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When competing in road races, runners enter starting corrals long before the starting gun triggers. Athletes consequently must complete warm up routines well in advance of race commencement. To optimize performance readiness warm up intensity may need altered to account for the prolonged time between warm up and performance. This study tested the effectiveness of various warm up intensities on 1600 m run performance given a 20 min separation between warm up and time trial, and assessed the physiological bases for performance outcomes. In a randomized, crossover design, 14 athletic men and women [(age (mean ± SEM) = 22 ± 1 y; V·O2peak = 50.3 ± 2.5 ml·kg−1·min−1] completed three warm up routines (light-, moderate-, or high-intensity warm up), rested for 20 min, and ran a 1600 m time trial. Warm up procedures were evaluated for their influence on performance, blood lactate, V·O2, and alterations to neuromuscular function. Time trial performance was significantly faster ( P −1) compared to a light-intensity warm up (6:30 ± 18 min:s·1600 m−1). Performance following the high-intensity warm up (6:18 ± 24 min:s·1600 m−1) fell between the light and moderate conditions. When stratified based on starting lactate concentrations, 1600 m performance was optimized when pre-time trial lactate was 2.0–4.9 mmol·l−1. When a prolonged rest separates warm up exercise from time trial performance, warming up remains efficacious. Optimal warm up intensity may be identified using starting lactate as a gauge for performance readiness.

INTRODUCTION The effects of radiosurgery for primary intracranial tumors on systemic immune response are unknown. Vestibular schwannomas (VS) treated with Gamma Knife (GK) have high control rates and low risk of adverse effects. This study examines if radiosurgery for VS is associated with an immune response detectable by peripheral blood sampling, and if that response can be correlated with tumoral expansion and/or toxicity. METHODS 50 patients treated with GK for VS were enrolled on an IRB-approved, prospective study at initial consultation. Blood samples were drawn preceding GK and 6 months and 1 year follow-up. Neurological and hearing outcomes were assessed. Tumor volume was measured at treatment, 6 months, and 1 year follow-up. Tumoral expansion (TE) was defined by volumetric increase >20%. Immunophenotyping via multicolor flow cytometry panels evaluated lymphoid and myeloid differentiation, phenotypic characterization, activation, tissue homing, and immune exhaustion. RESULTS Median volume at radiosurgery was 0.55cc (range 0.04-11.94) and median margin dose was 12.5Gy (11.5-13) prescribed to the 50% isodose line (50-60). 22 tumors exhibited TE, 20 at six months and 2 at one year. No VS with TE grew at median follow-up of 30.8 months (9.8-52.8). 1 tumor, non-expanding (NE) post-GK, showed progression at 24 months. Presence of cranial neuropathy and hearing decline was similar in both groups. Immunophenotyping showed numerous significant (p< .05) changes in the TE group, not seen in NE, at 6 months and 1 year follow-up compared to baseline. Major changes were observed in cytokine secretion (e.g. IFNg, TNF or IL-17) of CD4+ and CD8+ memory T cells, frequencies of regulatory T cells, increased death of CD8+ effector cells in culture, suggesting chronic activated state. CONCLUSION Vestibular schwannomas that expand after GK are associated with a peripherally measurable change in systemic immune response that is absent from non-expanding tumors. The biologic underpinnings of these findings require further study.

ObjectivesThe association between obesity and atrial fibrillation (AF) is well-established. We aimed to evaluate the impact of index body mass index (BMI) on AF recurrence at 12 months following catheter ablation using propensity-weighted analysis. In addition, periprocedural complications and fluoroscopy details were examined to assess overall safety in relationship to increasing BMI ranges.MethodsBaseline, periprocedural and follow-up data were collected on consecutive patients scheduled for AF ablation. There were no specific exclusion criteria. Patients were categorised according to baseline BMI in order to assess the outcomes for each category.ResultsAmong 3333 patients, 728 (21.8%) were classified as normal (BMI 2), 1537 (46.1%) as overweight (BMI 25.5–29.0 kg/m2) and 1068 (32.0%) as obese (BMI ≥30.0 kg/m2). Procedural duration and radiation dose were higher for overweight and obese patients compared with those with a normal BMI (p=0.002 and p2led to a 1.2-fold increased likelihood of experiencing recurrent AF at 12-months follow-up as compared with overweight patients (HR 1.223; 95% CI 1.047 to 1.429; p=0.011), while no significant correlation was found between overweight and normal BMI groups (HR 0.954; 95% CI 0.798 to 1.140; p=0.605) and obese versus normal BMI (HR 1.16; 95% CI 0.965 to 1.412; p=0.112).ConclusionsPatients with a baseline BMI ≥30 kg/m2have a higher recurrence rate of AF following catheter ablation and therefore lifestyle modification to target obesity preprocedure should be considered in these patients.

Background: Breast cancer is still not curable with a substantial resistance rate in all subgroups. Alterations in immunological mechanisms are assumed to play a role in pathophysiology and potential efficiency of immunotherapy approaches. Understanding the immunological changes in these patients may have major implications as predictive biomarkers for disease progression. The aim of our study was to determine immune subsets and functions in patient blood between treatment naïve locally advanced and metastatic breast cancer at diagnosis and to compare it with multiple time points during and after different treatments. Subjects and Methods: The immunological profile of 25 stage II-III patients who were candidates for neoadjuvant treatment and 27 stage IV treatment naïve patients in two comprehensive oncology clinics (Marmara University and Medeniyet University, Istanbul, Turkey) were analyzed. Age-sex-matched healthy samples (n=26) were collected from volunteers. Peripheral blood mononuclear cells (PBMC) isolated from blood samples were frozen. PBMC were thawed and stained using multi parameter antibodies for immune profiling using flow cytometry in Jackson Laboratory, Farmington, CT. Results: Differences between T cell subsets among patients (metastatic and locally advanced group separately) and healthy controls were assessed. We found significant differences (all p values Conclusions: Our results reveal significant differences in potential T cell activation and regulation in locally advanced and metastatic breast cancer patients, suggesting complex immune response at different disease stages. These findings have implications for as predictive indicators for disease progression for development of future immunotherapy strategies. Citation Format: Sezen BA, Koca S, Alan O, Renzullo S, Ozdemir FT, Kozhaya L, Telli TA, Karhan E, Ugurlu U, Gulluoglu B, Dane F, Yumuk FP, Unutmaz D. Prospective immune-profiling of locally advanced and metastatic breast cancer patients [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P4-06-29.

