Epidemiology and natural history of central venous access device use and infusion pump function in the NO16966 trial

Background: Central venous access devices in fluoropyrimidine therapy are associated with complications; however, reliable data are lacking regarding their natural history, associated complications and infusion pump performance in patients with metastatic colorectal cancer.<p></p> Methods: We assessed device placement, use during treatment, associated clinical outcomes and infusion pump perfomance in the NO16966 trial.<p></p> Results: Device replacement was more common with FOLFOX-4 (5-fluorouracil (5-FU)+oxaliplatin) than XELOX (capecitabine+oxaliplatin) (14.1% vs 5.1%). Baseline device-associated events and post-baseline removal-/placement-related events occurred more frequently with FOLFOX-4 than XELOX (11.5% vs 2.4% and 8.5% vs 2.1%). Pump malfunctions, primarily infusion accelerations in 16% of patients, occurred within 1.6–4.3% of cycles. Fluoropyrimidine-associated grade 3/4 toxicity was increased in FOLFOX-4-treated patients experiencing a malfunction compared with those who did not (97 out of 155 vs 452 out of 825 patients), predominantly with increased grade 3/4 neutropenia (53.5% vs 39.8%). Febrile neutropenia rates were comparable between patient cohorts±malfunction. Efficacy outcomes were similar in patient cohorts±malfunction.<p></p> Conclusions: Central venous access device removal or replacement was common and more frequent in patients receiving FOLFOX-4. Pump malfunctions were also common and were associated with increased rates of grade 3/4 haematological adverse events. Oral fluoropyrimidine-based regimens may be preferable to infusional 5-FU based on these findings

Evaluation of efficacy of hyaluronic acid preservative-free preparation 0.3 % in the prevention of secondary dry eye syndrome in patients after cataract phacoemulsification

Purpose: to determine the clinical efficacy of a non-preservative drug based on sodium hyaluronate 0.3 % (Gilan) in the correction of secondary dry eye syndrome (DES) manifestations in patients after cataract phacoemulsification (CPE), based on monitoring clinical and functional characteristics of the ocular surface. Materials and methods. 62 patients with immature cataracts underwent CPE with IOL implantation. Special examination techniques (Schirmer's test, Norn test, assessment of conjunctival hyperemia on the ORA scale (Ocular Redness Analysis)) were performed before the operation, 7 days and 30 days after it. The main group of patients (31 patients) received, in addition to the standard postoperative treatment, a non-preservative drug based on sodium hyaluronate 0.3 % (Gilan), whilst the control group (31 patients) received standard therapy. Results. The parameters studied showed a significant worsening in patients of both groups by the 7 th day after surgery, with no statistically significant difference between the groups. 30 days after CPE, the values of the Schirmer I test in the main group increased from 7.4 ± 2.3 mm (7 days after surgery) to 12.6 ± 1.7 mm, which significantly exceeded the respective values in patients of the control group: from 7.2 ± 2.1 mm (7 days after surgery) to 8.7 ± 2.0 mm (p < 0.001). Norn test scores also increased from 4.3 ± 1.9 s (7 days after surgery) to 7.9 ± 1.3 s in the main group and from 4.1 ± 2.1 s (7 days after the operation) to 5.3 ± 1.2 s in the control group with a statistically significant difference between the groups (p < 0.001). Conclusions. The use of a non-preservative drug based on sodium hyaluronate 0.3 % (Gilan) as part of combined therapy after CPE helps to effectively reduce the main manifestations of dry eye syndrome and improves postoperative rehabilitation