单病例随机对照试验的周期设计在中医药临床疗效评价中的应用研究
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摘要
目的:在中医药临床试验设计中,对单病例随机对照试验(N-of-1)的导入期与洗脱期的设置做进一步说明。方法:运用比较分析的方法,参考2010版CONSORT指南、2015最新版CENT指南以及收集、整理、阅读国内外相关文献。结果:单病例随机对照试验有必要设置合理的导入期与洗脱期,在中医药临床研究领域中应根据具体的干预措施、目标疾病的特点以及患者意愿设置个性化的导入期与洗脱期。结论:单病例随机对照试验符合中医个体化诊疗的特点,是对中医药临床疗效评价体系的补充。由于中医药临床干预具有复杂性,中药复方在体内的代谢机制尚不清楚,在此形势下规范中医药临床试验设计从而获得更加符合临床实际的试验证据就显得尤为必要。
Objective: To further explain the period of run-in and wash-out setting of a single-case randomized controlled trial( N-of-1) in clinical trial design of Chinese medicine. Methods:We used the methods comparative analysis,referring to the 2010 edition of the CONSORT guide,the 2015 latest edition of the CENT guide and the relevant literature at home and abroad. Results: It is necessary to set a reasonable period of run-in and wash-out during the N-of-1 trails. In Chinese medicine,it should be based on specific interventions,the characteristics of the target disease and the wishes of patients to set personalized run-in period and wash-out period. Conclusion:The single-case randomized controlled trial is in line with the characteristics of individualized diagnosis and treatment of TCM and is complementary to the evaluation system of TCM efficacy. Due to the complexity of clinical intervention of traditional Chinese medicine,the metabolism mechanism of TCM compound in vivo remains unclear. It is necessary to standardize the clinical trial design of TCM to obtain more experimental evidence in clinical practice.
Objective: To further explain the period of run-in and wash-out setting of a single-case randomized controlled trial( N-of-1) in clinical trial design of Chinese medicine. Methods:We used the methods comparative analysis,referring to the 2010 edition of the CONSORT guide,the 2015 latest edition of the CENT guide and the relevant literature at home and abroad. Results: It is necessary to set a reasonable period of run-in and wash-out during the N-of-1 trails. In Chinese medicine,it should be based on specific interventions,the characteristics of the target disease and the wishes of patients to set personalized run-in period and wash-out period. Conclusion:The single-case randomized controlled trial is in line with the characteristics of individualized diagnosis and treatment of TCM and is complementary to the evaluation system of TCM efficacy. Due to the complexity of clinical intervention of traditional Chinese medicine,the metabolism mechanism of TCM compound in vivo remains unclear. It is necessary to standardize the clinical trial design of TCM to obtain more experimental evidence in clinical practice.
引文
[1]陈新林,黄海茵,张长荣,等. 2015版CENT声明简介:单病例随机对照试验报告指南[J].中国循证医学杂志,2016(7):860-863.
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[5]Maura Marcucci,Federico Germini,Anna Coerezza1,et al. Efficacy of ultra-micronized Palmitoylethanolamide(um-PEA)in geriatric patients with chronic pain:study protocol for a series of N-of-1 randomized trials[J]. Bio Med central,2016(17):369.
[6]薛晶晶,杨佩兰,王洁,等.评价中医个体化治疗:单病例随机对照试验的初步研究[J].循证医学,2016,16(2):103-108.
[7]郭玥,王怡.中医药临床研究方法的应用[J].中国中医药现代远程教育,2017,15(10):146-149.
[8]Salima Punja,Catherine J. Nikles,Hugh Senior,et al. Melatonin in Youth:N-of-1 trials in astimulant-treated ADHD Population(MYNAP):study protocol for a randomizedcontrolled trial[J]. Bio Med central,2016,17:375.
[9]Jennifer A Pereira,Anne M Holbrook,Lisa Dolovich,et al. Are Brand-Name and Generic Warfarin Interchangeable Multiple N-of-1 Randomized,Crossover Trials[J]. The Annals of Pharmacotherapy,2005(39):1188-1193.
[10]Guyatt GH,Sackett D,Adachi J,et al. A clinician’s guide for conducting randomized trials in individual patients[J]. CMAJ,1988,139(6):497-503.
