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
This paper is the analysis of the main body, the object and their relationship concerning research of traditional Chinese medicine. The result proved that the main body of research of traditional Chinese medicine is r...This paper is the analysis of the main body, the object and their relationship concerning research of traditional Chinese medicine. The result proved that the main body of research of traditional Chinese medicine is researchers who possessed the fundamentals of traditional Chinese medicine. It is the objects of research of traditional Chinese medicine that origin of a class of traditional Chinese medical literature consisting of herbals which focus on descriptions of individual drugs; the relationship of the technological process of preparing Chinese medicine, as by parching, roasting, baking, steaming, soaking, and simmering, etc.;and technology of separating, extracting and purifying for composition; traditional Chinese medicine dynamics of one of the 12 two-hour periods into which the day was formerly divided before the introduction of western chronology; compatibility of medicines in active compositions; patent, effectiveness for a given period of time and constantly changing of traditional Chinese medicine.The relationship between the main body and the objects was that the former depends on the latter ones and the main body has subjective initiative as fully as possible.展开更多
The gradually ex—panding number of peo—pie suffering from hy—pertension and the trendof lowering of their ageindicate that one shouldpay more attention tothe illness and tOstrengthen preventionand treatment of it i...The gradually ex—panding number of peo—pie suffering from hy—pertension and the trendof lowering of their ageindicate that one shouldpay more attention tothe illness and tOstrengthen preventionand treatment of it inorder tO elevate clinicaltherapeutic effect,so as展开更多
OBJECTIVE: To help researchers selecting appropriate data mining models to provide better evidence for the clinical practice of Traditional Chinese Medicine(TCM) diagnosis and therapy.METHODS: Clinical issues based on...OBJECTIVE: To help researchers selecting appropriate data mining models to provide better evidence for the clinical practice of Traditional Chinese Medicine(TCM) diagnosis and therapy.METHODS: Clinical issues based on data mining models were comprehensively summarized from four significant elements of the clinical studies:symptoms, symptom patterns, herbs, and efficacy.Existing problems were further generalized to determine the relevant factors of the performance of data mining models, e.g. data type, samples, parameters, variable labels. Combining these relevant factors, the TCM clinical data features were compared with regards to statistical characters and informatics properties. Data models were compared simultaneously from the view of applied conditions and suitable scopes.RESULTS: The main application problems were the inconsistent data type and the small samples for the used data mining models, which caused the inappropriate results, even the mistake results. These features, i.e. advantages, disadvantages, satisfied data types, tasks of data mining, and the TCM issues, were summarized and compared.CONCLUSION: By aiming at the special features of different data mining models, the clinical doctors could select the suitable data mining models to resolve the TCM problem.展开更多
Traditional Chinese medicines (TCMs) have been used in China for thousands of years for the treatment of various diseases, highly treated as the Chinese cultural heritage. It has played the pivotal role in maintaini...Traditional Chinese medicines (TCMs) have been used in China for thousands of years for the treatment of various diseases, highly treated as the Chinese cultural heritage. It has played the pivotal role in maintaining the health of Chinese people and even the entire globe.展开更多
Prostate cancer(PC) is a common malignant tumor in the male seniors,and its incidence has been ascending in China in recent years. Over 80%of the patients are diagnosed as being in the late stage and lose the opportun...Prostate cancer(PC) is a common malignant tumor in the male seniors,and its incidence has been ascending in China in recent years. Over 80%of the patients are diagnosed as being in the late stage and lose the opportunity of radical operation because of its early stage metastasis. Endocrinotherapy is regarded展开更多
The issue of safety evaluation on postmarketing Chinese medicines has become a hot topic in China’s mainland recently. Researchers and decision-makers can obtain a variety of evidence resources about safety in order ...The issue of safety evaluation on postmarketing Chinese medicines has become a hot topic in China’s mainland recently. Researchers and decision-makers can obtain a variety of evidence resources about safety in order to evaluate the safety profile for postmarketing Chinese medicines. A registry study on ten Chinese medicine injections for postmarketing surveillance has come to the end. From such a study observing more than 300,000 patients for more than 4 years, a theoretical research question emerges, that is, how to identify and evaluate safety evidence systematically. We put forward a brand new research paradigm on the theory level, which is to establish a body of evidence on safety evaluation for postmarketing Chinese medicine. Therefore, multiple information sources were explored and extracted from preclinical experiments for toxicity, postmarketing clinical trials for efficacy and safety evaluation, registry study for surveillance, retrospective data analysis from hospital information system and spontaneous response system, and case reports and systematic review from literature. Greater efforts for this idea and cooperation with experts in this field both in China and abroad are urgently needed.展开更多
