intrauterine device

宫内节育器
  • 文章类型: Journal Article
    背景:全球超过4亿育龄妇女使用处方避孕。监测避孕药具的使用是一个主要的公共卫生问题,通常依赖于基于人群的调查。然而,这些调查平均每6年进行一次,不允许对避孕药具的使用进行密切随访。此外,他们的样本量通常太有限,无法研究特定的人群亚组,如低收入人群。卫生行政数据可能是研究避孕药具使用的创新且成本较低的来源。
    目的:我们旨在探索卫生管理数据在研究处方避孕药具使用方面的潜力,并将这些数据与基于调查数据的观察结果进行比较。
    方法:我们选择了所有15-49岁的女性,由法国健康保险覆盖并居住在法国,在卫生行政数据库中,占常住人口的98%(n=14,788,124),在上一次法国人口代表性调查中,健康晴雨表调查,2016年进行(n=4285)。在卫生行政数据中,记录了避孕药具的使用情况,并提供了有关产品的详细信息,而在调查中,这是由妇女自己宣布的。在这两个来源中,对所有处方避孕药具和避孕药具类型的全球避孕药具使用率进行了估计:口服避孕药,宫内节育器(IUD),和植入物。按年龄分析了患病率。
    结果:卫生行政数据中的低收入妇女多于基于人口的调查(1,576,066/14,770,256,11%vs188/4285,7%,分别;P<.001)。在卫生行政数据中,在基于人群的调查中,有47.6%(7034,710/14,770,256;95%CI47.6%-47.7%)的15-49岁女性使用了处方避孕药,而50.5%(2297/4285;95%CI49.1%-52.0%)。考虑到卫生行政数据与调查数据中避孕药具类型的患病率,口服避孕药分别为26.9%(95%CI26.9%-26.9%)和27.7%(95%CI26.4%-29.0%),宫内节育器的17.7%(95%CI17.7%-17.8%)与19.6%(95%CI18.5%-20.8%),和3%(95%CI3.0%-3.0%)与3.2%(95%CI2.7%-3.7%)的植入物。在这两个来源中,这3种避孕药具的总体流行趋势相同.植入物在各个年龄段都很少使用,口服避孕药在年轻女性中使用率很高,而年轻女性的宫内节育器使用率较低。
    结论:与调查数据相比,卫生行政数据显示口服避孕药的总体趋势相同,宫内节育器,和植入物。卫生行政数据的主要优势之一是关于避孕药具使用的高质量信息和大量的观察,允许研究人口的亚组。因此,卫生行政数据似乎是以人口为基础的方法监测避孕的有希望的新来源。它们可以为研究开辟新的视角,并成为指导生殖健康和性健康公共政策的宝贵新资产。
    BACKGROUND: Prescribed contraception is used worldwide by over 400 million women of reproductive age. Monitoring contraceptive use is a major public health issue that usually relies on population-based surveys. However, these surveys are conducted on average every 6 years and do not allow close follow-up of contraceptive use. Moreover, their sample size is often too limited for the study of specific population subgroups such as people with low income. Health administrative data could be an innovative and less costly source to study contraceptive use.
    OBJECTIVE: We aimed to explore the potential of health administrative data to study prescribed contraceptive use and compare these data with observations based on survey data.
    METHODS: We selected all women aged 15-49 years, covered by French health insurance and living in France, in the health administrative database, which covers 98% of the resident population (n=14,788,124), and in the last French population-based representative survey, the Health Barometer Survey, conducted in 2016 (n=4285). In health administrative data, contraceptive use was recorded with detailed information on the product delivered, whereas in the survey, it was self-declared by the women. In both sources, the prevalence of contraceptive use was estimated globally for all prescribed contraceptives and by type of contraceptive: oral contraceptives, intrauterine devices (IUDs), and implants. Prevalences were analyzed by age.
    RESULTS: There were more low-income women in health administrative data than in the population-based survey (1,576,066/14,770,256, 11% vs 188/4285, 7%, respectively; P<.001). In health administrative data, 47.6% (7034,710/14,770,256; 95% CI 47.6%-47.7%) of women aged 15-49 years used a prescribed contraceptive versus 50.5% (2297/4285; 95% CI 49.1%-52.0%) in the population-based survey. Considering prevalences by the type of contraceptive in health administrative data versus survey data, they were 26.9% (95% CI 26.9%-26.9%) versus 27.7% (95% CI 26.4%-29.0%) for oral contraceptives, 17.7% (95% CI 17.7%-17.8%) versus 19.6% (95% CI 18.5%-20.8%) for IUDs, and 3% (95% CI 3.0%-3.0%) versus 3.2% (95% CI 2.7%-3.7%) for implants. In both sources, the same overall tendency in prevalence was observed for these 3 contraceptives. Implants remained little used at all ages, oral contraceptives were highly used among young women, whereas IUD use was low among young women.
