在循证医学时代下,依托规范的技术方法和标准化的操作规程发掘中医药独特优势,是实现中医药现代化、国际化发展并惠泽人类的必由之路。中医理论、人用经验和研究证据三结合证据体系的提出标志着中医药特色评价体系思维方法取得了重要进...在循证医学时代下,依托规范的技术方法和标准化的操作规程发掘中医药独特优势,是实现中医药现代化、国际化发展并惠泽人类的必由之路。中医理论、人用经验和研究证据三结合证据体系的提出标志着中医药特色评价体系思维方法取得了重要进步,经过恰当方法整合后的多元证据体是中医药临床指南推荐意见和循证卫生决策的有力支撑。本文基于当前国际证据合成与分级方法学前沿进展,初步提出中医药多元证据整合的方法学框架——MERGE(Merge Evidence-based Research and artificial intelliGence to support smart dEcision)框架,以期为中医药循证医学方法学体系的完善和发展提供借鉴和参考。展开更多
中药疗效评价问题是长期制约中医药发展壮大及国际化的“卡脖子”问题。该文从医学认知的底层逻辑出发,在系统剖析中西医药诊疗理念、药效物质基础、研发范式、疗效认知和评价模式等方面客观差异的基础上,整合临床经验、实验研究和临床...中药疗效评价问题是长期制约中医药发展壮大及国际化的“卡脖子”问题。该文从医学认知的底层逻辑出发,在系统剖析中西医药诊疗理念、药效物质基础、研发范式、疗效认知和评价模式等方面客观差异的基础上,整合临床经验、实验研究和临床试验的证据要素,首次提出并建立中药有效性评价新策略和方法体系——中药有效性评价整合证据链法(integrated evidence chain-based effectiveness evaluation of traditional Chinese medicine,iEC-Eff),形成中药有效性“临床经验-实验研究-临床试验”一体化评价与确证模式。初步应用研究显示,该方法可使中药特别是流传千年、有口皆碑、至今临床常用的经典名方的有效性评价等级得到科学提升,使其有效性证据等级能够更加客观地反映其临床价值和地位,突破了当今中药有效性评价以随机对照试验(RCT)为唯一“金标准”的局面及局限,为破解中药有效性评价难题提供了具有原创性和引领性的策略和方法,为建立中医药理论、人用经验和临床试验相结合的中药注册审评证据体系提供了具有可操作性的新工具。该方法可用于中医药经典名方有效性评价、中药新药研发、上市后中成药有效性再评价等,亦可供国家医保药物目录、国家基本药物目录等中药品种遴选参考。展开更多
Chinese medicine has been used for centuries to treat a range of health conditions.This history has produced a wealth of classical literature,case studies and clinical research data detailing its use and effectiveness...Chinese medicine has been used for centuries to treat a range of health conditions.This history has produced a wealth of classical literature,case studies and clinical research data detailing its use and effectiveness.However,high-quality and conclusive evidence that meets modern requirements for clinical decision support is lacking.This evidence gap limits the integration of Chinese medicine with contemporary medicine,which in turn limits global access and acceptance of Chinese medicine as a form of safe and effective health care.Over the past 20 years,researchers and organisations around the world,including the World Health Organization(WHO)and United Nations,have worked to support the integration of traditional medicines,such as Chinese medicine,with conventional medicines to improve global health care.This paper provides an overview of Chinese medicine studies published in the top four general medical journals(BMJ,JAMA,Lancet and New England Journal of Medicine)from February 2005 to February 2024 in the past 20 years to highlight the progress in the development of this evidence base.It also highlights key actions taken to promote evidence-based clinical Chinese medicine,including product and practitioner regulation,formalising education standards,and international collaborations.Research conducted at the China-Australia International Research Centre for Chinese Medicine demonstrates the benefits of such a collaboration.Through development of its unique and inclusive‘whole-evidence’approach,plus clinical studies and systematic reviews,the Centre has significantly contributed to the evidence base for clinical Chinese medicine.In addition,its high-impact papers and groundbreaking monographs have been cited in international conventional medicine guidelines.While progress has certainly been made during the past 20 years to build a stronger evidence base for clinical Chinese medicine,there is still a considerable gap that limits its integration with conventional medicine.Future funding and research are needed to continue this work and achieve to safe,effective and accessible traditional medicine as part of the WHO’s Universal Health Coverage strategy.展开更多
