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世衛組織更新基本藥物清單,提出關于抗生素使用的新建議

2019-12-04

2017年6月6日 | 日內瓦 - 世衛組織2017年基本藥物標準清單增添了新內容, 其中包括就可用于常見感染的抗生素和應保留給最嚴重情況的抗生素提出了新建議。 其它補充包括列入了用于艾滋病毒、丙型肝炎、結核病和白血病的藥物。

更新后的清單為成人增加了30種藥物,

為兒童增加了25種藥物, 并為9種已列入清單的產品規定了新用途, 由此使解決最重要公共衛生需求所必須的基本藥物總共達433種。 許多國家利用世衛組織的基本藥物清單來增加藥物獲取, 并以清單為指導來決定可為其人口提供哪些產品。

“安全有效的藥物是任何衛生系統的必要組成部分, ”世衛組織衛生系統和創新部門助理總干事Marie-Paule Kieny博士說, “確保所有人能隨時隨地獲得所需的藥物對于各國實現全民健康覆蓋目標至關重要。 ”

新建議:三類抗生素

此次對抗生素部分的修訂是基本藥物清單四十年歷史中最大一次,

世衛組織專家將抗生素分為了三類:可用類、慎用類和備用類, 并就每個類別應在何時使用提出了建議。 最初, 這些新類別僅適用于治療21種最常見一般感染的抗生素。 如果經證明有效, 可在未來版本的基本藥物清單中擴大適用于治療其它感染的藥物。

這一變化的目的在于確保需要時有可用的抗生素, 并確保對感染開處正確的抗生素。 這應當能增強治療效果, 減少耐藥細菌的發展, 并保護所有其它藥物失靈時作為“最后手段”的抗生素的有效性。 這些變化支持世衛組織抗微生物藥物耐藥性全球行動計劃, 該計劃旨在通過確保最佳利用抗生素來抵抗耐藥性的發展。

世衛組織建議, “可用類”中的抗生素可隨時用于治療范圍廣泛的常見感染。 例如, 其中包括阿莫西林這種廣泛用于治療肺炎等感染的抗生素。

“慎用類”包括建議用于對少數感染進行一級或二級治療的抗生素。 例如, 應該大幅減少對用于治療膀胱炎(一種尿路感染)和上呼吸道感染(如細菌性鼻竇炎和細菌性支氣管炎)的環丙沙星的使用, 以避免耐藥性的進一步發展。

第三類為“備用類”, 包括應被視為最后手段的抗生素, 如粘菌素和一些頭孢菌素等, 并應僅在所有其它替代藥物失靈的最嚴重情況下使用, 例如用于因耐多藥細菌導致的危及生命的感染。

世衛組織專家在成人藥物清單中上增加了10種抗生素, 在兒童藥物清單中增加了12種抗生素。

“抗生素耐藥性的上升源于我們使用(包括濫用)這些藥物的方式, ”基本藥物和衛生產品司司長Suzanne Hill博士說, “新的世衛組織清單應該有助于衛生系統計劃者和處方人員確保有需要者能夠獲得并且能夠獲得正確的抗生素, 以防止耐藥性問題惡化。

其它補充

經更新的基本藥物清單還列入了幾種新藥, 如兩種口服癌癥治療藥物, 一種綜合了兩種藥物的新丙型肝炎藥丸, 一種更有效的艾滋病毒治療藥物, 以及一種可用于在高危人群中預防艾滋病毒感染的老藥物, 結核藥物的新型兒科配方和止痛藥物。 這些藥物具體包括:

兩種口服癌癥藥物(達沙替尼和尼羅替尼), 用于治療已對標準治療具有耐藥性的慢性骨髓性白血病。 在臨床試驗中, 每兩名服用這些藥物的患者中就有一人獲得了完全和持久的緩解;

索非布韋+維帕他韋作為治療所有六種類型丙型肝炎的第一種聯合療法(世衛組織目前正在更新關于丙型肝炎的治療建議);

用于治療艾滋病毒感染的多替拉韋鈉片, 最新證據顯示了該藥物的安全性, 療效和對耐藥性的高阻擋力;

單獨使用替諾福韋或者與恩曲他濱或拉米夫定聯合使用,

進行接觸前預防, 以預防艾滋病毒感染;

用于治療患耐多藥結核病的兒童和青少年的地依麥迪和用于治療患耐多藥結核病的兒童和成人的氯法齊明;

用于治療兒童結核病的便于兒童使用的異煙肼、利福平、乙胺丁醇和吡嗪酰胺的固定劑量組合制劑;

