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【热门文献】宫内节育器相关的子宫穿孔发生率和风险(APEX-IUD)研究

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2022-06-17      

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Reed SD et al. Lancet. 2022 Jun 4;399(10341):2103-2112.


关于产后立即置入宫内节育器(iud)和非产后个体穿孔风险的报道很少。节育器插入会增加哺乳和产后36周内插入节育器与子宫穿孔的风险。该研究目的是比较节育器插入时与非产后间隔时间、产后间隔时间、产后个体中节育器相关子宫穿孔的发生率和风险,以评估母乳喂养对这些结果的影响


研究纳入326 658例患者和产后亚队列中的94 817例患者数据。在整个队列中,5年累积发生率在非产后组达到最低(0.29%,95% CI 0.26 - 0.34)。5年累积发生率为1.37% (95% CI 1.24 - 1.52),母乳喂养的风险增加(aHR =1.37, 95% CI 1.12 - 1.66)


产后4天至6周或更短时间内插入节育器导致子宫穿孔的风险是非产后插入节育器的近7倍。在放置IUD时母乳喂养会轻微增加穿孔的风险,但利大于弊临床影响较小。因此,放置IUD的时间应根据个人对IUD避孕意愿和患者来确定。对子宫穿孔高危人群进行仔细随访是有必要的


Background: Reports of perforation risk related to intrauterine devices (IUDs) inserted immediately post partum and among non-post-partum individuals are scarce, and previous studies with only 12-month follow-ups underestimate the risk. Breastfeeding at IUD insertion and insertion within 36 weeks post partum have been associated with increased risk of uterine perforation. The aim of these analyses was to compare the incidence and risks of IUD-related uterine perforations by non-post-partum and post-partum intervals at IUD insertion, and among post-partum individuals, to assess the impact of breastfeeding on these outcomes.

Methods: We did a multisite cohort study in the USA, using electronic health records (EHR). Study sites were three health-care systems and a site that used data from a health-care information exchange. The study population included individuals who were aged 50 years or younger and had an IUD insertion between Jan 1, 2001, and April 30, 2018. Individuals were excluded if they had not been in the health-care system for at least 12 months before IUD insertion. The primary outcome for this analysis was any IUD-related uterine perforation diagnosis for the first IUD insertion in this time period. Both complete and partial IUD-related perforations were identified. Chart abstraction was done to validate EHR-based algorithms or confirm perforations. The crude rate and cumulative incidence of uterine perforation were evaluated by non-post-partum and post-partum intervals at IUD insertion in the full cohort, and by breastfeeding status in a subcohort of post-partum individuals. Cox models estimated crude and adjusted hazard ratios (aHRs).

Findings: Data from 326 658 individuals in the full cohort and 94 817 individuals in the post-partum subcohort were analysed. In the full cohort, we identified 1008 uterine perforations (51·2% complete), with the 5-year cumulative incidence being the lowest in the non-post-partum group (0·29%, 95% CI 0·26-0·34). The aHR for the post-partum interval relative to non-post partum ranged from 2·73 (95% CI 1·33-5·63; 0 to 3 days post partum) to 6·71 (4·80-9·38; 4 days to ≤6 weeks post partum). The post-partum subcohort of individuals with breastfeeding information had 673 uterine perforations (62% complete), with a 5-year cumulative incidence of 1·37% (95% CI 1·24-1·52) and an increased risk with breastfeeding (aHR 1·37, 95% CI 1·12-1·66).

Interpretation: Although the risk for uterine perforation with IUD insertion 4 days to 6 weeks or less post partum is nearly seven times that of insertion non-post partum, perforation remains an incredibly rare event for all clinical time points. Despite a slight increased risk of perforation with breastfeeding at IUD insertion, the benefits of breastfeeding and effective contraception generally outweigh risks and should have little clinical impact. Therefore, IUD insertion timing should be based on individual desire for IUD contraception and patient convenience to assure an IUD insertion can occur. Careful follow-up of individuals at higher risk of uterine perforation is warranted.



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