Objective:To study the differences in a special region(SR) corresponding to five internal organs between the young and the elderly and to verify the effectiveness of a developed system for objectifying research in ...Objective:To study the differences in a special region(SR) corresponding to five internal organs between the young and the elderly and to verify the effectiveness of a developed system for objectifying research in colour inspections of Chinese medicine(CICM).Methods:An image acquisition device imitating daylight to meet the requirement of CICM was designed.Image processing software based on CICM theory was developed.A total of 83 normal people were sampled and assigned to two groups.The first group(Group I)included 30 people with an average age of 24 ±2,and the second group(Group Ⅱ) included 53 people with an average age of 74 ±4.After image processing,the chromaticity of 10 SRs corresponding to five internal organs was calculated.R,G,and B represent the chromaticity of color red,green,and blue,L indicates color brightness,whereas a and b denote red and yellow respectively.The difference between the young and the elderly was analyzed.Results:(1) The chromaticity of each SR corresponding to five organs was obtained.The average R,G,B,L,a,and b of the sample were 194.4,147.6,119.3,65.2,15.5,and 22.3,respectively.(2) The R,G,B,and L of the young were greater than those of the elderly,but the a and b of the young were less than those of the elderly.(3) A statistically significant difference in each SR was found between the young and the elderly(P0.05).The total differences for the Lung(Fei),Heart(Xin),Liver(Gan),Spleen(Pi),and Kidney(Shen) were 50%(3/6),66.7%(4/6),66.7%(4/6),83.3%(5/6),and 91.7%(33/36),respectively.However,the Kidney SR had the greatest statistical discrepancy.Conclusion:The old Chinese saying that human Kidney deficiency worsens with age was verified by the results.The objectifying system used to examine CICM was effective.Thus,this system may be used as a basis for further research.展开更多
Chinese oncologists have made great progress on the prevention and treatment of tumor with the combined traditional Chinese medicine (TCM) and Western Medicine (WM). Combining TCM with WM features the cancer research ...Chinese oncologists have made great progress on the prevention and treatment of tumor with the combined traditional Chinese medicine (TCM) and Western Medicine (WM). Combining TCM with WM features the cancer research and control in China and has obtained world attention. Researches on cancer prevention with TCM. According to the theories of TCM, cancer is the result of the long-term action of carcinogenic factors under the condition of "Internal Insufficiency" of the body. Some chronic inflammatory changes could cause epithelial cell proliferation and malignant changes. Consequently, TCM treatment for precancerous lesions is very important. The interrup tion effect of Liuwei Dihuang decoction (六味地汤) in severe epithelial atypical hyperplasia of展开更多
In this special issue of Research Progress on Traditional Chinese Medicine and Medicinal Resources,articles describing the current advances of research on traditional Chinese medicine(TCM)will be invited for submissio...In this special issue of Research Progress on Traditional Chinese Medicine and Medicinal Resources,articles describing the current advances of research on traditional Chinese medicine(TCM)will be invited for submission.The directions of submissions include but not limited to:1.The separation and identification of the chemical components of TCM,pharmacological展开更多
The State Key Laboratory of Quality Research in Chinese Medicine (Macao University of Science and Technology) was formally established on January 25, 2011 upon approval from the Ministry of Science and Technology of...The State Key Laboratory of Quality Research in Chinese Medicine (Macao University of Science and Technology) was formally established on January 25, 2011 upon approval from the Ministry of Science and Technology of China. It is so far the only State Key Laboratory (SKL) specifically in the field of Traditional Chinese Medicine (TCM) over the country. It is also the jothed-laboratory partner of the State Key Laboratory of Natural and Biomimetic Drugs at the Peking University.展开更多
The State Key Laboratory of Quality Research in Chinese Medicine (Macao University of Science and Technology) was formally established on January 25, 2011 upon approval from the Ministry of Science and Technology of...The State Key Laboratory of Quality Research in Chinese Medicine (Macao University of Science and Technology) was formally established on January 25, 2011 upon approval from the Ministry of Science and Technology of China. It is so far the only State Key Laboratory (SKL) specifically in the field of Traditional Chinese Medicine (TCM) over the country. It is also the joined-laboratory partner of the State Key Laboratory of Natural and Bimnimetic Drugs at the Peking University.展开更多
