我国临床研究发展现状及中医临床研究存在的问题、策略和实践
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摘要
临床研究是医学科学研究的重要组成部分,随着国家临床医学研究中心的建设,我国的临床研究取得了较大的进展,但中医领域仍存在较多的问题,需加强研究目标、研究方法、过程监管、结果报告及证据转化等环节的设计、优化和实施,切实提高中医临床研究的证据质量。团队通过建立中医群体、个体相结合的研究评价方法、报告标准和质控技术,以及单病例随机对照试验和贝叶斯分析等个体化研究方法,整合了中医临床研究的多来源证据体,并应用药症关联网络方法研究并阐释中医临床多途径微效应的特色机制,逐步形成全面整体验证中医临床疗效的方法和技术体系,为中医临床研究的良性发展提供方法学支撑。
Clinical research is one of the most significant parts of medical scientific research. Clinical research in China has made great progress with the construction of the national center for clinical medical research. However, in the field of traditional Chinese medicine(TCM), it still exists many problems. The objectives, methods, supervision, reporting of the research and the translation of the research evidence have to be well designed, optimized and implemented so as to improve the evidence quality of clinical research of TCM. The clinical research evidence of TCM from multiple sources has been being integrated through the establishment of the evaluation methods for combining the group and individual research, the reporting standards and quality control techniques as well as the single case randomized controlled trials and Bayesian analysis. And the methodological and technological system has gradually formed for comprehensively assessing the curative effect of TCM together with the network methods associated with disease and medicine applied to explain characteristics and mechanism of the clinical efficacy of TCM. The system would provide a methodology support for the benign development of clinical research on TCM.
Clinical research is one of the most significant parts of medical scientific research. Clinical research in China has made great progress with the construction of the national center for clinical medical research. However, in the field of traditional Chinese medicine(TCM), it still exists many problems. The objectives, methods, supervision, reporting of the research and the translation of the research evidence have to be well designed, optimized and implemented so as to improve the evidence quality of clinical research of TCM. The clinical research evidence of TCM from multiple sources has been being integrated through the establishment of the evaluation methods for combining the group and individual research, the reporting standards and quality control techniques as well as the single case randomized controlled trials and Bayesian analysis. And the methodological and technological system has gradually formed for comprehensively assessing the curative effect of TCM together with the network methods associated with disease and medicine applied to explain characteristics and mechanism of the clinical efficacy of TCM. The system would provide a methodology support for the benign development of clinical research on TCM.
引文
1李幼平,杨克虎.循证医学.北京:人民卫生出版社,2014:7-8.
2 Wang C,Liu Q.A turning point for clinical research in China?Lancet,2013,382(9895):835-836.
3商洪才,张伯礼,王永炎.中医药临床研究待“突破”.天津中医药,2013,30(1):4-5.
4王家莹,王俊峰,承诗琪,等.中医药系统评价/Meta分析19年发展及现状分析.中医杂志,2017,58(11):919-925.
5张晓雨,李敏,邱瑞瑾,等.系统评价方法在中成药上市后再研究评价中的应用误区及反思.中国中西医结合杂志,2017,37(8):996-999.
6 Berry D A.The Brave New World of clinical cancer research:Adaptive biomarker-driven trials integrating clinical practice with clinical research.Mol Oncol,2015,9(5):951-959.
7赵晨,张晓雨,胡嘉元,等.中医同证候系疾病临床研究母方案设计方法.中医杂志,2018,59(02):111-115.
8 Woodcock J,Lavange L M.Master Protocols to Study Multiple Therapies,Multiple Diseases,or Both.N Engl J Med,2017,377(1):62-70.
9张晓雨,商洪才.近十年国内中医药临床研究发展现状及存在的问题.中医杂志,2018,59(21):1808-1811.
10 Moher D,Hopewell S,Schulz K F,et al.CONSORT 2010 Explanation and Elaboration:Updated guidelines for reporting parallel group randomised trials.J Clin Epidemiol,2010,63(8):e1-e37.
11 Shang H,Zhang J,Yao C,et al.Qi-shen-yi-qi dripping pills for the secondary prevention of myocardial infarction:a randomised clinical trial.Evid Based Complement Alternat Med,2013,2013:738391.
12商洪才,李幼平,张伯礼,等.中医药临床疗效个体化评价方法初探--循证目标成就量表法的提出.中国循证医学杂志,2007(7):537-541.
13翟静波,李江,商洪才,等.贝叶斯单病例随机对照试验简介.中国循证医学杂志,2017,17(7):848-851.
14 Cheng C W,Wu T X,Shang H C,et al.CONSORT Extension for Chinese Herbal Medicine Formulas 2017:Recommendations,Explanation,and Elaboration.Ann Intern Med,2017,167(2):112-121.
15付姝菲,郑颂华,张莉,et al.Consensus-Based Recommendations for Case Report in Chinese Medicine(CARC).Chin J Integ Med,2016(01):73-79.
2 Wang C,Liu Q.A turning point for clinical research in China?Lancet,2013,382(9895):835-836.
3商洪才,张伯礼,王永炎.中医药临床研究待“突破”.天津中医药,2013,30(1):4-5.
4王家莹,王俊峰,承诗琪,等.中医药系统评价/Meta分析19年发展及现状分析.中医杂志,2017,58(11):919-925.
5张晓雨,李敏,邱瑞瑾,等.系统评价方法在中成药上市后再研究评价中的应用误区及反思.中国中西医结合杂志,2017,37(8):996-999.
6 Berry D A.The Brave New World of clinical cancer research:Adaptive biomarker-driven trials integrating clinical practice with clinical research.Mol Oncol,2015,9(5):951-959.
7赵晨,张晓雨,胡嘉元,等.中医同证候系疾病临床研究母方案设计方法.中医杂志,2018,59(02):111-115.
8 Woodcock J,Lavange L M.Master Protocols to Study Multiple Therapies,Multiple Diseases,or Both.N Engl J Med,2017,377(1):62-70.
9张晓雨,商洪才.近十年国内中医药临床研究发展现状及存在的问题.中医杂志,2018,59(21):1808-1811.
10 Moher D,Hopewell S,Schulz K F,et al.CONSORT 2010 Explanation and Elaboration:Updated guidelines for reporting parallel group randomised trials.J Clin Epidemiol,2010,63(8):e1-e37.
11 Shang H,Zhang J,Yao C,et al.Qi-shen-yi-qi dripping pills for the secondary prevention of myocardial infarction:a randomised clinical trial.Evid Based Complement Alternat Med,2013,2013:738391.
12商洪才,李幼平,张伯礼,等.中医药临床疗效个体化评价方法初探--循证目标成就量表法的提出.中国循证医学杂志,2007(7):537-541.
13翟静波,李江,商洪才,等.贝叶斯单病例随机对照试验简介.中国循证医学杂志,2017,17(7):848-851.
14 Cheng C W,Wu T X,Shang H C,et al.CONSORT Extension for Chinese Herbal Medicine Formulas 2017:Recommendations,Explanation,and Elaboration.Ann Intern Med,2017,167(2):112-121.
15付姝菲,郑颂华,张莉,et al.Consensus-Based Recommendations for Case Report in Chinese Medicine(CARC).Chin J Integ Med,2016(01):73-79.