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中国临床药理学与治疗学 ›› 2013, Vol. 18 ›› Issue (1): 51-54.

• 定量药理学 • 上一篇    下一篇

计量资料非劣效临床试验样本量及把握度的计算与SAS程序实现

文世梅, 陈云飞, 刘华   

  1. 上海中医药大学附属岳阳中西医结合医院药物临床试验机构,上海 200437
  • 收稿日期:2012-07-12 修回日期:2012-07-12 发布日期:2013-02-05
  • 作者简介:文世梅,女,硕士,实习研究员,主要从事临床药理学研究。 Tel: 021-65162629 E-mail: wsm2319@126.com
  • 基金资助:
    上海高校青年教师培养资助计划(ZZszy12046)

SAS programming for sample size and power calculation of measurement data in non-inferior trials

WEN Shi-mei, CHEN Yun-fei, LIU Hua   

  1. Drug Clinical Trial Institution, Yueyang Hospital of Integrated Traditional Chinese and Western Medicone, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China
  • Received:2012-07-12 Revised:2012-07-12 Published:2013-02-05

摘要: 目的: 利用SAS简易快速对计量资料非劣效临床试验进行样本量及把握度的计算。方法: 比较公式及SAS编程两种计算方法,同时给出反推把握度的SAS宏程序。结果: 公式和SAS程序两种计算方法的结果一致,利用SAS程序可以直接给出结果,无需要再进行查表获得相关参数,更简单、快捷。结论: 利用本文提供的程序可以更好地帮助研究者理解与运用此程序进行样本量和把握度的估算,为此类新药临床试验服务。

关键词: 计量资料, 非劣效性试验, 样本量, 把握度, SAS程序

Abstract: AIM: To calculate sample size and power of measurement data in non-inferior trials using SAS programming. METHODS: Two calculation method, formula and SAS programming, were compared based on examples and the SAS macro for power was given as well. RESULTS: The calculation results of SAS programming was consistent with the formula, and SAS programming can directly give the result was more convenient without looking-up table to obtain the relevant parameters.CONCLUSION: It is helpful for investigator to have a better understanding at this programming to calculate sample size and power provided in this paper.

Key words: Measurement data, Non-inferior trial, Sample size, Power, SAS programming

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