Navegando por Palavras-chave "safety"

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    Are medicinal herbs safe? The opinion of plant vendors from Diadema (São Paulo, southeastern Brazil)
    (Sociedade Brasileira de Farmacognosia, 2012-02-01) Lanini, Juliana [UNIFESP]; Duarte-Almeida, Joaquim Mauricio [UNIFESP]; Nappo, Solange Aparecida [UNIFESP]; Carlini, Elisaldo Araujo [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)
    Medicinal plants (MP) have been used world-wide for the treatment or prevention of health conditions and due to their natural origin; they have been historically considered harmless. Semi-structured interviews were carried out with an intentional sample of twenty plant vendors in the city of Diadema to explore their knowledge and beliefs on the safety and efficacy of MP. Different levels of perceptions about the safety of MP were found, varying from completely safe to completely harmful. The majority of the interviewees declared that if herbs have an effect, they are also likely to have a side effect, depending on many factors such as dosage, concomitant use of other drugs, characteristics of the plant material and consumer related factors, specially those related to pregnant women, children and elderly people. Thirty-nine unexpected events related to 21 species of MP were reported. One case of serious gastrointestinal disease related to the consumption of a contaminated slim mixture was also described. Adverse events and other problems that result from MP are relatively uncommon, but they are almost certainly underreported and occur more often than acknowledged. This study strengthens the call for further research and educational efforts into this complex area.
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    Efficacy 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 Res
    Background: 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.
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    Efficacy and Safety of Tipranavir Coadministered with Ritonavir in HIV-1-Infected Children and Adolescents: 5 Years of Experience
    (Lippincott Williams & Wilkins, 2014-04-01) Salazar, Juan C.; Cahn, Pedro; Della Negra, Marinella; De Aquino, Maria Zilda; Robinson, Patrick A.; Jelaska, Ante; Mikl, Jaromir; Univ Connecticut; Fdn Huesped; Universidade de São Paulo (USP); Universidade Federal de São Paulo (UNIFESP); Boehringer Ingelheim Pharmaceut Inc
    Background: To evaluate the long-term (up to week 292) safety, efficacy and tolerability of ritonavir-boosted tipranavir in HIV-1-infected pediatric patients. Long-term follow up of patients enrolled in the randomized, open-label pediatric trial (1182.14/PACTG1051). Methods: HIV-1-infected pediatric patients (2-18 years) who participated in the PACTG 1051 trial were followed for ritonavir-boosted tipranavir-based regimen efficacy, safety and tolerability through week 292. Results: in patients < 12 years of age, 51/62 (82%) were receiving drug at week 48 and 13/62 (21%) at week 288. Among adolescents (12-18 years of age), 35/53 (66%) were receiving drug at week 48 and 2/53 (4%) at week 288. Among patients 2 to < 6 years of age, 18/25 (72%) had viral loads < 400 copies/mL at week 48. By week 292, 9/25 (36%) of patients had viral loads < 400 copies/mL. Among older patients, week 48 responder rates were 35% (13/37 of patients 6 to < 12 years of age) and 32% (17/53 of patients 12 to 18 years of age). By week 292, 6/37 (16%) of those 6 to < 12 years of age and 2/53 (4%) of those 12 to 18 years of age had viral loads < 400 copies/mL. Overall safety and tolerability profiles were best for children who initiated treatment between 2 and < 6 years of age. Drug-related adverse events (investigator defined) were similar across all age groups (55-65%). Conclusions: Pediatric patients who begin treatment at the earlier ages, and who are stable on a ritonavir-boosted tipranavir-based regimen at week 48, generally continue to demonstrate good safety, tolerability and virologic efficacy profiles up to 292 weeks of treatment.
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    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.