用于緩解癌癥患者疼痛的芬太尼皮膚貼片和美沙酮, 目的是增加對臨終護理藥物的獲取。

編者按

世衛組織基本藥物標準清單于1977年推出, 與此同時各國政府在世界衛生大會上支持將“人人享有衛生保健”作為世衛組織和國家衛生政策的指導原則。

許多國家采用了基本藥物的概念, 并以基本藥物清單為指導, 制定了本國的清單。 世衛組織基本藥物的選擇和使用專家委員會每兩年對基本藥物清單進行更新和修訂。

專家委員會第二十一次會議于2017年3月27-31日在世衛組織總部舉行。 委員會審議了92項申請,涉及大約100種藥物,并在標準清單中增加了55種藥物(在一般基本藥物清單中增加了30種,在兒童基本藥物清單中增加了25種)。

專家委員會名單 Committee members


Zeba AZIZ (Pakistan)
Zeba Aziz is a Medical Oncologist with a busy clinical practice based in Hameed Latif Hospital, Lahore, Pakistan. She previously served as the Head of Department of Oncology and Professor at Jinnah Hospital Lahore. Currently she is Dean of Medical Oncology for the College of Physicians and Surgeons Pakistan and is also the Program Director for the Medical Oncology Fellowship at Hameed Latif Hospital. Her international efforts include being on the steering committee for the Australian & Asia Pacific Oncology Research Development (ACORD) Workshop and being an invited panel list and speaker for multiple conferences around the world. She has made contributions to research through her 79 peer-reviewed publications on Oncology. Her specific fields of interest are malignant hematology and breast cancer.

Lisa BERO (USA) 
Lisa Bero is a pharmacologist with a focus on research integrity and the translation of clinical sciences into practice and health policy. She is Chair of Medicines Use and Health Outcomes at the University of Sydney in Australia and Co-Chair of the Cochrane Collaboration Governing Board. She has published over 180 peer reviewed publications, has served on numerous international committees and has been recognized for her mentoring of students with numerous awards.

Franco CAVALLI (Switzerland)
Franco Cavalli is the Scientific Director of the Oncology Institute of Southern Switzerland, which he founded. As an international expert on treatment and research related to malignant lymphoma and new drugs, he has published extensively and has received numerous awards. He is currently Chairman of the Scientific Committee of the European School of Oncology and the World Oncology Forum.

Graham COOKE (United Kingdom)
Graham Cooke is a clinical academic trained in infectious diseases with a research interest in HIV, TB and hepatitis. Prior to taking up a position at Imperial College he was based in KwaZulu-Natal researching the impact of HIV treatment scale-up. He leads the clinical work stream of the UK STOP-HCV consortium and his current interests include developing the evidence to inform scaling up the global response to viral hepatitis.

Facundo GARCIA BOURNISSEN (Argentina)
Facundo Garcia Bournissen is a pediatrician, clinical pharmacologist and independent researcher for Argentina's National Council for Science and Technological Research (CONICET), based in Buenos Aires Children's Hospital. He received his medical and pediatric specialty degrees from the University of Buenos Aires (Argentina) and his PhD and clinical pharmacology fellowship from the University of Toronto (Canada). His current focus of research is in the pharmacology of pediatric neglected diseases.

Mohammed HASSAR (Morocco)
Mohammed Hassar is an internist and a clinical pharmacologist and a Professor at the Rabat School of Medicine and Pharmacy in Rabat, Morocco. For the past thirty five years, he has been active in the field of global public health with an emphasis on rational therapy, pharmaco- economics and the safety of drugs. He has served on several WHO committees and panels. He represented WHO on the governing board of the WHO Uppsala Monitoring Centre for drug safety and was a member of the WHO ATC/DDD working group in Oslo.

Greg KEARNS (United States of America)
Greg Kearns is a pharmacist and a paediatric clinical pharmacologist and is currently President of the Arkansas Children’s Hospital Research Institute and Senior Vice President / Chief Research Officer of the Arkansas Children’s Hospital. He also is a Professor of Paediatrics at the University of Arkansas for Medical Sciences. Dr Kearns’ research has focused on developmental regulation of pharmacokinetics/pharmacodynamics, the evaluation of mechanisms underlying adverse drug reactions, the design of innovative clinical trials for new therapeutic interventions for children and the integration of pharmacogenetics into Phase II clinical trials in children. He has received continuous research support from NIH for paediatric clinical pharmacology research since 1993 and has authored over 285 peer-reviewed publications.