Background Methotrexate (MTX) is the gold standard as first line treatment in rheumatoid arthritis (RA). Identifying predictors of response to MTX should be crucial in the view of a personalized therapy. Objectives To identify prevalence and potential clinical baseline predictors of inadequate response (IR) to MTX in RA patients naive to disease modifying anti-rheumatic drugs (DMARDs)*. Methods Data of 233 consecutive RA patients (according to ACR/EULAR 2010 criteria) naive to traditional and biologic DMARDs, attending the AOU University Clinic, Rheumatology Unit, Monserrato (Cagliari), Italy, were analyzed. Table 1 shows baseline demographic, clinical and serological characteristics of the cohort. Patients failing to reach low disease activity state (DAS 28 > 3.2) at 6 months (T1) since the beginning of MTX (T0) or patients undergoing therapeutic modification for persistently high disease activity (switch or addition of other traditional or biological DMARDs) before T1 were considered as IR. By univariate analysis, demographic, clinical and serological factors recorded at T0 were evaluated as potential predictors of IR at T1. Afterwards, factors with p Results At T1, 104 patients (44.6%) were classified as IR to MTX. In univariate analysis, factors significantly associated with IR were: female gender (69.2% vs. 54.3%; p=0.02), condition of ”current smoker” (22.1% vs. 10.9%; p=0.012), ESR [median (IQR): 30.0 (19.0-48.0) vs. 40.0 (25-62); p=0.035] and DAS28 (mean ± standard deviation: 5.5 ± 1.1 vs. 5.2 ± 1.3; p=0.037). High-titre positivity for RF and/or ACPA (57.3% vs. 45.9%; p=0.095) and high cumulative steroids dose [852 mg (300-1200) vs. 691 mg (0-150); p=0.071] were numerically higher in IR. In multivariate analysis, the ”current smoker” condition was confirmed as the only independent factor associated with IR to MTX after 6 months of treatment (OR: 2.333, 95% CI: 1.132-4.805; p=0.022). No significant association between ex-smoker status and IR to MTX was demonstrated. This result was confirmed even after stratification of ex-smokers over the time since smoking stop. Finally, for both current smokers and ex-smokers, the duration of exposure to cigarette smoking did not show any significant association with IR. Conclusion In this RA cohort, the condition of ”current smoker” was the only predictor of IR to MTX. This observation, together with the lack of association between previous smoking habit and IR to MTX, further prompt to recommend cessation of cigarette smoking in patients with RA who begin treatment with MTX. Acknowledgement This study was supported by an unconditioned Research grant from Pfizer Inc. Disclosure of Interests None declared

Background In patients with coronary artery disease, ventricular tachycardia (VT) is usually related to left ventricular (LV) post-infarction scars. Case summary A case of a 78-year-old man with post-infarction VT originating from the right ventricular (RV) free wall is described. Following recurrent episodes of VT with left bundle branch block morphology and left superior axis deviation, a patient with prior myocardial infarction was submitted to catheter ablation. Two areas of abnormal bipolar electrograms were observed at 3D electroanatomical mapping: one located at the basal aspect of the posterior and postero-septal LV, and the other one extending from the antero-lateral to the posterior mid-basal RV free wall. Ventricular late potentials (LPs) were recorded within both scars, but only pacing from those located in the RV resulted in long stimulus-to-QRS latency and optimal pace-mapping. Accordingly, this substrate was deemed the culprit of the clinical VT. Radiofrequency catheter ablation aimed at eliminating all LPs recorded from both scars was effective in preventing VT recurrences at follow-up. Discussion A post-infarction RV free-wall scar may exceptionally be responsible of VT occurrence. Right ventricular mapping should be considered in selected cases based on 12-lead electrocardiogram VT morphology and prior RV infarct.

Objectives and Study: SARS-CoV-2, a novel coronavirus causing the pandemic clinical disease COVID-19, is generally associated with mild disease in most young patients with inflammatory bowel disease (IBD) despite their receiving immunosuppressive therapy. The aim of this study was to longitudinally evaluate characteristics of clinical and serologic response to SARS-CoV-2 infection in a cohort of young patients with IBD receiving biologics. Methods: Starting May 2020 we obtained serum on patients with IBD at the time of infusion with either infliximab or vedolizumab, along with baseline demographic and clinical data, as well possible SARSCoV2 exposure history (patient, family member). To measure antibodies to SARS-CoV-2, we used a fluorescent bead-based immunoassay that takes advantage of the high dynamic range of fluorescent molecules using flow cytometry. We immobilized biotinylated SARS-CoV-2 Spike protein receptor binding domain (S-RBD) or Nucleocapsid protein of SARS-CoV-2 (N) to detect specific IgG antibodies to the virus in patient serum. Spike protein-RBD-specific antibodies were detectable in serial dilutions up to 100,000-fold of serum samples. Titration curves from COVID-19 convalescent and healthy controls were used to normalize the area under the curve (AUC) values to quantitate the antibody levels. Antibody isotypes were measured using anti-Ig (IgG, IgA, IgM, IgG1-4) specific secondary antibodies conjugated to a fluorescent tag. We used a sensitive and high throughput SARS-CoV-2 neutralization assay using a lentivirus that expresses Spike protein to assess specific inhibition of viral entry. The results shown reflect the first serum sample obtained from unique patients. Results: 410 subjects were studied (mean age 17 years, 59% male, 305 (74%) Crohn's disease, 105 (25%) ulcerative colitis/IBD-U, 341 (83%) on infliximab, 69 (17%) vedolizumab, 13% concomitant methotrexate. 27/410 (6.6%) were positive for S-RBD and Nucleocapsid specific IgG. AUC values varied from 3150 to 285724 (Fig 1). S-RBD specific IgA+ 4/27 (15%) and IgG1+ 20/27 (74%) were found. Other isotypes undetectable. Patients' serum efficiently neutralized the virus at up to 10,000-fold serial dilution in only 10/27 (37%). (Fig 2). No differences in age, gender, diagnosis, or specific therapies were noted for (+) vs (-) anti-SARS-CoV-2 antibody status. 13/27 (48%) patients were asymptomatic. Non-exclusive symptoms were rhinorrhea 9 (33%), headache 8 (30%), sore throat 4 (15%). cough 4 (15%), diarrhea 4 (15%), chills 3 (11%), loss of smell/taste 2 (7%), fever 1 (4%). No patient was hospitalized. 4 (15%) had a family member with PCR+ COVID-19. Conclusions: We found a significant prevalence of anti SARS-CoV-2 antibody in our IBD population with the majority of + patients having non-neutralizing antibody. The role of biologics in mitigating clinical and serologic response to SARS-CoV-2 requires exploration.

Summary Aims The action of a hospital pharmacist can improve drug management and should focus on high risk drugs, services or patients. The aim of this study was to identify risk factors in medical files and thus identify patients with high iatrogenic risks. Method This multicenter study was based on a search for iatrogenic risk factors during prescription analysis. An analysis of pharmaceutical interventions and medical acceptance was performed in relation to the presence or absence of risk factors. Results In three hospital centers, 1813 patients were included. For these patients, 5866 prescriptions were included, with at least one risk factor in 1567 of these prescriptions. The rate of pharmaceutical interventions was significantly different between the patients with and without risk factors (30.4% vs 9.5%, respectively, P −6 ). Acceptance was 79% vs 71%, respectively, according to the presence or not of risk factors ( P Discussion/conclusion This study shows that biological or clinical factors can be used to identify prescriptions with a high iatrogenic risk. This must be confirmed by further studies with a larger number of prescriptions.

