| 中药新药临床研究方案设计中相关问题探讨 |
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| 引用本文： | 杜宝俊.中药新药临床研究方案设计中相关问题探讨[J].中国临床药理学与治疗学,2005,10(9):1073-1075. |
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| 作者姓名： | 杜宝俊 |
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| 作者单位： | 中国中医研究院西苑医院临床研究基地,北京,100091 |
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| 摘 要： | 临床研究是新药研发过程中的重要环节,临床研究成功的前提是科学、合理的方案设计。本文针对中药新药临床研究方案设计过程中的关键问题,如证型的确立、中药治疗水平的定位、盲法实施中存在的问题,临床研究分期的实施、诊断标准与疗效判定标准的运用、安慰剂的使用以及安全性评价等相关问题进行了探讨,对中药新药临床研究方案设计有一定的参考作用。
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| 关 键 词： | 中药新药 临床研究 方案设计 GCP 问题探讨 |
| 文章编号： | 1009-2501(2005)09-1073-03 |
| 收稿时间： | 07 26 2005 12:00AM |
| 修稿时间： | 08 16 2005 12:00AM |
Some problems in clinical trials design of new traditional Chinese medicine |
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| DU Bao-jun.Some problems in clinical trials design of new traditional Chinese medicine[J].Chinese Journal of Clinical Pharmacology and Therapeutics,2005,10(9):1073-1075. |
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| Authors: | DU Bao-jun |
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| Institution: | Clinical Pharmacological Base, Xiyuan Hospital, China Academy of Traditional Chinese Medicine, Beijing 100091, China |
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| Abstract: | Some problems of clinical trial design of new traditional Chinese medicine were discussed in this article, including the establishment of TCM syndromes, the determination of efficacy level, the implement of different stage of clinical trial, the selection of diagnose standard and efficacy effect standard, the use of placebo, and the safety evaluation. |
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| Keywords: | new traditional Chinese medicine clinical trial clinical trial-design GCP discussion of related problems |
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