Navegando por Palavras-chave "anticorpos monoclonais"
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- ItemAcesso aberto (Open Access)Monoclonal antibodies to identify Tomato mosaic tobamovirus (ToMV)(Sociedade Brasileira de Microbiologia, 2001-10-01) Duarte, Keila M.R.; Gomes, Luiz Humberto; Gesztesi, Jean-Luc [UNIFESP]; Lopes, Jose Daniel [UNIFESP]; Tavares, Flávio C.A.; Universidade de São Paulo (USP); Universidade Federal de São Paulo (UNIFESP)Monoclonal antibodies were obtained against Tomato mosaic tobamovirus (ToMV) isolated in Brazil. One antibody (8G7G2) isotyped as IgG2b (kappa light chain) showed strong specificity and very low cross reaction with the Tobacco mosaic virus (TMV). It can be used in identification of tomato mosaic virus (ToMV).
- ItemAcesso aberto (Open Access)Respiratory infections in children up to two years of age on prophylaxis with palivizumab(Sociedade de Pediatria de São Paulo, 2014-06-01) Monteiro, Ana Isabel Melo Pereira [UNIFESP]; Bellei, Nancy Cristina Junqueira [UNIFESP]; Sousa, Alessandra Ramos; Dos Santos, Amelia Miyashiro [UNIFESP]; Weckx, Lily Yin [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)OBJECTIVE: To identify the viruses involved in acute respiratory tract infections and to analyze the rates of hospitalization and death in children on palivizumab prophylaxis.METHODS:Prospective cohort of 198 infants up to one year old who were born before 29 weeks of gestational age and infants under two years old with hemodynamically unstable cardiopathy or chronic pulmonary disease who received prophylactic palivizumab against severe respiratory syncytial virus infections in 2008. During the study period, in each episode of acute respiratory tract infection, nasopharyngeal aspirate was collected to identify respiratory syncytial virus, adenovirus, parainfluenza 1, 2 and 3, influenza A and B by direct immunofluorescence, rhinovirus and metapneumovirus by polymerase chain reaction preceded by reverse transcription. Data regarding hospitalization and deaths were monitored.RESULTS:Among the 198 studied infants, 117 (59.1%) presented acute respiratory tract infections, with a total of 175 episodes. Of the 76 nasopharyngeal aspirates collected during respiratory tract infections, 37 were positive, as follow: rhinovirus (75.7%), respiratory syncytial virus (18.9%), parainfluenza (8.1%), adenovirus 2 (2.7%), metapneumovirus (2.7%) and three samples presented multiple agents. Of the 198 children, 48 (24.4%) were hospitalized: 30 (15.2%) for non-infectious etiology and 18 (9.1%) for respiratory causes. Among these 18 children, one case of respiratory syncytial virus was identified. Two deaths were reported, but respiratory syncytial virus was not identified.CONCLUSIONS:During the prophylaxis period, low frequency of respiratory syncytial virus infections and low rates of hospitalization were observed, suggesting the benefit of palivizumab prophylaxis.