文摘在循证医学时代下,依托规范的技术方法和标准化的操作规程发掘中医药独特优势,是实现中医药现代化、国际化发展并惠泽人类的必由之路。中医理论、人用经验和研究证据三结合证据体系的提出标志着中医药特色评价体系思维方法取得了重要进步,经过恰当方法整合后的多元证据体是中医药临床指南推荐意见和循证卫生决策的有力支撑。本文基于当前国际证据合成与分级方法学前沿进展,初步提出中医药多元证据整合的方法学框架——MERGE(Merge Evidence-based Research and artificial intelliGence to support smart dEcision)框架,以期为中医药循证医学方法学体系的完善和发展提供借鉴和参考。
文摘中药疗效评价问题是长期制约中医药发展壮大及国际化的“卡脖子”问题。该文从医学认知的底层逻辑出发,在系统剖析中西医药诊疗理念、药效物质基础、研发范式、疗效认知和评价模式等方面客观差异的基础上,整合临床经验、实验研究和临床试验的证据要素,首次提出并建立中药有效性评价新策略和方法体系——中药有效性评价整合证据链法(integrated evidence chain-based effectiveness evaluation of traditional Chinese medicine,iEC-Eff),形成中药有效性“临床经验-实验研究-临床试验”一体化评价与确证模式。初步应用研究显示,该方法可使中药特别是流传千年、有口皆碑、至今临床常用的经典名方的有效性评价等级得到科学提升,使其有效性证据等级能够更加客观地反映其临床价值和地位,突破了当今中药有效性评价以随机对照试验(RCT)为唯一“金标准”的局面及局限,为破解中药有效性评价难题提供了具有原创性和引领性的策略和方法,为建立中医药理论、人用经验和临床试验相结合的中药注册审评证据体系提供了具有可操作性的新工具。该方法可用于中医药经典名方有效性评价、中药新药研发、上市后中成药有效性再评价等,亦可供国家医保药物目录、国家基本药物目录等中药品种遴选参考。
文摘Chinese medicine has been used for centuries to treat a range of health conditions.This history has produced a wealth of classical literature,case studies and clinical research data detailing its use and effectiveness.However,high-quality and conclusive evidence that meets modern requirements for clinical decision support is lacking.This evidence gap limits the integration of Chinese medicine with contemporary medicine,which in turn limits global access and acceptance of Chinese medicine as a form of safe and effective health care.Over the past 20 years,researchers and organisations around the world,including the World Health Organization(WHO)and United Nations,have worked to support the integration of traditional medicines,such as Chinese medicine,with conventional medicines to improve global health care.This paper provides an overview of Chinese medicine studies published in the top four general medical journals(BMJ,JAMA,Lancet and New England Journal of Medicine)from February 2005 to February 2024 in the past 20 years to highlight the progress in the development of this evidence base.It also highlights key actions taken to promote evidence-based clinical Chinese medicine,including product and practitioner regulation,formalising education standards,and international collaborations.Research conducted at the China-Australia International Research Centre for Chinese Medicine demonstrates the benefits of such a collaboration.Through development of its unique and inclusive‘whole-evidence’approach,plus clinical studies and systematic reviews,the Centre has significantly contributed to the evidence base for clinical Chinese medicine.In addition,its high-impact papers and groundbreaking monographs have been cited in international conventional medicine guidelines.While progress has certainly been made during the past 20 years to build a stronger evidence base for clinical Chinese medicine,there is still a considerable gap that limits its integration with conventional medicine.Future funding and research are needed to continue this work and achieve to safe,effective and accessible traditional medicine as part of the WHO’s Universal Health Coverage strategy.