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    Information technology and patient safety in nursing practice: an international perspective
    (Elsevier B.V., 2004-08-01) Van de Castle, B.; Kim, J.; Pedreira, MLG; Paiva, A.; Goossen, W.; Bates, D. W.; Johns Hopkins Univ; PAHO WHO Collaborating Ctr Informat Syst Nursing; Yonsei Univ; Universidade Federal de São Paulo (UNIFESP); Coll Nursing; Acquest Res & Dev; Univ Iowa; Brigham & Womens Hosp; Harvard Univ
    When people become patients, they place their trust in their health care providers. As providers assume responsibility for their diagnosis and treatment, patients have a right to expect that this will include responsibility for their safety during all aspects of care. However, increasing epidemiological data make it clear that patient safety is a global problem. Improved nursing care may prevent many adverse events, and nursing must take a stronger leadership rote in this area. Although errors are almost inevitable, safety can be improved, and health care institutions are increasingly making safety a top priority. Information technology provides safety benefits by enhancing communication and delivering decision-support; its use will likely be a cornerstone for improving safety. This paper will discuss the status of patient safety from an international viewpoint, provide case studies from different countries, and discuss information technology solutions from a nursing perspective. (C) 2004 Elsevier Ireland Ltd. All rights reserved.
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    Long-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.
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    Long-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.
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    Mini-incisions by lombotomy or subcostal access in living kidney donors: a randomized trial comparing pain, safety, and quality of life
    (Blackwell Publishing, 2007-03-01) Aguiar, Wilson Ferreira; Passerotti, Carlo Camargo; De Almeida Claro, Joaquim Francisco; Almeida, Claudio Jose Ramos; Gattas, Nelson; Cedenho, Agnaldo Pereira; Pestana, Jose Osmar Medina; Ortiz, Valdemar; Universidade Federal de São Paulo (UNIFESP)
    Objectives: the aim of this study was to compare two mini-incision techniques and judge the impact on the quality of life, pain, and safety of living kidney donors.Patients and methods: From March through September 2003, a prospective randomized study with 60 donors had nephrectomy performed - 30 through a lombotomy and another 30 patients underwent subcostal mini-incisions. the same anesthetic procedure was used for both groups. All patients were evaluated from baseline (T0) to day 90 after surgery. Pain evaluation included visual analog scale (VAS) and drug usage. To assess quality of life (QOL), the questionnaire SF-36 was used and surgical outcomes were also checked.Results: Sixty patients (41.6 +/- 8.9 yr old) were included in the protocol. Regarding incision length and blood loss, no statistical difference was observed. However, irrespective to the site of the mini-incision, patients with body mass index (BMI) higher than 25 kg/m(2) had significantly longer incision length as well as higher blood loss. There were no complications. No significant difference in tramadol or in pain perception was observed between groups. QOL was also not different between groups, however, there was a significant loss with subsequent return to baseline levels.Conclusion: the position of the mini-incision (lombotomy or subcostal) has no significant impact on surgical outcomes, pain perception, and QOL of living kidney donors. Mini-incision techniques represent fast and safe approaches to perform nephrectomy in the healthy population. Special care must be taken in obese patients in order to minimize surgical complications.
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    Mycophenolate mofetil vs. sirolimus in kidney transplant recipients receiving tacrolimus-based immunosuppressive regimen
    (Blackwell Publishing, 2008-03-01) Sampaio, Edison L. [UNIFESP]; Pinheiro-Machado, Paula G. [UNIFESP]; Garcia, Riberto [UNIFESP]; Felipe, Claudia R. [UNIFESP]; Park, Sung I. [UNIFESP]; Casarini, Dulce E. [UNIFESP]; Moreira, Silvia [UNIFESP]; Franco, Marcello F. [UNIFESP]; Tedesco-Silva, Helio [UNIFESP]; Medina-Pestana, Jose O. [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)
    Mycophenolate mofetil (MMF) and sirolimus (SRL) are effective immunosuppressive drugs with distinct safety profile.Methods: Kidney transplant recipients receiving tacrolimus (TAC)-based immunosuppressive regimen were randomized to receive fixed daily doses of MMF (2 g/d, n = 50) or SRL (one loading dose of 15 mg, 5 mg/d till day 7 and 2 mg/d thereafter, n = 50) without induction therapy.Results: No differences were observed in the incidence of the composite (biopsy-confirmed acute rejection, graft loss or death) end-point (18% vs. 16%, p = 1.000), biopsy confirmed acute rejection (12% vs. 14%, p = 1.000), one-yr patient (94% vs. 98%, p = 0.308), graft (92% vs. 98%, p = 0.168), and death-censored graft survival (98% vs. 100%, p = 0.317) comparing patients receiving MMF or SRL respectively. Patients receiving SRL showed worse safety outcomes, higher mean creatinine (1.6 +/- 0.5 mg/dL vs. 1.4 +/- 0.3 mg/dL, p = 0.007), higher proportion of patients with proteinuria (52.0% vs. 10.7%, p = 0.041), higher mean urinary protein concentrations (0.3 +/- 0.5 g/L vs. 0.1 +/- 0.2 g/L, p = 0.012), higher mean cholesterol concentration (217 mg/dL vs. 190 mg/dL, p = 0.030), and higher proportion of patients prematurely discontinued from randomized therapy (26% vs. 8%, p = 0.031).Conclusion: in patients receiving TAC, MMF produced similar efficacy but superior safety profile compared with SRL.