As a kind of complex medical science,Chinese medicine(CM) has a long history of development and application and has demonstrated on evidence basis its efficacy in many diseases affecting multiple organ systems.In re...As a kind of complex medical science,Chinese medicine(CM) has a long history of development and application and has demonstrated on evidence basis its efficacy in many diseases affecting multiple organ systems.In recent years,great progress in CM research has been achieved with the initiation of application of sustained and multifaceted use of modern organ systems. In recent years, great progress in CM research has been achieved with the initiation of application of sustained and multifaceted use of modern scientific methods. More and more innovative methods are widely used in CM modernization researches, and the application of new methods becomes the key to further develop CM modernization.展开更多
Owing to its unique superiority in improving quality of life and prolonging survival time among advanced lung cancer patients, Chinese medicine(CM) has, in recent years, received increased attentions worldwide. We u...Owing to its unique superiority in improving quality of life and prolonging survival time among advanced lung cancer patients, Chinese medicine(CM) has, in recent years, received increased attentions worldwide. We utilized a bibliometric statistical method based on MEDLINE/Go Pub Med to conduct a comprehensive analysis of the current application status of CM in lung cancer, by including annual and accumulated publications, origin distribution of countries and journals, and keywords with a higher frequency score. Then the relevant clinical trials and mechanistic studies were systematically summarized within the field according to research types. We have raised potential problems and provided potentially useful reference information that could guide similar studies in the future. The basic experimental results are highly consistent with clinical trials, leading us to conclude that CM can offer better overall therapeutic benefits when used in combination with routine Western medicine for patients with advanced lung cancer.展开更多
Although many population pharmacokinetics(PPK) researches have been conducted on chemical drugs,few have been in the field of Chinese medicine(CM).Each ingredient in CMs possesses different pharmacokinetic charact...Although many population pharmacokinetics(PPK) researches have been conducted on chemical drugs,few have been in the field of Chinese medicine(CM).Each ingredient in CMs possesses different pharmacokinetic characteristics,therefore,it is important to develop methods of PPK studies on them to identify the differences in CM drug safety and efficacy among the population subgroups and to conduct quantitative studies on the determinants of CM drug concentrations.To develop an expert consensus on study design and implementation for PPK of CM,in August 2013,6 experts in the field of PPK,CMs pharmacology,and statistics discussed problems on the PPK research protocol of CMs,and a consensus was reached.The medicines with toxicity and narrow therapeutic windows and with wide range of target population or with frequent adverse reactions were selected.The compositions with definite therapeutic effects were selected as indices,and specific time points and sample sizes were designed according to standard PPK design methods.Target components were tested through various chromatography methods.Total quantity statistical moment analysis was used to estimate PPK parameters of each component and PPK models reflecting the trend of CMs(which assists in reasonable adjustments on clinical dosage).This consensus specifies the study design and implementation process of PPK.It provides guidance for the following:post-marketing clinical studies,in vivo investigations related to the metabolism in different populations,and development and clinical adjustment of dosages of CMs.展开更多
A post-marketing study is an integral part of research that helps to ensure a favorable risk-benefit profile for approved drugs used in the market. Because most of post-marketing studies use observational designs, whi...A post-marketing study is an integral part of research that helps to ensure a favorable risk-benefit profile for approved drugs used in the market. Because most of post-marketing studies use observational designs, which are liable to confounding, estimation of the causal effect of a drug versus a comparative one is very challenging. This article focuses on methodological issues of importance in designing and analyzing studies to evaluate the safety of marketed drugs, especially marketed traditional Chinese medicine (TCM) products. Advantages and limitations of the current designs and analytic methods for postmarketing studies are discussed, and recommendations are given for improving the validity of postmarketing studies in TCM products.展开更多
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.
