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- ItemSomente MetadadadosAngiotensin II antagonists for hypertension: Are there differences in efficacy?(Elsevier B.V., 2000-04-01) Conlin, P. R.; Spence, J. D.; Williams, B.; Ribeiro, A. B.; Saito, I; Benedict, C.; Bunt, AMG; Brigham & Womens Hosp; Harvard Univ; Univ Western Ontario; Univ Leicester; Universidade Federal de São Paulo (UNIFESP); Keio Univ; Univ Texas; Merck & Co IncWe compared the antihypertensive efficacy of available drugs in the new angiotensin-II-antagonist (AIIA) class. the antihypertensive efficacy of losartan, valsartan, irbesartan, and candesartan was evaluated from randomized controlled trials (RCT) by performing a metaanalysis of 43 published RCT. These trials involved AIIA compared with placebo, other antihypertensive classes, and direct comparisons between AIIA. A weighted-average for diastolic and systolic blood pressure reduction with AIIA monotherapy, dose titration, and with addition of low-dose hydrochlorothiazide (HCTZ) were calculated. Weighted-average responder rates were also determined. the metaanalysis assessed a total of 11,281 patients. the absolute weighted-average reductions in diastolic (8.2 to 8.9 mm Hg) and systolic (10.4 to 11.8 mm Hg) blood pressure reductions (not placebo-corrected) for AIIA monotherapy were comparable for all AIIA. Responder rates for AIIA monotherapy were 48% to 55%. Dose titration resulted in slightly greater blood pressure reduction and an increase in responder rates to 53% to 63%. AIIA/hydrochlorothiazide combinations produced substantially greater reduction in systolic (16.1 to 20.6 mm Hg) and diastolic (9.9 to 13.6 mm Hg) blood pressure reductions than AIIA monotherapy and responder rates for AIIA/HCTZ combinations were 56% to 70%. This comprehensive analysis shows comparable antihypertensive efficacy within the AIIA class, a near-flat AIIA-dose response when titrating from starting to maximum recommended dose, and substantial potentiation of the antihypertensive effect with addition of HCTZ. (C) 2000 American Journal of Hypertension, Ltd.
- ItemSomente MetadadadosAvaliação da eficácia clínica do dispositivo sensifemme no diagnóstico de nódulo de mama(Universidade Federal de São Paulo (UNIFESP), 2014-07-30) Sanvido, Vanessa Monteiro [UNIFESP]; Nazario, Afonso Celso Pinto Nazario [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)Introduction: The Sensifemme® device is a glove with three layers of polyurethane With a thickness of 0.5 mm and has mineral oil interposed between the layers. The glove has been developed With the objective of allowing a greater slip of the examiner's hand over the breast, which would increase The sensitivity of breast examination and self-examination. Objective: To evaluate the clinical efficacy of the Sensifemme® device in the diagnosis of Breast Method: A randomized clinical study in which 202 patients from the Mastology Department of the Department of Gynecology of the Paulista School of Medicine of the Federal University of São Paulo were examined by clinical examination and the Sensifemme® device. Subsequently all the patients performed bilateral ultrasonography to confirm or exclude the findings of the physical examination. Results: The mean age of the patients was 43 years and 298 breast lesions were detected after clinical examination and Image, distributed in 80% of solid nodules and 20% of cystic nodules. At the Sensifemme® device group the sensitivity was 68.1%, the specificity was 58% and the accuracy was 66.7%. In the clinical examination group were 54%, 78% and 57.4%, respectively. Aluva increased the diagnosis of breast nodules in 14.9% and there was no interobserver variability.
