报告率比例失衡信号检测的实证研究

Use of Proportional Reporting Ratios (PRRs) for Signals Detection from Spontaneous Reporting Database of Adverse Drug Reactions

目的:了解报告率比例法对药物不良反应志愿呈报数据库进行信号筛选和检测效果。方法:江苏省药物不良反应监测中心数据库中2004年所有报告,信号阈值为PRR值≥2,卡方值≥4,至少有3例以上的相关报道。将检测结果与产品说明书进行比较。结果:符合PRRs阈值的Drug-ADR组合共275种,其中115种没有在产品说明书中列出。结论:PRRs方法有助于在药物不良反应数据库中发现新的ADR信号及突出的药物安全性问题,为更深入的研究提供科学依据。

Objective： To screen and detect signal from Spontaneous Reporting database of adverse drug reactions. Method： The whole database of ADRs Monitoring Center of Jiangsu was investigated during the period of 2004 with the proportional reporting ratios. The minimum criterion for a signal is PRR at least 2, chi-squared at least 4. There were at least 3 related reports about them. The detection results were compared with that of their product instruction, Result： The method detected 275 Drug-ADR combinations meeting the minimum criteria, of which 115 were not marked in the production instruction, Conclusion： PRRs is a useful aid to detect the predominant drug safety issue and new signal from Spontaneous Reporting database of adverse drug reactions, and to decide combinations which need further investigation. It is valuable to promote the rational and safe use of clinical medication.