دورية أكاديمية
Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report.
| العنوان: | Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report. |
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| المؤلفون: | Borisov S; Moscow Research and Clinical Center for TB Control, Moscow Government's Health Department, Moscow, Russian Federation.; These authors contributed equally., Danila E; Clinic of Chest Diseases, Immunology and Allergology, Vilnius University Medical Faculty, Centre of Pulmonology and Allergology, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania., Maryandyshev A; Northern State Medical University, Arkhangelsk, Russian Federation., Dalcolmo M; Reference Center Hélio Fraga, Fundação Oswaldo Cruz (Fiocruz)/Ministry of Health, Rio de Janeiro, Brazil., Miliauskas S; Dept of Pulmonology, Lithuanian University of Health Sciences, Kaunas, Lithuania., Kuksa L; MDR-TB Dept, Riga East University Hospital for TB and Lung Disease Centre, Riga, Latvia., Manga S; Dept of Infectious Diseases, University National San Antonio Abad Cusco, Cusco, Peru., Skrahina A; Republican Research and Practical Centre for Pulmonology and Tuberculosis, Minsk, Belarus., Diktanas S; Tuberculosis Dept, 3rd Tuberculosis Unit, Republican Klaipėda Hospital, Klaipėda, Lithuania., Codecasa LR; TB Reference Centre, Villa Marelli Institute, Niguarda Hospital, Milan, Italy., Aleksa A; Dept of Phthisiology and Pulmonology, Grodno State Medical University, Grodno, Belarus., Bruchfeld J; Division of Infectious Diseases, Dept of Medicine, Karolinska Institute, Solna, Sweden.; Dept of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden.; These authors contributed equally., Koleva A; Pulmonology and Physiotherapy Dept, Gabrovo Lung Diseases Hospital, Gabrovo, Bulgaria., Piubello A; Tuberculosis Division, International Union against Tuberculosis and Lung Disease (The Union), Paris, France.; Tuberculosis Division, Damien Foundation, Niamey, Niger.; These authors contributed equally., Udwadia ZF; Dept of Respiratory Medicine, P.D. Hinduja National Hospital and MRC, Mumbai, India., Akkerman OW; University of Groningen, University Medical Center Groningen, Dept of Pulmonary Diseases and Tuberculosis, Groningen, The Netherlands.; University of Groningen, University Medical Center Groningen, TB Center Beatrixoord, Haren, The Netherlands.; These authors contributed equally., Belilovski E; Moscow Research and Clinical Center for TB Control, Moscow Government's Health Department, Moscow, Russian Federation., Bernal E; Unidad de Enfermedades Infecciosas, Hospital General Universitario Reina Sofia, Murcia, Spain., Boeree MJ; Radboud University Medical Center, Center Dekkerswald, Nijmegen, The Netherlands., Cadiñanos Loidi J; Internal Medicine Dept, Hospital General de Villalba, Collado Villalba, Spain., Cai Q; Zhejiang Integrated Traditional and Western Medicine Hospital, Hangzhou, China., Cebrian Gallardo JJ; Unidad de Neumología, Agencia Sanitaria Costa del Sol, Marbella, Spain., Dara M; World Health Organization Regional Office for Europe, Copenhagen, Denmark., Davidavičienė E; National TB Registry, Public Health Dept, Ministry of Health, Vilnius, Lithuania.; Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania., Forsman LD; Division of Infectious Diseases, Dept of Medicine, Karolinska Institute, Solna, Sweden.; Dept of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden., De Los Rios J; Centro de Excelencia de TB 'Niño Jesus', Servicio de Neumologia, Hospital Maria Auxiliadora, Lima, Peru., Denholm J; Victorian Tuberculosis Program, Melbourne Health, Melbourne, Australia.; Dept of Microbiology and Immunology, University of Melbourne, Melbourne, Australia.; These authors contributed equally., Drakšienė J; Tuberculosis