- ItemSomente MetadadadosEfficacy and Safety of 1 and 2 Doses of Live Attenuated Influenza Vaccine in Vaccine-Naive Children(Lippincott Williams & Wilkins, 2009-05-01) Bracco Neto, Humberto [UNIFESP]; Farhat, Calil K. [UNIFESP]; Tregnaghi, Miguel Wenceslao; Madhi, Shabir A.; Razmpour, Ahmad; Palladino, Giuseppe; Small, Margaret G.; Gruber, William C.; Forrest, Bruce D.; D153-P504 LAIV Study Grp; Universidade Federal de São Paulo (UNIFESP); Hosp Infantil Cordoba; Chris Hani Baragwanath Hosp; Wyeth Vaccines ResBackground: We investigated the efficacy and safety of 1 versus 2 doses of live attenuated influenza vaccine (LAIV) in influenza vaccine-naive children aged 6 to <36 months.Patients/Methods: Subjects were randomized to 1 of 4 regimens in year 1: 2 doses LAIV, 1 dose LAIV, excipient placebo, or saline placebo. in year 2, LAW recipients were to receive 1 dose of LAIV and placebo recipients were to receive saline placebo. Because of an unintended treatment allocation error in year 2, 1 block of subjects who were randomized to LAW received saline placebo and 1 block who were randomized to placebo received LAIV.Results: in year 1, vaccine efficacy versus placebo among recipients of 2 and 1 doses of LAW was 73.5% and 57.7%, respectively, against anti-genically similar strains. in year 2, absolute efficacy of a single dose of LAW was 73.6% and 65.2%, respectively, in recipients of 2 and 1 doses of LAW in year 1. Year 2 efficacy was 57.0% in subjects who received 2 doses of LAW in year 1 and placebo in year 2. Safety and tolerability of LAW were consistent with previous studies. Reactogenicity was similar between placebo groups. Seroconversion rates were significantly higher in the 2-dose versus the 1-dose LAW group in year 1 and in both LAW groups versus placebo in years 1 and 2.Conclusions: One dose of LAIV provided clinically significant protection against influenza in young children previously unvaccinated against influenza; 2 doses provided additional protection. Protection after 2 doses in year 1 persisted through a second season without revaccination. LAW excipients were not a major contributor to reactogenicity. These benefits provide support for increased use of LAW in children >= 2 years of age.
- ItemSomente MetadadadosEFFICACY of INTERPERSONAL THERAPY-GROUP FORMAT ADAPTED TO POST-TRAUMATIC STRESS DISORDER: AN OPEN-LABEL ADD-ON TRIAL(Wiley-Blackwell, 2010-01-01) Campanini, Rosaly F. B. [UNIFESP]; Schoedl, Aline E. [UNIFESP]; Pupo, Mariana C. [UNIFESP]; Costa, Ana Clara H. [UNIFESP]; Krupnick, Janice L.; Mello, Marcelo F. [UNIFESP]; Universidade Federal de São Paulo (UNIFESP); Georgetown UnivBackground: Post-traumatic stress disorder (PTSD) is a highly prevalent condition, yet available treatments demonstrate only modest efficacy. Exposure therapies, considered by many to be the gold-standard therapy for PTSD, tire poorly tolerated by many patients and show high attention. We evaluated interpersonal therapy, in a group format, adapted to PTSD (IPT-G PTSD), as an adjunctive treatment for patients who failed to respond to conventional psychopharmacological treatment. Methods: Research participants included 40 patients who sought treatment through a program on violence in the department of psychiatry of Federal University of São Paulo (UNIFESP). They had received conventional psychopharmacological treatment for at least 12 weeks and failed to have an adequate clinical response. After signing an informed consent, approved earlier by the UNIFESP Ethics Review Board, they received a semi-structured diagnostic interview (SCID-I), administered by a trained mental health worker, to confirm. the presence of a PTSD diagnosis according to DSM-IV criteria. Other instruments were administered, and patients completed out 47-report instruments at baseline, and endpoint to evaluate clinical outcomes. Results: Thirty-three patients completed the trial, but all bad at least one second outcome evaluation. There were significant improvements on all measures, with large effect sizes. Conclusions: IPT-G PTSD was effective not only in decreasing symptoms of PTSD, but also in decreasing symptoms of anxiety and depression. It led to significant improvements in social adjustment and quality of life. It was well tolerated and there were few dropouts. Our results are very preliminary; they need further confirmation through randomized controlled clinical trials. Depression and Anxiety 27:72-77, 2010. (C) 2009 Wiley-Liss, Inc.
