| 中医药大规模随机对照临床试验的病例募集 |
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| 引用本文： | 曹红波,商洪才,任明,张俊华,高鑫,项耀祖,戴国华,汪洋,高秀梅,张伯礼. 中医药大规模随机对照临床试验的病例募集[J]. 中西医结合学报, 2007, 5(3): 243-246 |
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| 作者姓名： | 曹红波 商洪才 任明 张俊华 高鑫 项耀祖 戴国华 汪洋 高秀梅 张伯礼 |
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| 作者单位： | 天津中医药大学中医药研究院临床研究评价中心,天津300193 |
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| 基金项目： | 国家科技攻关计划;国家自然科学基金 |
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| 摘 要： | 大型临床试验募集的病例在质和量上都有很严格的要求,募集工作的顺利与否关乎整个试验的成败。本文旨在以国家“十五”攻关课题“芪参益气滴丸对心肌梗死二级预防的临床试验研究”为主线,探讨在大样本、多中心临床试验病例募集工作中的主要困难及相应的解决办法。
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| 关 键 词： | 中医学 随机对照试验 病人参与 病人选择 |
| 文章编号： | 1672-1977（2007）03-0243-04 |
Case recruitment in large-scale clinical trials of traditional Chinese medicine |
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| Hong-bo CAO,Hong-cai SHANG,Ming REN,Jun-hua ZHANG,Xin GAO,Yao-zu XIANG,Guo-hua DAI,Yang WANG,Xiu-mei GAO,Bo-li ZHANG. Case recruitment in large-scale clinical trials of traditional Chinese medicine[J]. Journal of Chinese integrative medicine, 2007, 5(3): 243-246 |
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| Authors: | Hong-bo CAO Hong-cai SHANG Ming REN Jun-hua ZHANG Xin GAO Yao-zu XIANG Guo-hua DAI Yang WANG Xiu-mei GAO Bo-li ZHANG |
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| Affiliation: | Clinical Research Assessment Centre, Research Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China |
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| Abstract: | Case recruitment of large-scale clinical trials should be strictly checked in quality and quantity for it is the key to clinical trial.This study discusses the main difficulties and countermeasures in the case recruitment of large sample,multi-center clinical trials according to the national research project "Myocardial Infarction Secondary Prevention Study in Traditional Chinese Medicine". |
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| Keywords: | traditional Chinese medicine randomized controlled trials patient participation patient selection |
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