巢式病例对照研究在中药注射剂上市后安全性研究中的应用

Application of nested case-control study on safe evaluation of post-marketing traditional Chinese medicine injection

目前开展上市中药注射剂安全性研究有多种方法,由于上市中药注射剂不良反应的发生率相对较小,故常需要进行大规模的队列研究。大规模队列研究存在许多现实的困难,如研究样本量大、随访时间长、易失访、费用高等。巢式病例对照研究近年在此领域的应用受到了越来越多的重视。该文介绍了巢式病例对照研究的概念、特点及分类,并介绍了在中药注射剂上市后安全性再评价中的应用原理、具体方法及步骤。

The nested case-control study design （or the case-control in a cohort study） is described here as a new study design used in safe evaluation of post-marketing traditional Chinese medicine injection. In the nested case-control study, cases of a disease that occur in a defined cohort are identified and, for each, a specified number of matched controls is selected from among those in the cohort who have not developed the disease by the time of disease occurrence in the case. For many research questions, the nested case-control design potentially offers impressive reductions in costs and efforts of data collection and analysis compared with the full cohort approach, with relatively minor loss in statistical efficiency. The nested case-control design is particularly advantageous for studies in safe evaluation of post-marketing traditional Chinese medicine injection. Some examples of the application of nested case-control study were given.