活性γ型宫内节育器型号-宫腔深度匹配度与医学原因终止风险的关联研究

A study of the association between medicated γ intrauterine device model-cavity depth match degree and the risk of termination for medical reasons

目的探讨现行指南或产品说明书推荐活性γ型宫内节育器(intrauterine device,IUD)型号选择标准是否降低IUD医学原因终止风险。方法基于国家卫生健康委重点实验室开展的避孕药具首诊排查登记项目选取江苏地区2015年1月至2020年10月期间月经后放置IUD的女性建立观察队列,按照产品说明书建议的型号选择标准对型号-宫腔深度匹配情况进行分组,分为匹配组、IUD偏小组和IUD偏大组,收集活性γ型IUD放置后的随访信息。采用多因素Cox比例风险回归模型分析不同的型号-宫腔深度匹配度与IUD医学原因终止风险之间的关联。结果共纳入4631例研究对象,其中匹配组2331例,IUD偏大组182例,IUD偏小组2118例。中位随访29个月(1~65个月),研究期间IUD医学原因终止528例(11.33%),IUD非医学原因终止108例(2.32%),失访333例(7.19%),其中,月经异常终止率发生最高。多因素Cox回归分析显示,与匹配组相比,IUD偏大组和IUD偏小组对象总医学原因、意外妊娠、IUD脱落、IUD下移、疼痛等相关终止的发生风险差异均无统计学意义(均P>0.05)。结论活性γ型IUD型号与宫腔深度不匹配不增加医学原因终止风险,在临床实践中可适当放宽活性γ型IUD的型号选择范围。

Objective:To explore whether the size selected criteria for medicatedγintrauterine device(γ-IUD)in current guideline or product manuals can reduce the risk of IUD termination for medical reasons.Methods:An observation cohort was established by selecting women who had an IUD placed after menstruation between January 2015 and October 2020 in the Jiangsu region based on the contraceptive first diagnosis registration program carried out by the Key Laboratory of the National Health Commission.Then the cohort were divided into the matched group,smaller size group,and larger size group according to the model selection criteria recommended by the product manual for model-uterine cavity depth matching.The follow-up information after the placement of theγ-IUD was collected.Multifactorial Cox proportional risk regression models were used to analyze the association between different model-cavity depth matches and the risk of IUD termination for medical reasons.Results:A total of 4631 study participants were included,including 2331 in the matched group,182 in the larger size group,and 2118 in the smaller size group.With a median follow-up of 29 months(1-65 months),528(11.33%)IUD terminations were for medical reasons,108(2.32%)IUD terminations were for non-medical reasons,and 333(7.19%)were lost to follow-up during the study period,with the highest rate of termination occurring for menstrual abnormalities.Multifactorial Cox regression analysis showed that there were no statistically significant differences in the risk of termination related to total medical reasons,unintended pregnancy,IUD expulsion,IUD dislocation,and pain in subjects with large IUDs or small IUDs compared with those in the matched group(all P>0.05).Conclusion:The mismatch betweenγ-IUD model and the depth of the uterine cavity does not increase the risk of IUD termination for medical reasons.In clinical practice,the model selection range ofγ-IUD can be appropriately relaxed.