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    Nasal 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 GmbH
    Allergies 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)
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    Patient safety initiatives in Brazil: a nursing perspective
    (Elsevier B.V., 2004-08-01) Pedreira, MLG; Marin, H. F.; Universidade Federal de São Paulo (UNIFESP)
    The science development and technology application improvement in all areas of knowledge, including health care, represent an advance in patient care. the health care providers face challenges to accomplish complex procedures and treatments, which demand infrastructure, defined framework, constant process establishment and redesign of nursing care, based on a continuous outcomes evaluation. Therefore, this development requires nurses with advanced knowledge and skills. As the main health care provider in Brazilian hospitals, the nursing staff perform and control the majority of direct patient care procedures, and as such, nursing professionals can be responsible for triggering adverse events that can compromise patient safety. Research conducted in Brazil showed that the quality of health care delivery system and the results of care have significant variation nationwide. Health care professionals should be valued as the one who can promote patient safety, providing high quality care within cost-effective services. Technology is a key element to support and enhance the professional's performance. However, it is also important to promote and facilitate its implementation and development to retain a creative, engaged, skilled, satisfied, competent, and accountable professional capable of identifying and using technology resources in order to assure the quality of care for the population. (C) 2004 Elsevier Ireland Ltd. All rights reserved.
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    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; Roche
    Peginterferon 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.
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    Pharmacological and Toxicological Study of Maytenus ilicifolia Leaf Extract Part IIClinical Study (Phase I)
    (Wiley, 2017) Tabach, Ricardo [UNIFESP]; Duarte-Almeida, Joaquim M. [UNIFESP]; Carlini, E. A. [UNIFESP]
    Maytenus ilicifolia is a plant widely used in South American folk medicine as an effective anti-dyspeptic agent, and the aim of this study was to evaluate their clinical and toxicological effects in healthy volunteers in order to establish its maximum safe dose. We selected 24 volunteers (12 women and 12 men) between 20 and 40years of age and put them through clinical/laboratory screening and testing to ascertain their psychomotor functions (simple visual reaction, speed and accuracy, finger tapping tests). M. ilicifolia tablets were administered in increasing weekly dosages, from an initial dose of 100mg to a final dose of 2000mg. The volunteers' clinical and biochemical profiles and psychomotor functions were evaluated weekly, and they also completed a questionnaire about any adverse reactions. All subjects completed the study without significant changes in the evaluated parameters. The most cited adverse reactions were xerostomia (dry mouth syndrome) (16.7%) and polyuria (20.8%), with reversal of these symptoms without any intervention during the study. The clinical Phase I study showed that the administration of up to 2000mg of the extract was well tolerated, with few changes in biochemical, hematological or psychomotor function parameters, and no significant adverse reactions. Copyright (c) 2017 John Wiley & Sons, Ltd.