文摘This paper is the analysis of the main body, the object and their relationship concerning research of traditional Chinese medicine. The result proved that the main body of research of traditional Chinese medicine is researchers who possessed the fundamentals of traditional Chinese medicine. It is the objects of research of traditional Chinese medicine that origin of a class of traditional Chinese medical literature consisting of herbals which focus on descriptions of individual drugs; the relationship of the technological process of preparing Chinese medicine, as by parching, roasting, baking, steaming, soaking, and simmering, etc.;and technology of separating, extracting and purifying for composition; traditional Chinese medicine dynamics of one of the 12 two-hour periods into which the day was formerly divided before the introduction of western chronology; compatibility of medicines in active compositions; patent, effectiveness for a given period of time and constantly changing of traditional Chinese medicine.The relationship between the main body and the objects was that the former depends on the latter ones and the main body has subjective initiative as fully as possible.
文摘The gradually ex—panding number of peo—pie suffering from hy—pertension and the trendof lowering of their ageindicate that one shouldpay more attention tothe illness and tOstrengthen preventionand treatment of it inorder tO elevate clinicaltherapeutic effect,so as
基金Supported by Research on Pattern differentiation of AIDS based on Graph Theroy of National Natural Science Foundation of China(No.81202858)Research on Intervention Evaluation of TCM Health Differentiation of National Key Technology Support Program(No.2012BAI25B02)+3 种基金Research and Development in Digital Information System of Traditional Chinese Medicine of National 863 Program of China(No.2012AA02A609)Acupuncture Efficacy of Gastrointestinal Dysfunction(No.ZZ05003)Acupuncture-point Specialty Analysis based on Image Processing Technology(No.ZZ03090)of Self-selected subject of China Academy of Chinese Medical SciencesSemantic Recognition of Tongue and Pulse based on Image Content of the Beijing Key Laboratory of Advanced Information Science and Network Technology(No.XDXX1306)
文摘OBJECTIVE: To help researchers selecting appropriate data mining models to provide better evidence for the clinical practice of Traditional Chinese Medicine(TCM) diagnosis and therapy.METHODS: Clinical issues based on data mining models were comprehensively summarized from four significant elements of the clinical studies:symptoms, symptom patterns, herbs, and efficacy.Existing problems were further generalized to determine the relevant factors of the performance of data mining models, e.g. data type, samples, parameters, variable labels. Combining these relevant factors, the TCM clinical data features were compared with regards to statistical characters and informatics properties. Data models were compared simultaneously from the view of applied conditions and suitable scopes.RESULTS: The main application problems were the inconsistent data type and the small samples for the used data mining models, which caused the inappropriate results, even the mistake results. These features, i.e. advantages, disadvantages, satisfied data types, tasks of data mining, and the TCM issues, were summarized and compared.CONCLUSION: By aiming at the special features of different data mining models, the clinical doctors could select the suitable data mining models to resolve the TCM problem.
文摘Traditional Chinese medicines (TCMs) have been used in China for thousands of years for the treatment of various diseases, highly treated as the Chinese cultural heritage. It has played the pivotal role in maintaining the health of Chinese people and even the entire globe.
