Dapsone salvage therapy for adult patients with immune thrombocytopenia relapsed or refractory to steroid and rituximab.

Dapsone is an antibacterial sulfonamide with anti-inflammatory property, which showed therapeutic activity in patients with immune thrombocytopenia (ITP); the activity in patients who showed refractoriness to rituximab is unknown. We evaluated the effect of dapsone in 20 consecutive adult patients, median age 51 years, with primary ITP previously treated at least with steroids and rituximab. Median baseline platelet count was 19 × 109/L, and the median interval between diagnosis of ITP and dapsone therapy was 46 months. Response (platelet count ≥ 30 × 109/L) and complete response (CR; platelet count ≥ 100 × 109/L) were 55 and 20%, respectively; median time to response (TTR) was 1 month. All responders were able to interrupt any other specific anti-ITP treatment. The median duration of dapsone therapy in responders and the median response duration were 31 and 42 months, respectively. None of responders lost response during treatment. One patient in CR interrupted dapsone after 9 months and still maintained the response after 48 months. None of the patients interrupted the treatment for toxicity. All the patients were screened for normal glucose-6-phosphate-dehydrogenase (G6PD); two patients showed mild increase of methemoglobin (MHb). These results highlight the therapeutic activity and good safety profile of dapsone in patients with ITP who previously failed rituximab treatment.

Factors Associated with Exclusive Breastfeeding in a Maternity Hospital Reference in Humanized Birth.

OBJECTIVE: To analyze the factors associated with the prevalence of exclusive breastfeeding (EBF) for up to six months in mother/infant binomials cared for at a usual-risk maternity hospital. METHODS: The present is a descriptive, longitudinal, prospective, quantitative study. Socioeconomic, obstetric and perinatal variables from 101 mother/infant binomials in a Public Maternity Hospital in the city of Curitiba, state of Paraná, Brazil, were investigated during hospitalization after delivery and 6 months after birth. For the statistical analysis, the Chi-squared test was used. The variables that showed values of p < 0.25 for the Chi-squared test were also submitted to an odds ratio (OR) analysis. RESULTS: The prevalence (42.6%) of EBF was observed. Most women (93.1%) had had more than 6 prenatal consultations, and the variables maternity leave and support to breastfeeding were associated with EBF. Support to breastfeeding by professionals and family members increased 4-fold the chance of maintenance of EBF (OR = 0.232; 95% confidence intercal [95%CI]: 0.079 to 0.679; p = 0.008). Cracked nipples were the biggest obstacle to breastfeeding, and low milk production was the main responsible factor for weaning. CONCLUSION: The encouragement of breastfeeding and the mother's stay for a longer period with the child contributed to the maintenance of EBF until the sixth month of life of the infant.

OBJETIVO: Analisar os fatores associados à prevalência do aleitamento materno exclusivo (AME) até seis meses em binômios mãe/recém-nascido atendidos em uma maternidade de risco habitual. MéTODOS: Trata-se de um estudo descritivo, longitudinal, prospectivo e quantitativo. Foram investigadas variáveis socioeconômicas, obstétricas e perinatais de 101 binômios mãe/recém-nascido de uma maternidade pública em Curitiba-PR no internamento após o parto e 6 meses após o nascimento. Para a análise estatística, utilizou-se o teste do qui-quadrado. As variáveis cujo teste do qui-quadrado tiveram valores de p < 0,25 foram testadas para análises de razão de probabilidades (RP). RESULTADOS: Observou-se a prevalência (42,6%) do AME. A maioria das mulheres (93,1%) havia realizado mais de 6 consultas de pré-natal, e as variáveis licença maternidade e apoio para amamentar estiveram associadas ao AME. O apoio para amamentar por parte do profissional e do familiar aumentou em 4 vezes a chance da permanência em AME (RP = 0,232; intervalo de confiança de 95% [IC95%]: 0,079 a 0.679; p = 0,008). A fissura foi o maior obstáculo para a amamentação, e a baixa produção de leite, o principal responsável pelo desmame. CONCLUSãO: O incentivo ao aleitamento e a permanência da mãe por mais tempo com a criança contribuíram para a manutenção do AME até o sexto mês de vida do bebê.

Timing and Duration of Observation Periods of Foraging Behavior in Natural Grasslands.

