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CLINICAL STANDARDS FOR THE DOSING AND MANAGEMENT OF TB DRUGS
Farmacocinética
Farmacodinâmica
Reação adversa à droga
Gestão
Dosagem
Author
Alffenaar, J. W. C.
Stocker, S. L.
Forsman, L. Davies
Garcia-Prats, A.
Heysell, S. K.
Aarnoutse, R. E.
Akkerman, O. W.
Aleska, A.
van Altena, R.
Oñata, W. Arrazola de
Bhavani, P. K.
van‘t Boveneind-Vrubleuskaya, N.
Carvalo, A. C. C.
Centis, R.
Chakaya, J. M.
Cirllo, D. M.
Cho, J. G.
D’Ambrosio, L.
Dalcolmo, M. P.
Denti, P.
Dheda, K.
Fox, G. J.
Hesseling, A. C.
Kim, H. Y.
Köser, C. U.
Marais, B. J.
Margineanu, I.
Märtson, A. G.
Torrico, M. Munoz
Nataprawira, H. M.
Ong, C. W. M.
Otto-Knapp, R.
Peloquin, C. A.
Silva, D. R.
Ruslami, R.
Santoso, P.
Savic, R. M.
Singla, R.
Svensson, E. M.
Skrahina, A.
van Soolingen, D.
Srivastava, S.
Tadolini, M.
Tiberi, S,
Thomas, T. A.
Udwadia, Z. F.
Vu, D. H.
Zhan, W.
Mpagama, S. G.
Schön, T.
Migliori, G. B.
Stocker, S. L.
Forsman, L. Davies
Garcia-Prats, A.
Heysell, S. K.
Aarnoutse, R. E.
Akkerman, O. W.
Aleska, A.
van Altena, R.
Oñata, W. Arrazola de
Bhavani, P. K.
van‘t Boveneind-Vrubleuskaya, N.
Carvalo, A. C. C.
Centis, R.
Chakaya, J. M.
Cirllo, D. M.
Cho, J. G.
D’Ambrosio, L.
Dalcolmo, M. P.
Denti, P.
Dheda, K.
Fox, G. J.
Hesseling, A. C.
Kim, H. Y.
Köser, C. U.
Marais, B. J.
Margineanu, I.
Märtson, A. G.
Torrico, M. Munoz
Nataprawira, H. M.
Ong, C. W. M.
Otto-Knapp, R.
Peloquin, C. A.
Silva, D. R.
Ruslami, R.
Santoso, P.
Savic, R. M.
Singla, R.
Svensson, E. M.
Skrahina, A.
van Soolingen, D.
Srivastava, S.
Tadolini, M.
Tiberi, S,
Thomas, T. A.
Udwadia, Z. F.
Vu, D. H.
Zhan, W.
Mpagama, S. G.
Schön, T.
Migliori, G. B.
Affilliation
Sydney Institute for Infectious Diseases, The University of Sydney, Sydney, NSW / School of Pharmacy, The University of Sydney Faculty of 492 The International Journal of Tuberculosis and Lung Disease Medicine and Health, Sydney, NSW / 3Westmead Hospital, Sydney, NSW.
School of Pharmacy, The University of Sydney Faculty of 492 The International Journal of Tuberculosis and Lung Disease Medicine and Health, Sydney, NSW / Department of Clinical Pharmacology and Toxicology, St Vincent’s Hospital, Sydney, NSW / St Vincent’s Clinical Campus, University of NSW, Kensington, NSW, Australia.
Division of Infectious Diseases, Department of Medicine, Karolinska Institutet, Solna / Department of Infectious Diseases Karolinska University Hospital, Solna, Sweden.
Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg, South Africa / Department of Pediatrics, University of Wisconsin, Madison, WI.
Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, VA, USA.
Department of Pharmacy, Radboud Institute for Health Sciences & Radboudumc Center for Infectious Diseases, Radboud University Medical Center, Nijmegen.
University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases and Tuberculosis, Groningen / University of Groningen, University Medical Center Groningen, Tuberculosis Center Beatrixoord, Haren, The Netherlands.
Educational Institution ‘‘Grodno State Medical University’’, Grodno, Belarus.
Asian Harm Reduction Network (AHRN) and Medical Action Myanmar (MAM) in Yangon, Myanmar.
Belgian Scientific Institute for Public Health (Belgian Lung and Tuberculosis Association), Brussels, Belgium.
Indian Council of Medical Research-National Institute for Research in Tuberculosis-International Center for Excellence in Research, Chennai, India.
Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen / Department of Public Health TB Control, Metropolitan Public Health Services, The Hague, The Netherlands.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. 0Laboratório de Inovações em Terapias, Ensino e Bioprodutos (LITEB. Rio de Janeiro, RJ, Brasil.
Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Tradate, Italy.
Department of Medicine, Therapeutics and Dermatology, Kenyatta University, Nairobi, Kenya / Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.
Emerging Bacterial Pathogens Unit, Division of Immunology, Transplantation and Infectious Diseases, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Sydney Institute for Infectious Diseases, The University of Sydney, Sydney, NSW / Westmead Hospital, Sydney, NSW / Parramatta Chest Clinic, Parramatta, NSW, Australia.
Public Health Consulting Group, Lugano, Switzerland.
Fundação Oswaldo Cruz. Escola Nacional de Saúde Pública. Centro de Referência Helio Fraga. Rio de Janeiro, RJ, Brasil.
Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town.
Centre for Lung Infection and Immunity, Department of Medicine, Division of Pulmonology and UCT Lung Institute, University of Cape Town, Cape Town, South Africa / University of Cape Town Lung Institute & South African MRC Centre for the Study of Antimicrobial Resistance, Cape Town, South Africa / Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene & Tropical Medicine, London, UK.
Faculty of Medicine and Health, Sydney Medical School, The University of Sydney, Sydney, NSW / Woolcock Institute of Medical Research, Glebe, NSW, Australia.
Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg, South Africa.
Sydney Institute for Infectious Diseases, The University of Sydney, Sydney, NSW / School of Pharmacy, The University of Sydney Faculty of 492 The International Journal of Tuberculosis and Lung Disease Medicine and Health, Sydney, NSW / 3Westmead Hospital, Sydney, NSW.
Department of Genetics, University of Cambridge, Cambridge, UK.
Sydney Institute for Infectious Diseases, The University of Sydney, Sydney, NSW / Department of Infectious Diseases and Microbiology, The Children’s Hospital at Westmead, Westmead, NSW, Australia.
Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen.
Antimicrobial Pharmacodynamics and Therapeutics, Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.
Clínica de Tuberculosis, Instituto Nacional de Enfermedades Respiratorias, Ciudad de México, Mexico.
Division of Paediatric Respirology, Department of Child Health, Faculty of Medicine, Universitas Padjadjaran, Hasan Sadikin Hospital, Bandung, Indonesia
Infectious Disease Translational Research Programme, Department of Medicine, Yong Loo Lin School of Medicine / Institute for Health Innovation & Technology (iHealthtech), National University of Singapore, Singapore / Division of Infectious Diseases, Department of Medicine, National University Hospital, Singapore;.
German Central Committee against Tuberculosis (DZK), Berlin, Germany.
Infectious Disease Pharmacokinetics Laboratory, Pharmacotherapy and Translational Research, University of Florida College of Pharmacy, Gainesville, FL, USA.
Universidade Federal do Rio Grande do Sul. Faculdade de Medicina. Porto Alegre, RS, Brasil.
TB/HIV Research Centre, Faculty of Medicine, Universitas Padjadjaran, Bandung / Department of Biomedical Sciences, Division of Pharmacology and Therapy, Faculty of Medicine, Universitas Padjadjaran, Bandung.
Division of Respirology and Critical Care, Department of Internal Medicine, Faculty of Medicine, Universitas Padjadjaran/Hasan Sadikin General Hospital, Bandung, Indonesia
Department of Bioengineering and Therapeutic Sciences, Division of Pulmonary and Critical Care Medicine, Schools of Pharmacy and Medicine, University of California San Francisco, San Francisco, CA, USA.
Department of TB & Respiratory Diseases, National Institute of TB & Respiratory Diseases, New Delhi, India.
Department of Pharmacy, Radboud Institute for Health Sciences & Radboudumc Center for Infectious Diseases, Radboud University Medical Center, Nijmegen / Department of Pharmacy, Uppsala University, Uppsala, Sweden.
The Republican Research and Practical Centre for Pulmonology and TB, Minsk, Belarus.
National Institute for Public Health and the Environment, TB Reference Laboratory (RIVM), Bilthoven, The Netherlands.
Department of Pulmonary Immunology, University of Texas Health Science Center at Tyler, Tyler, TX, USA.
Infectious Diseases Unit, IRCCS Azienda Ospedaliero- Universitaria di Bologna, Bologna / Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.
Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, VA, USA.
