利伐沙班预防乳腺癌患者导管相关性血栓的临床研究_桑蝶.pdf

癌症进展2022 年 12 月第 20 卷第 24 期ONCOLOGY PROGRESS,Dec 2022 V ol.20,No.24*论著*利伐沙班预防乳腺癌患者导管相关性血栓的临床研究利伐沙班预防乳腺癌患者导管相关性血栓的临床研究桑蝶，范善民#，赵晓慧，郑利军，张金涛，李诗语，张晓燕，王银凤北京市朝阳区三环肿瘤医院肿瘤内科，北京 1001220摘要摘要：目的目的探讨利伐沙班预防乳腺癌深静脉置管化疗患者导管相关性血栓（CRT）的疗效及安全性，为制订个体化血栓防治策略提供参考依据。方法方法收集88例行深静脉置管化疗乳腺癌患者的病历资料，观察利伐沙班预防CRT的疗效及安全性。结果结果88例患者CRT发生率为20.5%（18/88），血栓厚度为0.21.1 cm。其中经外周静脉穿刺的中心静脉导管（PICC）置管CRT发生率为17.9%（14/78），血栓位于贵要静脉、锁骨下静脉、腋静脉、颈内静脉；锁骨下静脉置管CRT发生率为50.0%（3/6），血栓位于锁骨下静脉、颈内静脉；输液港CRT发生率为25.0%（1/4），血栓位于颈内静脉。深静脉置管后30天内形成血栓的患者占50.0%（9/18），3060天形成血栓的患者占38.9%（7/18），6190天形成血栓的患者占5.6%（1/18），91150天形成血栓的患者占5.6%（1/18）。不同年龄、置管类型、病理分期、化疗方案及置管前D-二聚体、血清脂蛋白、血红蛋白水平患者CRT发生情况比较，差异均无统计学意义（P0.05）。诊断为CRT的患者接受利伐沙班抗凝治疗至少3个月，抗凝的同时保留深静脉置管按期化疗，治疗顺利，未出现新发血栓及肺栓塞等异常。88例患者接受利伐沙班治疗无药物相关性出血、肝功能不全、骨髓抑制等不良反应。结论结论利伐沙班预防乳腺癌深静脉置管化疗患者CRT可能有一定疗效，安全性较好；深静脉置管化疗有效且便捷，CRT患者抗凝治疗的同时不影响同期化疗。医务人员应争取早预防、早发现、早治疗，以改善肿瘤患者的生活质量及预后。关键词关键词：乳腺癌；利伐沙班；深静脉置管；导管相关性血栓；化疗中图分类号中图分类号：R R737737.9 9文献标志码文献标志码：AdoiAdoi：10.11877/j.issn.1672-1535.2022.20.24.08Clinical research rivaroxaban in prevention of catheter related thrombosis inClinical research rivaroxaban in prevention of catheter related thrombosis inbreast cancer patientsbreast cancer patientsSANG Die,FAN Shanmin#,ZHAO Xiaohui,ZHENG Lijun,ZHANG Jintao,LI Shiyu,ZHANG Xiaoyan,WANG YinfengDepartment of Medical Oncology,Beijing Chaoyang District Sanhuan Cancer Hospital,Beijing 100122,ChinaAbstract:ObjectiveAbstract:ObjectiveTo investigate the efficacy and safety of rivaroxaban in preventing catheter related thrombosis(CRT)in breast cancer patients undergoing chemotherapy with deep venous catheter,and to provide reference for the for-mulation of personalized thrombosis prevention strategies.MethodMethodThe medical records of 88 breast cancer patients un-dergoing chemotherapy with deep venous catheter were collected to observe the efficacy and safety of rivaroxaban in pre-venting CRT.ResultResultThe incidence of CRT was 20.5%(18/88),and the thrombus thickness was 0.2-1.1 cm.The inci-dence of CRT in peripherally inserted central venous catheter(PICC)was 17.9%(14/78),and the thrombus was locatedaround the basilic vein,subclavian vein,axillary vein and internal jugular vein.The incidence of CRT in subclavian veinwas 50.0%(3/6),and the thrombus was located around the subclavian vein and internal jugular vein.The incidence ofthrombus in the implantable venous access port was 25.0%(1/4),and the thrombus was located internal jugular vein.There were 50.0%(9/18)of patients forming thrombosis within 