Robert MVUNGI (United Republic of Tanzania)
Robert Mvungi, a cardiologist, former heads the Department of Cardiovascular Medicine at Muhimbili National Hospital in Tanzania. He is President of the Tanzanian Cardiac Society, Chairman of the Tanzanian Cardiac Task Force and a member of numerous other cardiac societies. His research has been focused on the causes, characteristics and consequences of heart disease.

Francis OFEI (Ghana)
Francis Ofei is a physician in internal medicine and therapeutics and sub-specialized in endocrinology and diabetes medicine. He is serving his second term as Chairperson for the National Standard Treatment Guidelines and Essential Medicines selection committee in Ghana and is a Fellow of the Ghana College of Physicians and the Royal Colleges of Physicians of London and Edinburgh. He is currently Associate Professor of Internal Medicine and Dean of the School of Medical Sciences, University of Cape Coast in Ghana.

Gabriela PRUTSKY LOPEZ (United States of America)
Gabriela Prutsky Lopez is a pediatrician and Assistant in Medicine at Boston Children’s Hospital. She was a post-doctoral research fellow at Knowledge and Evaluation Research (KER) Unit, Mayo Clinic and one of the founders of “Unidad de Conocimiento y Evidencia” (CONEVID), Lima, Peru. She serves as a member of PAHO’s Expert Committee on the Selection and Use of Essential Medicines. She is a Cochrane author and has published several systematic reviews and meta-analyses.

Celine PULCINI (Luxembourg)
Celine Pulcini is an infectious diseases specialist working in Nancy, France. She has been doing research on antimicrobial stewardship for fifteen years and is author/co-author in more than 130 international publications. She is the secretary of the ESCMID Study Group for Antibiotic Policies ESGAP.

Shalini SRI RANGANATHAN (Sri Lanka)
Shalini Sri Ranganathan is a Professor in Pharmacology and Specialist in Paediatrics at the University of Colombo, Sri Lanka. She has won numerous medals and awards during her professional career, notably twice winning the President’s Award for Scientific Publication in both 2013 and 2014. She serves on many national and international organizations and is a member of the editorial board of the Ceylon Medical Journal.

Fatima SULEMAN (South Africa)
Fatima Suleman Fatima Suleman is an Associate Professor in the Discipline of Pharmaceutical Sciences at the University of KwaZulu-Natal, South Africa. She is also a Professor, and the Prince Claus Chair of Development and Equity for the theme Affordable (Bio)Therapeutics for Public Health (September 2016 to September 2018) Faculty of Sciences, Utrecht University, Utrecht, The Netherlands. Her research focus is on pharmaceutical policy, and systems. She has previously served on the Essential Medicines Technical Committees in South Africa and on several WHO panels.

Worasuda YOONGTHONG (Thailand)
Worasuda Yoongthong is Chief of National Drug Policy Division and Director, Pilot office for herbal and medicinal product assessment and registration, Food and Drug Administration of Thailand. She is a pharmacist and epidemiologist by training. She has been responsible for selection of National List of Essential Medicines of Thailand since 1988. She play an important role in establishing system for evidence-based selection of Essential Medicines as well as pricing for medicine procurement. Her research focus is on development of national medicine control system especially for registration and re-evaluation.

Temporary advisers:

Sumanth GANDRA (India)
Sumanth Gandra is an infectious disease physician and a public health researcher. He is currently a resident scholar at the Center for Disease Dynamics, Economics & Policy, New Delhi. His research focus is on global surveillance of antimicrobial resistance and antimicrobial use.

Stephan HARBARTH (Switzerland)
Stephan Harbarth is associate professor at the University of Geneva Hospitals in Geneva (CH), where he works as infectious diseases physician, hospital epidemiologist and clinical researcher. He has extensive experience in antibiotic stewardship and control of antimicrobial resistance. Dr Harbarth’s work has been published in leading medical journals and garnered several awards. He is active member of the WHO collaborating center on patient safety and provided advice as an external expert with WHO for 15 years.

Mike SHARLAND (United Kingdom)
Mike Sharland is one of the UK and Europe’s leading experts in antimicrobial prescribing, resistance and healthcare associated infection in children. He has an interest in policy initiative to reduce the burden of antimicrobial resistance (AMR) and has been closely involved in the implementation of the National AMR Strategy. He has developed the Paediatric Infectious Diseases Unit at St George’s into a recognised Centre of excellence for clinical care, teaching and research and was appointed Professor of Paediatric Infectious Diseases in November 2010. Mike Sharland chairs the Department of Health’s Expert Advisory Body on antimicrobial resistance and healthcare associated infection (ARHAI).

