医学
内科学
临床终点
胃肠病学
外科
随机对照试验
作者
Raffaele Longo,M Elviro Llorens,Christophe Goetz,Christian Platini,Nada Eid,Jocelyne Sellies,Nadia Ouamara,Philippe Quétin
出处
期刊:Oncology
[S. Karger AG]
日期:2017-01-01
卷期号:93 (2): 99-105
被引量:15
摘要
Totally implantable venous access port (TIVAP)-related infections (RIs) remain a serious health problem in cancer patients receiving an intravenous (i.v.) therapy.The ATAPAC study was a prospective, randomized, monocentric, phase IV trial evaluating the efficacy of taurolidine lock solution versus standard saline solution for primary TIVAP-RI prevention in nonhematological cancer patients receiving i.v. chemotherapy. The primary endpoint was the TIVAP-RI incidence rate. From December 2014 to September 2015, 163 patients were enrolled in the study (taurolidine: n = 86 vs.n = 77). Four patients in the control group (5%) had a Staphylococcus epidermidis TIVAP-RI, and 1 patient (1%) in the taurolidine group had a Staphylococcus aureus infection. The TIVAP-RI incidence rate was 0.4 and 0.1‰ catheter-days, respectively (p = 0.21). The infection-free TIVAP survival was not statistically significant (p = 0.09). TIVAP-RI required a total of 22 hospitalization days in the taurolidine group versus 106 days in the control arm with associated costs of EUR 4,849 and EUR 36,020, respectively. Taurolidine-related toxicity was transitory and classified as grade I.The ATAPAC trial did not show a significant risk-infection reduction by TauroLock™. A larger, prospective, randomized trial is needed to assess TauroLock efficacy for primary TIVAP-RI prevention in low-risk cancer patients.
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