30 days after deep vein catheterization,38.9%(7/18)within 30-60 days,5.6%(1/18)within 61-90 days,and 5.6%(1/18)within 91-150 days.There were no significant differ-ences for CRT in patients with different age,catheterization types,pathological staging,chemotherapy and pre-catheter-ized D-dimer,serum lipoprotein and hemoglobin(P0.05).Patients diagnosed as CRT received anticoagulation therapyby rivaroxaban for at least 3 months.Simultaneously,chemotherapy with deep venous catheter was performed on sched-ule.The treatment was successful without new thrombosis and pulmonary embolism.A total of 88 rivaroxaban-treated pa-tients had no drug-related bleeding,hepatic impairment,bone marrow depression or other side effects.ConclusionConclusionRiva-roxaban is potentially effective in preventing CRT in breast cancer patients undergoing chemotherapy with deep venouscatheter,and shows good safety.Chemotherapy with deep venous catheter is effective and convenient,and anticoagula-tion therapy given in CRT patients does not affect concurrent chemotherapy.Medical staff should assess the risk of throm-bosis,and conduct early prevention,detection,and treatment,so as to improve the quality of life and prognosis of cancerpatients.Key words:Key words:breast cancer;rivaroxaban;deep vein catheterization;catheter related thrombosis;chemotherapyOncol Prog,2022,20(24)基金项目：国家癌症中心攀登基金临床研究课题（NCC201901B01）#通信作者（corresponding author），邮箱：2512ONCOLOGY PROGRESS,Dec 2022 V ol.20 No.24最新癌症统计数据显示，乳腺癌发病率居全世界第一位，严重危害女性身心健康1。化疗为乳腺癌的重要治疗策略，多周期化疗的患者将深静脉置管作为输液通路十分必要。然而，导管相关性血栓（catheter related thrombosis，CRT）为深静脉置管的常见并发症之一2，发生率为1.5%66.0%3，具有一定风险且影响患者生活质量。因此，如何预防或减少CRT是临床医师讨论的热点。利伐沙班为新型口服抗凝药物，通过直接抑制凝血因子a而达到抗凝效果，在中国，利伐沙班预防恶性肿瘤静脉血栓有指南推荐和文献支持4，而缺少真实世界研究数据。本研究旨在分析利伐沙班预防CRT的作用及安全性，为血栓防治提供参考依据，现报道如下。1 1资料与方法资料与方法1 1.1 1 一般资料一般资料收集2020年9月至2021年9月北京市朝阳区三环肿瘤医院收治的乳腺癌患者的病历资料。纳入标准：经病理组织学检查确诊为乳腺癌；置管类型包括经外周静脉穿刺的中心静脉导管（pe-ripherally inserted central venous catheter，PICC）、锁骨下静脉置管、输液港；年龄20岁且75岁；接受利伐沙班预防抗凝治疗；美国东部肿瘤协作组（Eastern Cooperative Oncology Group，ECOG）体力状况评分02分，生存期3个月。排除标准：非乳腺癌；既往有静脉血栓病史；合并其他类型恶性肿瘤；血小板减少，有出血倾向；拔管后6个月内失访。根据纳入、排除标准，共纳入88例乳腺癌患者，均为女性；年龄2670岁，中位年龄51岁；化疗48个周期，中位化疗6个周期，蒽环类+紫杉类方案67例（76.1%），其他方案（主要包括铂 类、吉 西 他 滨、艾 立 布 林、靶 向 药 物）21 例（23.9%）；Luminal型56例（63.6%），人表皮生长因子受体2（human epidermal growth factor receptor 2，HER2）过表达型 15 例（17.0%），三阴性乳腺癌 17例（19.3%）；病理分期：期11例（12.5%），期31例（35.2%），期 28 例（31.8%），期 18 例（20.5%）；PICC 置管 78 例（88.6%），锁骨下静脉置管6例（6.8%），输液港4例（4.5%）；置管前D-二聚体 升 高 37 例（42.0%），血 红 蛋 白 降 低 32 例（36.4%），血清脂蛋白降低45例（51.1%）。1 1.2