世卫组织更新基本药物清单,提出关于抗生素使用的新建议

博主:healthhealth 3年前 ( 2017-06-20 ) 745 0条评论
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2017年6月6日 | 日内瓦 - 世卫组织2017年基本药物标准清单增添了新内容,其中包括就可用于常见感染的抗生素和应保留给最严重情况的抗生素提出了新建议。其它补充包括列入了用于艾滋病毒、丙型肝炎、结核病和白血病的药物。

更新后的清单为成人增加了30种药物,为儿童增加了25种药物,并为9种已列入清单的产品规定了新用途,由此使解决最重要公共卫生需求所必须的基本药物总共达433种。许多国家利用世卫组织的基本药物清单来增加药物获取,并以清单为指导来决定可为其人口提供哪些产品。

“安全有效的药物是任何卫生系统的必要组成部分,”世卫组织卫生系统和创新部门助理总干事Marie-Paule Kieny博士说,“确保所有人能随时随地获得所需的药物对于各国实现全民健康覆盖目标至关重要。”

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新建议:三类抗生素


此次对抗生素部分的修订是基本药物清单四十年历史中最大一次,世卫组织专家将抗生素分为了三类:可用类、慎用类和备用类,并就每个类别应在何时使用提出了建议。最初,这些新类别仅适用于治疗21种最常见一般感染的抗生素。如果经证明有效,可在未来版本的基本药物清单中扩大适用于治疗其它感染的药物。

这一变化的目的在于确保需要时有可用的抗生素,并确保对感染开处正确的抗生素。这应当能增强治疗效果,减少耐药细菌的发展,并保护所有其它药物失灵时作为“最后手段”的抗生素的有效性。这些变化支持世卫组织抗微生物药物耐药性全球行动计划,该计划旨在通过确保最佳利用抗生素来抵抗耐药性的发展。

世卫组织建议,“可用类”中的抗生素可随时用于治疗范围广泛的常见感染。例如,其中包括阿莫西林这种广泛用于治疗肺炎等感染的抗生素。

“慎用类”包括建议用于对少数感染进行一级或二级治疗的抗生素。例如,应该大幅减少对用于治疗膀胱炎(一种尿路感染)和上呼吸道感染(如细菌性鼻窦炎和细菌性支气管炎)的环丙沙星的使用,以避免耐药性的进一步发展。

第三类为“备用类”,包括应被视为最后手段的抗生素,如粘菌素和一些头孢菌素等,并应仅在所有其它替代药物失灵的最严重情况下使用,例如用于因耐多药细菌导致的危及生命的感染。

世卫组织专家在成人药物清单中上增加了10种抗生素,在儿童药物清单中增加了12种抗生素。

“抗生素耐药性的上升源于我们使用(包括滥用)这些药物的方式,”基本药物和卫生产品司司长Suzanne Hill博士说,“新的世卫组织清单应该有助于卫生系统计划者和处方人员确保有需要者能够获得并且能够获得正确的抗生素,以防止耐药性问题恶化。”

其它补充

经更新的基本药物清单还列入了几种新药,如两种口服癌症治疗药物,一种综合了两种药物的新丙型肝炎药丸,一种更有效的艾滋病毒治疗药物,以及一种可用于在高危人群中预防艾滋病毒感染的老药物,结核药物的新型儿科配方和止痛药物。这些药物具体包括:

  • 两种口服癌症药物(达沙替尼和尼罗替尼),用于治疗已对标准治疗具有耐药性的慢性骨髓性白血病。在临床试验中,每两名服用这些药物的患者中就有一人获得了完全和持久的缓解;

  • 索非布韦+维帕他韦作为治疗所有六种类型丙型肝炎的第一种联合疗法(世卫组织目前正在更新关于丙型肝炎的治疗建议);

  • 用于治疗艾滋病毒感染的多替拉韦钠片,最新证据显示了该药物的安全性,疗效和对耐药性的高阻挡力;

  • 单独使用替诺福韦或者与恩曲他滨或拉米夫定联合使用,进行接触前预防,以预防艾滋病毒感染;

  • 用于治疗患耐多药结核病的儿童和青少年的地依麦迪和用于治疗患耐多药结核病的儿童和成人的氯法齐明;

  • 用于治疗儿童结核病的便于儿童使用的异烟肼、利福平、乙胺丁醇和吡嗪酰胺的固定剂量组合制剂;

  • 用于缓解癌症患者疼痛的芬太尼皮肤贴片和美沙酮,目的是增加对临终护理药物的获取。


编者按

世卫组织基本药物标准清单于1977年推出,与此同时各国政府在世界卫生大会上支持将“人人享有卫生保健”作为世卫组织和国家卫生政策的指导原则。

许多国家采用了基本药物的概念,并以基本药物清单为指导,制定了本国的清单。世卫组织基本药物的选择和使用专家委员会每两年对基本药物清单进行更新和修订。

专家委员会第二十一次会议于2017年3月27-31日在世卫组织总部举行。委员会审议了92项申请,涉及大约100种药物,并在标准清单中增加了55种药物(在一般基本药物清单中增加了30种,在儿童基本药物清单中增加了25种)。


专家委员会名单 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.