非甾体抗炎药不良反应队列研究的样本量估计

Sample Size Determination in Cohort Study about NSAID's Adverse Reactions

目的:估算非甾体抗炎药不良反应队列研究的样本量,为临床科研设计提供依据。方法:根据研究目的及统计分析计划选择样本量的估算方法,多种估算方法相结合,提出几种方案以供决策和选择。结果:依据文献资料数据以及研究需要解决的问题,计算并给了多种前提条件下的最小观测例数。结论:在考虑样本增量的条件下,根据本研究的具体情况确定每一平行组观测例数为150例,并以此为依据进行实验设计。

OBJECT: To determine the sample size of cohort study about NSAID's adverse reactions, which is the foundation of study design. METHODS: According to the study objective and the plan of statistics analysis, to select the appropriate methods of calculation and to bring out several projects, it will be useful for decision-making. RESULTS: According to the data of reference documents and the problem need to be solved, to find out the minimum number of observation cases of difference condition. CONCLUSION: Considering the patients' drop-out, at last, we determined the sample size as 150 patients in every parallel group.