RESUMO
OBJECTIVES: This study aimed to assess the incidence of late-onset sepsis (LOS), associated risk factors, and short-term prognosis in very low birth weight (VLBW) infants in a 10-year period. STUDY DESIGN: A cohort study was conducted with 752 VLBW preterm infants-23 to 33 gestational weeks and 400 to 1,500 g birth weight-admitted to a neonatal intensive care unit from 2008 to 2017 and who survived over 72 hours. LOS was defined as clinical and laboratory signs of infection, whether or not confirmed by blood culture. VLBW infants were divided into groups and compared: no LOS versus proven LOS versus clinical LOS. Study variables included maternal, birth, and neonatal data, morbidities, procedures, etiological agents, and outcome-death, bronchopulmonary dysplasia (BPD), severe intraventricular hemorrhage, and retinopathy of prematurity (ROP). Analysis of variance with multiple Tukey's or Wald's comparison with gamma distribution, and stepwise multiple logistic regression model, adjusted for year, and gestational age, were used for statistical analysis. RESULTS: LOS incidence was 39% (proven LOS: 29%; clinical LOS: 10%). Septic VLBW infants showed higher mortality (proven LOS: 23.2%; clinical LOS: 41.9%) compared with no LOS (8.9%). Coagulase-negative staphylococci (56%), Gram-negative (26%), and fungi (8%) were the most frequent etiological agents. In comparing the groups, septic VLBW infants had lower gestational age and birth weight, presented more morbidities, and underwent more invasive procedures. The risk factors for proven and clinical LOS were days of mechanical ventilation and parenteral nutrition. LOS was associated with increased risk of death, BPD, and ROP. CONCLUSION: LOS showed high incidence and mortality, often caused by Gram-positive bacteria. Care interventions were the main risk factors associated. LOS had a major negative impact on short-term prognosis in VLBW infants. LOS reduction strategies are necessary and urgent. KEY POINTS: · LOS is associated with clinically significant neonatal morbidities and death in VLBW premature infants.. · There is association between LOS and duration of intensive care interventions.. · Quality improvement initiatives can be a pathway for LOS reduction..
RESUMO
In this phase II trial, we used the combination of gemcitabine and 5-fluorouracil (5-FU) to treat 26 patients: 17 (65%) with advanced pancreatic adenocarcinoma and 9 (35%) with advanced biliary tract adenocarcinoma (10 locally advanced and 16 metastatic); 15 (57.7%) male and 11 (42.3%) female; median age 58 (range, 39-68); median performance status 2 (range, 1-3). A total of 102 cycles were administered (median, 4 per patient). There were 8 objective responses, plus 1 complete response not confirmed by second-look laparotomy, thus the overall objective response rate was 30.7% (95% CI 12%-47%). Among the patients with biliary tract carcinoma, 33% (3/9) had PR. Six (23%) patients had stable disease (SD). All 8 responders and 3 of the patients with SD experienced clinical benefit (42%). The median overall survival was 9 months (range, 6-38), and the 1-year survival rate was 30%. The regimen was very well tolerated. One patient developed reversible World Health Organization grade IV febrile neutropenia. We observed grade III neutropenia in 11 (11%) cycles; grade III thrombocytopenia in 7 (7%) cycles; grade III mucositis in 7 (7%) cycles; and grade III diarrhea in 10 (10%) cycles. Asthenia grades I and II occurred in 30% of cycles and flulike syndrome grade II in 11 (11%) cycles. The combination of gemcitabine and 5-FU in patients with advanced pancreatic or biliary tract cancer produces promising activity and tolerability with the added potential for clinical benefit, and thus warrants further investigation.