Surgery is the primary therapy for pheochromocytoma (PHEO), a catecholamine-producing tumor. Benign and malignant PHEO could develop recurrences, and the intraoperative risk of recurrent PHEO is an important unresolved issue. Non-surgical treatments of PHEO recurrence would therefore better prepare patients for reintervention as well as provide them with palliative management. We investigated the effects of the new somatostatin analog (pasireotide) SOM230 versus octreotide (OCT) in primary PHEO cell cultures (Pheo-c). Pheo-c from six benign surgical samples were set up and characterized by immunocytochemistry. Real-time PCR, using both PHEO tissues and Pheo-c, showed different levels of somatostatin receptor1–5 mRNA expression. Cells treated with various doses of OCT or SOM230 for 48 and 72 h were analyzed to assess their effects on cell proliferation and apoptosis and catecholamine levels. Even if reduction of cell viability was observed in Pheo-c treated for 48 h with either OCT or SOM230 and this effect increased after 72 h, a more significant inhibition of cell growth as well as a significantly higher induction of apoptosis was seen in Pheo-c treated with SOM230 versus OCT. In particular, apoptosis in Pheo-c was detected after 48 h and was associated with increased expression and activation of caspase-3 and cleaved poly(ADP-ribose) polymerase. OCT 10−6 M and SOM230 10−7 M significantly reduced catecholamine levels. Our results indicate that while both OCT and SOM230 modulate cell growth and apoptosis and catecholamine levels in Pheo-c through specific receptors, SOM230 is more effective. This improves our knowledge on the mechanism of SOM230 action in PHEO and supports a possible therapeutic use in benign PHEO recurrence.

Background Atrial fibrillation (AF) promotes atrial remodeling that in turn promotes AF perpetuation. The aim of our study is to investigate the impact of AF history length on 1-year outcome of AF catheter ablation in a cohort of patients enrolled in the Atrial Fibrillation Ablation Registry. Methods We described the real-life clinical epidemiology, therapeutic strategies, and the short- and mid-term outcomes of 1948 patients (71.9% with paroxysmal AF) undergoing AF ablation procedures, stratified according to AF history duration (= 2 years). Results The mean AF history duration was 46.2 +/- 57.4 months, 592 patients had an AF history duration = 2 years (mean 75.5 +/- 63.5 months) (P < 0.001). Patients with AF history duration = 2 years (34.0%) (P = 0.037). AF history duration >= 2 years, overall ablation procedure duration, hypertension, and chronic kidney disease were all predictors of recurrences after the blanking period. Conclusions In this multicenter registry, performing catheter ablation in patients with an AF history >= 2 years was associated with higher rates of AF recurrences at 1 year. Since cumulative time in AF in not necessarily equivalent to AF history, its role remains to be clarified.

Background Medication reconciliation (MR) makes it possible to identify medication errors. Because it is labour-intensive, it is often limited to certain specific hospital units (HU). Purpose The goal of this study was to evaluate a MR activity targeting patients at the highest risk admitted to the emergency unit. Material and methods A single-centre prospective study was performed for 6 months in patients hospitalised through the emergency unit. Emergency unit physicians or nurses would fill in a prioritisation grid of MR including 10 clinical and therapeutic factors. This grid, which was based on a bibliographic study and a prior internal study, included a box « don’t know » (DK) for every factor. A pharmacist collected the grids daily and calculated the risk score of each patient: in the case of a score ≥10, a pharmacist performed a MR of the patient in the unit where s/he was hospitalised. Results A prioritisation grid was filled out for 583 patients. Ten and 36% of the grids included at least one DK box checked by the physicians and the nurses, respectively. Twenty-four per cent of the patients were eligible for MR according to the physicians, 11% according to the nurses, for a total of 130 patients. Fifty-six MR were performed in 15 different HU, which represented 43% of the identified patients, with an average of 1 hour per MR of the pharmacist’s time. The number of unintended medication discrepancies (UMD) was 1.2/patient. Conclusion This grid seems to be adapted to the prioritisation of MR, because 24% and 11% of the patients had a score ≥10. It identified the need for MR in a large number of HU, which is the originality of our MR activity. All the priority MR could not be performed because of early release/death of patients or lack of time. The low rate of patients at risk and the high rate of DK checked by nurses suggests that nurses under-evaluate this risk. Physicians seem to have a better understanding of the patients and treatment. The MR of patients at risk made it possible to identify a number of UMD similar to that found in other French studies. No conflict of interest

Type IIIb polyglandular autoimmune disease comprises autoimmune thyroid disease (HT) and chronic atrophic gastritis (AIG). Hypergastrinemia, secondary to AIG, predisposes to gastric enterochromaffin-like cell (ECL) hyperplasia, a preneoplastic condition. We evaluated the prevalence of AIG, hypergastrinemia and ECL hyperplasia in HT patients. A secondary end-point was to assess the efficacy of treatment with a somatostatin analogue in HT patient with ECL hyperplasia. From 2009 to 2011, 146 HT patients were enrolled in a prospective study. All cases underwent hormonal profile, and parietal cell antibody (PCA), gastrin, and chromogranin A (CgA) serum level assays. Selected patients with elevated gastrin and CgA levels underwent gastro esophageal endoscopy (EGDS). Patients positive for ECL hyperplasia received Octreotide LAR 30 mg/28 days for 12 months. Gastrin and CgA assays were repeated every three months and EGDS after one year. The results show that gastrin and CgA were significantly higher than normal in 17/115 (14.7%) patients. Seven more HT had isolated PCA positivity and in the 17 PCA positive patients histology diagnosed AIG, corpus prevalent, with mild to moderate atrophy. Diffuse ECL hyperplasia of the gastric body was present in three subjects, one of them presenting a type-1 carcinoid. Gastrin and CgA levels were significantly reduced (p

Background Nutrition is an environmental factor affecting bone health. Nutrition is considered essential to achieve and maintain optimal bone mass. Mediterranean diet (MD) has shown to prevent bone disease. Aim of this study is to investigate the relationship between bone health status and adherence the MD. Methods Four-hundred eighteen healthy people (105 males and 313 females, age 50 ± 14 years) were recruited in the outdoor hospital of the “Campus Salute Onlus” held in Piazza del Plebiscito in Naples, October 17–20th 2013 and 09–11th October 2014. All subjects underwent clinical assessment, calcaneal quantitative ultrasound (QUS) scanner and PREvención con DIeta MEDiterránea (PREDIMED) questionnaire. Results Globally, prevalence of osteoporosis and osteopenia were 7.7 and 46.0%, respectively. The majority of subjects (60.5%) had an average score (score 6–9) of adherence to MD. The T-score showed positive correlation with PREDIMED score (r = 0.250, p