文摘Prostate cancer(PC) is a common malignant tumor in the male seniors,and its incidence has been ascending in China in recent years. Over 80%of the patients are diagnosed as being in the late stage and lose the opportunity of radical operation because of its early stage metastasis. Endocrinotherapy is regarded
基金Supported by the Ninth-Science Foundation of Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences(No.Z0406)the Seventh Science Foundation of China Academy of Chinese Medical Sciences(No.ZZ070817)+1 种基金National Natural Science Foundation of China(General Program,No.81202776)China Postdoctoral Science Foundation project(No.2014T70202)
文摘The issue of safety evaluation on postmarketing Chinese medicines has become a hot topic in China’s mainland recently. Researchers and decision-makers can obtain a variety of evidence resources about safety in order to evaluate the safety profile for postmarketing Chinese medicines. A registry study on ten Chinese medicine injections for postmarketing surveillance has come to the end. From such a study observing more than 300,000 patients for more than 4 years, a theoretical research question emerges, that is, how to identify and evaluate safety evidence systematically. We put forward a brand new research paradigm on the theory level, which is to establish a body of evidence on safety evaluation for postmarketing Chinese medicine. Therefore, multiple information sources were explored and extracted from preclinical experiments for toxicity, postmarketing clinical trials for efficacy and safety evaluation, registry study for surveillance, retrospective data analysis from hospital information system and spontaneous response system, and case reports and systematic review from literature. Greater efforts for this idea and cooperation with experts in this field both in China and abroad are urgently needed.
基金Supported by Nanjing University of Aeronautics and Astronautics Innovation Team FundChinese Medical Association-L'Oreal Chinese Healthy Skin/Hair Research Project(S10)
文摘Objective:To study the differences in a special region(SR) corresponding to five internal organs between the young and the elderly and to verify the effectiveness of a developed system for objectifying research in colour inspections of Chinese medicine(CICM).Methods:An image acquisition device imitating daylight to meet the requirement of CICM was designed.Image processing software based on CICM theory was developed.A total of 83 normal people were sampled and assigned to two groups.The first group(Group I)included 30 people with an average age of 24 ±2,and the second group(Group Ⅱ) included 53 people with an average age of 74 ±4.After image processing,the chromaticity of 10 SRs corresponding to five internal organs was calculated.R,G,and B represent the chromaticity of color red,green,and blue,L indicates color brightness,whereas a and b denote red and yellow respectively.The difference between the young and the elderly was analyzed.Results:(1) The chromaticity of each SR corresponding to five organs was obtained.The average R,G,B,L,a,and b of the sample were 194.4,147.6,119.3,65.2,15.5,and 22.3,respectively.(2) The R,G,B,and L of the young were greater than those of the elderly,but the a and b of the young were less than those of the elderly.(3) A statistically significant difference in each SR was found between the young and the elderly(P0.05).The total differences for the Lung(Fei),Heart(Xin),Liver(Gan),Spleen(Pi),and Kidney(Shen) were 50%(3/6),66.7%(4/6),66.7%(4/6),83.3%(5/6),and 91.7%(33/36),respectively.However,the Kidney SR had the greatest statistical discrepancy.Conclusion:The old Chinese saying that human Kidney deficiency worsens with age was verified by the results.The objectifying system used to examine CICM was effective.Thus,this system may be used as a basis for further research.
文摘Chinese oncologists have made great progress on the prevention and treatment of tumor with the combined traditional Chinese medicine (TCM) and Western Medicine (WM). Combining TCM with WM features the cancer research and control in China and has obtained world attention. Researches on cancer prevention with TCM. According to the theories of TCM, cancer is the result of the long-term action of carcinogenic factors under the condition of "Internal Insufficiency" of the body. Some chronic inflammatory changes could cause epithelial cell proliferation and malignant changes. Consequently, TCM treatment for precancerous lesions is very important. The interrup tion effect of Liuwei Dihuang decoction (六味地汤) in severe epithelial atypical hyperplasia of
文摘In this special issue of Research Progress on Traditional Chinese Medicine and Medicinal Resources,articles describing the current advances of research on traditional Chinese medicine(TCM)will be invited for submission.The directions of submissions include but not limited to:1.The separation and identification of the chemical components of TCM,pharmacological
文摘The State Key Laboratory of Quality Research in Chinese Medicine (Macao University of Science and Technology) was formally established on January 25, 2011 upon approval from the Ministry of Science and Technology of China. It is so far the only State Key Laboratory (SKL) specifically in the field of Traditional Chinese Medicine (TCM) over the country. It is also the jothed-laboratory partner of the State Key Laboratory of Natural and Biomimetic Drugs at the Peking University.