P. D. Hinduja National Hospital and Medical Research Centre, Mumbai, India.
National Drug Information and Adverse Drug Reaction Monitoring Centre, Hanoi University of Pharmacy, Hanoi, Vietnam.
Department of Infectious Diseases, National Medical Center for Infectious Diseases, Shanghai Key Laboratory of Infectious Diseases and Biosafety Emergency Response, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People’s Republic of China.
Kilimanjaro Christian Medical University College, Moshi / Kibong’oto Infectious Diseases Hospital, Sanya Juu, Siha, Kilimanjaro, United Republic of Tanzania.
Department of Infectious Diseases, Linköping University Hospital, Linköping / Institute of Biomedical and Clinical Sciences, Division of Infection and Inflammation, and Department of Infectious Diseases, Kalmar County Hospital, Kalmar, Linköping University, Linköping, Sweden.
Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Tradate, Italy.
School of Pharmacy, The University of Sydney Faculty of 492 The International Journal of Tuberculosis and Lung Disease Medicine and Health, Sydney, NSW / Department of Clinical Pharmacology and Toxicology, St Vincent’s Hospital, Sydney, NSW / St Vincent’s Clinical Campus, University of NSW, Kensington, NSW, Australia.
Division of Infectious Diseases, Department of Medicine, Karolinska Institutet, Solna / Department of Infectious Diseases Karolinska University Hospital, Solna, Sweden.
Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg, South Africa / Department of Pediatrics, University of Wisconsin, Madison, WI.
Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, VA, USA.
Department of Pharmacy, Radboud Institute for Health Sciences & Radboudumc Center for Infectious Diseases, Radboud University Medical Center, Nijmegen.
University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases and Tuberculosis, Groningen / University of Groningen, University Medical Center Groningen, Tuberculosis Center Beatrixoord, Haren, The Netherlands.
Educational Institution ‘‘Grodno State Medical University’’, Grodno, Belarus.
Asian Harm Reduction Network (AHRN) and Medical Action Myanmar (MAM) in Yangon, Myanmar.
Belgian Scientific Institute for Public Health (Belgian Lung and Tuberculosis Association), Brussels, Belgium.
Indian Council of Medical Research-National Institute for Research in Tuberculosis-International Center for Excellence in Research, Chennai, India.
Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen / Department of Public Health TB Control, Metropolitan Public Health Services, The Hague, The Netherlands.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. 0Laboratório de Inovações em Terapias, Ensino e Bioprodutos (LITEB. Rio de Janeiro, RJ, Brasil.
Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Tradate, Italy.
Department of Medicine, Therapeutics and Dermatology, Kenyatta University, Nairobi, Kenya / Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.
Emerging Bacterial Pathogens Unit, Division of Immunology, Transplantation and Infectious Diseases, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Sydney Institute for Infectious Diseases, The University of Sydney, Sydney, NSW / Westmead Hospital, Sydney, NSW / Parramatta Chest Clinic, Parramatta, NSW, Australia.
Public Health Consulting Group, Lugano, Switzerland.
Fundação Oswaldo Cruz. Escola Nacional de Saúde Pública. Centro de Referência Helio Fraga. Rio de Janeiro, RJ, Brasil.
Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town.
Centre for Lung Infection and Immunity, Department of Medicine, Division of Pulmonology and UCT Lung Institute, University of Cape Town, Cape Town, South Africa / University of Cape Town Lung Institute & South African MRC Centre for the Study of Antimicrobial Resistance, Cape Town, South Africa / Faculty of Infectious and Tropical Diseases, Department of Immunology and Infection, London School of Hygiene & Tropical Medicine, London, UK.
Faculty of Medicine and Health, Sydney Medical School, The University of Sydney, Sydney, NSW / Woolcock Institute of Medical Research, Glebe, NSW, Australia.
Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg, South Africa.
Sydney Institute for Infectious Diseases, The University of Sydney, Sydney, NSW / School of Pharmacy, The University of Sydney Faculty of 492 The International Journal of Tuberculosis and Lung Disease Medicine and Health, Sydney, NSW / 3Westmead Hospital, Sydney, NSW.
Department of Genetics, University of Cambridge, Cambridge, UK.
Sydney Institute for Infectious Diseases, The University of Sydney, Sydney, NSW / Department of Infectious Diseases and Microbiology, The Children’s Hospital at Westmead, Westmead, NSW, Australia.
Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen.
Antimicrobial Pharmacodynamics and Therapeutics, Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.
Clínica de Tuberculosis, Instituto Nacional de Enfermedades Respiratorias, Ciudad de México, Mexico.
