TY - JOUR T1 -耐药结核病治疗不良事件监测:首次全球报告JF -欧洲呼吸杂志》乔和J - 10.1183/13993003.01522 -2019欧元六世- 54 - 6 SP - 1901522 AU -鲍里索夫,谢尔盖盟——Danila Edvardas盟——Maryandyshev安德烈•AU - Dalcolmo Margareth盟——Miliauskas Skaidrius盟——Kuksa联赛盟——漫画,月之女神盟——Skrahina阿勒娜盟——Diktanas Saulius盟——CodecasaLuigi Ruffo盟——Aleksa阿勒娜AU - Bruchfeld,朱迪思盟——Koleva Antoniya盟——Piubello Alberto盟——Udwadia Zarir Farokh盟——Akkerman应该w . AU - Belilovski Evgeny AU -伯纳尔,恩里克盟——Boeree马丁j . AU - Cadinanos Loidi, Julen AU - Cai,青山盟——Cebrian Gallardo Jose华金盟——达拉Masoud AU - Davidavič观看<ė,Edita AU - Forsman声称通过莉娜戴维斯AU -德洛里奥斯,豪尔赫盟——Denholm贾斯汀盟——观看<ė庄严赞歌š,杰西塔盟——杜阿尔特拉克尔盟——Elamin Seifeldin Eltaeb AU - Escobar萨利纳斯,Nadia盟——Ferrarese Maurizio盟——Filippov Alexey AU -加西亚,安娜AU - Garcia-Garcia,前首相何塞•玛丽亚•盟——Gaudiesiute Ieva盟——Gavazova Blagovesta盟——GayosoRegina AU -戈麦斯罗索,Roscio盟——Gruslys Vygantas盟——Gualano吉娜盟——Hoefsloot Wouter AU -琼森,肌肉抽搐盟——Khimova Elena盟——Kunst Heinke AU - Laniado-Laborin,拉斐尔•李盟——杨AU - Magis-Escurra,塞西尔盟——Manfrin维尼乔盟——Marchese瓦伦蒂娜AU -马丁内斯罗伯斯,Elena盟——Matteelli Alberto盟——Mazza-Stalder杰西卡盟——Moschos Charalampos盟——Munoz-Torrico玛赛拉盟-穆斯塔法哈姆丹,哈姆丹AU - Nakčerienė,Birutė盟——Nicod Laurent AU -尼托马科斯,木兰AU - Palmero,多明戈胡安AU - Palmieri,法盟——Papavasileiou Apostolos AU - Payen,玛丽- AU - Pontarelli Agostina盟——奎洛斯撒莱AU -瑞,艾德里安非盟- Saderi,劳拉AU -Š螨,Agnese盟——Solovic伊凡AU - Souleymane,迪亚拉Bassirou盟——Tadolini滨AU - van den繁荣,马丁盟——Vescovo玛丽莎盟——Viggiani Pietro盟——Yedilbayev阿非盟- Zablockis Rolandas盟——Zhurkin德米特里•AU - Zignol Matteo AU - Visca,蒂娜盟——Spanevello安东尼奥盟——Caminero Jose a . AU - AlffenaarJan-Willem AU - Tiberi, Simon AU - centes, Rosella AU - 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 -世界卫生组织(世卫组织)建议各国实施药物警戒,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根据世卫组织aDSM项目,在连续使用新药物(即贝达奎林、德拉曼尼)和再用药物(即氯法齐明、利奈唑胺)治疗的结核病患者队列中,评估抗结核药物不良事件的频率和严重程度。 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 -