The goals of this study were to evaluate the length of time grazing which should be monitored over a 24-h period to predict the grazing behavior of beef heifers within a season and determine the patterns of foraging activity over 24 h. A database was constructed between 2010 and 2012 for beef heifers managed under rotational grazing in a natural grassland. Grazing, rumination, and other activity times were assessed visually during 24 h on 15 occasions. Data were classified according to climatic seasons, generating 12 replicates in summer, 18 in spring, 24 in autumn, and 36 in winter. Treatments were the evaluation of four distinct periods: from sunrise to sunset (DAY-SUN), daylight duration from dawn to nightfall (DAYLIGHT), DAYLIGHT plus 2 h (DAYLIGHT+2), DAYLIGHT to midnight (DAYLIGHT to 0), and the entire 24 h period (CONTROL). Differences for grazing, rumination, and other activities were found in all seasons for the evaluation periods. Sampling sufficiency was reached only with the DAYLIGHT to 0 and CONTROL for all four climatic seasons. The DAYLIGHT to 0 treatment covered 75% of a 24-h period and 95% of the mean foraging time took place during this time interval. Considering grazing distribution during a day, in the warm seasons, the major grazing period during mornings occurred earlier than in the cool seasons, and in cool seasons, the grazing peak was observed during the afternoon. Visual observations from dawn until midnight represented the total grazing time and natural behavior of heifers and could be used to represent grazing activities for the entire day.

Lower dose rituximab is active in adults patients with idiopathic thrombocytopenic purpura.

Rituximab 375 mg/m(2) weekly for four weeks has significant activity in patients with immune thrombocytopenia. We evaluated the activity of lower dose rituximab (100 mg iv weekly for 4 weeks) in 28 adults with idiopathic thrombocytopenic purpura. Overall (platelet count > 50 x 10(9)/L) and complete responses (platelet count > 100 x 10(9)/L) were achieved in 21/28 (75%) and 12/28 (43%) patients respectively. The median time to response and time to complete response were 31 and 44 days respectively. After a median follow-up of 11 months (range 3-18), 7/21 (33%) patients relapsed and 3 needed further treatments. In patients with idiopathic thrombocytopenic purpura, lower dose rituximab seems to show similar activity to standard dose.

Safety and efficacy of switching from branded to generic imatinib in chronic phase chronic myeloid leukemia patients treated in Italy.

The use of generic drugs after patent expiration of their originators is a relative novelty in the treatment of chronic cancer patients in Western countries. In this observational study we analyzed a cohort of 294 Italian chronic phase chronic myeloid leukemia patients treated frontline with branded imatinib (Glivec®) for at least 6 months and then uniformly switched to generic imatinib upon requirement of health authorities in early 2017. Median age at diagnosis was 57 years (range 19-87). Sokal risk was low/intermediate/high in 55%, 32% and 8% of cases, respectively. Median duration of branded imatinib treatment was 7.4 years (range 0.5-16.7). At a median follow-up of 7.5 months after switch to generic imatinib, 17% of patients reported new or worsening side effects, but grade 3-4 non-hematological adverse events were rare. Six patients switched back to branded imatinib, with improvement in the side effect profile, and 4 pts moved to bosutinib or nilotinib for resistance/intolerance. The majority of patients were in major (26%) or deep molecular response (66%) at the time of switch. Molecular responses remained stable, improved or worsened in 61%, 25% and 14% of patients, respectively. We conclude that switch to generic imatinib for patients who have been receiving branded imatinib appears to be effective and safe. Molecular responses may continue to improve over time. Some patients experienced new or worsened side effects but less than 5% of the whole cohort needed to switch back to branded imatinib or move to other treatments. Savings were around 3 million Euros.

Factors associated with exclusive breastfeeding in a maternity hospital reference in humanized birth / Fatores associados ao aleitamento materno exclusivo em uma maternidade referência em parto humanizado

Abstract Objective To analyze the factors associated with the prevalence of exclusive breastfeeding (EBF) for up to six months in mother/infant binomials cared for at a usual-risk maternity hospital. Methods The present is a descriptive, longitudinal, prospective, quantitative study. Socioeconomic, obstetric and perinatal variables from 101 mother/infant binomials in a Public Maternity Hospital in the city of Curitiba, state of Paraná, Brazil, were investigated during hospitalization after delivery and 6 months after birth. For the statistical analysis, the Chi-squared test was used. The variables that showed values of p < 0.25 for the Chi-squared test were also submitted to an odds ratio (OR) analysis. Results The prevalence (42.6%) of EBF was observed. Most women (93.1%) had had more than 6 prenatal consultations, and the variables maternity leave and support to breastfeeding were associated with EBF. Support to breastfeeding by professionals and family members increased 4-fold the chance of maintenance of EBF (OR = 0.232; 95% confidence intercal [95%CI]: 0.079 to 0.679; p = 0.008). Cracked nipples were the biggest obstacle to breastfeeding, and low milk production was the main responsible factor for weaning. Conclusion The encouragement of breastfeeding and the mother's stay for a longer period with the child contributed to the maintenance of EBF until the sixth month of life of the infant.

