摘要
目的：以标准治疗为对照的非劣性／等效性检验中样本含量估计及软件实现。方法：采用PASS11软件和相关计算公式，并通过实例分析计算两样本均数和两样本率比较时所需样本含量。结果：应用软件PASS11和所给的公式计算中，两样本均数比较时结果相等，两样本率比较时非劣效性检验所需样本含量为111例，等效性检验所需样本含量为154例，与软件结果（分别为112、154）也是非常接近。结论：相同的准确度下，该文章中介绍的公式计算简单、实现方便、易被接受，实用性强；但PASS11软件界面简洁、操作方便、结果输出更快。
Objective： To realize sample size estimation and software implementation in non-inferiority/equivalence tests with standard therapy for comparison. Methods： Using PASS 11 and related calculation formula calculate sample size of two sample means and two sample proportions by CaseStudy. Results： The two sample means were equal by using PASS 11 and the formula given. Comparing the two sample proportions, sample size required for non-inferiority tests was 111 cases, and sample size required for equivalence tests was 154 cases, which the result was very close to software （ respectively 112/154 ） . Conclusion： Under the same accuracy, the formula described in this article was simple, easily achievable, easily acceptable, and practical; while for PASS 11, its software interface is simple, easy to operate, and output faster.