- ItemAcesso aberto (Open Access)Eficácia, tolerabilidade e segurança do uso do sirolimo após o transplante renal(Sociedade Brasileira de Nefrologia, 2009-12-01) Oliveira, Nagilla Ione de [UNIFESP]; Harada, Kelly Miyuki [UNIFESP]; Spinelli, Glaucio Amaral [UNIFESP]; Park, Sung In [UNIFESP]; Sampaio, Edison Luiz Mandia [UNIFESP]; Felipe, Claudia Rosso [UNIFESP]; Tedesco-Silva Junior, Hélio [UNIFESP]; Pestana, Jose Osmar Medina [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)INTRODUCTION: Sirolimus (SRL) is an immunosuppressive drug with confirmed efficacy and safety profile in the prophylaxis of acute rejection after renal transplantation. OBJECTIVES: To assess the efficacy, safety, and tolerability of SRL and prednisone in combination with cyclosporine (CSA) or tacrolimus (TAC) after renal transplantation. METHODS: Retrospective study of 332 renal transplant recipients from 1999 to 2006. Primary outcome included treatment failure, defined as the cumulative incidence of biopsy-proven acute rejection, graft loss, death, or SRL discontinuation. RESULTS: Living donors were the primary source of kidneys (92%). Regarding the recipients, mean age was 37 years, 65% were males, 46% were white, and the prevalence of diabetes was 6%. Sirolimus was combined with CSA and TAC in 70.8% and 29.2% of patients, respectively. Treatment failure rates at the first and fifth year of transplantation were 22.2% and 47.8%, respectively, without difference between the groups receiving CSA and TAC. At five years, the survival rates were as follows: patient's, 92.8%; graft's, 86.1%; deathcensored graft's, 92.7%; and free from biopsy-proven acute rejection, 82.2%. Treatment with SRL was discontinued in 27.1% of the patients, due to adverse effects (22.9%) and inefficacy (3.3%). The main reasons for SRL discontinuation were as follows: dyslipidemia (6%); graft dysfunction (5.2%); proteinuria (4.5%); infection (1.5%); delayed wound healing (1.2%); and anemia (0.9%). CONCLUSION: In this cohort of patients, SRL efficacy and safety were similar when combined with either CSA or TAC. Oral tolerability was adequate, considering the relatively low SRL discontinuation rate.
- ItemSomente MetadadadosInhaled budesonide for the treatment of acute wheezing and dyspnea in children up to 24 months old receiving intravenous hydrocortisone(Mosby-year Book Inc, 2000-04-01) Sano, F.; Cortez, G. K.; Solé, Dirceu [UNIFESP]; Naspitz, Charles Kirov [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)Background: Inhaled corticosteroids are highly effective in the treatment of asthma at all ages, and their use in younger children is increasing. There are no data currently available on the treatment of infants with acute wheeze and dyspnea with nebulized budesonide.Objective: Our purpose was to assess the clinical effect of nebulized budesonide in infants with acute wheeze and dyspnea.Methods: A prospective study was performed comparing the addition of nebulized budesonide 0.25 mg every 6 hours (group A, n = 32) and nebulized ipratropium bromide 0.1 mg every 6 hours (group B, n = 39) with the normal treatment regimen with intravenous fluid, hydrocortisone, and nebulized fenoterol. A clinical score was made at admission and every 12 hours. the score included wheezing and costal retraction (0-6) and respiratory rate (counts per minute).Results: Seventy-one infants aged 3 to 24 months were studied (42 boys). A statistically significant reduction was seen in clinical score and respiratory rate in both groups 12 hours after admission. the children who received budesonide improved significantly faster than the children who received ipratropium bromide, and the hospitalization period was significantly lower in the budesonide group (66.4 hours) compared with the ipratropium bromide group (93 hours) (P <.01). Three patients from the budesonide group and 2 from the ipratropium bromide group were readmitted within the first 4 weeks.Conclusion: Treatment of infants with acute wheeze with nebulized budesonide is associated with faster clinical improvement and reduction in hospital stay period.
- ItemSomente MetadadadosLong-Term Follow-Up of De Novo Use of mTOR and Calcineurin Inhibitors After Kidney Transplantation(Lippincott Williams & Wilkins, 2016) de Paula, Mayara Ivani [UNIFESP]; Medina-Pestana, Jose Osmar [UNIFESP]; Ferreira, Alexandra Nicolau [UNIFESP]; Cristelli, Marina Pontello [UNIFESP]; Franco, Marcello Fabiano [UNIFESP]; Aguiar, Wilson Ferreira [UNIFESP]; Tedesco-Silva, Helio [UNIFESP]; Felipe, Claudia Rosso [UNIFESP]Background:Long-term efficacy and safety of de novo use of the mammalian target of rapamycin inhibitors (mTORi) have been evaluated primarily using registry data.Methods:This was a pooled retrospective analysis of data obtained from 10 prospective randomized trials in de novo kidney transplant recipients (n = 581) receiving calcineurin inhibitors (CNIs) combined with sirolimus (n = 329), everolimus (n = 128), or antimetabolites (n = 124).Results:There were no differences in patient (84.5 versus 80.9 versus 89.7%, P = 0.996), graft (65.4 versus 59.5 versus 73.1%, P = 0.868), and biopsy-confirmed acute rejection-free (78.1 versus 77.3 versus 79.0%, P = 0.976) survivals, respectively. The incidence of cytomegalovirus infection was lower (6 versus 3 versus 11%, P = 0.024) but treatment discontinuation was higher among patients receiving mTORi (66.0 versus 47.7 versus 31.5%, P < 0.001), respectively. At 5 years, median estimated glomerular filtration rate (49.6 versus 43.9 versus 53.2 mL/min, P = 0.006) was lower and the proportion of patients with proteinuria (53 versus 40 versus 23%, P < 0.001) was higher among patients receiving mTORi, respectively.Conclusions:The efficacy of de novo use of mTORi is comparable with that of antimetabolites in kidney transplant recipients receiving calcineurin inhibitor. Apart from the lower cytomegalovirus infection rate, the safety profile is unfavorable, showing higher treatment discontinuation rates and higher incidence of proteinuria.
