Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report
Rattachement africain : ru, lt, br, lv, pe, by, it, se, bg, fr, bd, be, in, nl, es, dk, au, pt, cl, ar, gb, mx, cn, ch, gr, sk. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
The World Health Organization (WHO) recommends that countries implement pharmacovigilance and collect information on active drug safety monitoring (aDSM) and management of adverse events. The aim of this prospective study was to evaluate the frequency and severity of adverse events to anti-tuberculosis (TB) drugs in a cohort of consecutive TB patients treated with new ( i.e. bedaquiline, delamanid) and repurposed ( i.e. clofazimine, linezolid) drugs, based on the WHO aDSM project. Adverse events were collected prospectively after attribution to a specific drug together with demographic, bacteriological, radiological and clinical information at diagnosis and during therapy. This interim analysis included patients who completed or were still on treatment at time of data collection. Globally, 45 centres from 26 countries/regions reported 658 patients (68.7% male, 4.4% HIV co-infected) treated as follows: 87.7% with bedaquiline, 18.4% with delamanid (6.1% with both), 81.5% with linezolid and 32.4% with clofazimine. Overall, 504 adverse event episodes were reported: 447 (88.7%) were classified as minor (grade 1–2) and 57 (11.3%) as serious (grade 3–5). The majority of the 57 serious adverse events reported by 55 patients (51 out of 57, 89.5%) ultimately resolved. Among patients reporting serious adverse events, some drugs held responsible were discontinued: bedaquiline in 0.35% (two out of 577), delamanid in 0.8% (one out of 121), linezolid in 1.9% (10 out of 536) and clofazimine in 1.4% (three out of 213) of patients. Serious adverse events were reported in 6.9% (nine out of 131) of patients treated with amikacin, 0.4% (one out of 221) with ethionamide/prothionamide, 2.8% (15 out of 536) with linezolid and 1.8% (eight out of 498) with cycloserine/terizidone. The aDSM study provided valuable information, but implementation needs scaling-up to support patient-centred care.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report
- Date Crossref
- 10/10/2019
- Éditeur
- European Respiratory Society (ERS)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
-
Government of Russia pays non établi dans la noticeOrganisme public
-
Vilnius University Clinic of Chest Diseases pays non établi dans la noticeUniversité ou école supérieure
-
Northern State Medical University pays non établi dans la noticeUniversité ou école supérieure
-
Ministério da Saúde pays non établi dans la noticeOrganisme public
-
Fundação Oswaldo Cruz Reference Center Hélio Fraga pays non établi dans la noticeStructure de recherche
-
Lithuanian University of Health Sciences Dept of Pulmonology pays non établi dans la noticeUniversité ou école supérieure
-
Riga East University Hospital MDR-TB Dept pays non établi dans la noticeÉtablissement de santé
-
National University of Saint Anthony the Abbot in Cuzco pays non établi dans la noticeUniversité ou école supérieure
-
Republican Scientific and Practical Centre of Pulmonology and Tuberculosis pays non établi dans la noticeStructure de recherche
-
Republic Klaipeda Hospital pays non établi dans la noticeÉtablissement de santé
-
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda pays non établi dans la noticeÉtablissement de santé
-
Grodno State Medical University Dept of Phthisiology and Pulmonology pays non établi dans la noticeUniversité ou école supérieure
Government of Russia, Clinic of Chest Diseases — Vilnius University et Northern State Medical University, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.