Background Adverse drug events (ADE) represent up to 27% of intensive care unit (ICU) admissions and 28% of deaths, whereas they could be prevented in 86% of cases. Metformin associated lactic acidosis (MALA) is rare ( Purpose The main objective of our study was to identify the main risk factors of MALA responsible for hospitalisation in the intensive care unit. Material and methods This was a 20 month prospective study, including all ICU patients admitted for MALA. We recovered hospitalisation reports before pharmaceutically analysing each clinical case. Results 21 cases were studied for MALA for an average age of 69 years (55–87) and an average IGSII score of 52 (25–87). This ADE was avoidable in 76.2% of cases. On average, patients were hospitalised 7 days (1–15) in the ICU and 14 days post-ICU (0–44). 2 patients (9.5%) died during their stay. 1 patient was lost to follow-up. 5 patients died after their hospital discharge for an average time of follow-up of 10.7 months (1–22). 2 patients maintained renal functional impairment. Regarding the main risk factors, 71.4% of patients were dehydrated by diarrhoea and/or vomiting leading to the nephrotoxicity of their continuous associated treatments, acute kidney injury (AKI) and MALA. The other cases were due to urinary obstructions, liver failure, sepsis and cardiogenic shock. 90.5% of patients had potentially nephrotoxic treatments. Conclusion Hospitalisations for MALA are still too frequent despite the fact that it is avoidable in most cases. Dehydration, continuation of nephrotoxic treatment and AKI remain the main risk factors. Consequently, it is necessary to continue and develop prevention strategies to prevent their appearance, to limit their consequences and to reduce their recurrences. In our department, we will electronically send this information to general practitioners in order to make their diabetic patients more aware of the precautions with this type of treatment. References and/or acknowledgements DeFronzo R, Fleming GA, Chen K, et al. Metformin-associated lactic acidosis: Current perspectives on causes and risk. Metabolism2016;65:20–9. No conflict of interest

Background: Several epidemiological studies have demonstrated an increased mortality from cardiovascular causes in patients with Klinefelter Syndrome (KS). Little information is available about the nature of the underlying cardiovascular abnormalities. Aim of the study was to investigate exercise performance, left ventricular architecture and function, vascular reactivity, and carotid intima-media thickness in a group of patients with KS. Materials and methods: Sixty-nine patients with KS and 48 age-matched controls participated in our population-controlled study. Forty-eight Klinefelter subjects were on testosterone treatment at the time of the investigation while 21 were naive and underwent a complete Doppler echocardiographic examination, a cardiopulmonary exercise test as well as a vascular study including measures of carotid intima-media thickness and endothelial function with flow-mediated dilation of the brachial artery. Patientswith KS on testosterone therapy (n=48) were also matched against a population of men with treated secondary hypogonadism (n=21). Results: Patients with KS exhibited a wide array of cardiovascular abnormalities including left ventricular diastolic dysfunction, reducedmaximal oxygen consumption (p

ContextCDKN1B encodes the cyclin-dependent kinase inhibitor p27Kip1 and is mutated in multiple endocrine neoplasia-like syndromes. CDKN1B also harbors single nucleotide polymorphisms; the T/G transversion at nucleotide 326 (the V109G variant) has been reported to be protective in breast, hereditary prostate, and pancreatic tumors. Association of CDNK1B mutations or polymorphisms with sporadic medullary thyroid carcinoma (MTC) has not been investigated yet.Objective and designWe screened germline DNA from 84 patients affected by sporadic MTC and 90 healthy age- and gender-matched controls for CDKN1B mutations or polymorphisms by PCR amplification and sequencing of the amplicons. We also tested all germline and 50 tumor tissue DNA for RET proto-oncogene mutations. Computed tomography, ultrasound scans, and serum calcitonin were carried out before surgery and during the follow-up and associated with CDKN1B polymorphism and disease remission.ResultsThe T/G transversion at nucleotide 326 was the only DNA variation detected. The overall frequency of the T/G and G/G alleles in combination was 46.4%. This variant (V109G) was correlated with post-operative calcitonin levels in the normal range and biochemical remission. Conversely, the wild-type (T/T) allele was associated with post-operative calcitonin levels above normal and a higher risk to develop clinical recurrence and distant metastases. Somatic RET mutations were significantly associated with a more aggressive behavior especially in wild-type allele-bearing patients.ConclusionsCollectively, in sporadic MTC, the CDKN1B V109G polymorphism correlates with a more favorable disease progression than the wild-type allele and might be considered a new promising prognostic marker.

BACKGROUND: Despite frequent anemia and multiple transfusions in patients undergoing chemotherapy and allogeneic hematopoietic stem cell transplantation (allo-HSCT) for acute myeloid leukemia , recommendations for use of erythropoiesis-stimulating agents (ESAs) in these populations are still missing. The primary objective was the effect of ESA administration on patient's quality of life (QoL). Secondary objectives were hemoglobin (Hb) recovery, red blood cell (RBC) transfusions, overall survival, and event-free survival. METHODS: Adult patients with Hb ≤ 11 g/dL after consolidation chemotherapy for acute myeloid leukemia (group 1), or after allo-HSCT for any hematological diseases (group 2), were prospectively included. ESA was administered subcutaneously once per week during a maximum period of 6 months and was stopped when Hb level reached 12 g/dL. A paired-matched analysis using a historical control group was performed for secondary endpoints. Fifty-two patients were included in group 1, and 55 patients were in group 2. RESULTS: For the global population, a significant improvement of QoL was noticed with ESA use; 83% (group 1) and 71% (group 2) of patients achieved an Hb level ≥ 12 g/dL without transfusion requirement. The pair-matched analysis showed a reduction of 4 RBC units per patient in group 1 (P = .0002) and 3 RBC units per patient in group 2 (P = .04). No significant difference in terms of thromboembolic events, overall survival, and event-free survival was observed between ESA and control groups. A RBC transfusion median savings of €1712 per patient was estimated in each group. CONCLUSIONS: ESAs have a clinical and economic benefit on Hb recovery, could improve a patient's QoL, and lead to a significant reduction in number of RBC transfusions with no effect on survival. Cancer 2013. © 2012 American Cancer Society.

A cross-sectional study was performed to determine the prevalence and risk factors for HIV-1 infection among agricultural plantation residents in Kericho, Kenya. Volunteers were recruited, interviewed, and phlebotomized for HIV-1 serologic testing. Sex-specific adjusted odds ratios were estimated using logistic regression. The overall HIV-1 prevalence was 9.9% (81/820), with prevalence in women more than twice that in men (17.4% vs 8.0%, P = 0.001). Among men, elevated HIV-1 prevalence was seen with increasing age, peaking in those older than 30 years (10.3%), marriage (10.4%), Luo tribe affiliation (23.5%), employment (8.9%), travel (11.0%), and being uncircumcised (29.2%). Among women, elevated HIV-1 prevalence was seen in those with no formal education (36.8%) and those who received goods in exchange for sex (36.0%). More than 97% of volunteers expressed a willingness to participate in future HIV-1 studies requiring semiannual visits. HIV prevention efforts have been implemented, along with further research to characterize this population for future cohort feasibility studies and HIV-1 vaccine efficacy trials.

Klinefelter syndrome (KS) is a hypergonadotropic hypogonadism characterized by a 47, XXY karyotype. The risk of testicular cancer in KS is of interest in relation to theories about testicular cancer etiology generally; nevertheless it seems to be low. We evaluated the need for imaging and serum tumor markers for testicular cancer screening in KS. Participants were 40 consecutive KS patients, enrolled from December 2009 to January 2013. Lactate dehydrogenase (LDH), alpha‐fetoprotein (AFP), and beta‐human chorionic gonadotrophin subunit (‐HCG) serum levels assays and testicular ultrasound (US) with color Doppler, were carried out at study entry, after 6 months and every year for 3 years. Abdominal magnetic resonance (MR) was performed in KS when testicular US showed micro‐calcifications, testicular nodules and cysts. Nearly 62% of the KS had regular testicular echotexture, 37.5% showed an irregular echotexture and 17.5% had micro‐calcifications and cysts. Eighty seven percent of KS had a regular vascular pattern, 12.5% varicocele, 12.5% nodules 1 cm. MR ruled out the diagnosis of cancer in all KS with testicular micro calcifications, nodules and cysts. No significant variations in LDH, AFP, and ‐HCG levels and in US pattern have been detected during follow‐up. We compared serum tumor markers and US pattern between KS with and without cryptorchidism and no statistical differences were found. We did not find testicular cancer in KS, and testicular US, tumor markers and MR were, in selected cases, useful tools for correctly discriminating benign from malignant lesions.

