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中国临床药理学与治疗学 ›› 2011, Vol. 16 ›› Issue (3): 281-286.

• 定量药理学 • 上一篇    下一篇

对临床试验中显著性检验、区间检验及置信区间检验之间关系一致性的认识

王静, 胡镜清   

  1. 中国中医科学院广安门医院临床评价中心,北京 100053
  • 收稿日期:2011-02-08 修回日期:2011-02-28 出版日期:2011-03-26 发布日期:2011-05-18
  • 通讯作者: 胡镜清,男,博士后,研究员,硕导,主要从事中医药临床疗效评价方法学研究。Tel: 010-88001294 E-mail: gcp306@126.com
  • 作者简介:王静,女,硕士,助理研究员,主要从事临床评价与统计分析工作。Tel: 010-88001292 E-mail: summeroceanwang@163.com
  • 基金资助:
    国家科技重大专项中药新药临床研究技术平台规范建设(2008ZX09312-012)

Understanding of relation among significance test, interval test and confidence interval test in clinical trial

WANG Jing, HU Jing-qing   

  1. Clinical Evaluation Center, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053
  • Received:2011-02-08 Revised:2011-02-28 Online:2011-03-26 Published:2011-05-18

摘要: 显著性检验是最基本的统计假设检验,它的基本思想是小概率原理;区间检验是传统显著性检验的延伸,它用来检验两个总体的差异是否在某范围之内;置信区间检验是先找到药物疗效差值的置信区间,通过置信区间下限或(和)上限与界值的关系来判断两种药物非劣效、等效、优效的关系。通过公式推导发现,区间检验与显著性检验的主要区别是前者的假设中包含了有临床意义的界值△,而区间检验和置信区间检验是一致的,可以用置信区间检验实现区间检验的目的。

关键词: 显著性检验, 区间检验, 非劣效检验, 等效性检验, 优效性检验, 置信区间检验

Abstract: The significance test is the most primary statistical hypothesis test, and it's basic principle is the principle of little probability. The interval test in clinical trial is the extension of the significance test, which is used to testify whether the difference between two populations is within a certain interval. In the confidence interval test, firstly, we find the confidence interval of the difference between two treatments' effects, and then we can decide whether it is non-inferior, equivalent or superior or not through comparing the confidence interval with the margin. Through the transformation of equations, it can be revealed that the most essential difference between the significance test and the interval test is the margin, which has the clinical meaning, is included in the interval test. In this paper, the consistency is confirmed between the interval test and the confidence interval test, so we can use the confidence interval test to achieve the result of the interval test.

Key words: Significance test, Interval test, Non-inferiority test, Equivalence test, Superiority test, Confidence interval test

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