对完善我国皮下埋植避孕剂风险管理制度的探讨  

Suggestions for Risk Management System of Subdermal Implant Contraceptives in China

作　　者：朱向珺[1] 陈颖[1] 李瑛[1] 

机构地区：[1]国家人口计生委计划生育药具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

出　　处：《中国药事》2012年第12期1289-1291,共3页Chinese Pharmaceutical Affairs

基　　金：国家"十一五"科技支撑计划"避孕药具上市后监测和风险再评价研究"(编号2006BAI 15B07);中央财政专项"避孕药具不良反应监测与防治";江苏省科技厅项目"江苏避孕药具上市后监测与风险评价业务建设"(编号BM2009904)

摘　　要：目的为完善我国皮下埋植避孕剂的风险管理制度提供参考。方法对我国皮下埋植避孕剂的风险管理制度进行剖析,对国内外皮下埋植避孕剂不良反应发生情况进行文献检索和分析。结果我国皮下埋植避孕剂的风险管理制度存在不足。结论应将皮下埋植避孕剂纳入我国医疗器械分类管理范畴,对皮下埋植避孕剂中的硅胶棒实行医疗器械注册,并为皮下埋植剂因硅胶棒造成的不良事件在我国医疗器械不良事件报告系统中列出具体的报告项目。Objective To provide references for improving risk management system of subdermal implant contraceptives in China.Methods The current Chinese risk management system of subdermal implant contraceptives was analyzed and literatures at home and abroad on implant contraceptive adverse reactions were retrieved and reviewed.Results There are deficiencies in our risk management system of subdermal implant contraceptives in China.Conclusion It is suggested that subdermal implant contraceptives should be put into Chinese medical equipment classification management;the medical equipment of subdermal implant contraceptives should be registered;specific report items for subdermal implant contraceptive adverse reactions should be added in national medical equipment adverse reaction surveillance system.

关 键 词：皮下埋植避孕剂 风险管理 不良反应 

分 类 号：R95[医药卫生—药学] R979.21