Intrauterine growth retardation may permanently influence the endocrine system by affecting its programming during development. The aim of this study was to evaluate thyroid and adrenal function together with insulin sensitivity in a group of children born small for gestational age (SGA). Forty SGA children (mean age, 6.7 +/- 1.7 yr) and 35 children born appropriate for gestational age (mean age, 6.5 +/- 2.2 yr) were selected for the study. TSH, free T4, free T3 (fT3), rT3, antithyroid antibodies, cortisol, and dehydroepiandrosterone sulfate (DHEAS) were assessed. Insulin sensitivity was evaluated with the quantitative insulin sensitivity check index (QUICKI). A thyroid ultrasound was also performed in the SGA children. We found that TSH was significantly higher in SGA than in children born appropriate for gestational age [2.9 +/- 1.1 vs. 1.7 +/- 0.7 microU/ml (mIU/liter); P < 0.001]; furthermore, eight SGA children (20%), seven born preterm and one at term, had TSH levels above the upper limit of normality. fT3 was also higher in SGA children (4.2 +/- 0.4 vs. 3.6 +/- 0.6 pg/ml; 6.4 +/- 0.6 vs. 5.5 +/- 0.9 pmol/liter; P < 0.0001), whereas no difference was found for free T4, rT3, and the fT3/rT3 ratio. Urinary iodine was normal, and antithyroid antibodies were absent. Thyroid ultrasound showed a normal echographic pattern with a normal volume in SGA children. Serum cortisol was similar in both groups, whereas DHEAS was significantly lower in SGA subjects (43 +/- 18 vs. 65 +/- 50 microg/dl; 1.1 +/- 0.4 vs. 1.7 +/- 1.3 micromol/liter; P < 0.05). There was no difference in insulin sensitivity between the two groups. Birth length and birth weight were the main determinants of TSH and DHEAS serum levels, respectively. In conclusion, functional thyroid and adrenal changes have been found in children who suffered from intrauterine growth retardation. A larger survey with an appropriate follow-up is, however, required to confirm these findings and to assess their natural evolution.

BACKGROUND: Endocrine gland-derived vascular endothelial growth factor (Prok1) and prokineticin 2 (Prok2) are involved in the organ-specific regulation of angiogenesis, which is a crucial step toward cancer progression in most tumors, including those of thyroid gland. The oncogene BRAF V600E mutation is associated with poor clinical outcome of papillary thyroid cancer (PTC) and can independently predict its recurrence. DESIGN: Our hypothesis was that Prok1 and Prok2 expression levels associated with BRAF mutations can be prognostic factors for PTC outcome. Prok1 and Prok2 were examined in PTC, a cell line derived from a human PTC (designated FB-2), euthyroid multinodular goiter (MNG), Graves' disease (GD), and contralateral normal thyroid (NT) tissues from PTC cases. We evaluated BRAF mutation and its relationship with Prok1 expression pattern in PTC. METHODS: We studied Prok1 and Prok2 mRNAs by real-time polymerase chain reaction and BRAF mutation by mutant allele-specific polymerase chain reaction amplification. Formalin-fixed, paraffin-embedded blocks of PTC and NT were used for the immunohistochemical determination of Prok1 using anti-endocrine gland vascular endothelial growth factor primary antibody. RESULTS: Prok1 and Prok2 transcripts were both present in thyroid tissues, and Prok1 was differentially expressed in PTC compared to MNG, GD, and NT. Prok1 mRNA levels were very low in NT and MNG and significantly higher in PTC, FB-2, and GD (p

Objectives: This study examined demographic and geographic correlates of HIV-1 prevalence among civilian applicants for US military service. Methods: HIV-1 test results and demographic and geographic data were available for 5.3 million applicants. Results: Between October 1985 and December 2000, a total of 5,340,694 individuals applied to join one of the armed service branches of the US military. Overall, HIV-1 prevalence was 0.80 per 1000 applicants (95% CI: 0.78-0.82), with 4276 applicants testing positive for HIV-1 infection. Prevalence declined over the 16-year period from a high of 2.89 per 1000 applicants in 1985 to 0.36 per 1000 applicants in 2000. The majority of applicants (82.7%) were male, and the majority of HIV-1 cases (89.4%) occurred in men. HIV-1 prevalence was higher among African Americans (2.47/1000) and Hispanics (0.90/1000) than among white applicants (0.36/1000). HIV-1 prevalence was lowest in the West North Central region of the United States (0.33/1000) and highest in the Middle Atlantic region (1.61/1000) and Puerto Rico (3.56/1000). Conclusions: Civilian applicants for US military service comprise a unique cohort for following trends in the evolving HIV-1 epidemic.

En 2000, les pinces a biopsie endoscopiques digestives froides mises a la disposition des praticiens, etaient vendues soient reutilisables, soient a usage unique. Face aux ecarts de prix importants recontres entre les differentes presentations et marques, nous avons realise la description technique puis la comparaison economique de certains de ces dispositifs medicaux afin d'en faciliteur leur choix.

A cohort of Royal Thai Army (RTA) conscripts was followed in civilian life after completing 2 years of military service, to determine whether such a cohort might be suitable for HIV vaccine trials. Objectives were to identify correlates of participation and to determine the occurrence of risk behaviors for HIV infection after discharge from the military. The cohort was selected from among conscripts who had participated in HIV studies from 1991 to 1993. Risk factors were surveyed at 3, 9, and 15 months after discharge (1993–1995). Change in risk was evaluated based on deviations from expected distributions of risk categories for sentinel behaviors, assessed with chi-square analysis. HIV seroconversion rates (SR) and 95% confidence intervals (CI) were calculated. A total of 380 men returned after discharge. Seven men seroconverted after discharge; the SR (95% CI) was 2.02/100 person-years (0.81–4.17). Among changes in risk were reduced visits to commercial sex workers (CSWs), more condom use with CSWs, and less alcohol use prior to CSW visits. Behaviors associated with increased risk of HIV seroconversion declined after military service. Thus, sufficient numbers of outcome events for vaccine trials may not be attained with this type of cohort. Nonetheless, these findings provide data on the dynamics of the HIV epidemic in Thailand and the development of HIV vaccine cohorts.

