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
Objective:To assess the risk of aristolochic acid(AA)-associated cancer in patients with AA nephropathy(AAN).Methods:A retrospective study was conducted on patients diagnosed with AAN at Peking University First Hospit...Objective:To assess the risk of aristolochic acid(AA)-associated cancer in patients with AA nephropathy(AAN).Methods:A retrospective study was conducted on patients diagnosed with AAN at Peking University First Hospital from January 1997 to December 2014.Long-term surveillance and follow-up data were analyzed to investigate the influence of different factors on the prevalence of cancer.The primary endpoint was the incidence of liver cancer,and the secondary endpoint was the incidence of urinary cancer during 1 year after taking AA-containing medication to 2014.Results:A total of 337 patients diagnosed with AAN were included in this study.From the initiation of taking AA to the termination of follow-up,39 patients were diagnosed with cancer.No cases of liver cancer were observed throughout the entire follow-up period,with urinary cancer being the predominant type(34/39,87.17%).Logistic regression analysis showed that age,follow-up period,and diabetes were potential risk factors,however,the dosage of the drug was not significantly associated with urinary cancer.Conclusions:No cases of liver cancer were observed at the end of follow-up.However,a high prevalence of urinary cancer was observed in AAN patients.Establishing a direct causality between AA and HCC is challenging.展开更多
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。
基金Supported by National Key Technology R&D Program(No.2018zX09101002-001-002)Innovation Team and Talents Cultivation Program of National Administration of Traditional Chinese Medicine(No.ZYYCXTD-C-202005)the Science and Technology Project Affiliated to the Education Department of Chongqing Municipality(No.KJQN202215119)。
文摘Objective:To assess the risk of aristolochic acid(AA)-associated cancer in patients with AA nephropathy(AAN).Methods:A retrospective study was conducted on patients diagnosed with AAN at Peking University First Hospital from January 1997 to December 2014.Long-term surveillance and follow-up data were analyzed to investigate the influence of different factors on the prevalence of cancer.The primary endpoint was the incidence of liver cancer,and the secondary endpoint was the incidence of urinary cancer during 1 year after taking AA-containing medication to 2014.Results:A total of 337 patients diagnosed with AAN were included in this study.From the initiation of taking AA to the termination of follow-up,39 patients were diagnosed with cancer.No cases of liver cancer were observed throughout the entire follow-up period,with urinary cancer being the predominant type(34/39,87.17%).Logistic regression analysis showed that age,follow-up period,and diabetes were potential risk factors,however,the dosage of the drug was not significantly associated with urinary cancer.Conclusions:No cases of liver cancer were observed at the end of follow-up.However,a high prevalence of urinary cancer was observed in AAN patients.Establishing a direct causality between AA and HCC is challenging.
