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Maladies fréquentes, l’asthme touche 8,4% de la population canadienne âgée de 12 ans et plus et la maladie pulmonaire obstructive chronique (MPOC) touche de 5 à 15% de la population âgée entre 35 et 79 ans. L’asthme et la MPOC peuvent coexister chez un patient. Ce phénomène appelé syndrome de chevauchement de l’asthme et de la MPOC (ACOS) toucherait environ 10% à 55% des patients MPOC. Afin de mieux caractériser l’ACOS et les effets indésirables des médicaments utilisés pour traiter la MPOC, deux études ont été mises en place. Une première étude réalisée auprès de pneumologues a permis de décrire les méthodes de diagnostic, de traitement et d’évaluation de la maitrise de l’ACOS dans la pratique clinique. Les pneumologues rapportent que le diagnostic devrait être basé sur les caractéristiques cliniques, les tests de fonction pulmonaire et l'intuition clinique du médecin. De plus, un corticostéroïde inhalé en combinaison et un bronchodilatateur inhalé à longue durée d’action devraient être introduits rapidement dans le plan de traitement. La deuxième étude a permis d’évaluer la fréquence des effets indésirables chez les patients MPOC/ACOS traités avec un bronchodilatateur inhalé à longue durée d’action. Cette étude démontre que les effets indésirables sont fréquents chez les patients MPOC/ACOS et que la sécheresse buccale et la gorge sèche sont les plus rapportés. Ces résultats démontrent que la mise en place de lignes directrices pour l’ACOS ainsi qu’une meilleure connaissance du profil de tolérance des bronchodilatateurs inhalés à longue durée d’action seraient bénéfiques pour les patients / Asthma and chronic obstructive pulmonary disease (COPD) are frequent in Canada with a prevalence of 8.4% among Canadians aged 12 and over for asthma and a prevalence of 5 to 15% among Canadians aged 35 to 79 years. Asthma and COPD can coexist in a patient and this Asthma-COPD overlap syndrome (ACOS) affects about 10% to 55% of COPD patients. To better understand this syndrome, two studies were designed and conducted. First, focus groups evaluated how pulmonologists diagnose and treat ACOS, and how they assess its control in routine clinical practice. The pulmonologists reported that the diagnosis must be based on clinical characteristics, pulmonary function tests, and clinical intuition. They also agreed that the treatment should target the features of both asthma and COPD. The second study assessed the prevalence of adverse events in COPD/ACOS patients on long-acting inhaled anticholinergics (LAAC) and β2-agonists (LABA) in a real-world setting. This study demonstrates that side effects are common among COPD/ACOS patients. Dry mouth and dry throat were the most reported side effects. These results demonstrate that more explicit guidelines for ACOS and a better understanding of the safety profile of long-acting bronchodilators would be beneficial for patients.

Made available in DSpace on 2011-05-04T12:36:16Z (GMT). No. of bitstreams: 0 Previous issue date: 2009 / Objetivos: Analisar a temperatura axilar no estudo da vacina contra difteria, tétano, o componente pertussis e hemófilo (DTP/Hib), a frequência de febre e a associação dos eventos adversos. Analisar a metodologia para verificação da temperatura corpórea e febre utilizada em diferentes estudos clínicos com a vacina DTP/Hib. Materiais e métodos: Este trabalho é baseado em dados obtidos do Estudo de imunogenicidade e reatogenicidade de vacina combinada contra difteria, tétano, pertussis e hemófilo tipo b: validação clínica de produto produzido totalmente no Brasil, com 1000 lactentes, realizado no município do Rio de Janeiro, no ano de 2006. Foi analisada a temperatura axilar nos tempos 3, 6, 12, 24, 48 e 72 horas após a vacinação. Foram analisadas as associações entre os eventos adversos locais e eventos adversos sistêmicos. Resultados: A freqüência de febre foi de 53,4 por cento após a primeira dose, 39,9 por cento após a segunda dose e 31,5 por cento após a terceira dose nas 24 horas após a vacinação. A freqüência de febre foi diminuindo com a aplicação das doses. Não houve padrão de associação entre os eventos adversos locais e sistêmicos. A mediana da distribuição da temperatura axilar foi maior nostempos 6 e 12 horas após a vacinação. Conclusões: A definição de febre e as metodologias utilizadas