Mei Gao ZENG (People’s Republic of China)
Mei Gao Zeng is a Professor and the Director of Department of Infectious Diseases of Children’s Hospital of Fudan University in Shanghai. She is currently the Vice Chairman of Shanghai Steering Committee on Immunization and the Chairman of the Subspecialty Group of Pediatrics of Chinese Society of Infectious Diseases. Her interests include childhood infectious diseases, antibiotic resistance, vaccine-related issues and public health.

委員會審議了92項申請,涉及大約100種藥物,并在標準清單中增加了55種藥物(在一般基本藥物清單中增加了30種,在兒童基本藥物清單中增加了25種)。

專家委員會名單 Committee members


Zeba AZIZ (Pakistan)
Zeba Aziz is a Medical Oncologist with a busy clinical practice based in Hameed Latif Hospital, Lahore, Pakistan. She previously served as the Head of Department of Oncology and Professor at Jinnah Hospital Lahore. Currently she is Dean of Medical Oncology for the College of Physicians and Surgeons Pakistan and is also the Program Director for the Medical Oncology Fellowship at Hameed Latif Hospital. Her international efforts include being on the steering committee for the Australian & Asia Pacific Oncology Research Development (ACORD) Workshop and being an invited panel list and speaker for multiple conferences around the world. She has made contributions to research through her 79 peer-reviewed publications on Oncology. Her specific fields of interest are malignant hematology and breast cancer.

Lisa BERO (USA) 
Lisa Bero is a pharmacologist with a focus on research integrity and the translation of clinical sciences into practice and health policy. She is Chair of Medicines Use and Health Outcomes at the University of Sydney in Australia and Co-Chair of the Cochrane Collaboration Governing Board. She has published over 180 peer reviewed publications, has served on numerous international committees and has been recognized for her mentoring of students with numerous awards.

Franco CAVALLI (Switzerland)
Franco Cavalli is the Scientific Director of the Oncology Institute of Southern Switzerland, which he founded. As an international expert on treatment and research related to malignant lymphoma and new drugs, he has published extensively and has received numerous awards. He is currently Chairman of the Scientific Committee of the European School of Oncology and the World Oncology Forum.

Graham COOKE (United Kingdom)
Graham Cooke is a clinical academic trained in infectious diseases with a research interest in HIV, TB and hepatitis. Prior to taking up a position at Imperial College he was based in KwaZulu-Natal researching the impact of HIV treatment scale-up. He leads the clinical work stream of the UK STOP-HCV consortium and his current interests include developing the evidence to inform scaling up the global response to viral hepatitis.

Facundo GARCIA BOURNISSEN (Argentina)
Facundo Garcia Bournissen is a pediatrician, clinical pharmacologist and independent researcher for Argentina's National Council for Science and Technological Research (CONICET), based in Buenos Aires Children's Hospital. He received his medical and pediatric specialty degrees from the University of Buenos Aires (Argentina) and his PhD and clinical pharmacology fellowship from the University of Toronto (Canada). His current focus of research is in the pharmacology of pediatric neglected diseases.

Mohammed HASSAR (Morocco)
Mohammed Hassar is an internist and a clinical pharmacologist and a Professor at the Rabat School of Medicine and Pharmacy in Rabat, Morocco. For the past thirty five years, he has been active in the field of global public health with an emphasis on rational therapy, pharmaco- economics and the safety of drugs. He has served on several WHO committees and panels. He represented WHO on the governing board of the WHO Uppsala Monitoring Centre for drug safety and was a member of the WHO ATC/DDD working group in Oslo.

Greg KEARNS (United States of America)
Greg Kearns is a pharmacist and a paediatric clinical pharmacologist and is currently President of the Arkansas Children’s Hospital Research Institute and Senior Vice President / Chief Research Officer of the Arkansas Children’s Hospital. He also is a Professor of Paediatrics at the University of Arkansas for Medical Sciences. Dr Kearns’ research has focused on developmental regulation of pharmacokinetics/pharmacodynamics, the evaluation of mechanisms underlying adverse drug reactions, the design of innovative clinical trials for new therapeutic interventions for children and the integration of pharmacogenetics into Phase II clinical trials in children. He has received continuous research support from NIH for paediatric clinical pharmacology research since 1993 and has authored over 285 peer-reviewed publications.

Robert MVUNGI (United Republic of Tanzania)
Robert Mvungi, a cardiologist, former heads the Department of Cardiovascular Medicine at Muhimbili National Hospital in Tanzania. He is President of the Tanzanian Cardiac Society, Chairman of the Tanzanian Cardiac Task Force and a member of numerous other cardiac societies. His research has been focused on the causes, characteristics and consequences of heart disease.

