He B J, Zhang M X, Zhan S Y
Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China.
Institute of Reproductive and Child Health, Peking University, Beijing 100191, China.
Zhonghua Liu Xing Bing Xue Za Zhi. 2021 Sep 10;42(9):1641-1649. doi: 10.3760/cma.j.cn112338-20201208-01386.
To systematically evaluate and analyze the original research of prescription sequence symmetry analysis (PSSA), summarize its research progress and methodological details, and provide a reference for the future use of this method. The keywords related to PSSA were used for literature retrieval from Chinese databases (CNKI, Wanfang, and VIP) and English databases (PubMed, Embase, and Cochrane). Original articles that were related to PSSA and published before June 30, 2020 were selected. Information form was developed by Excel. Stata was used for the statistics analysis. There were 45 eligible articles included in the research. Since 2013, the number of studies using PSSA has increased rapidly. These studies were mainly conducted in Japan (=11, 24.44%), China (=10, 22.22%), Denmark (=9, 20.00%), and Australia (=8, 17.78%). Medical claim database was used most commonly when PSSA was implemented. The included studies involved 16 types of drugs, of which the number of studies of psychotropic drugs and statins was highest (=8, 17.78%), and adverse reactions of almost all human systems were involved. In terms of methodology, 35 (77.78%) and 43 (95.56%) studies clearly reported the run-in period and interval period, of which 14 (31.11%) and 9 (20.00%) respectively gave the method or reason for determining the duration. In addition, 16 articles (35.56%) and 18 articles (40.00%) reported sensitivity analysis and subgroup analysis results, respectively. PSSA, one of the effective methods for safety signal detection in healthcare databases, has developed rapidly, but the methodological details and result reporting need to be improved. In China, PSSA research is still in its infancy, and it is necessary to pay attention to the quality of research and promote methodological exploration.
为系统评价和分析处方序列对称分析（PSSA）的原始研究，总结其研究进展和方法学细节，为该方法的未来应用提供参考。使用与PSSA相关的关键词在中国数据库（知网、万方和维普）和英文数据库（PubMed、Embase和Cochrane）中进行文献检索。选取2020年6月30日前发表的与PSSA相关的原始文章。用Excel制作信息表。使用Stata进行统计分析。本研究共纳入45篇符合条件的文章。自2013年以来，使用PSSA的研究数量迅速增加。这些研究主要在日本（=11，24.44%）、中国（=10，22.22%）、丹麦（=9，20.00%）和澳大利亚（=8，17.78%）开展。实施PSSA时最常使用医疗索赔数据库。纳入的研究涉及16类药物，其中精神药物和他汀类药物的研究数量最多（=8，17.78%），几乎涉及人体所有系统的不良反应。在方法学方面，35项（77.78%）和43项（95.56%）研究明确报告了导入期和间隔期，其中分别有14项（31.11%）和9项（20.00%）给出了确定持续时间的方法或理由。此外，分别有16篇文章（35.56%）和18篇文章（40.00%）报告了敏感性分析和亚组分析结果。PSSA作为医疗保健数据库中安全信号检测的有效方法之一，发展迅速，但方法学细节和结果报告有待改进。在中国，PSSA研究仍处于起步阶段，有必要关注研究质量并促进方法学探索。