nos estudos clínicos para verificar a temperatura corpórea ainda são heterogêneas, o que dificulta a comparabilidade entre eles. / Objectives: To analyze the axillary temperature in the study of the vaccine DTP/Hib (Martins et al., 2008), the frequency of fever and the association of the adverse events. To analyze the methodology for checking of the corporal temperature and fever used in different clinical trial with the vaccine DTP/Hib. Materials and methods: This work is based on obtained data of the “Study of immunogenicity and reactogenicity of vaccine combined against diphtheria, tetanus, pertussis and haemophylus type b: clinical validation of product produced totally in Brazil ”, with 1000 infants,carried out in the local authority of the Rio of January, in the year of 2006. The axillary temperature was analyzed in the times 3, 6, 12, 24, 48 and 72 hours after the vaccination. The associations were analyzed between the adverse local events and adverse systemic events. Results: The frequency of fever was 53.4 % after the first dose, 39.9 % after the second dose and 31.5 % after the third dose in 24 hours after the vaccination. The frequency of fever was lessening with the application of the doses. There was no standard of association between the adverse local events and systemic adverse events. The medium one of the distribution of the axillary temperature was bigger in the times 6 and 12 hours after the vaccination. Conclusions: The definition of fever and the methodologies used in the clinical studies to check the corporal temperature they are still heterogeneous what makes difficult the comparability between them.

Submitted by Anderson Silva (avargas@icict.fiocruz.br) on 2012-09-30T16:24:14Z No. of bitstreams: 1 edna_m_queiroz_ipec_pesquisaclinicadi_0001_2008.pdf: 1325959 bytes, checksum: fdbb83407bcd934e88f394e837a9b759 (MD5) / Made available in DSpace on 2012-09-30T16:24:14Z (GMT). No. of bitstreams: 1 edna_m_queiroz_ipec_pesquisaclinicadi_0001_2008.pdf: 1325959 bytes, checksum: fdbb83407bcd934e88f394e837a9b759 (MD5) Previous issue date: 2008 / Fundação Oswaldo Cruz. Instituto de Pesquisa Clínica Evandro Chagas. Rio de Janeiro, RJ, Brasil / A tuberculose é uma doença antiga e curável que permanece como um dos maiores problema de saúde pública no mundo. Um aumento na incidência coincidiu com a pandemia de HIV/AIDS. Como conseqüência, observou-se um aumento das formas extrapulmonares e disseminadas, mais freqüentes em indivíduos HIV+. Esse estudo visa descrever as formas exclusivamente extrapulmonares de tuberculose, suas características clínicas e desfechos terapêuticos em pacientes com e sem a infecção pelo HIV. A coleta de dados foi retrospectiva, longitudinal, baseada na revisão dos protocolos de atendimento do ambulatório de tuberculose do Instituto de Pesquisa Evandro Chagas - FIOCRUZ. Todos os pacientes com diagnóstico de tuberculose extrapulmonar no período de janeiro de 2003 até dezembro de 2006 foram incluídos. Foram excluídos os pacientes com mais de dois sítios extrapulmonares não contíguos e as formas disseminadas clássicas. A análise dos dados foi descritiva e em algumas situações foram comparados subgrupos através do teste do λ2 ou Mann-Whitney. Foram selecionados 89 pacientes sendo 56,2% HIV negativo, com predomínio do sexo masculino, solteiros, idade <40 anos, raça não branca, baixa escolaridade, renda até 3 salários mínimos, habitantes de casas de alvenaria, sem presença de aglomeração no domicílio, moradores da baixada fluminense e sem fatores de risco aparentes para tuberculose, porém relatavam relações sexuais desprotegidas. Nenhum paciente relatou tratamento anterior para a infecção latente ou tuberculose. O tabagismo foi revelado por 20,7% dos indivíduos, o uso de drogas intravenosas por 2,2 e o alcoolismo por 11%. As doenças pregressas mais freqüentes foram as alergias (21,1%), doenças digestivas (14%), cirurgias (26,7%) câncer/terapia com imunossupressores (5,6%). As co-morbidades mais freqüentes foram: hipertensão arterial (15,5), hepatite (9,8%), diabetes mellitus (4,2%), e doença renal (4,2%). As formas clínicas mais freqüentes foram: ganglionar (56,2%), pleural (12,4%), oftálmica (10,1%), cutânea (7,9%). A sintomatologia variou segundo o sítio. O teste tuberculínico foi positivo na maioria dos pacientes,e os HIV negativos apresentaram menos reação ao