of 28.6% (2/7). The patients who developed CRT within 30 days after catheterization accounted for 54.4% (31/57), 22.8% (13/57) in a period during 30 days and 60 days) and 22.8% (13/57) in a period during 60 days and 180 days). The diagnosed CRT patients had been treated with rivaroxaban 15 mg. bid. po for 3 months. During the 3 months, 100.0% of the thrombosis waned, 71.9% (41/57) of the thrombosis waned within 30 days, 19.3% (11/57) in a period during 30 and 60days and 8.8% (5/57) in a period during 60 days and 90 days. Univariate and multivariate analysis indicated that the risk of CRT in subclavian vein catheterization was higher than that in PICC, respectively (OR=2.898, 95% CI: 1.386-6.056 P=0.005), and the type of catheterization was an independent factor for the formation of thrombosis. Safety analysis result showed that in the prevention of CRT, rivaroxaban treatment did not induce drug-related bleeding, liver function damage, bone marrow suppression or any other side effects. While CRT diagnosed patients were treated with anticoagulation, they kept the central venous catheter, and the infusion was smooth. These patients all finished the anti-tumor treatment as planned, and no abnormalities like new thrombosis or pulmonary embolism were observed. Conclusions In the mid-term analysis, the proportion of Rivaroxaban in preventing anticoagulant CRT decreases, but it don't reach statistical significance. The sample size should be further increased for observation. Rivaroxaban is proved effective and very safe in the treatment of CRT, and does not affect the concurrent chemotherapy. Medical personnel should carry out the policy of "early prevention, early detection and early treatment" for CRT so as to improve the patients' quality of life. [ABSTRACT FROM AUTHOR]

目的　探讨使用利伐沙班预防乳腺癌深静脉置管化疗患者导管相关血栓 (CRT) 的疗效 和安全性。方法　采取前瞻性队列研究方法，选择2020年9月至2022年3月在北京市朝阳区三环肿 瘤医院接受深静脉置管化疗的乳腺癌患者，治疗组接受利伐沙班抗凝治疗，10 mg 口服1次/d，连续用 药1个月；对照组未接受预防抗凝治疗。通过血管超声检查确认CRT的发生情况，组间比较采取 χ2 检 验，CRT 形成影响因素分析采用 logistic 回归分析。结果　共纳入 235 例乳腺癌患者，置管总天数共 19 035 d，平均置管天数为 81 d。对照组 118例，CRT发生率为 28.0% (33/118) ；治疗组 117例，CRT发 生率为20.5% (24/117), 差异无统计学意义 (P=0.183) 。亚组分析结果显示，外周静脉穿刺中心静脉置 管 (PICC) 165例，CRT发生率为18.2% (30/165), 血栓最常见于腋静脉管周 (63.3%，19/30) ；锁骨下静脉 置管 63例，CRT发生率为 39.7% (25/63), 血栓最常见于锁骨下静脉管周 (88.0%，22/25) ；输液港 7例， CRT 发生率为 28.6% (2/7), 位于锁骨下静脉管周及颈内静脉。置管后＜30 d 内形成 CRT 患者占 54.4% (31/57), 30～＜60 d形成 CRT 患者占 22.8% (13/57), 60～＜180 d形成CRT患者占22.8% (13/57) 。 确诊 CRT患者接受利伐沙班抗凝治疗 15 mg，每 12 h给药 1次，口服，共 3个月。3个月内血栓消退率 为 100.0% (57/57), 其中＜30 d血栓消退占 71.9% (41/57), 30～＜60 d为 19.3% (11/57), 60～＜90 d为 8.8% (5/57) 。单因素分析显示，锁骨下静脉置管较 PICC 发生 CRT 的风险高 (P=0.001) ；多因素分析显 示，置管类型是血栓形成独立影响因素 (OR=2.898，95% CI：1.386～6.056，P=0.005) 。安全性分析显 示，利伐沙班预防 CRT 过程中无药物相关出血、肝功能损害及骨髓抑制等不良反应。确诊 CRT患者 在抗凝治疗同时保留深静脉置管，输液顺畅，均按计划完成抗肿瘤治疗，未出现新发血栓和肺栓塞等 异常。结论　利伐沙班预防抗凝 CRT发生比例下降，但并未达到统计学意义，需进一步增加样本量 观察；利伐沙班治疗 CRT 疗效与安全性较好，不影响同期化疗。医务人员应针对CRT进行早预防、早 发现、早治疗，改善患者的生活质量。 [ABSTRACT FROM AUTHOR]

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