- ItemSomente MetadadadosLong-Term Follow-Up of De Novo Use of mTOR and Calcineurin Inhibitors After Kidney Transplantation(Lippincott Williams & Wilkins, 2016) de Paula, Mayara Ivani [UNIFESP]; Medina-Pestana, Jose Osmar [UNIFESP]; Ferreira, Alexandra Nicolau [UNIFESP]; Cristelli, Marina Pontello [UNIFESP]; Franco, Marcello Fabiano [UNIFESP]; Aguiar, Wilson Ferreira [UNIFESP]; Tedesco-Silva, Helio [UNIFESP]; Felipe, Claudia Rosso [UNIFESP]Background:Long-term efficacy and safety of de novo use of the mammalian target of rapamycin inhibitors (mTORi) have been evaluated primarily using registry data.Methods:This was a pooled retrospective analysis of data obtained from 10 prospective randomized trials in de novo kidney transplant recipients (n = 581) receiving calcineurin inhibitors (CNIs) combined with sirolimus (n = 329), everolimus (n = 128), or antimetabolites (n = 124).Results:There were no differences in patient (84.5 versus 80.9 versus 89.7%, P = 0.996), graft (65.4 versus 59.5 versus 73.1%, P = 0.868), and biopsy-confirmed acute rejection-free (78.1 versus 77.3 versus 79.0%, P = 0.976) survivals, respectively. The incidence of cytomegalovirus infection was lower (6 versus 3 versus 11%, P = 0.024) but treatment discontinuation was higher among patients receiving mTORi (66.0 versus 47.7 versus 31.5%, P < 0.001), respectively. At 5 years, median estimated glomerular filtration rate (49.6 versus 43.9 versus 53.2 mL/min, P = 0.006) was lower and the proportion of patients with proteinuria (53 versus 40 versus 23%, P < 0.001) was higher among patients receiving mTORi, respectively.Conclusions:The efficacy of de novo use of mTORi is comparable with that of antimetabolites in kidney transplant recipients receiving calcineurin inhibitor. Apart from the lower cytomegalovirus infection rate, the safety profile is unfavorable, showing higher treatment discontinuation rates and higher incidence of proteinuria.
- ItemSomente MetadadadosNasal allergies in the Latin American population: Results from the Allergies in Latin America survey(Ocean Side Publications Inc, 2010-05-01) Neffen, Hugo; Mello, Joao F.; Sole, Dirceu; Naspitz, Charles K. [UNIFESP]; Eduardo Dodero, Alberto; Leon Garza, Hector; Novelo Guerra, Edgard; Baez-Loyola, Carlos; Boyle, John M.; Wingertzahn, Mark A.; Childrens Hosp Orlando Alassia; Universidade de São Paulo (USP); Universidade Federal de São Paulo (UNIFESP); Univ Buenos Aires; Univ Autonoma Mexico; Mexican Assoc Resp Care; Hosp Angeles de las Lomas; Univ Nacl Autonoma Mexico; Schulman Ronca & Bucuvalas Inc; Nycomed GmbHAllergies in Latin America is the first cross-national survey that describes the symptoms, impact, and treatment of nasal allergies (NAs) in individuals >= 4 years old in Latin America (LA). in total, 22,012 households across the Latin American countries of Argentina, Brazil, Chile, Colombia, Ecuador, Mexico, Peru, and Venezuela were screened for children, adolescents, and adults with a diagnosis of NA and either symptoms or treatment in the past 12 months. A total of 1088 adults and 457 children and adolescents were included and the sample was probability based to ensure valid statistical inference to the population. Approximately 7% of the LA population was diagnosed with NAs with two of three respondents stating that their allergies were seasonal or intermittent in nature. A general practice physician or otolaryngologist diagnosed the majority of individuals surveyed. Nasal congestion was the most common and bothersome symptom of NAs. Sufferers indicated that their symptoms affected productivity and sleep and had a negative impact on quality of life. Two-thirds of patients reported taking some type of medication for their NAs, with a roughly equal