NEC is a common and severe complication in premature neonates, particularly those with very-low-birth-weight (VLBW,1500 g at birth). Probiotics including lactobacillus rhamnosus GG (LGG) proved effective in preventing NEC in preterm infants in several RCTs.Lactoferrin, a mammalian milk glycoprotein involved in innate immune host defences, can reduce the incidence of NEC in animal models, and its action is enhanced by LGG. We tried to assess whether bovine lactoferrin (BLF), alone or with the probiotic LGG, has a similar effect in human infants, something that has not yet been studied.An international, multicenter, randomized, double-blind, placebo-controlled trial conducted from October 1st, 2007 through July 31st, 2010.Thirteen Italian and New Zealand tertiary neonatal intensive care units.743 VLBW neonates were assessed until discharge for development of NEC.Infants were randomly assigned to receive orally either BLF (100 mg/day) alone (group LF; n = 247) or with LGG (at 6×10(9) CFU/day; group BLF + LGG; n = 238), or placebo (Control group; n = 258) from birth until day 30 of life (45 for neonates1000 g at birth).≥ stage 2 NEC; death-and/or-≥ stage 2 NEC prior to discharge.Demographics, clinical and management characteristics of the 3 groups were similar, including type of feeding and maternal milk intakes. NEC incidence was significantly lower in groups BLF and BLF + LGG [5/247 (2.0%)] and 0/238 (0%), respectively] than in controls [14/258 (5.4%)] (RR = 0.37; 95% CI: 0.136-1.005; p = 0.055 for BLF vs. control; RR = 0.00; p0.001 for BLF + LGG vs. control). The incidence of death-and/or-NEC was significantly lower in both treatment groups (4.0% and 3.8% in BLF and BLF + LGG vs. 10.1% in control; RR = 0.39; 95% CI: 0.19-0.80; p = 0.008. RR = 0.37; 95% CI: 0.18-0.77; p = 0.006, respectively). No adverse effects or intolerances to treatment occurred.Compared with placebo, BLF supplementation alone or in combination with LGG reduced the incidence of ≥ stage 2 NEC and of death-and/or ≥ stage 2 NEC in VLBW neonates. BLF might be a promising strategy to prevent NEC in NICU settings. Further data on larger sample sizes are warranted before BLF can be widespreadly used in clinical settings.ISRCTN53107700-http://www.controlled-_trials.com/ISRCTN53107700.

OBJECTIVES. This study sought to examine risk factors associated with human immunodeficiency virus type 1 (HIV-1) seroconversion among active-duty men in the US Army. METHODS. One hundred twenty-eight men with documented HIV-1 seroconversion between 1988 and 1991 were matched to control subjects on demographic variables. Risk factor information was collected for the seroconversion period. RESULTS. Forty-nine case subjects and no control subjects reported same-gender sex; this includes 34 case subjects who also reported sex with women. Seventy case and 118 control subjects reported no risk factors other than heterosexual intercourse. Among heterosexuals, excess risk was noted for men who had sex with women in risk categories defined by the Centers for Disease Control and Prevention (odds ratio = 10.0; 95% confidence interval = 1.3, 78.1). Significant trends of increasing risk for seroconversion were found with increasing numbers of female partners, nonsteady partners, and partners with whom sex occurred on the first day of acquaintance. CONCLUSIONS. In this population, the major risk factor for HIV-1 seroconversion was same-gender sex. Among heterosexuals, sex with anonymous or causal partners increased this risk. Intervention programs should emphasize the risk of indiscriminate partner selection in addition to "safe sex" practices.

The direct measurement of the incidence of new infections with the human immunodeficiency virus type 1 (HIV-1) can be made among soldiers because of the routine and periodic nature of HIV-1 testing in the United States Army. Between November 1985 and October 1993, 978 HIV-1 seroconversions were seen among 1,061,768 soldiers, contributing over 3.6 million person-years of follow-up [seroconversion rate (95% confidence interval) = 0.27/1,000 person-years (0.25-0.29)]. A significant decreasing trend in HIV-1 seroconversion rates was seen over the analysis period. The rate of new infections declined significantly from the first interval, 1985-1987, (0.43/1,000 person-years) to the second interval, 1987-1988, (0.28/1,000 person-years), but stabilized at approximately 0.22/1,000 person-years after 1988, representing new infections in approximately 100-150 soldiers annually. The risk of seroconversion among active duty soldiers was significantly associated with racial/ethnic group, age, gender, and marital status. Surveillance of HIV-1 seroconversion rates in the U.S. Army continues to offer a unique opportunity to assess temporal trends in the evolving HIV-1 infection epidemic. Monitoring the rate of new HIV-1 infections allows for identification of subgroups in need of intervention, refocusing of intervention strategies, and evaluation of their effectiveness.

To determine the anticipated participation in a prophylactic AIDS vaccine trial and to identify perceived benefits and barriers to enrollment of HIV-seronegative volunteers at risk of HIV infection in northern Thailand.A cross-sectional survey.Subjects interviewed in a cross-sectional survey included female commercial sex workers (n = 215), men attending sexually transmitted disease clinics (n = 219), conscripts in the Royal Thai Army (n = 1453), and men discharged from the army (n = 293) who had returned to civilian life. We determined AIDS vaccine knowledge and attitudes, perceived vulnerability to HIV infection, barriers and incentives to participate in a future vaccine trial and agreement to participate in a randomized trial.Awareness of vaccines (88-97%) and AIDS vaccine development efforts (62-77%) were common and viewed to be a complement to behavior change (74-94%). Approximately 25% of subjects would definitely join a trial if asked, and an additional 38% would accept an AIDS vaccine if they were convinced it would be safe and effective. Important barriers to participation included concerns with discrimination (16-45%), short- (37-60%) and long-term (30-55%) vaccine side-effects, fear of disability and death (36-58%), and beliefs that partners would refuse to have sex (24-49%) after immunization. The principal inducement to join a trial was health insurance (62%).Potential HIV vaccine trial participants have several fears of joining a vaccine study at this time. Information derived from Phase I/II trials is needed to address these concerns if enrollment in efficacy trials is to be successful in the near future.Thailand has been designated a site for preventive human immunodeficiency virus (HIV) vaccine trials, and Phase I and II trials are currently underway. To assess the feasibility of large-scale Phase III trials involving high-risk individuals, questionnaires were administered to four cohorts of potential participants from North Thailand: 215 female commercial sex workers recruited from sexually transmitted disease (STD) clinics, 219 male STD clients from the same area, 1453 men conscripted into the Royal Thai Army in 1993, and 293 men discharged from the Army in 1993. Approximately 25% of members of each cohort indicated they would definitely join a prophylactic acquired immunodeficiency syndrome (AIDS) trial. The major barriers to participation were concerns about vaccine safety (61% of military cohorts and 32% of civilians) and fear of acquiring AIDS through vaccination (21%). Also expressed were concerns about social discrimination, immediate side effects, and rejection by sexual partner. Two-thirds of respondents indicated that provision of a five-year family health insurance plan would induce them to participate in a vaccine trial, while another 25% did not require any incentive. Overall, these findings indicate that steps must be taken to alleviate fears and misconceptions associated with HIV vaccines before Phase III is initiated.

