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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 被引量：8

The Selection of Evaluation Index of Clinical Efficacy of Traditional Chinese Medicine Based on the Three Phase FDA Clinical Trials of Compound Danshen Dripping Pills
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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.
作者 刘育函 戴国华 高武霖 袁琛皓 王宁 毕冬雪 刘春花 LIU Yuhan;DAI Guohua;GAO Wulin;YUAN Chenhao;WANG Ning;BI Dongxue;LIU Chunhua(Shandong University of Traditional Chinese Medicine,Jinan 250355,Shandong,China;Affiliated Hospital of Shandong University of Traditional Chinese Medicine,Jinan 250011,Shandong,China)
机构地区 山东中医药大学 山东中医药大学附属医院
出处 《中西医结合心脑血管病杂志》 2019年第5期720-722,共3页 Chinese Journal of Integrative Medicine on Cardio-Cerebrovascular Disease
基金 国家自然科学基金(No.81373827 81774047) 山东省一流学科资助项目(中医学)
关键词 复方丹参滴丸 中医药 评价指标 Ⅲ期临床试验 compound Danshen dripping pills traditional Chinese medicine indicators of evaluation phaseⅢclinical trials
分类号 R286 [医药卫生—中药学]
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  • 1ICH指导委员会.人群暴露程度:评价无生命威胁条件下长期治疗药物的临床安全性.药品注册的国际技术要求[M].北京:人民卫生出版社,2007:1-5.
  • 2ICH指导委员会.临床研究的一般考虑.药品注册的国际技术要求[M].北京:人民卫生出版社,2007:251-265.
  • 3FDA. Providing clinical evidence of effectiveness for human drug and bi- ological products [ EB/OL]. http://www. fda. ggv/cder/guidance/, 2007 - 11 - 12.
  • 4Eclat DS, Liebson PR, Mitchell LB ,et al . Mortality and mobidity in patients receiving encainide flecainide , or placebo. The cardiac arrlaythmia suppression trial [ J ]. N Engl J Med, 1991 ; 329 : 781 - 788.
  • 5Fleming TR. Surrogate endpoints and FDA' s accelerated approval process [ J]. Health Aff,2005 ;24:67 - 68.
  • 6Psaty BM, Weiss NS, Furberg CD, et al. Surrogate end points, health outcomes and the drug-approval process for the treatment of risk factors for cardiovascular disease. JAMA.1999 ;282(8): 786-790.
  • 7Johnston K. What are surrogate outcome measures and why do they fail in clinical research? Neuroepidemiology 1999; 18(4): 167-173.
  • 8The Cochrance Reviewer' Handbook Glossary (Version 4.1.4), 26-27. The Cochrane Collaboration 2001.
  • 9Chuang-Stein C, DeMasi R. Surrogate endpoints in AIDS drug development: current status. Drug Information J 1998;32: 439-448, 457-459.
  • 10Gould AL. Discussion of "Surrogate endpoints in AIDS drug evelopment: current status" by C. Chuang-Stein and Ralph DeMasi. Drug Information J 1998 ;32: 453-456.

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中西医结合心脑血管病杂志
2019年 第5期

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