Dept, 3rd Tuberculosis Unit, Republican Klaipėda Hospital, Klaipėda, Lithuania., Duarte R; National Reference Centre for MDR-TB, Hospital Centre Vila Nova de Gaia, Dept of Pneumology, Public Health Science and Medical Education Dept, Faculty of Medicine, University of Porto, Porto, Portugal., Elamin SE; MDR-TB Department, Abu anga Teaching Hospital, Khartoum, Sudan., Escobar Salinas N; Division of Disease Prevention and Control, Dept of Communicable Diseases, National Tuberculosis Control and Elimination Programme, Ministry of Health, Santiago, Chile., Ferrarese M; TB Reference Centre, Villa Marelli Institute, Niguarda Hospital, Milan, Italy., Filippov A; Moscow Research and Clinical Center for TB Control, Moscow Government's Health Department, Moscow, Russian Federation., Garcia A; Pulmonology Division, Municipal Hospital F.J. Muñiz, Buenos Aires, Argentina., García-García JM; Tuberculosis Research Programme, SEPAR, Barcelona, Spain., Gaudiesiute I; Dept of Pulmonology, Lithuanian University of Health Sciences, Kaunas, Lithuania., Gavazova B; 'Improve the Sustainability of the National TB Programme', Sofia, Bulgaria., Gayoso R; Reference Center Hélio Fraga, Fundação Oswaldo Cruz (Fiocruz)/Ministry of Health, Rio de Janeiro, Brazil., Gomez Rosso R; National Institute of Respiratory and Environmental Diseases 'Prof. Dr. Juan Max Boettner' Asunción, Paraguay., Gruslys V; Clinic of Chest Diseases, Immunology and Allergology, Vilnius University Medical Faculty, Centre of Pulmonology and Allergology, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania., Gualano G; Respiratory Infectious Diseases Unit, National Institute for Infectious Diseases 'L. Spallanzani', IRCCS, Rome, Italy., Hoefsloot W; Radboud University Medical Center, Center Dekkerswald, Nijmegen, The Netherlands., Jonsson J; Dept of Public Health Analysis and Data Management, Public Health Agency of Sweden, Solna, Sweden., Khimova E; Northern State Medical University, Arkhangelsk, Russian Federation., Kunst H; Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK., Laniado-Laborín R; Universidad Autónoma de Baja California, Baja California, Mexico; Clínica de Tuberculosis del Hospital General de Tijuana, Tijuana, Mexico.; These authors contributed equally., Li Y; Dept of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, China., Magis-Escurra C; Radboud University Medical Center, Center Dekkerswald, Nijmegen, The Netherlands., Manfrin V; S. Bortolo Hospital, Vicenza, Italy., Marchese V; Clinic of Infectious and Tropical Diseases, WHO Collaborating Centre for TB elimination and TB/HIV co-infection, University of Brescia, Brescia, Italy., Martínez Robles E; Internal Medicine Dept, Tuberculosis Unit, Hospital de Cantoblanco - Hospital General Universitario La Paz, Madrid, Spain., Matteelli A; Clinic of Infectious and Tropical Diseases, WHO Collaborating Centre for TB elimination and TB/HIV co-infection, University of Brescia, Brescia, Italy., Mazza-Stalder J; Division of Pulmonary Medicine, University Hospital of Lausanne CHUV, Lausanne, Switzerland.; These authors contributed equally., Moschos C; Dept of Tuberculosis, Sotiria Athens Hospital of Chest Diseases, Athens, Greece., Muñoz-Torrico M; Clínica de Tuberculosis, Instituto Nacional De Enfermedades Respiratorias Ismael Cosio Villegas, Ciudad De Mexico, Mexico.; These authors contributed equally., Mustafa Hamdan H; MDR-TB Department, Abu anga Teaching Hospital, Khartoum, Sudan., Nakčerienė B; National TB Registry, Public Health Dept, Ministry of Health, Vilnius, Lithuania.; Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania., Nicod L; Division of Pulmonary Medicine, University Hospital of Lausanne CHUV, Lausanne, Switzerland., Nieto Marcos M; Internal Medicine