Resumo Objetivo Analisar os fatores associados à prevalência do aleitamento materno exclusivo (AME) até seis meses em binômios mãe/recém-nascido atendidos em uma maternidade de risco habitual. Métodos Trata-se de um estudo descritivo, longitudinal, prospectivo e quantitativo. Foram investigadas variáveis socioeconômicas, obstétricas e perinatais de 101 binômios mãe/recém-nascido de uma maternidade pública em Curitiba-PR no internamento após o parto e 6 meses após o nascimento. Para a análise estatística, utilizou-se o teste do qui-quadrado. As variáveis cujo teste do qui-quadrado tiveram valores de p < 0,25 foram testadas para análises de razão de probabilidades (RP). Resultados Observou-se a prevalência (42,6%) do AME. A maioria das mulheres (93,1%) havia realizado mais de 6 consultas de pré-natal, e as variáveis licença maternidade e apoio para amamentar estiveram associadas ao AME. O apoio para amamentar por parte do profissional e do familiar aumentou em 4 vezes a chance da permanência em AME (RP = 0,232; intervalo de confiança de 95% [IC95%]: 0,079 a 0.679; p = 0,008). A fissura foi o maior obstáculo para a amamentação, e a baixa produção de leite, o principal responsável pelo desmame. Conclusão O incentivo ao aleitamento e a permanência da mãe por mais tempo com a criança contribuíram para a manutenção do AME até o sexto mês de vida do bebê.

Manejo psicológico del paciente sometido a cirugía bariátrica. Consenso Núcleo de Psicólogos de Cirugía de la Obesidad de Chile / Chilean consensus on the psychological management of patients undergoing bariatric surgery

Background Bariatric Surgery is the most effective alternative for weight reduction. However, weight regain is a serious problem. Therefore, pre and post-operative psychological management becomes relevant for these patients. Aim To unify criteria about the psychological management patients undergoing bariatric surgery. Material and Methods A questionnaire about psychological practice in bariatric surgery was sent to 50 national expert psychologists, members of the Chilean Bariatric and Metabolic Society. When no agreement among them was achieved, the Delphi methodology was applied. Scores of 86% or greater were used to reach consensus. Results The specialized clinical assessment is crucial for a good preoperative evaluation and to obtain and adequate compliance after surgery. Psychological interventions evolved towards a preparation process to achieve behavioral changes aiming to maintain good long term weight reduction results. Conclusions The indications and recommendations emanating from this consensus generated a document that establishes minimum criteria and quality care standards, which should reduce mental health risks of bariatric surgery and enhance lifestyle changes.

Fludarabine + prednisone +/- alpha-interferon followed or not by alpha-interferon maintenance therapy for previously untreated patients with chronic lymphocytic leukemia: long term results of a randomized study.

BACKGROUND AND OBJECTIVES: Fludarabine is an effective therapy for patients with chronic lymphocytic leukemia (CLL) and interferon-alpha (IFN-alpha) has been reported to have anti-leukemic activity in CLL patients. A randomized study was designed to evaluate whether the addition of IFN-alpha to a first-line treatment with fludarabine and prednisone could increase the response rate in patients with advanced CLL and whether IFN-alpha given as maintenance therapy could improve the duration of response. DESIGN AND METHODS: One hundred and thirty-three patients were randomized to receive fludarabine (25 mg/m2/i.v., days 9-13) and prednisone (20 mg/m2, days 1, 3, 5, 7 and 14 and 40 mg/m2, days 9-13) (arm A: 66 patients) or in addition to the same schedule, IFN-alpha (2 MUI/sc, days 1, 3, 5, 7, 9, 11, 13 and 15) (arm B: 67 patients). Seventy-eight patients responsive to therapy entered the post-remission phase of the study in which 41 patients were randomized to receive IFN-alpha (3 MUI three times a week) and 37 to clinical observation. RESULTS: A similar response rate (complete responses + partial responses) was observed in the 2 arms: 86% for arm A and 84% for arm B (p = 0.4). A longer response duration was observed in patients who achieved a complete response (p = 0.001) and in patients who received maintenance therapy with IFN-alpha (p < 0.05). However, the quality of response was the only significant and independent factor influencing response duration (p < 0.01). No benefits in terms of infection-related mortality and morbidity could be ascribed to IFN-alpha administration. INTERPRETATION AND CONCLUSIONS: In previously untreated CLL patients with advanced disease a high response rate is obtained from first-line fludarabine and prednisone and no benefit is derived from the addition of IFN-alpha to this regimen. The achievement of a good quality response to therapy was the only independent predictor of a prolonged response.

