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Hospital de Órbigo, Spain

Omenaca F.,Neonatal Unit | Merino J.M.,Hospital General Yague | Tejedor J.-C.,Hospital de Mostoles | Constantopoulos A.,Childrens Hospital Iaso Paidon | And 8 more authors.
Pediatrics | Year: 2011

OBJECTIVE: The safety and immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in preterm infants were assessed in this study. METHODS: Three parallel groups of infants received 3-dose primary immunization with PHiD-CV at 2, 4, and 6 months of age and a booster dose at 16 to 18 months: preterm I (gestation period ≥ 27 and <31 weeks, N = 50); preterm II (≥31 and <37 weeks, N = 87); and term (≥37 weeks, N = 149). Solicited symptoms and adverse events were recorded. Immune responses to PHiD-CV and coadministered vaccine antigens were measured. RESULTS: The incidence of solicited general symptoms was similar across groups, and the frequency of grade 3 general symptoms was low. Incidences of redness and swelling were generally lower in preterm infants. PHiD-CV was immunogenic for each of the 10 vaccine pneumococcal serotypes (postprimary, ≥92.7% of infants reached enzyme-linked immunosorbent assay antibody concentrations ≥ 0.2 μg/mL and postbooster, ≥97.6%) and for protein D, with a trend for lower postprimary geometric mean antibody concentrations and opsonophagocytic activity (OPA) titers in preterm infants for some pneumococcal serotypes. Postbooster, ≥91.9% of subjects in each group had an OPA titer ≥ 8 for each of the vaccine serotypes. Pneumococcal antibody concentrations and OPA titers after priming and booster vaccination were comparable between the 2 preterm groups. CONCLUSIONS: PHiD-CV was well tolerated and immunogenic in preterm infants when given as a 3-dose primary vaccination, with robust enzyme-linked immunosorbent assay antibody and OPA booster responses in the second year of life. Copyright © 2011 by the American Academy of Pediatrics. Source


Fernandez-Cotarelo M.J.,Hospital de Mostoles | Guerra-Vales J.M.,University Hospital | Colina F.,University Hospital | De La Cruz J.,University Hospital
Tumori | Year: 2010

Aims and background. Patients with cancer of an unknown primary site (CUP) usually have a poor outcome. The identification of prognostic factors that affect survival can help clinicians find a better approach to such cases in terms of diagnostic and therapeutic management. Methods.We conducted a retrospective study including the cases of CUP recorded at the University Hospital 12 de Octubre Tumor Registry between 1999 and 2003. Results. CUP was diagnosed in 265 patients during the analyzed period. One hundred and seventy-one were men (64.5%) and the mean age of the patients was 66.9 years (range 32-98 years). The median survival was 2.5 months, and the survival rate was 35.1% 6 months from diagnosis (95% CI: 28.9-41.3) and 24.5% 1 year from diagnosis (95% CI: 18.7-30.3). Univariate analysis revealed as significant predictive variables of a better outcome age under 70 years; involvement of a single organ; normal serum levels of alkaline phosphatase and albumin; normal erythrocyte sedimentation rate; normal levels of the serum tumor markers CEA, CA 19.9 and CA 15.3; squamous carcinoma histology; clinical presentation as lymph node enlargement; and the administration of treatment. Multivariate analysis showed that albumin and alkaline phosphatase levels, squamous carcinoma histology, age and treatment were the most important prognostic factors. Other variables analyzed (liver, bone or lung involvement, lactate dehydrogenase levels, gender) did not affect survival. Conclusions. CUP has a poor prognosis. Some prognostic factors that affect survival in these patients, however, may be identified. Free full text available at www.tumorionline.it. Source


Oliveras A.,Hospital Universitari Del Mar | Garcia-Ortiz L.,Health Center la Alamedilla | Segura J.,Hypertension Unit | Banegas J.R.,Autonomous University | And 10 more authors.
Journal of Hypertension | Year: 2013

Background: Central blood pressure (cBP) predicts cardiovascular events. Regarding subclinical organ damage, the relationship between urinary albumin excretion (UAE) and cBP is rather unknown. Objective: We aimed to determine whether cBP is related to UAE, and if this relationship is stronger than that observed with peripheral blood pressure (pBP). Methods: Three hundred and twenty-four hypertensives (61% men, aged 65 ± 10 years) with insulin-resistance (77% diabetics; 23% nondiabetics with metabolic syndrome) were studied. Office pBP and cBP (radial applanation tonometry) were determined. UAE (albumin/creatinine) was averaged from three first-morning-void urine samples. Differences between patients with/without microalbuminuria, and the relationship between UAE and both pBP and cBP were analyzed. The strength of such relationship (cBP vs. pBP) was compared using a noninferiority test. Results: Microalbuminuria was detected in 25% of all patients. After age-adjustment and sex-adjustment, both central and peripheral SBP and pulse pressure (PP) (mmHg) were higher in microalbuminurics than in normoalbuminurics [central SBP (cSBP): 130 ± 20 vs. 124 ± 19; peripheral (pSBP): 147 ± 22 vs. 139 ± 20; central pulse pressure (cPP): 52 ± 15 vs. 47 ± 14; peripheral pulse pressure (pPP): 67 ± 16 vs. 62 ± 16, P < 0.05 for all]. Partial correlation coefficients (age-adjusted and sex-adjusted) between blood pressure (BP) and UAE were 0.175 for cSBP, 0.143 for pSBP, 0.124 for cPP (P < 0.05 for all), and 0.092 for pPP (P = 0.117). Neither cBP nor pBP were superior to each other in their association with UAE or with microalbuminuria. Comparisons between cBP and pBP by means of noninferiority tests revealed no differences in the magnitude of correlation coefficients (P = 0.265 for SBP; P = 0.212 for PP), or differences in means between patients with/without microalbuminuria (P = 0.327 for SBP; P = 0.054 for PP). Conclusion: Although cBP is related with UAE, this relationship is not superior to that of office peripheral BP. © 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins. Source


