Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices
Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices
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DOI：
10.1016/j.contraception.2015.01.007
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发表时间：
2015-04-01
期刊：
影响因子：
2.9
通讯作者：
Do Minh, Thai
中科院分区：
文献类型：
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作者：
Heinemann, Klaas;Reed, Suzanne;Do Minh, Thai
目的：目的是确定和比较子宫穿孔和其他与左炔诺孕酮宫内缓释系统相关的医学不良事件的发生率（LNG-IUSs，每天释放20 mcg LNG）和铜宫内节育器（IUD）在代表典型使用者的研究人群中在常规使用条件下的比较。这是一项针对液化天然气宫内节育器和铜宫内节育器新用户的跨国、前瞻性、非干预性队列研究。除了基线问卷调查外，女性及其治疗医疗保健专业人员在12个月后完成了一份随访问卷。所有患者报告的结果都经过了治疗医生的验证。结果：2006年至2013年期间，共有6个欧洲国家的61，448名女性接受了超过68，000名女性-年的观察（70% LNG，30%铜器械）。总体而言，报告了81例子宫穿孔：LNG-IUS组61例[1.4/1000次插入（95%置信区间{CI}：1.1-1.8）]和20例铜IUD [1.1/1000次插入（95% CI：0.7-1.7）]，调整后的风险比（RRadj）为1.6（95% CI：1.0-2.7），调整后的年龄，体重指数，母乳喂养时插入和分娩。插入时母乳喂养与六倍增加相关（RR 6.1，95% CI：3.9-9.6），LNG和铜KID用户之间没有差异。总共81例穿孔中有63例与先前怀疑的风险因素有关（例如，母乳喂养，距离上次分娩周的时间）。没有穿孔导致严重的疾病或腹腔内或盆腔结构的损伤。结论：在这项研究中，子宫穿孔的发病率低，此后的良性临床过程。液化天然气IUSs和铜宫内节育器没有临床上重要的差异穿孔rate.Implications：欧洲宫内节育器的主动监测研究是第一个大规模的，前瞻性的，非干预性的研究，比较液化天然气IUS和铜宫内节育器用户的穿孔风险。这是第一次检查母乳喂养状态和产后状态对穿孔风险的独立作用。在常规临床实践中进行，结果可推广到更广泛的人群。(C)2015作者爱思唯尔公司出版
Objectives: The objectives were to identify and compare the incidence of uterine perforation and other medically adverse events associated with levonorgestrel-releasing intrauterine systems (LNG-IUSs, releasing 20 mcg LNG daily) and copper intrauterine devices (IUDs) under routine conditions of use in a study population representative of typical users.Methods and materials: This is a multinational, prospective, non-interventional cohort study with new users of LNG-IUSs and copper IUDs. In addition to a baseline questionnaire, women and their treating health care professional completed a single follow-up questionnaire after 12 months. All patient-reported outcomes were validated by the treating physicians.Results: A total of 61,448 women in six European countries were followed between 2006 and 2013 for more than 68,000 women-years of observation (70% LNG, 30% copper devices). Overall, 81 uterine perforations were reported: 61 for LNG-IUSs [1.4 per 1000 insertions (95% confidence interval {CI}: 1.1-1.8)] and 20 for copper IUDs [1.1 per 1000 insertions (95% CI: 0.7-1.7)], for an adjusted risk ratio (RRadj) of 1.6 (95% CI: 1.0-2.7) when adjusted for age, body mass index, breastfeeding at time of insertion and parity. Breastfeeding at time of insertion was associated with a sixfold increase (RR 6.1, 95% CI: 3.9-9.6), with no differences between LNG and copper KID users. Sixty-three of the total 81 perforations were associated with previously suspected risk factors (e.g., breastfeeding, time since last delivery weeks). No perforations led to serious illness or to injury of intra-abdominal or pelvic structures.Conclusions: Uterine perforation incidence in this study was low, with a benign clinical course thereafter. The LNG-IUSs and copper IUDs did not have clinically important differences in perforation rates.Implications: The European Active Surveillance Study on Intrauterine Devices is the first large-scale, prospective, noninterventional study to compare the perforation risk in LNG-IUS and copper IUD users. It is the first to examine the independent roles that breastfeeding status and postpartum status have on perforation risk. Conducted during routine clinical practice, the findings are generalizable to broader populations. (C) 2015 The Authors. Published by Elsevier Inc.