teste que os demais nas formas ganglionares (χ2, p=0,03). O diagnóstico de tuberculose foi baseado em critério histopatológico em 59,5%, O diagnóstico por cultura foi possível em 34% dos casos. A carga bacilar foi pequena (< 1+) em 18% das realizadas e observamos a cultura negativa em 72%. O HbsAg foi evidenciado em 18,3% dos casos e a sorologia para hepatite C foi positiva em 6,4%. A maioria dos pacientes (95,6%) foi tratada com esquema I ou I-R. O tempo de tratamento foi mais longo nos casos de tuberculose cutânea que nos demais (M-W, p=0,07). A resistência às drogas anti-tuberculose foi observada em 2 casos. Os eventos adversos foram freqüentes (88,7%) e 22,1% dos casos precisaram interromper o tratamento da tuberculose. A cura foi obtida na maioria dos casos e foi limitada pelo abandono (18%) principalmente em pacientes soronegativos. Um óbito ocorreu em paciente co-infectado com o HIV. As formas exclusivamente extrapulmonares apresentam características demográficas e epidemiológicas diferentes das formas pulmonares, são paucibacilares e de difícil diagnóstico, a cura foi obtida na maioria dos casos e foi limitada pelo abandono. O percentual de óbitos foi baixo. / Tuberculosis is an old curable disease that still is the biggest health problem in the world. An increase in the incidence was concurrent with the HIV/AIDS pandemia. As a consequence an increase in extrapulmonary and disseminated forms was observed, that were frequent in HIV+ individuals. The aim of this study is to describe the strictly extrapulmonary forms of tuberculosis, its clinical, characteristics and therapeutic endpoints in patients with and without HIV infection. Data collection was retrospective, longitudinal, based in the revision of clinical protocols of the tuberculosis outpatients clinics of Instituto de Pesquisa Clínica Evandro Chagas, Fiocruz. All patients with diagnosis of extrapulmonary tuberculosis during of January 2003 to December 2006 were included. All patients with more than two extrapulmonary sites or disseminated tuberculosis were excluded. Data analysis was descriptive and in some situations subgroups were compared using the λ2 or Mann-Whitney tests. Were selected 89 patients from these 56,2% were HIV negative, the occurrence was more frequent in male sex, not married , age <40 years, non white race, low schooling, monthly income of more than 3 salaries, living in brick homes, no evident, risk factors for tuberculosis, however they reported sex without protection. No patients reported previous therapy to latent infection or tuberculosis. Tobacco use was revealed in 20,7% of the individuals, injection of drugs by 2,2% and alcohol abuse by 11%. The more prevalents previous pathologies were allergy (21,1%), Gastrointestinal diseases (14%), surgery (26,7%) cancer or therapy with immunossupressors (5,6%). The more frequents co-morbidities were: hypertension (15,5), hepatitis (9,8%), diabetes mellitus (4,2%), and renal disease (4,2%). The more frequents clinical forms were: lymph nodes (56,2%), pleural (12,4%), ophthalmic (10,1%) and cutaneous (7,9%). Symptoms varied according to the site. Tuberculin test was positive in the majority of patients, and the HIV negative presented less reaction to the test than the others in the lymph nodes forms (χ2, p=0,03). Tuberculosis diagnose was based on histopatologic criteria in 59,5% of cases, Isolation in culture was possible in 34% of cases. The bacillus load was small (<1+) in 18% of the performed exams and were negative in 72%. The HbsAg was detected in 18, 3% of cases and hepatitis C serology was positive in 6,4%. Most of the patients (95, 6%) were treated with regimen I or I-R. The length of therapy was longer among cases of cutaneous tuberculosis (M-W,p=0,07). Resistance to anti-tuberculosis drugs was observed in two cases. Adverse events were frequent (88, 7%) and 22, 1% of cases needed tuberculosis treatment interruption. The cure was obtained in most of cases and was affected by the abandonment (18%), mainly in seronegative patients. A death occurred in a patient co-infected with HIV. Strictly extrapulmonary forms present different demographic and epidemiological characteristics from pulmonary forms, are paucibacillary and the diagnose is difficult. The cure was obtained in the majority of cases and was limited by abandonment. The proportion of deaths was low.