Background The expiry of patents for infliximab in Europe coincides with the arrival on the market of new biosimilars with potential savings. However, many clinicians are reluctant to consider biosimilars as a treatment option for their patients. Purpose The aim of this study was to evaluate concerns raised about biosimilars in the medical community in our hospital in order to reference infliximab biosimilars. Material and methods A questionnaire with different items was put online: knowledge about the regulation of biosimilars in France, the degree of confidence in biosimilars, existence of high level evidence studies on the safety of biosimilars, and the acceptance of prescription and substitution. An item was used to evaluate the prescription frequency of biosimilars: regular prescribers (more than 1 prescription/week), occasional prescribers (between 6 and 12 prescriptions/year) and potential prescribers ( Results 36 prescribers responded to the survey. 47% (n = 17) were potential prescribers, 30.5% (n = 11) were occasional prescribers and 22% (n = 8) were regular prescribers. 61% (n = 22) had a good knowledge of the regulation of biosimilars. The degree of confidence was high for 70% (n = 25) of prescribers. However, 53% (n = 19) emphasised the lack of high level evidence for safety. 64% (n = 23) of prescribers were willing to prescribe a biosimilar and 50% (n = 18) to authorise substitution in patients already being treated with the originator product. The refusal rate for substitution seemed to be significantly different depending on the prescribing habits (p = 0.031). 75% (n = 6) of regular prescribers refused a substitution, while the refusal rate was 18% (n = 2) among occasional prescribers and 58.8% (n = 10) among potential prescribers. There were no statistically significant differences between prescribers groups about confidence level (p = 0.118). Conclusion Major concerns voiced about biosimilars in this survey related to their pharmaceutical quality, safety (especially immunogenicity), efficacy (particularly in extrapolated indications) and interchangeability with the originator product. However, the acceptance of biosimilars in our hospital seems to be high. This allows pharmacists to initiate a process introducing infliximab biosimilars. References and/or Acknowledgements Thanks to the medical staff. No conflict of interest.

After the spread of H5N1 highly pathogenic avian influenza virus (AIV) from Asia into Russia, the Middle East, Europe, and Africa in 2005–06, the Swiss national AIV surveillance program was extended. One of the new focal points was Lake Constance, where sentinel duck stations and swim-in traps were established within the project Constanze in collaboration with Germany and Austria. More than 2000 samples from 41 species were collected in Switzerland between September 2006 and December 2008. Approximately 4% were AIV-positive by quantitative reverse transcriptase–PCR. Subsequent typing revealed 13 different AIV subtypes, of which H5N2 and H9N2 were the most prevalent. All H7 isolates and all but one H5 isolate were characterized as low pathogenic; however, a highly pathogenic H5N1 AIV was detected in a healthy pochard. This study demonstrates that a wide selection of different AIV subtypes can cocirculate among the waterfowl population in wild bird habitats.

BACKGROUND. A natural history study of human immunodeficiency virus (HIV) disease was carried out among 1575 HIV-infected US Army men and 6220 demographically similar uninfected soldiers. Inpatient morbidity occurring up to 8 years prior to the date of HIV infection diagnosis among those men who became HIV infected was evaluated for both groups. METHODS. Incidence density rates were calculated for hospital admissions. Poisson regression was used to assess the trend in hospital admissions among those subsequently diagnosed with HIV infection. Prevalence ratios for discharge diagnoses were also calculated. RESULTS. Sixteen diagnoses/diagnosis categories occurred statistically more frequently among subsequently HIV diagnosed individuals than among those who remained uninfected. Among these were hepatitis B and abscess of anal/rectal region (6 to 8 years prior to HIV infection diagnosis); unspecified viral infection, enlarged lymph nodes, syphilis (3 to 5 years prior to HIV infection diagnosis); and diagnoses suggestive of acute retroviral syndrome (1 to 2 years prior to HIV infection diagnosis). CONCLUSIONS. Data such as these may provide useful information to HIV surveillance efforts regarding patterns of morbidity experienced prior to HIV infection as well as to health care providers regarding patients at high risk for becoming infected with HIV.

During the 1984-1985 influenza season, outbreaks of influenza A (H3N2) occurred in three Connecticut nursing homes. Influenza vaccination rates were 67% (96 out of 144), 35% (30 out of 85) and 69% (332 out of 483), respectively. The relative risk of illness for vaccinated compared to unvaccinated residents was 1.8 (95% confidence interval, 0.6, 5.9), 1.6 (95% confidence interval, 0.8, 3.0) and 1.1 (95% confidence interval, 0.8, 1.7) for each of the three nursing homes, respectively. In the third outbreak, 22 vaccinated residents without clinical illness had a geometric mean titer of hemagglutination-inhibition (HI) antibody of 20. Although low, this titer was significantly higher than that of nine unvaccinated residents without clinical illness (12, p less than .05); only three (14%) vaccinated residents had HI titers of greater than or equal to 40. These results suggest that levels of HI antibody in vaccinated residents were not protective at the time of the third outbreak, four to five months after vaccination. In general, the study of vaccine effectiveness in nursing homes is limited by sample size and statistical power. Despite these limits, the retrospective investigation of influenza outbreaks in nursing homes is often the only practical way to evaluate influenza vaccine effectiveness in the elderly on a yearly basis.

SUMMARYHuman immunodeficiency virus type 1 (HIV-1) epidemiology among residents of a rural agricultural plantation in Kericho, Kenya was studied. HIV-1 prevalence was 14·3%, and was higher among women (19·1%) than men (11·3%). Risk factors associated with HIV-1 for men were age (⩾25 years), marital history (one or more marriages), age difference from current spouse (⩾5 years), Luo ethnicity, sexually transmitted infection (STI) symptoms in the past 6 months, circumcision (protective), and sexual activity (⩾7 years). Among women, risk factors associated with HIV-1 were age (25–29 years, ⩾35 years), marital history (one or more marriages), age difference from current spouse (⩾10 years), Luo ethnicity, STI symptoms in the past 6 months, and a STI history in the past 5 years. Most participants (96%) expressed a willingness to participate in a future HIV vaccine study. These findings will facilitate targeted intervention and prevention measures for HIV-1 infection in Kericho.

Background Adverse drug reactions are frequently encountered in older people. They represent the cause of hospitalisation of 10 to 20% of hospitalised people aged 60 years or over. The quality of geriatric prescription is thus a healthcare priority. Potentially inappropriate drugs (PIDs) are medicines with an unfavourable benefit/risk ratio or questionable efficacy while other and safer therapeutic alternatives are available. Purpose To evaluate the quality of prescribing in our hospital for patients who are 75 years old or over. Are PIDs prescribed to our patients? Who first prescribed this treatment: our hospital doctors or family doctors? Materials and Methods A list of potentially inappropriate medicines, judged by 34 criteria, specially adapted to French medical practise, was used as reference. 28 of these drugs are used in our hospital. We analysed the prescriptions of patients who were 75 years old or over, hospitalised on one day chosen arbitrarily, in order to collect data about their treatments. Results 133 patients (29.6% of patients hospitalised in medical and surgical care units) were included. On average, 8 systemic drugs were prescribed per patient. 31 patients had at least 1 PID prescribed (23.3%): 24 (18%) had 1 PID, 5 (3.8%) had 2 PIDs and 2 (1.6%) had 3 or more PIDs. 70.9% were psychotropic drugs. 53.7% of them were initiated by doctors working in our hospital, 86.4% of which by a senior doctor versus 13.6% by a resident. Conclusions This study shows that a significant proportion of PIDs are initiated in our hospital. To improve practise, pharmacists have to make doctors aware of PIDs and suggest therapeutic alternatives before treatment is started. If PIDs are prescribed, pharmacists should formulate pharmaceutical interventions. We will add this criterion to our trigger tool which selects high-risk prescriptions. No conflict of interest.