Anti-CD20 therapy for chronic lymphocytic leukemia-associated autoimmune diseases.

Rituximab is active in chronic lymphocytic leukemia (CLL) and may interfere with autoantibodies production in some immune diseases. We report the results of rituximab treatment in 7 patients with CLL-associated symptomatic autoimmune diseases refractory to standard immunosuppressive therapies: warm antibody hemolytic anemia (AHA) 4 patients, cold agglutinin disease (CAD) 1, immune thrombocytopenia (IT) 1, axonal degenerating neuropathy (ADN) 1. Rituximab was given at the dose of 375 mg/m2 per week for 4 weeks. One patient with AHA and one with CAD achieved complete normalization of hemoglobin levels and laboratory signs of haemolysis, with response duration (RD) of 8+ and 38+ months, respectively. In the patient with IT, complete remission was reached after the first week of treatment and RD was 6 months. The patient with ADN achieved a marked neurological improvement after rituximab therapy, with RD of 12 months. Retreatment of both patients with IT and ADN was effective. Rituximab may be an alternative agent for the treatment CLL-associated autoimmune diseases.

EUTOS score predicts long-term outcome but not optimal response to imatinib in patients with chronic myeloid leukaemia.

To test the recently developed EUTOS score in predicting optimal response to imatinib and the long-term outcome, 265 patients with early chronic phase chronic myeloid leukaemia treated with standard dose imatinib were analysed. Achievement of optimal response endpoints were higher in low-risk patients, though the difference was not statistically significant: PCyR at 6th month 86% vs 67% (p=0.06), CCyR at 12th month 80% vs 63% (p=0.09), MMR at 18th month 61% vs 36% (p=0.11). However, EUTOS score was predictive for the long-term response. With a median follow-up of 61 months, 53% high-risk patients experienced imatinib failure, compared to 23% in the low-risk group (p=0.013). Among high-risk patients, 4/17 (23%) progressed to accelerated/blastic phase or died, compared to 11/248 (5%) low-risk patients, with 5-year progression-free survival rates of 84±10% and 96±1%, respectively (p=0.04). Our data confirm that EUTOS score envisions the long-term outcome of imatinib therapy.

Type 2 diabetes mellitus in patients with mild obesity: preliminary results of surgical treatment.

In the last years, type 2 diabetes mellitus (T2DM) and obesity have become a serious public health problem, behaving as epidemic diseases. There is great interest in exploring different options for the treatment of T2DM in nonmorbidly obese patients. The purpose of this study is to report parameters of glycemic control in patients with T2DM and mild obesity who underwent laparoscopic Roux-en-Y gastric bypass (RYGBP). This prospective clinical trial includes patients with T2DM with a body mass index (BMI) between 30 and 35 kg/m(2) who underwent laparoscopic RYGBP from July 2008 through October 2010. Thirty-one patients were included in the study, 15 men and 16 women, with an average age of 48.7 ± 8.6 years. The average time since onset of T2DM was 5.8 years. The average postoperative follow-up was 30.4 months. The average preoperative blood glucose and glycosylated hemoglobin were 152 ± 70 mg/dl and 7.7 ± 2.1 %, respectively. All of them were using oral hypoglycemic agents, and four patients were insulin dependent. Only one patient had a postoperative complication (hemoperitoneum). At 36 months follow-up, the average BMI decreased to 24.7 kg/m(2), all patients (31) showed improvement in their glycemic control, and 29 of them (93.6 %) met the criteria for remission of T2DM in the last control. Laparoscopic RYGBP is a safe and effective procedure that improves glycemic control in patients with T2DM and mild obesity at midterm follow-up.