Univ. Bordeaux, Inserm, Bordeaux Population Health Research Centre, team PHARMACOEPIDEMIOLOGY, UMR 1219, Bordeaux, France; Bordeaux PharmacoEpi, INSERM CIC1401, Bordeaux, France.
Univ. Bordeaux, Inserm, Bordeaux Population Health Research Centre, team PHARMACOEPIDEMIOLOGY, UMR 1219, Bordeaux, France; CHU de Bordeaux, Pôle de Santé Publique, Service de Pharmacologie Médicale, Bordeaux, France.
Contraception. 2019 Jun;99(6):345-349. doi: 10.1016/j.contraception.2019.02.011. Epub 2019 Mar 12.
To compare the risk of all-cause death, hospitalizations (any cause), ectopic pregnancy, pelvic inflammatory disease or infection, uterine perforation, device removal, neuro-psychiatric drugs initiation, or new psychiatric visit(s) between levonorgestrel (LNG) 52 mg intrauterine system (IUS) and copper intrauterine device (IUD) users in France.
We identified a historical cohort of women aged 20-55 years with a first dispensing of either LNG 52 mg IUS or copper-IUD between January 1, 2010, and December 31, 2014, in the French National Claims database, SNDS. We used propensity score matching to balance the two groups on baseline sociodemographic and clinical characteristics to minimize confounding. We estimated Cox proportional hazards models to compare health outcomes between LNG 52 mg IUS and copper-IUDs users.
We matched 9318 LNG 52 mg IUS users (mean age 36.2±6.8 years) to 10,185 copper-IUD users (mean age 35.4±7.1 years). After matching and age-adjustment, LNG 52 mg IUS users had a slightly higher risk of anxiolytic drugs initiation (HR 1.08, 95%CI 1.01-1.15) and device removal (HR 1.05, 95%CI 1.01-1.10) compared to copper-IUD users, with no differences for other studied outcomes.
French IUS users report slightly more anxiolytic treatment initiation and IUD removal compared to copper-IUD users. These results are consistent with a potential pharmacovigilance signal of anxiety-related disorders in LNG 52 mg IUS users.
In French LNG 52 mg IUS users, there was slightly more anxiolytic treatment initiation and IUD removal compared to copper-IUD users. No risk difference was found for all-cause death, hospitalizations, ectopic pregnancy, pelvic disorders, and uterine perforation. We cannot exclude that the associations are related to differences in characteristics of women who chose each type of type of IUD.
比较左炔诺孕酮（LNG）52mg 宫内节育系统（IUS）和铜宫内节育器（IUD）使用者全因死亡、住院（任何原因）、异位妊娠、盆腔炎或感染、子宫穿孔、器械取出、神经精神药物使用或新的精神科就诊之间的风险。
我们在法国国家索赔数据库 SNDS 中确定了一组年龄在 20-55 岁之间的女性，她们在 2010 年 1 月 1 日至 2014 年 12 月 31 日期间首次配药 LNG 52mg IUS 或铜 IUD。我们使用倾向评分匹配来平衡两组的基线社会人口统计学和临床特征，以最大程度地减少混杂。我们估计 Cox 比例风险模型来比较 LNG 52mg IUS 和铜 IUD 使用者的健康结果。
我们匹配了 9318 名 LNG 52mg IUS 使用者（平均年龄 36.2±6.8 岁）和 10185 名铜 IUD 使用者（平均年龄 35.4±7.1 岁）。在匹配和年龄调整后，与铜 IUD 使用者相比，LNG 52mg IUS 使用者使用抗焦虑药物的风险略高（HR 1.08，95%CI 1.01-1.15）和器械取出（HR 1.05，95%CI 1.01-1.10），但其他研究结果没有差异。
与铜 IUD 用户相比，法国 IUS 用户报告抗焦虑治疗的起始率和 IUD 取出率略高。这些结果与 LNG 52mg IUS 用户焦虑相关障碍的潜在药物警戒信号一致。
在法国 LNG 52mg IUS 用户中，与铜 IUD 用户相比，抗焦虑治疗的起始率和 IUD 取出率略高。全因死亡、住院、异位妊娠、盆腔疾病和子宫穿孔无风险差异。我们不能排除这些关联与选择每种类型 IUD 的女性的特征差异有关。
