中文摘要：

如何正确估计样本量是随机对照药物临床试验设计阶段的主要研究内容之一。本文在对随机对照临床试验样本量估计的影响因素一一分析的基础上,通过实例介绍临床试验样本量估计的分析过程,并讨论了临床试验样本量估计中的注意事项,为随机对照临床试验正确估计样本量提供参考。

英文摘要：

Sample size estimation is a key research aspect in randomized controlled drug clinical trial.Sample size estimation factors,parameters and basic rules are discussed in our research.In addition,sample size estimation procedures are introduced based on two examples.A reference is provided for estimating sample size in randomized controlled clinical trials.