Dept, Hospital Doctor Moliner, Valencia, Spain., Palmero DJ; Pulmonology Division, Municipal Hospital F.J. Muñiz, Buenos Aires, Argentina., Palmieri F; Respiratory Infectious Diseases Unit, National Institute for Infectious Diseases 'L. Spallanzani', IRCCS, Rome, Italy., Papavasileiou A; Dept of Tuberculosis, Sotiria Athens Hospital of Chest Diseases, Athens, Greece., Payen MC; Division of Infectious Diseases, CHU Saint-Pierre, Université Libre de Bruxelles (ULB), Brussels, Belgium., Pontarelli A; Reference Center for MDR-TB and HIV-TB, Eugenio Morelli Hospital, Sondalo, Italy., Quirós S; Pneumology Dept, Tuberculosis Unit, Hospital de Cantoblanco - Hospital General Universitario La Paz, Madrid, Spain., Rendon A; Centro de Investigación, Prevención y Tratamiento de Infecciones Respiratorias CIPTIR, University Hospital of Monterrey UANL (Universidad Autonoma de Nuevo Leon), Monterrey, Mexico., Saderi L; Clinical Epidemiology and Medical Statistics Unit, Dept of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy.; These authors contributed equally., Šmite A; MDR-TB Dept, Riga East University Hospital for TB and Lung Disease Centre, Riga, Latvia., Solovic I; National Institute for TB, Lung Diseases and Thoracic Surgery, Vysne Hagy, Catholic University Ruzomberok, Ruzomberok, Slovakia., Souleymane MB; Tuberculosis Division, Damien Foundation, Niamey, Niger., Tadolini M; Unit of Infectious Diseases, Dept of Medical and Surgical Sciences Alma Mater Studiorum University of Bologna, Bologna, Italy., van den Boom M; World Health Organization Regional Office for Europe, Copenhagen, Denmark.; These authors contributed equally., Vescovo M; Pulmonology Division, Municipal Hospital F.J. Muñiz, Buenos Aires, Argentina., Viggiani P; Reference Center for MDR-TB and HIV-TB, Eugenio Morelli Hospital, Sondalo, Italy., Yedilbayev A; World Health Organization Regional Office for Europe, Copenhagen, Denmark., Zablockis R; Clinic of Chest Diseases, Immunology and Allergology, Vilnius University Medical Faculty, Centre of Pulmonology and Allergology, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania., Zhurkin D; Republican Research and Practical Centre for Pulmonology and Tuberculosis, Minsk, Belarus., Zignol M; Global Tuberculosis Programme, World Health Organization, Geneva, Switzerland., Visca D; Division of Pulmonary Rehabilitation, Istituti Clinici Scientifici Maugeri, IRCCS, Tradate, Italy.; Dept of Medicine and Surgery, Respiratory Diseases, University of Insubria, Tradate, Italy.; These authors contributed equally., Spanevello A; Division of Pulmonary Rehabilitation, Istituti Clinici Scientifici Maugeri, IRCCS, Tradate, Italy.; Dept of Medicine and Surgery, Respiratory Diseases, University of Insubria, Tradate, Italy., Caminero JA; Pneumology Dept, Hospital General de Gran Canaria 'Dr. Negrin', Las Palmas de Gran Canaria, Spain.; MDR-TB Unit, Tuberculosis Division, International Union against Tuberculosis and Lung Disease (The Union), Paris, France.; These authors contributed equally., Alffenaar JW; University of Sydney, Faculty of Medicine and Health, School of Pharmacy, Sydney, Australia.; Westmead Hospital, Sydney, Australia.; University of Groningen, University Medical Center Groningen, Dept of Pharmacy and Pharmacology, Groningen, The Netherlands.; These authors contributed equally., Tiberi S; Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.; Dept of Infection, Royal London and Newham Hospitals, Barts Health NHS Trust, London, UK.; These authors contributed equally., Centis R; Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri IRCCS, Tradate, Italy.; These authors contributed equally., D'Ambrosio L; Public Health Consulting Group, Lugano, Switzerland.; These authors contributed equally., Pontali E; Dept of Infectious Diseases, Galliera Hospital, Genova, Italy.; These authors contributed equally., Sotgiu G; Clinical Epidemiology and Medical Statistics Unit, Dept of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy.; These authors contributed equally., Migliori GB; Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri IRCCS, Tradate, Italy giovannibattista.migliori@icsmaugeri.it.; These authors contributed equally. |
