中文摘要：

目的通过对盲态和揭盲状态下内部预试验样本量调整的模拟比较,确定自适应设计中相对合理的样本量调整方法。方法利用蒙特-卡罗模拟不断改变内部预试验的样本量,在盲态和揭盲状态下分别比较I型错误和检验效能。结果两种状态下Ⅰ型错误和检验效能没有根本区别。结论盲态样本量调整更可取。

英文摘要：

Objective To determine the appropriate methods to sample size adjustment for adaptive design through simulations by comparing sample size adjustment of blinding internal pilot design with that of unblinding one in clinical trials. Methods Compare type I error and the power of blinding and unblinding internal pilot design through Monte Carlo simulation. Results Either type I error rates or the powers are not substantially distinct in two kinds of settings. Conclusion Blinding sample size adjustment is more preferable.