percentage of patients reporting taking over-the-counter versus prescription medications. Changing medications was most commonly done in those reporting inadequate efficacy. the most common reasons cited for dissatisfaction with current medications were related to inadequate effectiveness, effectiveness wearing off with chronic use, failure to provide 24-hour relief, and bothersome side effects (e.g., unpleasant taste and retrograde drainage into the esophagus). Findings from this cross-national survey on NAs have confirmed a high prevalence of physician-diagnosed NAs and a considerable negative impact on daily quality of life and work productivity as well as substantial disease management challenges in LA. Through identification of disease impact on the LA population and further defining treatment gaps, clinicians in LA may better understand and treat NAs, thus leading to improvements in overall patient satisfaction and quality of life. (Allergy Asthma Proc 31:S9-S27, 2010; doi: 10.2500/aap.2010.31.3347)
- ItemAcesso aberto (Open Access)Peginterferon alfa-2a (40KD) (PEGASYS®) plus ribavirin (COPEGUS®) in retreatment of chronic hepatitis C patients, nonresponders and relapsers to previous conventional interferon plus ribavirin therapy(Brazilian Society of Infectious Diseases, 2006-02-01) Parise, Edison Roberto [UNIFESP]; Cheinquer, H.; Crespo, D.; Meirelles, A.; Martinelli, A.; Sette Junior, Hoel; Gallizi, J.; Silva, R.; Lacet, C.; Correa, E.; Cotrim, H.; Fonseca, J.; Paraná, Raymundo; Spinelli, V.; Amorim, W.; Tatsch, F.; Pessoa, M.; Universidade Federal de São Paulo (UNIFESP); Santa Casa de Misericórdia Gastroenterology Service; Federal University of Pará; Federal University of Juiz de Fora; São Paulo University Medical School of Ribeirão Preto; Emílio Ribas Institute; Federal University of Minas Gerais; Medical School of São José do Rio Preto; Federal University of Alagoas; Federal University of Santa Catarina; Federal University of Bahia; Tropical Medicine Fundation; Oswaldo Cruz Hospital; Federal University of Paraíba; RochePeginterferon alfa plus ribavirin is currently the treatment of choice for chronic hepatitis C. Peginterferon alfa-2a (40KD) plus ribavirin has given an overall sustained virological response of 18% in F3/F4 previous nonresponder US patients. We evaluated the effectiveness of peginterferon alfa-2a (40KD) plus ribavirin in Brazilian patients who were relapsers or nonresponders to previous interferon-based therapy. One-hundred-thirty-four patients with biopsy-proven chronic hepatitis C, HCV RNA positive, elevated ALT and who were either relapsers (n=37) or nonresponders (n=97) to at least 24 weeks of conventional interferon/ribavirin therapy were retreated with peginterferon alfa-2a (40KD) 180mg/qw and ribavirin 800mg bid for 48 weeks. Efficacy was assessed as virological response (defined as undetectable HCV RNA) at the end of treatment (EoT) and at the end of follow-up (SVR - Sustained Virological Response). Safety assessments consisted of clinical and laboratory evaluations. In the patient sample, 72% were genotype 1 and 34% were cirrhotic. In an intention-to-treat analysis, relapser patients showed 78% EoT response and 51% SVR. Nonresponders showed 57% EoT response and 26% SVR. Positive predictive factors of SVR were non-1 genotype and relapser state. Six percent of the patients interrupted treatment because of adverse events and 45% had dose reduction (mainly associated with leucopenia and anemia). Brazilian patient relapsers and nonresponders to conventional interferon and ribavirin treatment can achieve a sustained virological response when retreated with peginterferon alfa-2a (40KD) and ribavirin. The safety profile is similar to that of naive patients.