| المصدر: | The European respiratory journal [Eur Respir J] 2019 Dec 19; Vol. 54 (6). Date of Electronic Publication: 2019 Dec 19 (Print Publication: 2019). |
| نوع المنشور: | Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: European Respiratory Society Country of Publication: England NLM ID: 8803460 Publication Model: Electronic-Print Cited Medium: Internet ISSN: 1399-3003 (Electronic) Linking ISSN: 09031936 NLM ISO Abbreviation: Eur Respir J Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Sheffield, United Kingdom : European Respiratory Society Original Publication: Copenhagen : Published jointly by the Society and Munksgaard, 1988- |
| مواضيع طبية MeSH: | Antitubercular Agents/*adverse effects , Drug-Related Side Effects and Adverse Reactions/*diagnosis , Drug-Related Side Effects and Adverse Reactions/*epidemiology , Tuberculosis, Multidrug-Resistant/*drug therapy, Adult ; Aged ; Female ; Humans ; Male ; Middle Aged ; Pharmacovigilance ; Prospective Studies |
| مستخلص: | 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. Competing Interests: Conflict of interest: S. Borisov has nothing to disclose. Conflict of interest: E. Danila has nothing to disclose. Conflict of interest: A. Maryandyshev has nothing to disclose. Conflict of interest: M. Dalcolmo has nothing to disclose. Conflict of interest: S. Miliauskas has nothing to disclose. Conflict of interest: L. Kuksa reports personal fees for trial participation from Otsuka and Tibotec, personal fees for lectures from Johnson and Johnson Services Inc., outside the submitted work. Conflict of interest: S. Manga has nothing to disclose. Conflict of interest: A. Skrahina has nothing to disclose. Conflict of interest: S. Diktanas reports personal fees for trial participation from Otsuka, grants for meeting attendance from Janssen (Sirturo), outside the submitted work. Conflict of interest: L.R. Codecasa has nothing to disclose. Conflict of interest: A. Aleksa has nothing to disclose. Conflict of interest: J. Bruchfeld has nothing to disclose. Conflict of interest: A. Koleva has nothing to disclose. Conflict of interest: A. Piubello has nothing to disclose. Conflict of interest: Z.F. Udwadia has nothing to disclose. Conflict of interest: O.W. Akkerman has nothing to disclose. Conflict of interest: E. Belilovski has nothing to disclose. Conflict of interest: E. Bernal has nothing to disclose. Conflict of interest: M.J. Boeree has nothing to disclose. Conflict of interest: J. Cadiñanos Loidi has nothing to disclose. Conflict of interest: Q. Cai has nothing to disclose. Conflict of interest: J.J. Cebrian Gallardo has nothing to disclose. Conflict of interest: M. Dara has nothing to disclose. Conflict of interest: E. Davidavičienė has nothing to disclose. Conflict of interest: L. Davies Forsman has nothing to disclose. Conflict of interest: J. De Los Rios has nothing to disclose. Conflict of interest: J. Denholm has nothing to disclose. Conflict of interest: J. Drakšienė has nothing to disclose. Conflict of interest: R. Duarte has nothing to disclose. Conflict of interest: S.E. Elamin has nothing to disclose. Conflict of interest: N. Escobar Salinas has nothing to disclose. Conflict of interest: M. Ferrarese has nothing to disclose. Conflict of interest: A. Filippov has nothing to disclose. Conflict of interest: A. Garcia has nothing to disclose. Conflict of interest: J.M. García-García has nothing to disclose. Conflict of interest: I. Gaudiesiute has nothing to disclose. Conflict of interest: B. Gavazova has nothing to disclose. Conflict of interest: R. Gayoso has nothing to disclose. Conflict of interest: R. Gomez Rosso has nothing to disclose. Conflict of interest: V. Gruslys has nothing to disclose. Conflict of interest: G. Gualano has nothing to disclose. Conflict of interest: W. Hoefsloot has nothing to disclose. Conflict of interest: J. Jonsson has nothing to disclose. Conflict of interest: E. Khimova has nothing to disclose. Conflict of interest: H. Kunst has nothing to disclose. Conflict of interest: R. Laniado-Laborín has nothing to disclose. Conflict of interest: Y. Li has nothing to disclose. Conflict of interest: C. Magis-Escurra has nothing to disclose. Conflict of interest: V. Manfrin has nothing to disclose. Conflict of interest: V. Marchese has nothing to disclose. Conflict of interest: E. Martínez Robles has nothing to disclose. Conflict of interest: A. Matteelli has nothing to disclose. Conflict of interest: J. Mazza-Stalder has nothing to disclose. Conflict of interest: C. Moschos has nothing to disclose. Conflict of interest: M. Muñoz-Torrico has nothing to disclose. Conflict of interest: H. Mustafa Hamdan has nothing to disclose. Conflict of interest: B. Nakčerienė has nothing to disclose. Conflict of interest: L. Nicod has nothing to disclose. Conflict of interest: M. Nieto Marcos has nothing to disclose. Conflict of interest: D.J. Palmero has nothing to disclose. Conflict of interest: F. Palmieri has nothing to disclose. Conflict of interest: A. Papavasileiou has nothing to disclose. Conflict of interest: M-C. Payen has nothing to disclose. Conflict of interest: A. Pontarelli has nothing to disclose. Conflict of interest: S. Quirós has nothing to disclose. Conflict of interest: A. Rendon has nothing to disclose. Conflict of interest: L. Saderi has nothing to disclose. Conflict of interest: A. Šmite has nothing to disclose. Conflict of interest: I. Solovic has nothing to disclose. Conflict of interest: M.B. Souleymane has nothing to disclose. Conflict of interest: M. Tadolini has nothing to disclose. Conflict of interest: M. van den Boom has nothing to disclose. Conflict of interest: M. Vescovo has nothing to disclose. Conflict of interest: P. Viggiani has nothing to disclose. Conflict of interest: A. Yedilbayev has nothing to disclose. Conflict of interest: R. Zablockis has nothing to disclose. Conflict of interest: D. Zhurkin has nothing to disclose. Conflict of interest: M. Zignol has nothing to disclose. Conflict of interest: D. Visca has nothing to disclose. Conflict of interest: A. Spanevello has nothing to disclose. Conflict of interest: J.A. Caminero has nothing to disclose. Conflict of interest: J-W. Alffenaar has nothing to disclose. Conflict of interest: S. Tiberi has nothing to disclose. Conflict of interest: R. Centis has nothing to disclose. Conflict of interest: L. D'Ambrosio has nothing to disclose. Conflict of interest: E. Pontali has nothing to disclose. Conflict of interest: G. Sotgiu has nothing to disclose. Conflict of interest: G.B. Migliori has nothing to disclose. (Copyright ©ERS 2019.) |
| التعليقات: | Comment in: Pulmonology. 2021 Mar-Apr;27(2):94-96. (PMID: 33272908) |
| المشرفين على المادة: | 0 (Antitubercular Agents) |
| تواريخ الأحداث: | Date Created: 20191012 Date Completed: 20201005 Latest Revision: 20210218 |
| رمز التحديث: | 20221213 |
| DOI: | 10.1183/13993003.01522-2019 |
| PMID: | 31601711 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1399-3003 |
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| DOI: | 10.1183/13993003.01522-2019 |