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    Pressure ulcers in the intensive care unit: the relationship between nursing workload, illness severity and pressure ulcer risk
    (Wiley-Blackwell, 2013-08-01) Cremasco, Mariana F. [UNIFESP]; Wenzel, Fernanda; Zanei, Suely S. V. [UNIFESP]; Whitaker, Iveth Y. [UNIFESP]; Universidade Federal de São Paulo (UNIFESP); Municipal Hosp Dr Mario M Altenfelder Silva
    Aims and objective. To verify association between PU development with nursing workload and illness severity and to verify whether nursing workload and illness severity are related with Braden Scale scores. Background. Critically ill patients are more susceptible to treatment complications because of the severity of their clinical condition. Design. Prospective descriptive study. Methods. Patients consecutively admitted to three intensive care units (ICUs) of a public university hospital located in São Paulo, Brazil and without pressure ulcer (PU) at admission and a minimum stay of 24hours were included in the sample. Prospective data collection included demographic, clinical and hospitalisation data, Nursing Activities Score (NAS), Simplified Acute Physiology Score (SAPSII) and Braden Scale. Multivariate linear regression analysis was applied to verify whether nursing workload and illness severity are related with Braden Scale scores. Multivariate logistic regression analysis was used to verify whether nursing workload and illness severity were risk factors associated with PU development. Results. the study sample included 160 patients. the mean Braden score was 120 and PU incidence was 344%. Multivariate linear regression analysis identified as factors related to variation of Braden scores: illness severity (SAPSII), nursing workload (NAS) and age. Multivariate logistic regression showed a model with risk factors associated with PU development: sex, length of ICU stay, illness severity and nursing workload. Conclusion. Nursing workload, severity of illness, sex and length of ICU stay were identified as risk factors associated with PU development. However, nursing workload acted as a protective factor. Illness severity, nursing workload and age were related to Braden scores. Relevance to clinical practice. Accurate identification of risk factors and the use of clinical judgment in skin assessment are prerequisites for determining appropriate strategies to prevent pressure ulcers, to improve quality of care for patient safety and to reduce length of ICU and hospital stay and costs.
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    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.
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    Safety of ultrasonography in pregnancy: WHO systematic review of the literature and meta-analysis
    (Wiley-Blackwell, 2009-05-01) Torloni, Maria Regina [UNIFESP]; Vedmedovska, N.; Merialdi, M.; Betran, A. P.; Allen, T.; Gonzalez, R.; Platt, L. D.; ISUOG WHO Fetal Growth Study Grp; Brazilian Cochrane Ctr; Universidade Federal de São Paulo (UNIFESP); Riga Stradins Univ; WHO; Chilean Minist Hlth; Univ Calif Los Angeles
    Objective in the context of the planned International Society of Ultrasound in Obstetrics and Gynecology-World Health Organization multicenter study for the development of fetal growth standards for international application, we conducted a systematic review and meta-analysis to evaluate the safety of human exposure to ultrasonography in pregnancy.Methods A systematic search of electronic databases, reference lists and unpublished literature was conducted for trials and observational studies that assessed short- and long-term effects of exposure to ultrasonography, involving women and their fetuses exposed to ultrasonograpby, using B-mode or Doppler sonography during any period of pregnancy, for any number of times. the outcome measures were: (1) adverse maternal outcome; (2) adverse perinatal outcome; (3) abnormal childhood growth and neurological development, (4) non-right handedness; (5) childhood malignancy; and (6) intellectual performance and mental disease.Results the electronic search identified 6716 citations, and 19 were identified from secondary sources. A total of 6.1 publications reporting data from 41. different studies were included: 16 controlled trials,13 cohort and 12 case-control studies. Ultrasonography in pregnancy was not associated with adverse maternal or perinatal outcome, impaired physical or neurological development, increased risk for malignancy in childhood, subnormal intellectual performance or mental diseases. According to the available clinical trials, there was a weak association between exposure to ultrasonograpby and non-right handedness in boys (odds ratio 1.26; 95% CI, 1.03-1.54).Conclusion According to the available evidence, exposure to diagnostic ultrasonography during pregnancy appears to be safe. Copyright (C) World Health Organization (2009).