Francis OFEI (Ghana)
Francis Ofei is a physician in internal medicine and therapeutics and sub-specialized in endocrinology and diabetes medicine. He is serving his second term as Chairperson for the National Standard Treatment Guidelines and Essential Medicines selection committee in Ghana and is a Fellow of the Ghana College of Physicians and the Royal Colleges of Physicians of London and Edinburgh. He is currently Associate Professor of Internal Medicine and Dean of the School of Medical Sciences, University of Cape Coast in Ghana.

Gabriela PRUTSKY LOPEZ (United States of America)
Gabriela Prutsky Lopez is a pediatrician and Assistant in Medicine at Boston Children’s Hospital. She was a post-doctoral research fellow at Knowledge and Evaluation Research (KER) Unit, Mayo Clinic and one of the founders of “Unidad de Conocimiento y Evidencia” (CONEVID), Lima, Peru. She serves as a member of PAHO’s Expert Committee on the Selection and Use of Essential Medicines. She is a Cochrane author and has published several systematic reviews and meta-analyses.

Celine PULCINI (Luxembourg)
Celine Pulcini is an infectious diseases specialist working in Nancy, France. She has been doing research on antimicrobial stewardship for fifteen years and is author/co-author in more than 130 international publications. She is the secretary of the ESCMID Study Group for Antibiotic Policies ESGAP.

Shalini SRI RANGANATHAN (Sri Lanka)
Shalini Sri Ranganathan is a Professor in Pharmacology and Specialist in Paediatrics at the University of Colombo, Sri Lanka. She has won numerous medals and awards during her professional career, notably twice winning the President’s Award for Scientific Publication in both 2013 and 2014. She serves on many national and international organizations and is a member of the editorial board of the Ceylon Medical Journal.

Fatima SULEMAN (South Africa)
Fatima Suleman Fatima Suleman is an Associate Professor in the Discipline of Pharmaceutical Sciences at the University of KwaZulu-Natal, South Africa. She is also a Professor, and the Prince Claus Chair of Development and Equity for the theme Affordable (Bio)Therapeutics for Public Health (September 2016 to September 2018) Faculty of Sciences, Utrecht University, Utrecht, The Netherlands. Her research focus is on pharmaceutical policy, and systems. She has previously served on the Essential Medicines Technical Committees in South Africa and on several WHO panels.

Worasuda YOONGTHONG (Thailand)
Worasuda Yoongthong is Chief of National Drug Policy Division and Director, Pilot office for herbal and medicinal product assessment and registration, Food and Drug Administration of Thailand. She is a pharmacist and epidemiologist by training. She has been responsible for selection of National List of Essential Medicines of Thailand since 1988. She play an important role in establishing system for evidence-based selection of Essential Medicines as well as pricing for medicine procurement. Her research focus is on development of national medicine control system especially for registration and re-evaluation.

Temporary advisers:

Sumanth GANDRA (India)
Sumanth Gandra is an infectious disease physician and a public health researcher. He is currently a resident scholar at the Center for Disease Dynamics, Economics & Policy, New Delhi. His research focus is on global surveillance of antimicrobial resistance and antimicrobial use.

Stephan HARBARTH (Switzerland)
Stephan Harbarth is associate professor at the University of Geneva Hospitals in Geneva (CH), where he works as infectious diseases physician, hospital epidemiologist and clinical researcher. He has extensive experience in antibiotic stewardship and control of antimicrobial resistance. Dr Harbarth’s work has been published in leading medical journals and garnered several awards. He is active member of the WHO collaborating center on patient safety and provided advice as an external expert with WHO for 15 years.

Mike SHARLAND (United Kingdom)
Mike Sharland is one of the UK and Europe’s leading experts in antimicrobial prescribing, resistance and healthcare associated infection in children. He has an interest in policy initiative to reduce the burden of antimicrobial resistance (AMR) and has been closely involved in the implementation of the National AMR Strategy. He has developed the Paediatric Infectious Diseases Unit at St George’s into a recognised Centre of excellence for clinical care, teaching and research and was appointed Professor of Paediatric Infectious Diseases in November 2010. Mike Sharland chairs the Department of Health’s Expert Advisory Body on antimicrobial resistance and healthcare associated infection (ARHAI).

Mei Gao ZENG (People’s Republic of China)
Mei Gao Zeng is a Professor and the Director of Department of Infectious Diseases of Children’s Hospital of Fudan University in Shanghai. She is currently the Vice Chairman of Shanghai Steering Committee on Immunization and the Chairman of the Subspecialty Group of Pediatrics of Chinese Society of Infectious Diseases. Her interests include childhood infectious diseases, antibiotic resistance, vaccine-related issues and public health.

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