Dal Molin Alberto, Clerico Mario, Baccini Michela, Guerretta Linda, Sartorello Barbara, Rasero Laura
Nursing School, Biella Hospital, University of Eastern Piedmont, Biella, Italy.
Oncology Center of Biella, Biella, Italy.
Eur J Oncol Nurs. 2015 Dec;19(6):638-43. doi: 10.1016/j.ejon.2015.04.001. Epub 2015 Apr 29.
Our aim was to determine the non-inferiority of normal saline flushing compared to heparin flushing in maintaining the patency of totally implanted venous access devices (TIVADs).
Four hundred and thirty patients were recruited from 14 Italian centres. Patients were randomized to heparin group or to normal saline group. The primary outcome of the study was TIVAD occlusion.
After randomisation, 203 patients were assigned to normal saline group and 212 to heparin group. Median follow up time was 204 days in normal saline group and 294 in the heparin group. We observed 24 withdrawal occlusions (5.78%): 10 in the heparin group and 14 in the normal saline group. One total occlusion was observed in the normal saline group. Taking as reference the arm treated with heparin, the absolute risk difference was 2.67 with the 90% CI including the non - inferiority margin of 4%. No significant difference between hazards of occlusion was found.
This study failed to demonstrate that normal saline flushing is not inferior to heparin flushing, even if a significant difference between the two treatments was not found. The use of heparin is controversial and other prospective trials are necessary in this field.
EudraCT number: 2009-013620-22.
我们的目的是确定在维持完全植入式静脉通路装置（TIVADs）通畅方面，与肝素冲洗相比，生理盐水冲洗是否具有非劣效性。
从14个意大利中心招募了430名患者。患者被随机分为肝素组或生理盐水组。该研究的主要结局是TIVAD闭塞。
随机分组后，203名患者被分配到生理盐水组，212名被分配到肝素组。生理盐水组的中位随访时间为204天，肝素组为294天。我们观察到24例拔管后闭塞（5.78%）：肝素组10例，生理盐水组14例。生理盐水组观察到1例完全闭塞。以肝素治疗组为参照，绝对风险差异为2.67，90%置信区间包括4%的非劣效界值。未发现闭塞风险之间存在显著差异。
本研究未能证明生理盐水冲洗不劣于肝素冲洗，尽管未发现两种治疗方法之间存在显著差异。肝素的使用存在争议，该领域需要进行其他前瞻性试验。
欧洲药品管理局临床试验注册号：2009-013620-22。