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    Segurança com brinquedos de parques infantis: uma introdução ao problema
    (Escola de Enfermagem de Ribeirão Preto / Universidade de São Paulo, 2003-06-01) Harada, Maria de Jesus C. S.; Pedreira, Mavilde da Luz Gonçalves [UNIFESP]; Andreotti, Janaina Trevizan [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)
    This study aims to approach the theme of accident prevention in relation to the use of playground toys, which is little explored in national literature. It is estimated that, annually, more than 200,000 accidents with children happen in playgrounds in the United States of America. Besides discussing this problem, we present some general recommendations about safety in these places and a reflection on the need to alert and educate society about the importance of prevention.
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    Time-Dependent and Immunosuppressive Drug-Associated Adverse Event Profiles in De Novo Kidney Transplant Recipients Converted from Tacrolimus to Sirolimus Regimens
    (Wiley-Blackwell, 2016) Felix, Maria Julia Pereira [UNIFESP]; Felipe, Claudia Rosso [UNIFESP]; Tedesco-Silva, Helio [UNIFESP]; Medina-Pestana, Jose Osmar [UNIFESP]
    Study ObjectiveTo evaluate the safety and tolerability of immunosuppressive drugs used in a planned randomized conversion from a calcineurin inhibitor, tacrolimus, to a mammalian target of rapamycin inhibitor, sirolimus, in de novo kidney transplant recipients. DesignProspective safety analysis of data from a prospective, randomized, open-label, controlled study. PatientsA total of 119 adult kidney transplant recipients who received tacrolimus (TAC), mycophenolate sodium (MPS), and prednisone between February 2008 and May 2010; after 3 months of this regimen, 60 of these patients were randomized to conversion from TAC to sirolimus (SRL/MPS group), and 59 patients continued with the TAC regimen (TAC/MPS group). Measurements and Main ResultsBoth groups were followed for 24 months after transplantation for immunosuppressive regimen-associated and time-dependent occurrences of adverse events (AEs) and serious adverse events (SAEs). Before conversion from TAC to SRL, the cumulative incidence of AEs was 98%; 25% were SAEs. Gastrointestinal AEs (66%) and infections (58%) were the most frequent AEs. The incidences of TAC and MPS dose reductions due to AEs were 1.7% and 12%, respectively. After conversion, no significant differences were noted in the SRL/MPS group versus the TAC/MPS group in the cumulative incidences of AEs (100% vs 98%) and SAEs (27% vs 30%). The most common AEs were gastrointestinal (70% vs 54%, p=0.23) and infection (77% vs 73%, p=0.79) in the SRL/MPS versus TAC/MPS groups. The incidence of aphthous ulcer (28% vs 0%, p=< 0.01), sinusitis (10% vs 0%, p=0.01), dermatitis (15% vs 3%, p=0.03), and dyslipidemia (35% vs 14%, p=0.02) were higher in the SRL/MPS group compared with the TAC/MPS group. Cox proportion regression analysis showed a higher relative risk for gastrointestinal (hazard ratio [HR] 1.9, 95% confidence interval [CI] 1.2-3.01, p<0.05) and skin and subcutaneous tissue (HR 2.5, 95% CI 1.1-4.1, p<0.05) AEs in the SRL/MPS group compared with the TAC/MPS group. AE-related dose reductions occurred in 18.3% of patients receiving SRL and 3.3% of patients receiving TAC. MPS dose reductions due to AEs occurred in 11.7% of patients receiving SRL and 13.6% of patients receiving TAC. ConclusionSRL/MPS treatment was associated with a time-dependent higher incidence of gastrointestinal and skin and subcutaneous tissue AEs, which occurred mainly during the first 6 months after conversion from TAC/MPS. Although the treatments with SRL or TAC after 3 months of transplantation showed different safety profiles, both regimens demonstrated adequate tolerability, with low rates of early discontinuation related to AEs.
