避孕药具不良反应监测在宫内节育器有效性评价中的应用

Application of contraceptive adverse reaction surveillance in effectiveness evaluation of intrauterine device

目的:对常见宫内节育器(intrauterine device,IUD)的有效性进行分析评估,为临床合理使用IUD提供参考建议。方法:收集2011年至2020年江苏省内国家避孕药具不良反应监测点上报的使用IUD后发生意外妊娠的不良事件报告,与该地区新放置IUD的人群数据库进行记录联接,比较不同类型IUD妊娠发生粗率和累计发生粗率,评价避孕效果。结果:共收集常见10种不同类型IUD的妊娠对象4788例,新放置IUD的人群294834例。妊娠对象中,异位妊娠占比1.88%(90/4788);IUD脱落和位置形状改变分别占16.90%(809/4788)和32.31%(1547/4788)。放置IUD后第一年妊娠发生粗率为0.53%,随着使用时间的延长,各种IUD(安舒环除外)妊娠粗率呈逐年下降趋势。TCu220C累计3年、5年和8年的妊娠粗率均居10种IUD的首位,并显著高于平均发生粗率,相对危险度(relative risk,RR)分别为1.45(95%CI=1.37~1.55)、1.35(95%CI=1.28~1.43)和1.31(95%CI=1.24~1.38)。无论是否考虑脱器妊娠,吉妮累计3年、5年、8年和花式IUD累计3年、5年的妊娠粗率均显著低于平均水平,剔除脱落对象,吉妮RR分别为0.58(95%CI=0.49~0.70)、0.55(95%CI=0.47~0.66)和0.63(95%CI=0.53~0.75),花式IUD分别为0.36(95%CI=0.25~0.51)和0.45(95%CI=0.33~0.61)。结论:目前常见IUD均具有较好的避孕效果,吉妮和花式IUD的有效性更高。建议对IUD放置初期对象继续加强影像学随访检查,减少因脱落和位置改变导致的意外妊娠。

Objective To analyze and evaluate the effectiveness of common intrauterine device(IUD),and to provide reference for clinical use of IUD.Methods The IUD adverse events of unexpected pregnancy reported by the National Contraceptive Adverse Reaction Surveillance Sites in Jiangsu Province from 2011 to 2020 were collected,and the records were linked with the population database of IUDs placement in the region.The pregnancy incidence and cumulative incidence of different IUDs were compared to evaluate the contraceptive effect.Results A total of 4788 pregnant women with 10 common IUDs were collected,and 294834 IUDs were placed.Among the pregnant women,ectopic pregnancy accounted for 1.88%(90/4788);IUD expulsion and position change accounted for 16.90%(809/4788)and 32.31%(1547/4788)respectively.The incidence of pregnancy in the first year after IUD placement was 0.53%.The incidence of pregnancy in all kinds of IUDs(except for Anshu-IUD)decreased gradually with the extension of using time.The cumulative incidence of TCu220C in 3,5,8 years was significantly higher than the average incidence.The relative risk(RR)was 1.45(95%CI=1.37-1.55),1.35(95%CI=1.28-1.43)and 1.31(95%CI=1.24-1.38),respectively.Regardless of expulsion,Ginny's cumulative in 3,5,8 years and Hu280's cumulative 3-and 5-year incidence were significantly lower than the average level.Excluding expulsion,Ginny's RR was 0.58(95%CI=0.49-0.70),0.55(95%CI=0.47-0.66)and 0.63(95%CI=0.53-0.75),Hu280's RR was 0.36(95%CI=0.25-0.51)and 0.45(95%CI=0.33-0.61),respectively.Conclusion The common IUD has a good contraceptive effect,and Ginny and Hu280 are more effective.It is suggested that the imaging follow-up examination should be strengthened in the early stage of IUD placement to reduce the accidental pregnancy caused by expulsion and position change.