Division of Paediatric Respirology, Department of Child Health, Faculty of Medicine, Universitas Padjadjaran, Hasan Sadikin Hospital, Bandung, Indonesia
Infectious Disease Translational Research Programme, Department of Medicine, Yong Loo Lin School of Medicine / Institute for Health Innovation & Technology (iHealthtech), National University of Singapore, Singapore / Division of Infectious Diseases, Department of Medicine, National University Hospital, Singapore;.
German Central Committee against Tuberculosis (DZK), Berlin, Germany.
Infectious Disease Pharmacokinetics Laboratory, Pharmacotherapy and Translational Research, University of Florida College of Pharmacy, Gainesville, FL, USA.
Universidade Federal do Rio Grande do Sul. Faculdade de Medicina. Porto Alegre, RS, Brasil.
TB/HIV Research Centre, Faculty of Medicine, Universitas Padjadjaran, Bandung / Department of Biomedical Sciences, Division of Pharmacology and Therapy, Faculty of Medicine, Universitas Padjadjaran, Bandung.
Division of Respirology and Critical Care, Department of Internal Medicine, Faculty of Medicine, Universitas Padjadjaran/Hasan Sadikin General Hospital, Bandung, Indonesia
Department of Bioengineering and Therapeutic Sciences, Division of Pulmonary and Critical Care Medicine, Schools of Pharmacy and Medicine, University of California San Francisco, San Francisco, CA, USA.
Department of TB & Respiratory Diseases, National Institute of TB & Respiratory Diseases, New Delhi, India.
Department of Pharmacy, Radboud Institute for Health Sciences & Radboudumc Center for Infectious Diseases, Radboud University Medical Center, Nijmegen / Department of Pharmacy, Uppsala University, Uppsala, Sweden.
The Republican Research and Practical Centre for Pulmonology and TB, Minsk, Belarus.
National Institute for Public Health and the Environment, TB Reference Laboratory (RIVM), Bilthoven, The Netherlands.
Department of Pulmonary Immunology, University of Texas Health Science Center at Tyler, Tyler, TX, USA.
Infectious Diseases Unit, IRCCS Azienda Ospedaliero- Universitaria di Bologna, Bologna / Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.
Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, VA, USA.
P. D. Hinduja National Hospital and Medical Research Centre, Mumbai, India.
National Drug Information and Adverse Drug Reaction Monitoring Centre, Hanoi University of Pharmacy, Hanoi, Vietnam.
Department of Infectious Diseases, National Medical Center for Infectious Diseases, Shanghai Key Laboratory of Infectious Diseases and Biosafety Emergency Response, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People’s Republic of China.
Kilimanjaro Christian Medical University College, Moshi / Kibong’oto Infectious Diseases Hospital, Sanya Juu, Siha, Kilimanjaro, United Republic of Tanzania.
Department of Infectious Diseases, Linköping University Hospital, Linköping / Institute of Biomedical and Clinical Sciences, Division of Infection and Inflammation, and Department of Infectious Diseases, Kalmar County Hospital, Kalmar, Linköping University, Linköping, Sweden.
Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Tradate, Italy.
Abstract
Optimal drug dosing is important to ensure adequate response to treatment, prevent development of drug resistance and reduce drug toxicity. The aim of these clinical standards is to provide guidance on ‘best practice’ for dosing and management of TB drugs. METHODS : A panel of 57 global experts in the fields of microbiology, pharmacology and TB care were identified; 51 participated in a Delphi process. A 5-point Likert scale was used to score draft standards. The final document represents the broad consensus and was approved by all participants. RESULT S : Six clinical standards were defined: Standard 1, defining the most appropriate initial dose for TB treatment; Standard 2, identifying patients who may be at risk of sub-optimal drug exposure; Standard 3, identifying patients at risk of developing drug-related toxicity and how best to manage this risk; Standard 4, identifying patients who can benefit from therapeutic drug monitoring (TDM); Standard 5, highlighting education and counselling that should be provided to people initiating TB treatment; and Standard 6, providing essential education for healthcare professionals. In addition, consensus research priorities were identified. CONCLUS ION: This is the first consensus-based Clinical Standards for the dosing and management of TB drugs to guide clinicians and programme managers in planning and implementation of locally appropriate measures for optimal person-centred treatment to improve patient care.
Keywords in Portuguese
TuberculoseFarmacocinética
Farmacodinâmica
Reação adversa à droga
Gestão
Dosagem
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