@article {Borisov1901522,作者= {Borisov,Sergey和Danila,Edvardas和Maryandyshev,Andrei和Dalcolmo,Dalcolmo,Margareth和Miliauskas,Skaidrius和Kuksa and Skuksa and Kuksa,Liga,Liga,Liga,Liga,Liga,Selene和Skrahina,Selene and Skrahina and sauig andeek and sauigi and sauif and sauif and sauiui and anuius and sauiui fiffere and sauiui fiff,Alena和Bruchfeld,Judith和Koleva,Antoniya和Piubello,Alberto和Udwadia,Zarir Farokh和Akkerman,Onno W.,Onno W.以及Belilovski,Evgeny和Evgeny和Bernal,Enrique和Enrique和Boeree和Boeree和Boeree,Martin J.和Cadi J.和Cadi {和Cadi {和Cai,Qingshan和Cebrian Gallardo,Jose Joaqu {\'\ i}}{\'e} -mar {\'\ i} A和Gaudiesiute,Ieva和Gavazova,Blagovesta和Gayoso,Gayoso,Regina和Gomez Rosso,Roscio和Gruslys,vygantas和gualano,Gina and Hoe,Gina和HoeFSloot,Wouter和Jonsson,Jerker和Khimova,Elena和Kunst,Heinke和Laniado-Labor {\'\ i}'\ i} nez Robles,Elena和Matteelli,Alberto和Mazza-Stalder,Jesica和Moschos,Charalampos和Mu {\ 〜n} Oz-Torrico,Marcela和Marcela和Mustafa Hamdan,Hamdan和Nak {\ v C} Erien和Nicod,Buyute and Nicod,Buyute and Nicod,Buyute and Nicod,Buyute and Nicod和Nicod,Laurent和Nieto Marcos,Magnolia和Palmero,Domingo Juan和Palmieri,Fabrizio和Papavasileiou,Apostolos和Payen和Payen,Marie-Christine和Pontarelli,Pontarelli,Agostina,Agostina和Quir {\'o},Sarai和Rendon,Adrian and Sadrian and Saderi,Laura和Laura,Laura和laura和laura和laura and {\v S}mite, Agnese and Solovic, Ivan and Souleymane, Mahamadou Bassirou and Tadolini, Marina and van den Boom, Martin and Vescovo, Marisa and Viggiani, Pietro and Yedilbayev, Askar and Zablockis, Rolandas and Zhurkin, Dmitry and Zignol, Matteo还有Visca,Dina和Spanevello,Antonio和Caminero,Jos {\'e} A.以及Alffenaar,Jan-Willem和Tiberi,Simon和Centis,Rosella和D {\ texquoteright} Ambrosio,Lia和Pontali,Emanuele和Sotgiu,Giovanni和Migliori,Giovanni Battista},title = {监视不良事件在治疗药物耐药的结核病:首次全球报告},第一卷:{6},Elocation-id = {1901522},年= {2019},doi = {10.1183/13993003.01522-2019},出版商= {欧洲呼吸社会},摘要= {世界188bet官网地址卫生组织(WHO)药物警戒并收集有关主动药物安全监测(ADSM)和不良事件管理的信息。这项前瞻性研究的目的是评估一系列连续的TB患者,评估不良事件对抗结核药物(TB)药物的频率和严重程度有了新的(即 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{\textendash}2) and 57 (11.3\%) as serious (grade 3{\textendash}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}, issn = {0903-1936}, URL = {//www.qdcxjkg.com/content/54/6/1901522}, eprint = {//www.qdcxjkg.com/content/54/6/1901522.full.pdf}, journal = {European Respiratory Journal} }