Blade A.,University of Barcelona | Cararach M.,Institute Universitari Dexeus | Castro M.,Hospital de Mostoles | Catala-Lopez F.,Glaxosmithkline | And 3 more authors.
Journal of Lower Genital Tract Disease | Year: 2010

Objective: To evaluate the clinical management of women with abnormal cervical cytology results, the associated health care resource allocation, and costs in Spain. Materials and Methods: A retrospective, observational, multicenter study of 849 women with abnormal cervical cytology results: 162 cases of atypical squamous cells of undetermined significance (ASCUS; 19.1%), 272 cases of low-grade squamous intraepithelial lesions (LSILs; 32.0%), 369 cases of high-grade squamous intraepithelial lesions (HSILs; 43.5%), and 46 cases of cancer (5.4%). Health care resources allocated to the diagnosis and treatment of lesions for a minimum of 2 years from the first abnormal cervical cytology result were assessed from patients' charts. Results: Histologic diagnosis confirmed 159 cases of cervical intraepithelial neoplasia grade 1 (CIN 1; 18.7%), 120 cases of CIN 2 (14.1%), 295 cases of CIN 3 (34.8%), and 79 cases of cancer (9.3%). Median waiting time to first intervention after an abnormal cytology result was 47 days (diagnostic range = 31-60). The most common diagnostic procedures were colposcopy and additional cytology testing. The principal therapeutic procedure was loop electrosurgical excision. The costs generated according to cytology result were (euro)1,196.80 (ASCUS), (euro)912.43 (LSIL), (euro)1,333.00 (HSIL), and (euro)6,261.30 (cancer). The costs generated according to histology results were (euro)790.10 (CIN 1), (euro)1,131.20 (CIN 2), (euro)1,181.30 (CIN 3), and (euro)7,041.70 (cancer). Conclusions: Waiting time to the first intervention may be longer than clinically desirable. Direct costs associated with the management patterns of women with abnormal cervical cytology result are high and have important economic consequences to the Spanish National Health System. These results will allow to improve the effectiveness and efficiency of future intervention strategies. © 2010, American Society for Colposcopy and Cervical Pathology. Source


Vesikari T.,University of Tampere | Prymula R.,University of Hradec Kralove | Schuster V.,University of Leipzig | Tejedor J.-C.,Hospital de Mostoles | And 4 more authors.
Pediatric Infectious Disease Journal | Year: 2012

Background: Rotavirus is the main cause of severe gastroenteritis and diarrhea in infants and young children less than 5 years of age. Potential impact of breast-feeding on the efficacy and immunogenicity of human rotavirus G1P[8] vaccine was examined in this exploratory analysis. Methods: Healthy infants (N = 3994) aged 6-14 weeks who received 2 doses of human rotavirus vaccine/placebo according to a 0-1 or 0-2 month schedule were followed for rotavirus gastroenteritis during 2 epidemic seasons. Rotavirus IgA seroconversion rate (anti-IgA antibody concentration 20 mIU/mL) and geometric mean concentrations were measured prevaccination and 1-2 months post-dose 2. Vaccine efficacy against any and severe rotavirus gastroenteritis was analyzed according to the infants being breast-fed or exclusively formula-fed at the time of vaccination. Results: Antirotavirus IgA seroconversion rate was 85.5% (95% confidence interval [CI]: 82.4-88.3) in breast-fed and 89.2% (95% CI: 84.2-93) in exclusively formula-fed infants; geometric mean concentrations in the respective groups were 185.8 U/mL (95% CI: 161.4-213.9) and 231.5 U/mL (95% CI: 185.9-288.2). Vaccine efficacy was equally high in breast-fed and exclusively formula-fed children in the first season but fell in breast-fed infants in the second rotavirus season. During the combined 2-year efficacy follow-up period, vaccine efficacy against any rotavirus gastroenteritis was 76.2% (95% CI: 68.7-82.1) and 89.8% (95% CI: 77.6-95.9) and against severe rotavirus gastroenteritis 88.4% (95% CI: 81.6-93) and 98.1% (95% CI: 88.2-100) in the breast-fed and exclusively formula-fed infants, respectively. Conclusions: The difference in immunogenicity of human rotavirus vaccine in breast-fed and exclusively formula-fed infants was small. Vaccine efficacy was equally high in breast-fed and exclusively formula-fed children in the first season. Breast-feeding seemed to reduce slightly the efficacy in the second season. Copyright © 2012 by Lippincott Williams & Wilkins. Source

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