[11]许卫华.单病例随机对照试验在中医药临床研究中的应用与思考[J].中国临床药理学与治疗学,2005,10(11):1315-1317.
[12]Guyatt G,Keller L,Jaeschke R,et al. The N-of-1randomized controlled trial:clinical usefulness. Our threeyear experience[J]. Ann Intern Med,1990,112(4):293-299.
[13]Lindberg G. Single case studies in clinical trials[J]. Scand JGastroenterol Suppl,1988,23(147):30-32.
[14]Scheen AJ. Integrating evidence-based medicine and personalized medicine[J]. Rev Med Suisse,2013,9(395):1499-1500.
[15]李江,翟静波,商洪才,等.单病例随机对照试验的证据级别和报告规范[J].中国循证医学杂志,2017(17):612-615.
[16]李江,翟静波,商洪才,等.单病例随机对照试验的起源与发展[J].中国循证医学杂志,2017(17):235-238.
[17]刘玉,彭立生,秦秀德,等.单病例随机对照试验在证候类中药疗效评价中的应用与思考[J].中医药导报,2017(23):11-16.
[2]Vohra S,Shamseer L,Sampson M,et al. CONSORT extension for reporting N-of-1 trials(CENT)2015 Statement[J]. Journal of Clinical Epidemiology,2016,76:9-17.
[3]Larissa Shamseer,Margaret Sampson,Cecilia Bukutu,et al.CONSORT extension for reporting N-of-1 trials(CENT)2015:Explanation and elaboration[M]. Research Methods and Reporting,2015:350.
[4]王辉,翟静波,陈静,等.单病例随机对照试验的设计和实施要点[J].中国循证医学杂志,2017(17):364-368.
[5]Maura Marcucci,Federico Germini,Anna Coerezza1,et al. Efficacy of ultra-micronized Palmitoylethanolamide(um-PEA)in geriatric patients with chronic pain:study protocol for a series of N-of-1 randomized trials[J]. Bio Med central,2016(17):369.
[6]薛晶晶,杨佩兰,王洁,等.评价中医个体化治疗:单病例随机对照试验的初步研究[J].循证医学,2016,16(2):103-108.
[7]郭玥,王怡.中医药临床研究方法的应用[J].中国中医药现代远程教育,2017,15(10):146-149.
[8]Salima Punja,Catherine J. Nikles,Hugh Senior,et al. Melatonin in Youth:N-of-1 trials in astimulant-treated ADHD Population(MYNAP):study protocol for a randomizedcontrolled trial[J]. Bio Med central,2016,17:375.
[9]Jennifer A Pereira,Anne M Holbrook,Lisa Dolovich,et al. Are Brand-Name and Generic Warfarin Interchangeable Multiple N-of-1 Randomized,Crossover Trials[J]. The Annals of Pharmacotherapy,2005(39):1188-1193.
[10]Guyatt GH,Sackett D,Adachi J,et al. A clinician’s guide for conducting randomized trials in individual patients[J]. CMAJ,1988,139(6):497-503.
[11]许卫华.单病例随机对照试验在中医药临床研究中的应用与思考[J].中国临床药理学与治疗学,2005,10(11):1315-1317.
[12]Guyatt G,Keller L,Jaeschke R,et al. The N-of-1randomized controlled trial:clinical usefulness. Our threeyear experience[J]. Ann Intern Med,1990,112(4):293-299.
[13]Lindberg G. Single case studies in clinical trials[J]. Scand JGastroenterol Suppl,1988,23(147):30-32.
[14]Scheen AJ. Integrating evidence-based medicine and personalized medicine[J]. Rev Med Suisse,2013,9(395):1499-1500.
[15]李江,翟静波,商洪才,等.单病例随机对照试验的证据级别和报告规范[J].中国循证医学杂志,2017(17):612-615.
[16]李江,翟静波,商洪才,等.单病例随机对照试验的起源与发展[J].中国循证医学杂志,2017(17):235-238.
[17]刘玉,彭立生,秦秀德,等.单病例随机对照试验在证候类中药疗效评价中的应用与思考[J].中医药导报,2017(23):11-16.