- ItemAcesso aberto (Open Access)Rapid infusion of esketamine for unipolar and bipolar depression: a retrospective chart review(Dove Medical Press Ltd, 2017) Correia-Melo, Fernanda S.; Argolo, Felipe C.; Araujo-de-Freitas, Lucas; Leal, Gustavo Carneiro; Kapczinski, Flavio; Lacerda, Acioly Luiz Tavares de [UNIFESP]; Quarantini, Lucas C.Background: This study evaluated efficacy and safety of intravenous subanesthetic doses of esketamine using an administration time of 10 minutes in patients with treatment-resistant depression and bipolar depression. Methods: A retrospective chart review was conducted to identify patients who met the inclusion criteria for treatment-resistant depression and bipolar depression according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria, and these patients received rapid infusion of esketamine between June 2012 and December 2015. The Montgomery-angstrom sberg Depression Rating Scale (MADRS) was administered to measure and score depressive symptom severity before infusion and at 24 hours, 72 hours, and 7 days after infusion. In addition, Clinical Global Impression scale was administered before and 7 days after esketamine infusion. Results: Esketamine was administered to 30 patients. A total of 27 patients met the inclusion criteria and had MADRS evaluation data, which showed that 23 had unipolar and 4 had bipolar depression. Thirteen patients (48.1%) showed therapeutic response (MADRS reduction. 50%) within 1 week (7 days) of intervention. Remission (MADRS. 7) was observed in 10 patients (37.0%) in the same period. Therapeutic response and remission frequencies were seen in 16 (59.3%) and 11 (40.7%) patients, respectively, within 24 hours following drug infusion. The most relevant side effect observed during the esketamine infusion was dissociative symptoms ranging from mild to severe, which was reported by 11.1% of patients as a very disturbing experience. Limitations: This study was done retrospectively, had a small sample size, and there was no comparative group. Conclusion: The present study demonstrates that rapid infusion of esketamine is possibly not the optimal choice to administer this drug for treatment-resistant depression due to tolerability reasons. Further controlled studies are required to investigate efficacy, safety, and tolerability profiles among the different types of ketamines and methods of using this drug in depressed patients.
- ItemAcesso aberto (Open Access)Relative Efficacy of AS03-Adjuvanted Pandemic Influenza A(H1N1) Vaccine in Children: Results of a Controlled, Randomized Efficacy Trial(Oxford Univ Press Inc, 2014-08-15) Nolan, Terry; Roy-Ghanta, Sumita; Montellano, May; Weckx, Lily [UNIFESP]; Ulloa-Gutierrez, Rolando; Lazcano-Ponce, Eduardo; Kerdpanich, Angkool; Palazzi Safadi, Marco Aurelio; Cruz-Valdez, Aurelio; Litao, Sandra [UNIFESP]; Lim, Fong Seng; Mascarenas de Los Santos, Abiel; Rodriguez Weber, Miguel Angel; Tinoco, Juan-Carlos; Hernandez-de Mezerville, Marcela; Faingezicht, Idis; Kosuwon, Pensri; Lopez, Pio; Borja-Tabora, Charissa; Li, Ping; Durviaux, Serge; Fries, Louis; Dubin, Gary; Breuer, Thomas; Innis, Bruce L.; Vaughn, David W.; Univ Melbourne; GlaxoSmithKline Vaccines; Novavax; Mary Chiles Gen Hosp; De La Salle Hlth Sci Inst; Res Inst Trop Med; Universidade Federal de São Paulo (UNIFESP); Assoc Fundo Incent Pesquisa; Inst Costarricense Invest Clin; Natl Inst Publ Hlth Mexico; Univ Autonoma Nuevo Leon; Inst Nacl Pediat Mexico; Hosp Gen Durango; Phramongkutklao Hosp; Khon Kaen Univ; Natl Healthcare Grp Polyclin; Ctr Estudios Infect PediatBackground. the vaccine efficacy (VE) of 1 or 2 doses of AS03-adjuvanted influenza A(H1N1) vaccine relative to that of 2 doses of nonadjuvanted influenza A(H1N1) vaccine in children 6 months to <10 years of age in a multinational study conducted during 2010-2011.Methods. A total of 6145 children were randomly assigned at a ratio of 1: 1: 1 to receive 2 injections 21 days apart of A/California/7/2009(H1N1)-AS03 vaccine at dose 1 and saline placebo at dose 2, 2 doses 21 days apart of A/California/7/2009(H1N1)-AS03 vaccine (the Ad2 group), or 2 doses 21 days apart of nonadjuvanted A/California/7/2009(H1N1) vaccine (the NAd2 group). Active surveillance for influenza-like illnesses continued from days 14 to 385. Nose and throat samples obtained during influenza-like illnesses were tested for A/California/7/2009 (H1N1), using reverse-transcriptase polymerase chain reaction. Immunogenicity, reactogenicity, and safety were assessed.Results. There were 23 cases of confirmed 2009 pandemic influenza A(H1N1) (A[H1N1]pdm09) infection for the primary relative VE analysis. the VE in the Ad2 group relative to that in the NAd2 group was 76.8% (95% confidence interval, 18.5%-93.4%). the benefit of the AS03 adjuvant was demonstrated in terms of the greater immunogenicity observed in the Ad2 group, compared with the NAd2 group.Conclusion. the 4-8-fold antigen-sparing adjuvanted pandemic influenza vaccine demonstrated superior and clinically important prevention of A(H1N1)pdm09 infection, compared with nonadjuvanted vaccine, with no observed increase in medically attended or serious adverse events. These data support the use of adjuvanted influenza vaccines during influenza pandemics.
