2007－2011年国家避孕药品不良反应报告关联性评价分析Δ-中国药房.PDFVIP

·不良反应监测· 2007－2011年国家避孕药品不良反应报告关联性评价分析Δ ＊ # 陈 颖 ，朱向珺，李 瑛（国家人口计生委计划生育药品不良反应监测中心/ 江苏省计划生育科学技术研究所， 南京 210036） 中图分类号 R969.3 文献标志码 C 文章编号 1001-0408（2013）14-1303-03 DOI 10.6039/j.issn. 1001-0408.2013.14.22 摘 要 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。 关键词 避孕药品；不良反应；关联性评价 Analysis of Relationship Evaluation of State Contraceptives Adverse Drug Reaction Reports from 2007 to 2011 CHEN Ying ，ZHU Xiang-jun ，LI Ying （State Contraceptives Adverse Reaction Surveillance Center/Jiangsu Insti- tute of Planned Parenthood Research ，Nanjing 210036，China ） ABSTRACT OBJECTIVE ：To improve the level of contraceptives adverse drug reaction （ADR ）monitoring in China. METH- ODS ：The relationship of 1572 contraceptives ADR reports collected by State Contraceptives Adverse Reaction Surveillance Center （SCARS）from 2007to 2011were evaluated. RESULTS ：The majority of the total 1572ADR cases were the “vary probable”gen- eral reports ，and there were 1029cases ，accounting for 66.00％，mainly related to the oral contraceptives （567cases ）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. KEY WORDS Contraceptive ；Adverse drug reaction ；Relationship evaluation 药品不良反应/事件（ADR/ADE ）病例报告是药物警戒的