文摘The State Key Laboratory of Quality Research in Chinese Medicine (Macao University of Science and Technology) was formally established on January 25, 2011 upon approval from the Ministry of Science and Technology of China. It is so far the only State Key Laboratory (SKL) specifically in the field of Traditional Chinese Medicine (TCM) over the country. It is also the joined-laboratory partner of the State Key Laboratory of Natural and Bimnimetic Drugs at the Peking University.
文摘As a kind of complex medical science,Chinese medicine(CM) has a long history of development and application and has demonstrated on evidence basis its efficacy in many diseases affecting multiple organ systems.In recent years,great progress in CM research has been achieved with the initiation of application of sustained and multifaceted use of modern organ systems. In recent years, great progress in CM research has been achieved with the initiation of application of sustained and multifaceted use of modern scientific methods. More and more innovative methods are widely used in CM modernization researches, and the application of new methods becomes the key to further develop CM modernization.
文摘Owing to its unique superiority in improving quality of life and prolonging survival time among advanced lung cancer patients, Chinese medicine(CM) has, in recent years, received increased attentions worldwide. We utilized a bibliometric statistical method based on MEDLINE/Go Pub Med to conduct a comprehensive analysis of the current application status of CM in lung cancer, by including annual and accumulated publications, origin distribution of countries and journals, and keywords with a higher frequency score. Then the relevant clinical trials and mechanistic studies were systematically summarized within the field according to research types. We have raised potential problems and provided potentially useful reference information that could guide similar studies in the future. The basic experimental results are highly consistent with clinical trials, leading us to conclude that CM can offer better overall therapeutic benefits when used in combination with routine Western medicine for patients with advanced lung cancer.
基金Supported by the Significant Drug Research and Development in Important State Science and Technology Specific and Key Technique Research(No.2009ZX09502-030)Visiting Fellow Joint Innovation Research Project of the China Academy of Chinese Medicial Sciences(No.ZZ070834)the Specialty Committee of Evaluation of Postmarketing Chinese Medicines of World Federation of Chinese Medicine Societies
文摘Although many population pharmacokinetics(PPK) researches have been conducted on chemical drugs,few have been in the field of Chinese medicine(CM).Each ingredient in CMs possesses different pharmacokinetic characteristics,therefore,it is important to develop methods of PPK studies on them to identify the differences in CM drug safety and efficacy among the population subgroups and to conduct quantitative studies on the determinants of CM drug concentrations.To develop an expert consensus on study design and implementation for PPK of CM,in August 2013,6 experts in the field of PPK,CMs pharmacology,and statistics discussed problems on the PPK research protocol of CMs,and a consensus was reached.The medicines with toxicity and narrow therapeutic windows and with wide range of target population or with frequent adverse reactions were selected.The compositions with definite therapeutic effects were selected as indices,and specific time points and sample sizes were designed according to standard PPK design methods.Target components were tested through various chromatography methods.Total quantity statistical moment analysis was used to estimate PPK parameters of each component and PPK models reflecting the trend of CMs(which assists in reasonable adjustments on clinical dosage).This consensus specifies the study design and implementation process of PPK.It provides guidance for the following:post-marketing clinical studies,in vivo investigations related to the metabolism in different populations,and development and clinical adjustment of dosages of CMs.
基金Supported by the Research on Key Techniques of Reevaluation of Post-marketing Chinese Medicine,the Ministry of Science and Technology(No.2009ZX09502-030)the Sixth-Science Foundation of Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences(Grant No.Z0215)the Seventh-Science Foundation of Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences(Grant No.Z0255)
文摘A post-marketing study is an integral part of research that helps to ensure a favorable risk-benefit profile for approved drugs used in the market. Because most of post-marketing studies use observational designs, which are liable to confounding, estimation of the causal effect of a drug versus a comparative one is very challenging. This article focuses on methodological issues of importance in designing and analyzing studies to evaluate the safety of marketed drugs, especially marketed traditional Chinese medicine (TCM) products. Advantages and limitations of the current designs and analytic methods for postmarketing studies are discussed, and recommendations are given for improving the validity of postmarketing studies in TCM products.