- ItemSomente MetadadadosSafety and efficacy of a 1-year treatment with zoledronic acid compared with pamidronate in children with osteogenesis imperfecta(Walter de Gruyter & Co, 2012-06-01) Barros, Elizabete Ribeiro [UNIFESP]; Saraiva, Gabriela L. [UNIFESP]; Oliveira, Telma Palomo de [UNIFESP]; Lazaretti-Castro, Marise [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)Pamidronate (PAM) infusion is the standard treatment in children with osteogenesis imperfecta (OI). Zoledronic acid (ZOL) is a bisphosphonate with higher potency and faster intravenous infusion, but its efficacy and safety has not been established for OI patients. We report an open-label, prospective, and randomized clinical analysis to study the safety and efficacy of ZOL compared with PAM in 23 children with OI. They were selected to receive PAM (PAM group), 1 mg/kg/day, over 2 days or ZOL (ZOL group), 0.025-0.05 mg/kg/day, over 2 days every 3-4 months according to their ages, during a 1-year follow-up. They were observed for clinical and biochemical parameters, side effects, bone mineral density (BMD), and fracture rate. After treatment, the PAM and ZOL groups average lumbar spine (LS) BMD increased by 51.8% (p=0.053) and 67.6% (p=0.003), respectively. Parallel improvement was seen in LS Z-score in the PAM and ZOL groups, with scores of -5.3 to -3.8 (p=0.032) and -4.8 to -2.3 (p=0.007), respectively. LS Z-score for the ZOL group at the end of treatment was higher compared with the PAM group but only a borderline significance (p=0.053). the total alkaline phosphatase (AP) in the ZOL group significantly decreased from baseline at third and fourth infusion (p=0.032). Mild side effects were similar in both groups, but no severe clinical symptoms were reported. in conclusion, the present study shows that the use of ZOL in the dosage and period studied was safe and efficient to promote a clinical and densitometric improvement, similarly to PAM. Further studies are needed to establish optimal dosing and long-term safety.
- ItemSomente MetadadadosSatisfaction with the treatment, confidence and 'naturalness' in engaging in sexual activity in men with psychogenic erectile dysfunction: preliminary results of a randomized controlled trial of three therapeutic approaches(Wiley-Blackwell, 2012-04-01) Melnik, Tamara [UNIFESP]; Abdo, Carmita H. N.; Moraes, Jose F. de; Riera, Rachel [UNIFESP]; Universidade Federal de São Paulo (UNIFESP); Universidade de São Paulo (USP); Universidade Federal de Uberlândia (UFU)OBJECTIVETo assess the efficacy of group psychotherapy (GTP) and/or sildenafil for psychogenic erectile dysfunction (ED).PATIENTS and METHODSA randomized controlled single-blind trial was performed at the Institute of Psychiatry of the Medical School of at Universidade de São Paulo, São Paulo, Brazil.In all, 30 men with mild and moderate psychogenic ED were randomized to receive for 6 months: GPT plus 50 mg sildenafil on-demand, or 50 mg sildenafil on-demand exclusively, or GPT exclusively.Changes in score from baseline for three questions of the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) were evaluated at endpoint and after 3-months follow-up.RESULTSSatisfaction with the treatment, confidence and 'naturalness' increased in the GPT plus sildenafil and GPT exclusively groups (P = 0.001) from baseline to endpoint.The treatment-by-time comparison was not significant at endpoint vs the 3-month follow-up, in the three groups.There was no difference in the sildenafil group in the three study periods (P > 0.05)CONCLUSIONMen with mild and moderate psychogenic ED had higher treatment satisfaction, confidence and naturalness in engaging in sexual activity when receiving GPT plus sildenafil or GP exclusively, when compared with sildenafil exclusively, as assessed by these three EDITS questions after 6-months treatment.