Purpose To evaluate the effectiveness and safety of Selective Laser Trabeculoplasty (SLT) with the SLT mode of the VISULAS ® green laser in patients with primary open-angle glaucoma (POAG). Methods This prospective, interventional multicenter clinical investigation included patients with POAG who either needed a treatment escalation because the individual intraocular pressure (IOP) target was not met or treatment initiation and had an IOP ≥ 17 mmHg at baseline in the study eye. The study was conducted in five research centers across Germany. Approximately 100 laser applications were delivered to 360° of the trabecular meshwork. Glaucoma medications were not modified during the 3-month follow-up to allow evaluation of the sole effect of VISULAS ® green with SLT. Efficacy outcomes were postoperatively absolute and relative IOP changes at 1 and 3 months. Safety outcomes analyzed the rate of intra- and postoperative adverse events. Results Thirty-four eyes of 34 POAG patients were included. The overall mean number of preoperative glaucoma medications was 2.2 ± 1.4 in 29 treated eyes, 5 eyes were treatment naïve. Mean baseline IOP (mmHg) was 21.0 ± 2.69 and was reduced by − 3.53 ± 3.34 [95% CI − 4.61; − 2.45] and − 3.59 ± 3.41 [95% CI − 4.64; − 2.53] at the 1- and 3-month follow-up, respectively (p < 0.0001), with 48.5% of cases achieving a ≥ 20% IOP reduction at 3 months [95% CI = 30.8%; 66.5%]. The mean relative IOP reduction was − 16.4% and − 16.3% at 1 and 3 months, respectively (p < 0.0001). Potentially device- or procedure-related adverse events were mild to moderate and included 3 postoperative IOP-spikes and 6 reports regarding eye pain and discomfort. All were resolved without sequelae. Conclusions SLT performed with the VISULAS ® green laser achieved clinically significant additional IOP reductions in medically treated as well as in treatment naïve eyes with POAG and there were no relevant safety issues. The results are comparable to other reported SLT studies.

This study compared the immunogenicity of inactivated SARS-CoV-2 vaccines between people living with HIV (PLWH) and HIV-negative individuals. We recruited 120 PLWH and 53 HIV-negative individuals aged 18-59 years who had received an inactivated SARS-CoV-2 vaccine in two Chinese cities between April and June 2021. Blood samples were tested for immunogenicity of the inactivated SARS-CoV-2 vaccines. The prevalence and severity of adverse events associated with SARS-CoV-2 vaccines were similar between PLWH and HIV-negative individuals. The seropositivity of neutralizing activity against authentic SARS-CoV-2, of the total amount of antibody (total antibody) and of S-IgG were 71.3%, 81.9%, and 92.6%, respectively, among fully vaccinated PLWH. Among all participants, PLWH had lower neutralizing activity, total antibody, S-IgG, and T-cell-specific immune response levels, compared to HIV-negative individuals, after controlling for types of vaccine, time interval between first and second dose, time after receiving the second dose, and sociodemographic factors. PLWH with a longer interval since HIV diagnosis, who received their second dose 15-28 days prior to study commencement, and who had an interval of ≥21 days between first and second dose had higher neutralizing activity levels. The immunogenicity of the inactivated SARS-CoV-2 vaccines was lower among PLWH as compared to HIV-negative individuals. Vaccination guideline specific for PLWH should be developed.