中文摘要：

目的通过SAS编程实现两组事件发生率均为0%或100%时率差置信区间的估计。方法针对事件发生率均为100%或0%时率差置信区间的估计问题,采用SAS9.4编程,使置信区间估计的Miettinen Nurminen法、Newcombe-Wilson法及校正New combe-Wilson法等三种方法得以实现,并通过实例进行说明。结果所编程序实现了三种方法的置信区间估计,便于专业和非专业人员使用。实例中两组样本量分别为59,56,结果两组事件发生率均为100%,三种方法的95%置信区间：Miettinen Nurminen法为[-6.16%,6.47%];Newcombe法为[-6.11%,6.42%];校正Newcombe法为[-7.62%,8.00%]。结论本文所提供的SAS宏程序可以简便地实现两组事件发生率均为0%或100%时三种常用的率差置信区间的估计方法。

英文摘要：

Objective To estimate confidence intervals of clinical trials with success rates of 0% or 100% in both treatment and controlled groups using SAS programming. Methods To resolve the issue of calculating confidence intervals of rate differences in clinical trialswith both rates of 0% or 100%,programswere drafted using SAS 9. 4.Miettinen and Nurminen,New combe-Wilson Score and Continuity-corrected New combe-Wilson methods could all be implementedwith these programs.In addition,one examplewas displayed to illustrate the convenience of the programs. Results Confidence intervals in trialswith both success rates of 0% or 100% could be resolved using the 3 methods,and it can be used feasibly by professionals and nonprofessionals. In the given example,w ith sample size of 59,56,both of tw o groups had the success rate of 100%. 95% CI of rate differencewas [- 6. 16%,6. 47%] calculated byMiettinen Nurminen,[- 6. 11%,6. 42%] by New combe-Wilson Score and [- 7. 62%,8. 00%] by Continuity-corrected New combe-Wilson Score. ConclusionMiettinen and Nurminen,New combeWilson Score and Continuity-corrected New combe-Wilson methods could all be implemented easily to calculate confidence intervals of rate differences in clinical trialswith both rates of 0% or 100% by invoking the developed programs.