案例信息

标题：如何做到最佳临床证据——医疗器械临床试验的样本量计算

【专业学位类别】 公共卫生

【专业领域/方向】 试验流行病学

【作者】 许零

【单位】 厦门大学公共卫生学院

【关键词】公共卫生、医疗器械、样本量、临床试验

【适用课程】流行病学

【版权说明】真实性案例，仅用于教学目的

【案例摘要】本案是一起关于止血材料的安全性和有效性的随机对照临床试验的教学案例，旨在介绍如何计算样本量。本案首先介绍了止血材料的背景和目的，然后说明了随机对照临床试验的方法和指标，最后给出了样本量计算的公式和参数。本案通过一个简单的示例，展示了如何根据显著性水平、容忍度、最小临床差异和总体标准差等参数，计算出每个组和总体所需的样本量。本案适用于医学教育和研究中，帮助学习者掌握样本量计算的基本原理和方法。

Tittle: How to achieve the best clinical Evidence - Sample size calculation for clinical trials of medical Devices

Specialized fields: Public Health

Authors: Ling Xu

Affiliation: School of Public Health, Xiamen University

Key words: Public health, medical devices, sample size, clinical trials

Abstract

This case is an instructional case of a randomized controlled clinical trial on the safety and efficacy of hemostatic materials, aiming to introduce how to calculate sample size. This case first introduced the background and purpose of hemostatic materials, then explained the methods and indicators of randomized controlled clinical trials, and finally gave the formula and parameters of sample size calculation. Through a simple example, this case shows how to calculate the required sample size for each group and population based on parameters such as level of significance, tolerance, minimum clinical difference, and overall standard difference. This case is applicable in medical education and research to help learners master the basic principles and methods of sample size calculation.

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