TY - Jour T1 - 耐药结核病治疗中的不良事件监测：第一届全球报告JF - 欧洲呼吸期刊Jo - Eur Respir J Do - 10.1183 / 13993003.01522-2019 VL - 54是 - 6 SP - 1901522 Au - Borisov，Sergey Au - Danila，Edvardas Au - Maryandyshev，Andrei Au - Dalcarmo，Margareth Au - Miliauskas，Skaidrius Au - Kuksa，Liga Au - Manga，Selene Au - Skrahina，Alena Au - Diktanas，Saulius Au - CodeCasa，Luigi Ruffecasa，Luigi Ruffecasa，Luigi Ruffecasa，Luigi Ruffecasa，Luigi Ruffecasa，Luigi Ruffeca，Luigi Ruffecasa，Luigi Ruffo Au -Aleksa，Alena Au - Bruchfeld，Judith Au - Koleva，Antoniya Au - Piubello，Alberto Au - Udwadia，Zarir Farokh Au - Akkerman，Onno W. Au - Belilovski，Evgeny Au - Bernal，Enrique Au - Beeree，Martin J. Au -Cadiñanosloidi，努伦奥 - 蔡，青山奥 - 盖伊 - 罗纳，何塞JoaquínAu - Dara，Masoud Au - Davidavičienō，埃德塔·奥尔斯曼，Lina Davies Au - De Los Rios，Jorge Au - Denholm，Justin Au - Drakšienė，Jacinta Au- Duarte，Raquel Au - Elamin，Seifeldin Eltaeb Au - Escobar Salinas，Nadia Au - 法拉雷雷，Maurizio Au - Filippov，Alexey Au - Garcia，Ana Au - García-garcía - Gaudiesiute，Ieva Au - Gavazova，Blagovesta Au - Gayoso，Regina Au - Gomez Rosso，Roscio Au - Gruslys，Vygantas Au - Gualano，Gina Au - Hoefsloot，Wouter Au - Jonsson，Jerker Au - Khimova，Elena Au - Kunst，Heinke Au - Laniado-Langerín，Rafael Au - Li，Yangile Au - Magis-Escurra，Cecile Au - Manfrin，Vinicio Au - Marchese，Valentina Au - MartínezRobles，Elena Au - Alberto Au - Mazza-Stalder，Jesica Au - Moschos，Charalampos Au - Muñoz-Torrico，Marcela Au - Mustafa Hamdan，Hamdan Au - Nakčerienė，Birutėal - Nicod，Laurent Au - Nieto Marcos，Magnolia Au - Palmero，Domingo Juan Au - Palmizio Au - Papavasieiou，Apostolos Au - Payen，Marie-Christine Au - Pontarelli，Agostina Au - Quirós，Sarai Au - Rendon，Adrian Au - Saderi，Laura Au - Šmite，Agnese Au - Solovic，IvanAu - Souleymane，Mahamadou Bassirou Au - Tadolini，Marina Au - van den Boom，Martin Au - Vescovo，Marisa Au - Viggiani，Pietro Au - Yedilbayev，Askar Au - Zablockis，Rolandas Au - Zignol，Matteo Au - Zignol，Dina Au - Spanevello，Antonio Au - Caminero，JoséA.Au - Alffenaar，Jan-Willem Au - Tiberi，Simon Au - Centis，RosellaAu - D'Ambrosio，Lia Au - Pontali，Emanuele Au - Sotgiu，Giovanni Au - Migliori，Giovanni Battista Y1 - 2019/12/01 UR - //www.qdcxjkg.com/content/54/6/1901522。abstract N2 - 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.Previous evidence on adverse events is available from single studies. This global project (658 patients from 26 countries) demonstrates aDSM is feasible and serious adverse events of recommended drugs are reasonably low (overall 57 out of 504, 11.3%). http://bit.ly/2kzvbqe ER -