2007-2011年国家避孕药品不良反应报告关联性评价分析

Analysis of Relationship Evaluation of State Contraceptives Adverse Drug Reaction Reports from 2007 to 2011

目的:提高我国避孕药品不良反应(ADR)监测评价水平。方法:对国家人口计生委计划生育ADR监测中心2007-2011年收集到的1572例避孕药品ADR报告进行关联性评价。结果:1572例ADR报告以"很可能"的一般报告居多,有1029例,占66.00%,主要涉及口服避孕药(567例)和皮下埋植剂(415例);ADR评价为"很可能"的口服避孕药排序靠前的ADR类型主要为月经问题、血压升高等。结论:对个例报告进行关联性评价是提取可靠信号的基础和重要内容,因而需进一步提升基层业务人员的报告意识和关联性评价水平。

OBJECTIVE： To improve the level of contraceptives adverse drug reaction （ADR） monitoring in China. METH- ODS： ＇The relationship of 1 572 contraceptives ADR reports collected by State Contraceptives Adverse Reaction Surveillance Center （SCARS） from 2007 to 2011 were evaluated. RESULTS： The majority of the total 1 572 ADR cases were the ＂vary probable＂ gen- eral reports, and there were 1 029 cases, accounting for 66.00%, mainly related to the oral contraceptives （567 cases） and subcuta- neous implants （415 cases）. The types of ADR, which took up the top in the list of ＂very probable＂ oral contraceptives, were mainly problem of menstruation, increase of blood pressure, etc. CONCLUSIONS： It is the basic and important content to extract reliable signals by evaluating the relationship of case report, which is suggested to enhance the awareness of ADR reporting and im- prove the level of ADR relationship assessment of the professional staffs in primary areas.