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OBJECTIVES: High-dose rifampicin (R) and isoniazid (H) are known to be safe but were not yet combined in a single regimen. The primary objective of the TRIple-DOse RE-treatment (TRIDORE) study is to determine whether a 6-month firstline regimen with triple dose of both R and H (intervention arm; 6R3H3ZE) is non-inferior in terms of safety compared to a normal-dose regimen (6RHZE) in previously treated patients with R-susceptible (Rs) recurrent tuberculosis (TB). DESIGN/METHODS: TRIDORE is an ongoing pragmatic open-label multi-stage randomized clinical trial. RESULTS: Between March 2021 and February 2022, 127 consenting patients were randomly assigned to either the intervention or control arm: 62 and 65 were treated with 6R3H3ZE and 6RHZE, respectively. Of 127, 111 (87.4%) were male and the median age (interquartile range) was 37 (30-48) years. The median body mass index at enrollment was 18.1 (16.3-19.7) kg/m2. Drugrelated severe adverse events (AEs) (grade III-V) were significantly more frequent when 6R3H3ZE was used (5/62 vs 0/65, P = 0.03, difference weighted for site 8% [95% confidence interval: 1.0,14.3]). The Data and Safety Monitoring Board recommended publishing our interim safety data analysis. CONCLUSION: We show that the combination of triple-dose R with triple-dose H in a re-treatment regimen for patients with Rs-TB causes excess drug-related AEs.
Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Tuberculose , Humanos , Masculino , Adulto , Feminino , Rifampina/efeitos adversos , Isoniazida/efeitos adversos , Antituberculosos/efeitos adversos , Quimioterapia Combinada , Tuberculose/tratamento farmacológico , Resultado do TratamentoRESUMO
INTRODUCTION: This study aimed to describe the epidemiological, clinical and evolutionary profile of patients treated for tuberculosis at the Regional Hospital of Maradi. METHODS: We conducted a retrospective, descriptive and analytical study of data from the medical records of patients treated for tuberculosis from 1st January 2015 to 31st December 2017. RESULTS: A total of 595 patients were followed (406 men, 68.24%, and 189 women, 31.76%) with a prevalence of 27,71%. The average age of patients was 42.3 ranging from 13 months to 85 years; 70.5% of these patients were from urban areas. Merchants represented 36.9% of the cases. Bacterial test was positive in 64.7% of cases. Functional signs included: coughing (99.5%), fever (79.5%), and chest pain. Pulmonary tuberculosis represented 78.7% of cases. Therapy was effective in 81.28% of cases. HIV prevalence was 13.6%, lethality 10.42% (40.4% of patients died from TB/HIV co-infection). CONCLUSION: Tuberculosis is a scourge in low-income countries, with 10.42% of deaths. HIV/AIDS infection has negatively contributed to these deaths during the study period. The search for comorbidities in any patient with tuberculosis should be systematic in order to improve their global management.
Assuntos
Antituberculosos/administração & dosagem , Infecções por HIV/epidemiologia , Tuberculose Pulmonar/epidemiologia , Tuberculose/epidemiologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Coinfecção/epidemiologia , Feminino , Hospitais , Humanos , Lactente , Masculino , Pessoa de Meia-Idade , Níger/epidemiologia , Prevalência , Estudos Retrospectivos , Tuberculose/tratamento farmacológico , Tuberculose Pulmonar/tratamento farmacológico , Adulto JovemRESUMO
Introduction : Le tétanos est caractérisé par un tableau clinique fait des spasmes musculaires sévères faisant suite à des blessures. La bactérie en cause, Clostridium tétani, a été découverte en 1884 et mise en culture pour la première fois en 1889. C'est une maladie totalement évitable et d'ailleurs quasiment éliminée des pays développés grâce à la vaccination généralisée et à une rigoureuse prophylaxie post-exposition, toutes deux parfaitement codifiées. Objectif : Cette étude rétrospective avait pour but de décrire les aspects épidémiologiques, cliniques et évolutifs du tétanos au CHR de Maradi au Niger. Matériel et méthodes : Les dossiers de malades hospitalisés au service des maladies contagieuses du CHR de janvier 2011 à aout 2018 ont été évalués. Résultats : Nous avions colligé 49 cas de tétanos sur un total de 2930 malades hospitalisés dans le service soit un taux de prévalence de 1,67 %; 32,65 % des patients étaient âgés de 0 à 15 ans. La porte d'entrée tégumentaire a été la plus fréquemment retrouvée (vingt huit cas). D'autres portes d'entrée ont été notées : fracture ouverte (5 cas), injection intramusculaire (1 cas), ombilicale (2 cas), brulure corporelle (2cas). 57,14% des malades étaient au stade II de la classification de Mollaret. On a enregistré 19 décès sous traitement, soit un taux de létalité de 38,78 %. Le stade clinique des patients à l'admission a été associé au décès avec une P = 0,0030.Conclusion: La sensibilisation des populations, le renforcement du programme élargi de vaccination et l'amélioration de la prise en charge des malades devraient permettre de réduire encore davantage la mortalité liée au tétanos