- ItemAcesso aberto (Open Access)Terapia de indução com alentuzumabe em receptores de transplante renal(Sociedade Brasileira de Nefrologia, 2010-03-01) Sampaio, Edison Luiz Mandia [UNIFESP]; Freitas, Tainá Veras de Sandes [UNIFESP]; Galante, Nelson Zocoler [UNIFESP]; Park, Sung In [UNIFESP]; Harada, Kelly Miyuki [UNIFESP]; Haolla, Filipe Augusto Bettencourt [UNIFESP]; Felipe, Claudia Rosso [UNIFESP]; Troconis, Paul Henri Clesca [UNIFESP]; Franco, Marcello Fabiano de [UNIFESP]; Tedesco-Silva Junior, Hélio [UNIFESP]; Pestana, Jose Osmar Medina [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)INTRODUCTION: Induction therapy has been used in sensitized patients, re-transplants, and in patients who have high risk to delayed graft function (DGF) after renal transplantation. METHODS: Retrospective study with aim to compare transplant endpoints between recipients of deceased donors which have received induction with alemtuzumab (n = 9) versus thymoglobulin (n = 18). Patients were matched for age, duration of dialysis treatment and cold ischemia time. RESULTS: There were no differences at demographic characteristics. All patients received kidney grafts from deceased donors and 67% of these donors met the expanded criteria. The incidence of DFG was similar in alemtuzumab and thymoglobulin groups, 55% and 56%. At 12 months, rates of rejection free survival (67% versus 89%, p = 0,13), graft survival (62,5% versus 76,6%; p = 0,73), graft with death censored (62,5% versus 76,6%; p = 0,82) and patient survival (83,3% versus 81,2%; p = 0,63) were similar between the two groups. Viral infections and renal function were similar between groups. At the end of the first month, alemtuzumab patients displayed a fewer lymphocyte number (135 ± 78 versus 263 ± 112 N/mm³, p < 0,05) followed by a more rapid recovery after 3 months (day 90: 683 ± 367 versus 282 ± 72 N/mm³; p < 0,05). Cost associated with alemtuzumab and thymoglobulin inductions therapies were R$ 1,388.00 and R$ 7,398.00. CONCLUSION: In this cohort of patients, alemtuzumab induction showed efficacy and safety comparable to thymoglobulin but with significant cost reduction.
- ItemSomente MetadadadosViés de publicação em ensaios clínicos sobre anticorpos monoclonais e repercussão jurídica do direito fundamental à saúde baseada em evidências(Universidade Federal de São Paulo (UNIFESP), 2014-12-31) Santos, Douglas Henrique Marin dos [UNIFESP]; Atallah, Alvaro Nagib Atallah [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)Aims: We aimed to assess the proportion of publication and reporting of results of clinical trials on monoclonal antibodies adalimumab, bevacizumab, rituximab, trastuzumab and infliximab registered at ClinicalTrials.gov. We also aimed to evaluate the circumstances associated to publications bias and the effectiveness of FDAAA legislation in controlling it. Methods: In this cross-sectional, we searched ClinicalTrials.gov for protocols of interventional studies, phases III and IV, on monoclonal antibodies adalimumab, bevacizumab, rituximab, trastuzumab and infliximab, interventional (n = 243). After, we searched Pubmed, Embase, Lilacs, Cochrane Central and Google Scholar in order to evaluate and find published papers. Results: Among the 243 trials that comprised our initial sample, 178 (?73,2%) were published and 73 (?30%) had results reported at ClinicalTrials.gov. Industry sponsored trials were 169 (? 69.5%). Regarding the methodological quality of protocols, 159 (?65,4%) trials were designed with two or more comparison groups (intervention versus control), 149 (?61,3%) were randomized and 84 (?34,5%) were masked. Only 82 trials (?33,7%) were cumulatively designed with control groups, randomized allocation of participants, and masking. Among published studies (n=178), 118 (?66,3%) reported positive results, 18 (? 10%) reported negative results, 11 (?6,2%) found neutral or inconclusive results, and 24 (?13,5%) were partially positive. In the subsample of trials under FDAAA mandatory reporting (n=57), 48 (?84.2%) were published and 40 (?70,2%) had their results disclosed at ClinicalTrials.gov. Placebo-controlled trials were significantly more common among industry-funded trials when compared with independent trials (n=44/169 [26%] versus 9/74 [?12,2%]; p=0,025). Treatment as usual controlled trials were significantly more common among independent studies when compared to industry-funded trials (n=36/74 [?48.6%] versus 44/169 [?26%]; p<0,001). Conclusions: Publication bias in clinical trials is intense, despite the nature of intervention investigated (in this case, monoclonal antibodies). The source of funding (independent or industry) did not change the patterns of publication, suggesting that publication bias is evenly spread among different sponsors. However, studies involving placebo or single arm studies were more common in industry-funded trials. Our findings also suggest a higher prevalence of positive results among published trials. Lack of transparency, therefore, goes beyond selective publications and encompasses poor designed and biased protocols. Clinical trials subject to the FDAAA legislation had a greater proportion of published studies and disclosed results at ClinicalTrials.gov, suggesting the effectiveness of U.S. law in controlling publication bias and expanding in clinical research.