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    Time-Dependent and Immunosuppressive Drug-Associated Adverse Event Profiles in De Novo Kidney Transplant Recipients Converted from Tacrolimus to Sirolimus Regimens
    (Wiley-Blackwell, 2016) Felix, Maria Julia Pereira [UNIFESP]; Felipe, Claudia Rosso [UNIFESP]; Tedesco-Silva, Helio [UNIFESP]; Medina-Pestana, Jose Osmar [UNIFESP]
    Study ObjectiveTo evaluate the safety and tolerability of immunosuppressive drugs used in a planned randomized conversion from a calcineurin inhibitor, tacrolimus, to a mammalian target of rapamycin inhibitor, sirolimus, in de novo kidney transplant recipients. DesignProspective safety analysis of data from a prospective, randomized, open-label, controlled study. PatientsA total of 119 adult kidney transplant recipients who received tacrolimus (TAC), mycophenolate sodium (MPS), and prednisone between February 2008 and May 2010; after 3 months of this regimen, 60 of these patients were randomized to conversion from TAC to sirolimus (SRL/MPS group), and 59 patients continued with the TAC regimen (TAC/MPS group). Measurements and Main ResultsBoth groups were followed for 24 months after transplantation for immunosuppressive regimen-associated and time-dependent occurrences of adverse events (AEs) and serious adverse events (SAEs). Before conversion from TAC to SRL, the cumulative incidence of AEs was 98%; 25% were SAEs. Gastrointestinal AEs (66%) and infections (58%) were the most frequent AEs. The incidences of TAC and MPS dose reductions due to AEs were 1.7% and 12%, respectively. After conversion, no significant differences were noted in the SRL/MPS group versus the TAC/MPS group in the cumulative incidences of AEs (100% vs 98%) and SAEs (27% vs 30%). The most common AEs were gastrointestinal (70% vs 54%, p=0.23) and infection (77% vs 73%, p=0.79) in the SRL/MPS versus TAC/MPS groups. The incidence of aphthous ulcer (28% vs 0%, p=< 0.01), sinusitis (10% vs 0%, p=0.01), dermatitis (15% vs 3%, p=0.03), and dyslipidemia (35% vs 14%, p=0.02) were higher in the SRL/MPS group compared with the TAC/MPS group. Cox proportion regression analysis showed a higher relative risk for gastrointestinal (hazard ratio [HR] 1.9, 95% confidence interval [CI] 1.2-3.01, p<0.05) and skin and subcutaneous tissue (HR 2.5, 95% CI 1.1-4.1, p<0.05) AEs in the SRL/MPS group compared with the TAC/MPS group. AE-related dose reductions occurred in 18.3% of patients receiving SRL and 3.3% of patients receiving TAC. MPS dose reductions due to AEs occurred in 11.7% of patients receiving SRL and 13.6% of patients receiving TAC. ConclusionSRL/MPS treatment was associated with a time-dependent higher incidence of gastrointestinal and skin and subcutaneous tissue AEs, which occurred mainly during the first 6 months after conversion from TAC/MPS. Although the treatments with SRL or TAC after 3 months of transplantation showed different safety profiles, both regimens demonstrated adequate tolerability, with low rates of early discontinuation related to AEs.
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    Tolerability of up to 200days of prophylaxis with valganciclovir oral solution and/or film-coated tablets in pediatric kidney transplant recipients at risk of cytomegalovirus disease
    (Wiley, 2017) Varela-Fascinetto, G.; Benchimol, C.; Reyes-Acevedo, R.; Genevray, M.; Bradley, D.; Ives, J.; Silva, H. T., Jr. [UNIFESP]
    This multicenter, open-label study evaluated the tolerability of extended prophylaxis with valganciclovir in pediatric kidney transplant recipients at risk of CMV disease. Fifty-six patients aged 4 months to 16 years received once-daily valganciclovir oral solution and/or tablets, dosed by BSA and renal function, for up to 200 days. The most common AEs on treatment were upper respiratory tract infection (33.9%), urinary tract infection (33.9%), diarrhea (32.1%), leukopenia (25.0%), neutropenia (23.2%), and headache (21.4%). There were fewer AEs during days 101-228 vs days 1-100. Twenty-seven patients (48.2%) had treatment-related AEs during valganciclovir treatment, most commonly leukopenia (21.4%), neutropenia (19.6%), anemia (7.1%), and tremor (5.4%). Treatment-related serious AEs were reported for nine patients (16.1%) and six withdrew due to AEs. Viremia was centrally confirmed in 10 patients