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OBJECTIVES: To determine the benefits and harms of discontinuing unnecessary antibiotic therapy for uncomplicated respiratory tract infections (RTI) when antibiotics are considered no longer necessary. METHODS: Multicentre, open-label, randomized controlled clinical trial in primary care centres from 2017 to 2020 (ClinicalTrials.gov, NCT02900820). Adults with RTIs-acute rhinosinusitis, sore throat, influenza or acute bronchitis-who had previously taken any dose of antibiotic for less than 3 days, which physicians no longer deemed necessary were recruited. The patients were randomly assigned in a 1:1 ratio to discontinuing antibiotic therapy or the usual strategy of continuing antibiotic treatment. The primary outcome was the duration of severe symptoms (number of days scoring 5 or 6 on a six-item Likert scale). Secondary outcomes included days with symptoms, moderate symptoms (scores of 3 or 4), antibiotics taken, adverse events, patient satisfaction and complications within the first 3 months. RESULTS: A total of 467 patients were randomized, out of which 409 were considered valid for the analysis. The mean (SD) duration of severe symptoms was 3.0 (1.5) days for the patients assigned to discontinuation and 2.8 (1.3) days for those allocated to the control group (mean difference 0.2 days; 95% CI -0.1 to 0.4 days). Patients randomized to the discontinuation group used fewer antibiotics after the baseline visit (52/207 (25.1%) versus 182/202 (90.1%); p 0.001). Patients assigned to antibiotic continuation presented a relative risk of adverse events of 1.47 (95% CI 0.80-2.71), but the need for further health-care contact in the following 3 months was slightly lower (RR 0.61; 95% CI 0.28-1.37). CONCLUSIONS: Discontinuing antibiotic treatment for uncomplicated RTIs when clinicians consider it unnecessary is safe and notably reduces antibiotic consumption.
Assuntos
Bronquite , Faringite , Infecções Respiratórias , Adulto , Antibacterianos/efeitos adversos , Bronquite/tratamento farmacológico , Humanos , Atenção Primária à Saúde , Infecções Respiratórias/tratamento farmacológicoRESUMO
BACKGROUND: The Center of Molecular Immunology of Cuba has developed a programme for the conducting of multicentre oncology clinical trials in primary healthcare centres since 2009. AIM: To evaluate the ability to conduct oncology clinical trials in primary health care. DESIGN & SETTING: A longitudinal, prospective, analytical study was developed between July 2010 and August 2020 in the Villa Clara province. METHOD: Structure, process, and outcome indicators were evaluated by the methods of a structured interview, direct observation, documentary observation, and databases analysis. The investigators' curricula vitae, the investigator site file, minutes of workshops, the monitoring reports, the clinical trial training records, and databases were employed as sources of information. The following criteria were considered adequate: when the indicator met the standard; and not adequate: when the indicator did not meet the standard. RESULTS: The six structure indicators reached adequate results and showed that the programme has allowed building of capacities to conduct clinical trials in primary care. The eight processes indicators and two outcome indicators were considered adequate too. Trials conducted in primary care showed better indicators of patient recruitment than secondary care. Both scenarios showed similar behaviour for the process indicators: retention, protocol compliance, and safety. Survival and satisfaction with health services were also comparable in both scenarios. CONCLUSION: The evaluation of the programme showed adequate indicators for conducting oncology clinical trials in primary care in Villa Clara and these were comparable to those determined in the secondary care.
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NeuGc-containing gangliosides have been described in melanoma cells and are an attractive target for cancer immunotherapy because they are minimally or not expressed in normal human tissues. Melanoma patients treated with a vaccine based on N-glycolyl gangliosides have shown benefit in progression free survival and overall survival. We conducted a multicenter Phase I/II clinical trial in patients with metastatic cutaneous melanoma treated with the N-gycolyl GM3/very-small-size proteoliposomes vaccine by the subcutaneous route. Selecting the optimal biological dose of the vaccine was the principal objective based on immunogenicity, efficacy, and safety results. Six dose levels were studied and the treatment schedule consisted of five doses administered every 2 weeks and then monthly until 15 doses had been given. Dose levels evaluated were 150, 300, 600, 900, 1200, and 1500 µg with five patients included in each dose level except the 900 µg dose (n = 10). Immunogenicity was determined by antibody titers generated in patients after vaccination. Antitumor effect was measured by response criteria of evaluation in solid tumors and safety was evaluated by common toxicity criteria of adverse events. The vaccine was safe and immunogenic at all doses levels. The most frequent adverse events related to vaccination were mild to moderate injection site reactions and flu-like symptoms. Vaccination induced specific anti-NeuGcGM3 immunoglobulin M and immunoglobulin G antibody responses in all patients. Disease control (objective response or stable disease) was obtained in 38.46% of patients. Global median overall survival was 20.20 months. Two patients achieved overall survival duration of about 4 and 5 years, respectively. The 900 µg dose resulted in overall survival duration of 19.40 months and was selected as the biological optimal dose.
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Se realizó un estudio epidemiológico en el Distrito Sanitario Juan Griego a fin de caracterizar las ETA. Este estudio arrojó que el mayor número de casos de intoxicación por alimentos provenían del Barrio "Tari-Tari" y especialmente los menores de 5 años (57%) eran quienes se enfermaban y de ellos el 40% eran menores de un (1) año. Las condiciones higiénico-sanitarias del Distrito no son las más adecuadas ya que presentan graves fallas en los servicios básicos (agua, basura, eliminación de excretas. etc.); además, en los últimos años han venido creciendo barrios marginales que agravan la situación del Distrito, tal es el caso del Barrio "Francisco Adrián", ubicado cerca de uno de los basureros. Esto motivó la aplicación de la metodología de Análisis de Riesgos y Puntos Críticos de Control en los barrios mencionados. El trabajo fue dirigido a la aplicación del RPCC en la preparación de fórmulas lácteas para los menores de un (1) año. Se estudiaron 18 familias (9 en cada barrio) en las cuales había 20 niños menores de un (1) año. En muestreo se llevó acabo durante 7 semanas. Se realizaron análisis de Laboratorio para la determinación de salmollas, Staphylococcus aureus, coliformes totales y fecales en materia prima, alimentos y equipos usados durante la preparación de los teteros; así como también medición de la temperatura ambiente, de neveras y de la mezcla de harina para la preparación de teteros. Los resultados indicaron que en las materias primas empleadas (leche, harina, cereal) no se detectó salmonella; en las muestras de teteros hervidos, ,manos, pezones, agua, se identificaron Staphylococcus aureus y cifras elevadas de NMP Coliformes totales y fecales. Estos resultados microbiológicos en general indican deficiente higiene sanitaria de los habitantes fallas en la manipulación y conservación de los teteros, situación favorecida por la presencia de altas temperaturas ambientales y deficiente refrigeración que permite el crecimiento de los microorganismos