- ItemSomente MetadadadosSotrastaurin in Calcineurin Inhibitor-Free Regimen Using Everolimus in de Novo Kidney Transplant Recipients(Wiley-Blackwell, 2013-07-01) Tedesco-Silva Junior, Hélio [UNIFESP]; Kho, M. M. L.; Hartmann, A.; Vitko, S.; Russ, G.; Rostaing, L.; Budde, K.; Campistol, J. M.; Eris, J.; Krishnan, I.; Gopalakrishnan, U.; Klupp, J.; Universidade Federal de São Paulo (UNIFESP); Erasmus Univ; Univ Oslo; Inst Clin & Expt Med; Royal Adelaide Hosp; CHU Rangueil; Charite; Univ Barcelona; Royal Prince Alfred Hosp; Novartis Pharma AG; Novartis Healthcare Pvt LtdSotrastaurin, a novel selective protein-kinase-C inhibitor, inhibits early T cell activation via a calcineurin-independent pathway. Efficacy and safety of sotrastaurin in a calcineurin inhibitorfree regimen were evaluated in this two-stage Phase II study of de novo kidney transplant recipients. Stage 1 randomized 131 patients (2:1) to sotrastaurin 300mg or cyclosporine A (CsA). Stage 2 randomized 180 patients (1:1:1) to sotrastaurin 300 or 200mg or CsA. All patients received basiliximab, everolimus (EVR) and prednisone. Primary endpoint was composite efficacy failure rate of treated biopsy-proven acute rejection, graft loss, death or lost to follow-up. Main safety assessment was estimated glomerular filtration rate (eGFR) by MDRD-4 at Month 12. Composite efficacy failure rates at 12 months were higher in sotrastaurin arms (Stage 1: 16.5% and 10.9% for sotrastaurin 300mg and CsA; Stage 2: 27.2%, 34.5% and 19.4% for sotrastaurin 200mg, 300mg and CsA). eGFR was significantly better in sotrastaurin groups versus CsA at most time points, except at 12 months. Gastrointestinal and cardiac adverse events were more frequent with sotrastaurin. Higher treatment discontinuation, deaths and graft losses occurred with sotrastaurin 300mg. Sotrastaurin combined with EVR showed higher efficacy failure rates and some improvement in renal allograft function compared to a CsA-based therapy.
- ItemSomente MetadadadosA systematic review of research findings on the efficacy of interpersonal therapy for depressive disorders(Dr Dietrich Steinkopff Verlag, 2005-04-01) Mello, M. F. de; Mari, J. D.; Bacaltchuk, Josué [UNIFESP]; Verdeli, H.; Neugebauer, R.; Universidade Federal de São Paulo (UNIFESP); Columbia Univ Coll Phys & Surg; New York State Psychiat Inst & HospObjective Interpersonal psychotherapy (IPT) is a time-limited psychotherapy for major depression. the aim of this study is to summarize findings from controlled trials of the efficacy of IPT in the treatment of depressive spectrum disorders (DSD) using a meta-analytic approach. Methods Studies of randomized clinical trials of IPT efficacy were located by searching all available data bases from 1974 to 2002. the searches employed the following MeSH categories: Depression/Depressive Disorder; Interpersonal therapy; Outcome/Adverse Effects/Efficacy; in the identified studies. the efficacy outcomes were: remission; clinical improvement; the difference in depressive symptoms between the two arms of the trial at endpoint, and no recurrence. Currence. Drop out rates were used as an index of treatment acceptability. Results Thirteen studies fulfilled inclusion criteria and four meta-analyses were performed. IPT was superior in efficacy to placebo in nine studies ( Weight Mean Difference (WMD) -3.57 [-5.9, -1.16]). the combination of IPT and medication did not show an adjunctive effect compared to medication alone for acute treatment (RR 0.78 [0.30, 2.04]), for maintenance treatment (RR 1.01 [0.81, 1.25]), or for prophylactic treatment (RR 0.70 [0.30, 1.65]). IPT was significantly better than CBT (WMD -2.16 [-4.16, -0.15]). Conclusion the efficacy of IPT proved to be superior to placebo, similar to medication and did not increase when combined with medication. Overall, IPT was more efficacious than CBT. Current evidence indicates that IPT is an efficacious psychotherapy for DSD and may be superior to some other manualized psychotherapies.