Cia-Arriaza Melania, Cabrera-Jaime Sandra, Cano-Soria Rosario, Manzano-Castro Mireia, Domínguez-Gómez Margarita, Prieto-Arenas Dolores M, Benito-Yagüe Angeles, Sánchez-Martín Adela, González-Alonso Cristina, Fernández-Ortega Paz
Catalan Institute of Oncology (ICO-Badalona), Hospital Germans Trias i Pujol, Badalona, Spain.
GRIN Group, IDIBELL, Institute of Biomedical Research, Barcelona, Spain.
Asia Pac J Oncol Nurs. 2022 May 21;9(9):100085. doi: 10.1016/j.apjon.2022.100085. eCollection 2022 Sep.
To assess the safety and efficacy of port-locking with heparin every 2 months vs. every 4 months and vs. saline solution every 2 months in patients with cancer not receiving active chemotherapy. The hypothesis stated that locking with heparin at four-month intervals and saline at two-month intervals would not increment > 10% of port obstructions.
Multicentre, phase IV parallel, post-test control group study took place at the two chemotherapy units of oncology hospitals. Included patients with cancer with ports that completed the chemotherapy treatment but still having port maintenance care or blood samples taken up to four months. A sample of 126 patients with cancer in three arms was needed to detect a maximum difference of 10% for bioequivalence on the locking methods. Consecutive cases non-probabilistic sampling and randomized to one of the three groups; group A: received heparin 60 IU/mL every two months (control) vs. group B heparin every four months and vs. saline every two months in group C. Primary variables were the type of locking regimen, port obstruction, and absence of blood return, port-related infection, or venous thrombosis during the study period. Clinical and sociodemographic variables were also collected.
A total of 143 patients were randomly assigned; group A, 47 patients with heparin every 2 months, group B, 51 patients with heparin 4 months, and group C, 45 patients with saline every 2 months. All participants presented an adequate blood return and no obstructions, until the month of the 10th, when one participant in the group A receiving was withdrawn due to an absence of blood flow ( = 0.587).
Port locks with heparin every 4 months or saline every 2 months did not show differences in safety maintenance, infection, or thrombosis compared to heparin every 2 months.
评估在未接受积极化疗的癌症患者中，每2个月使用肝素封管与每4个月使用肝素封管以及每2个月使用生理盐水封管的安全性和有效性。假设表明，每4个月使用肝素封管和每2个月使用生理盐水封管导致的端口阻塞增加不会超过10%。
在肿瘤医院的两个化疗科室进行了多中心、IV期平行、试验后对照组研究。纳入的癌症患者带有端口，这些患者已完成化疗治疗，但仍需进行端口维护护理或在长达4个月的时间内采集血样。需要126例癌症患者样本分为三组，以检测封管方法生物等效性的最大差异为10%。采用连续非概率抽样并随机分为三组；A组：每2个月接受60 IU/mL肝素封管（对照组），B组每4个月接受肝素封管，C组每2个月接受生理盐水封管。主要变量为封管方案类型、端口阻塞情况，以及研究期间是否无回血、端口相关感染或静脉血栓形成。还收集了临床和社会人口统计学变量。
共随机分配了143例患者；A组47例患者每2个月接受肝素封管，B组51例患者每4个月接受肝素封管，C组45例患者每2个月接受生理盐水封管。所有参与者在第10个月前回血情况良好且无阻塞，此时A组有一名接受治疗的参与者因无血流而退出（P = 0.587）。
与每2个月使用肝素封管相比，每4个月使用肝素封管或每2个月使用生理盐水封管在安全性维持、感染或血栓形成方面没有差异。
