| 中药非双盲设计临床试验的疗效评价方法初探 |
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| 引用本文： | 蒋萌,熊宁宁.中药非双盲设计临床试验的疗效评价方法初探[J].金属学报,2002,7(4):369-371. |
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| 作者姓名： | 蒋萌 熊宁宁 |
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| 作者单位： | 南京中医药大学附属医院临床药理室, 南京 210029 |
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| 摘 要： | 由于中药的剂型、颜色、口味及服药方法的特殊性, 临床试验有时难以采用双盲设计, 因此在疗效评价时易混入研究者的主观因素, 造成评定结果的偏倚。本文结合具体实例, 尝试采用一种研究者职责相互隔离的设计方法, 试图避免研究者主观偏因。结果表明:在中药的药品临床试验中, 对于难以实现双盲设计的试验, 通过本法, 并结合严谨的质控措施, 可以达到接近双盲试验的结果。
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| 关 键 词： | 临床试验 双盲 偏性 疗效评价 |
| 收稿时间： | 2002-05-16 |
| 修稿时间： | 2002-06-27 |
Evaluation of the undoubled-blind design in the clinical trial of Chinese herb |
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| JIANG Meng,XIONG Ning-Ning.Evaluation of the undoubled-blind design in the clinical trial of Chinese herb[J].Acta Metallurgica Sinica,2002,7(4):369-371. |
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| Authors: | JIANG Meng XIONG Ning-Ning |
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| Affiliation: | Department of Clinical Pharmacology, Affiliated Hospital of Nanjing University of TCM, Nanjing 210029 |
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| Abstract: | Bias in undoubled-blind design in the clinical trial of Chinese herb affects the evaluation of efficacy and safety. With two examples, the paper recommended a “segregation” technique to minimize the bias in investigators during undoubled-blind trial. The results showed that this method combined other strict means can achieve the conclusions the same as a double-blind trial. |
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| Keywords: | clinical trial double-blind bias treatment evaluation |
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