Background Reviewing prescriptions for high-risk patients must be a priority. Because of their cardiac consequences, disorders of potassium blood levels represent a frequently-occurring preventable iatrogenic event. Purpose The authors decided to analyse the effect of pharmacists9 alerts on patients with dyskalaemia, and thus show that their prescriptions must be reviewed with priority. Materials and methods A prospective study was conducted in 2 medical units (neurology and pneumology) and a surgery department. Prescriptions were daily reviewed for four months with a computerised physician order entry (CPOE) system (Cristal Net). Dyskalaemic patients were identified (hypo/hyperkalaemia defined on biological laboratory limits). Therapeutic problems and pharmacists9 alerts were codified according to the French Clinical Pharmacy Society9s coding tables (SFPC). Physicians9 acceptance rate was evaluated. Results 873 patients were hospitalised during the study. A total of 3016 prescriptions were reviewed by pharmacists. 159 patients (18%) showed a blood potassium level disorder during their stay and 337 prescriptions were evaluated for these patients. Of these, 103 (31%) required pharmaceutical intervention (PI). 74% of PIs were directly related to kalaemia disorders. The numbers were higher in general surgery with 49% of PIs in dyskalaemic patients. The main causes of PI were: a contraindication (22%), an adverse drug effect (23%) or an overdose (17%). 12 patients left the ward before physicians responded to the PI. For the remaining patients, practitioners accepted 79% of PIs and modified their prescriptions. Conclusions The results show a higher percentage of PIs in dyskalaemic patients (31%) compared with the results in non-dyskalaemic patients (11%) and literature reviews (

Abstract 3810 Introduction: Despite frequent anemia and multiple transfusions during AML chemotherapy and allogeneic hematopoietic stem cell transplantation (allo-HSCT), recommendations and marketing authorization for erythropoietin (EPO) use are still missing. In the current prospective study, as primary objective, we evaluated the effect of EPO on patient's quality of life (QOL). Secondary objective was hemoglobin (Hb) recovery. In addition, a paired matched analysis using similar population was conducted to compare platelets (Pt) and red blood cells (RBC) transfusion number. Materials and methods: We included adult patients with Hb level ≤11g/dl induced by 1, 2 or 3 consolidation chemotherapy for AML in complete remission (CR) (group 1); or by allo-HSCT for any hematological disease (group 2). EPO was administered Sc. once per week during a maximum period of 6 months: for group 1, ARANESP® 150μg; for group 2, NEORECORMON® 30000IU; Hb level was monitored every week. Injections were stopped once the Hb level reached 12g/dl without any transfusion. If after 4 injections, no improvement was observed, doses were doubled, and if after 8 injections, no improvement was observed, patient was taken off-study for EPO inefficiency. The QOL was measured at baseline, at 1, 2, 3 and 6 months by the Functional Assessment of Cancer Therapy–Anemia (FACT–An). EPO responders patients were defined as having Hb level ≥12g/dl (EPO CR) or a ≥ 2g/dl increase [EPO partial response (EPO PR)] compared with baseline value without any transfusion requirement. The matching analysis took into account: sex, age, disease status, for the two groups, associated to cytogenetics, type of chemotherapy, sequential chemotherapy number for group 1, and diagnosis, conditioning, HSC source, number of previous transplants and GVHD for group 2. Results: Between April 2006 and December 2009, among 261 screened patients, 55 were included in group1 and 61 in group 2, patient characteristics for each group are summarized in Table1. Main exclusion criteria were EPO contra-indication and patient refusal. The median number of EPO injections/patient was 13 (3 – 24) in group1 and 8 (2 - 28) in group 2. For the global population (111 evaluable patients [52 group1 and 59 in group 2]), we have noticed a significant improvement of QOL during the 6 months follow-up according to FACT-An anemia (p=0.01). Despite a non-significant improvement for FACT-G, we observed a significant improvement in physical well-being (p Conclusion: This prospective study showed a real benefit of EPO administration on QOL, an achievement of a normal Hb level and a significant spare of RBC and Pt transfusions. Young AML patients, male allo-HSCT recipient, ABO compatible pairs seem to be the best candidates to benefit from EPO administration, with low AEs and no impact on OS or EFS. A cost-effectiveness study is ongoing and results will be communicated. Disclosures: No relevant conflicts of interest to declare.

Context Sepsis is a common and severe complication in premature neonates, particularly those with very low birth weight (VLBW) ( Objective To establish whether bovine lactoferrin (BLF), alone or in combination with LGG, reduces the incidence of late-onset sepsis in VLBW neonates. Design, Setting, and Patients Prospective, multicenter, double-blind, placebo-controlled, randomized trial conducted in 11 Italian tertiary neonatal intensive care units. Patients were 472 VLBW infants enrolled from October 1, 2007, through July 31, 2008, and assessed until discharge for development of sepsis. Intervention Infants were randomly assigned to receive orally administered BLF (100 mg/d) alone (n = 153), BLF plus LGG (6 × 10 9 colony-forming units/d) (n = 151), or placebo (n = 168) from birth until day 30 of life (day 45 for neonates Main Outcome Measure First episode of late-onset sepsis, ie, sepsis occurring more than 72 hours after birth with isolation of any pathogen from blood or from peritoneal or cerebrospinal fluid. Results Demographic, clinical, and management characteristics of the 3 groups were similar, including type of feeding and intake of maternal milk. Incidence of late-onset sepsis was significantly lower in the BLF and BLF plus LGG groups (9/153 [5.9%] and 7/151 [4.6%], respectively) than in the control group receiving placebo (29/168 [17.3%]) (risk ratio, 0.34; 95% confidence interval, 0.17-0.70; P = .002 for BLF vs control and risk ratio, 0.27; 95% confidence interval, 0.12-0.60; P Conclusion Compared with placebo, BLF supplementation alone or in combination with LGG reduced the incidence of a first episode of late-onset sepsis in VLBW neonates. Trial Registration isrctn.org Identifier: ISRCTN53107700

Because soldiers in the US Army are recurrently tested for the presence of antibody to the human immunodeficiency virus (HIV), HIV seroconversion rates can be directly measured. From November 1985 through October 1989,429 HIV seroconversions were detected among 718 780 soldiers who contributed 1 088 447 person-years of follow-up time (HIV seroconversion rate, 0.39 per 1000 person-years). Period-specific seroconversion rates declined significantly, from 0.49 per 1000 person-years (November 1985 through October 1987) to 0.33 per 1000 person-years (November 1987 through October 1988) to 0.29 per 1000 person-years (November 1988 through October 1989). The HIV seroconversion risk among active-duty soldiers was significantly associated with race/ ethnic group, age, gender, and marital status. Based on these trends, we estimate that approximately 220 soldiers (95% confidence interval, 160 to 297 soldiers) were infected with HIV during 1989 and 1990, with potentially fewer in future years. ( JAMA . 1991;265:1709-1714)