基于复方丹参滴丸美国FDAⅢ期临床试验探讨中医临床疗效评价指标的选取
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摘要
通过总结疗效评价指标的优缺点及适用范围,基于复方丹参滴丸的指标选择经验,从疾病特点、中医药特色和替代指标运用等方面探讨中医临床疗效评价指标的选取。
By summarizing the advantages and disadvantages of the efficacy evaluation indicators and the scope of application,based on the experience of the selection of the phaseⅢclinical trials of compound Danshen dripping pills,the selection of the clinical efficacy evaluation indicators of TCM was discussed from the aspects of disease characteristics,characteristics of traditional Chinese medicine and the use of alternative indicators.
By summarizing the advantages and disadvantages of the efficacy evaluation indicators and the scope of application,based on the experience of the selection of the phaseⅢclinical trials of compound Danshen dripping pills,the selection of the clinical efficacy evaluation indicators of TCM was discussed from the aspects of disease characteristics,characteristics of traditional Chinese medicine and the use of alternative indicators.
引文
[1]郭新峰,赖世隆,梁伟雄.中医药临床疗效评价中结局指标的选择与应用[J].广州中医药大学学报,2002,19(4):251-255.
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[3]郭新峰,朱泉,赖世隆.替代指标和中间指标及其在中医药疗效评价研究中应用价值的思考[J].中国中西医结合杂志,2005,25(7):585-590.
[4]ECHT D S,LIEBSON P R,MITCHELL L B,et al.Mortality and morbidity in patients receiving encainide,flecainide,or placebo.The cardiac arrhythmia suppression trial[J].The New England Journal of Medicine,1991,324(12):781.
[5]BUCHER H C,GUYATT G H,COOK D J,et al.Users′guides to the medical literature:XIX.Applying clinical trial results.A.How to use an article measuring the effect of an intervention on surrogate end points.Evidence-based Medicine morking group[J].JAMA,1999,282(8):771-778.
[6]朱文.复方丹参滴丸完成美国FDAⅢ期临床试验[N].中国医药报,2016-12-30(01).
[7]范维琥.中西医结合心血管病临床试验的特点和方法[C].江门:中国(江门)国际中西医结合心血管病学术会议,2010:4.
[8]FLEMING T R,DEMETS D L.Surrogate endpoints in clinical trials:are we being mislead?[J].Ann Intern Med,1996,125:605.
[9]卓宏.临床试验方案设计中主要疗效指标及试验时间的考虑要素[J].中国临床药理学杂志,2008,24(3):270-272.
[2]张伯礼.芪参益气滴丸对心肌梗死二级预防的研究[DB/OL].[2010-12-17].http://www.365yixue.com/m/shownews.asp.
[3]郭新峰,朱泉,赖世隆.替代指标和中间指标及其在中医药疗效评价研究中应用价值的思考[J].中国中西医结合杂志,2005,25(7):585-590.
[4]ECHT D S,LIEBSON P R,MITCHELL L B,et al.Mortality and morbidity in patients receiving encainide,flecainide,or placebo.The cardiac arrhythmia suppression trial[J].The New England Journal of Medicine,1991,324(12):781.
[5]BUCHER H C,GUYATT G H,COOK D J,et al.Users′guides to the medical literature:XIX.Applying clinical trial results.A.How to use an article measuring the effect of an intervention on surrogate end points.Evidence-based Medicine morking group[J].JAMA,1999,282(8):771-778.
[6]朱文.复方丹参滴丸完成美国FDAⅢ期临床试验[N].中国医药报,2016-12-30(01).
[7]范维琥.中西医结合心血管病临床试验的特点和方法[C].江门:中国(江门)国际中西医结合心血管病学术会议,2010:4.
[8]FLEMING T R,DEMETS D L.Surrogate endpoints in clinical trials:are we being mislead?[J].Ann Intern Med,1996,125:605.
[9]卓宏.临床试验方案设计中主要疗效指标及试验时间的考虑要素[J].中国临床药理学杂志,2008,24(3):270-272.