Diaz Jorge A, Rai Shesh N, Wu Xiaoyoung, Chao Ju-Hsien, Dias Ajoy L, Kloecker Goetz H
University of Louisville James Graham Brown Cancer Center, Louisville, KY.
J Oncol Pract. 2017 Jan;13(1):e22-e28. doi: 10.1200/JOP.2016.010843. Epub 2016 Oct 23.
Retrospective studies suggest that it may be safe to extend the maintenance flushing interval of implanted ports from once every month, as recommended by the manufacturer, to once every 3 months, but no prospective cohort studies have been done specifically assessing the safety and feasibility of this intervention.
This was a phase II study in oncologic patients who retained a functional port after completion of systemic chemotherapy. Patients enrolled in the study had their port flushed once every 3 months and were observed until completion of five scheduled flushes (one on enrollment and four additional flushes, one every 3 months) or development of any port-related complication, including infections, thrombosis, and occlusions. The primary end points were frequency of port-related complications and port failure requiring removal.
A total of 87 patients were enrolled in the study. The median follow-up time was 308 days, accounting for a total of 24,202 catheter-days. There were 10 port-related complications (11.49%; 95% CI, 4.85% to 18.14%). No infection or symptomatic thrombosis occurred. The mean time to port-related complication was 184 days. No patients developed port failure while on protocol, but on subsequent medical record review, four patients developed a complication that required port removal or port revision within 30 days of being removed from the trial (4.6%; 95% CI, 0.4% to 8.8%; 0.17/1,000 catheter-days).
Extending the maintenance flushes of implanted ports in adult oncologic patients to once every 3 months is safe, effective, and likely to increase patient adherence and satisfaction while decreasing the associated cost.
回顾性研究表明，将植入式端口的维护冲洗间隔从制造商推荐的每月一次延长至每三个月一次可能是安全的，但尚未进行专门评估这种干预措施安全性和可行性的前瞻性队列研究。
这是一项针对全身化疗完成后保留功能性端口的肿瘤患者的II期研究。纳入该研究的患者每三个月对其端口进行一次冲洗，并进行观察，直至完成五次预定冲洗（一次在入组时，另外四次冲洗，每三个月一次）或出现任何与端口相关的并发症，包括感染、血栓形成和堵塞。主要终点是与端口相关的并发症发生率和需要移除的端口故障情况。
共有87名患者纳入该研究。中位随访时间为308天，总计24202导管日。发生了10例与端口相关的并发症（11.49%；95%CI，4.85%至18.14%）。未发生感染或有症状的血栓形成。与端口相关并发症的平均发生时间为184天。在方案执行期间，没有患者出现端口故障，但在随后的病历审查中，有4名患者在退出试验后30天内出现了需要移除端口或对端口进行修复的并发症（4.6%；95%CI，0.4%至8.8%；0.17/1000导管日）。
将成年肿瘤患者植入式端口的维护冲洗延长至每三个月一次是安全、有效的，并且可能会提高患者的依从性和满意度，同时降低相关成本。