    CONCLUSIONS: Compared with survey data, health administrative data exhibited the same overall tendencies for oral contraceptives, IUDs, and implants. One of the main strengths of health administrative data is the high quality of information on contraceptive use and the large number of observations, allowing studies of subgroups of population. Health administrative data therefore appear as a promising new source to monitor contraception in a population-based approach. They could open new perspectives for research and be a valuable new asset to guide public policies on reproductive and sexual health.
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  • 文章类型: Journal Article
    目的:这项研究的目的是前瞻性评估是否有含铜宫内节育器(Cu-IUD)的妇女,目前列为MR条件,可以安全地进行3.0特斯拉(3T)磁共振成像(MRI)。
    方法:73名女性,年龄18-54岁,包括因任何原因正在接受MRI检查的Cu-IUD患者。完成了MRI前和后标准盆腔超声检查,以确定Cu-IUD的MRI前和后定位。移位的宫内节育器由不在子宫内膜腔底部的宫内节育器横杆定义,子宫中部或下部的可视化尖端,位于宫颈管或子宫内膜管外的装置的任何部分,一个断裂的装置,或者非可视化宫内节育器。此外,参与者完成了一项调查问卷,以确定MRI前后盆腔疼痛的水平.
    结果:在MRI后盆腔超声检查中观察到零移位的Cu-IUD(p=0/70,95%CI0,.043)。由于MRI前盆腔超声检查中宫内节育器错位,三名参与者从研究中退出。六名患者在MRI检查期间或之后报告了新的或恶化的盆腔疼痛/不适。
    结论:我们的结果表明,使用低SAR设置进行3TMRI不会导致铜宫内节育器移位,70名显示宫内节育器移位的患者中没有。
    OBJECTIVE: The aim of this study is to prospectively evaluate whether women with copper-containing intrauterine devices (Cu-IUD), currently listed as MR conditional, can safely undergo 3.0 Tesla (3 T) magnetic resonance imaging (MRI).
    METHODS: 73 women, age 18-54 years old, with a Cu-IUD who were undergoing MRI for any reason were included consecutively. Pre- and post-MRI standard pelvic ultrasound examinations were completed to determine the appropriate pre- and post-MRI positioning of the Cu-IUD. Displaced IUDs were defined by IUD crossbars not in the fundal portion of the endometrial cavity, a visualized tip in the mid or lower uterus, any part of the device located in the cervical canal or outside of the endometrial canal, a fractured device, or a non-visualized IUD. Additionally, a questionnaire was completed by participants to determine the level of pre- and post-MRI pelvic pain.
    RESULTS: There were zero observed displaced Cu-IUDs on post-MRI pelvic ultrasounds (p = 0/70, 95% CI 0, .043). Three participants were dropped from the study due to malpositioned IUDs on pre-MRI pelvic ultrasound. Six patients reported new or worsening pelvic pain/discomfort during or after their MRI examination.
    CONCLUSIONS: Our results suggest that performing 3 T MRI using a low SAR setting does not cause displacement of Cu-IUDs, with zero out of 70 patients demonstrating IUD displacement.
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  • 文章类型: Journal Article
    背景:尽管有临床和经济效益,门诊宫腔镜检查(OPH)期间的疼痛仍然是使用的障碍。缺乏证据支持常规使用一种镇痛药而不是另一种镇痛药。
    目的:研究甲氧氟烷用于OPH镇痛的有效性和安全性。
    方法:单中心,随机化,双盲,进行安慰剂对照实验;90例患者被随机分配(1:1).分配给治疗组(病例)的参与者通过吸入器接受3mL甲氧氟烷。对照组接受安慰剂。主要结果是疼痛的平均差异,通过诊断宫腔镜检查时视觉模拟量表(VAS)评分相对于基线的变化。次要结果是任何后续手术的VAS评分的平均差异;术后15分钟的VAS评分的平均差异;参与者和临床医生报告的不良反应和事件;以及参与者报告的手术可接受性。辅助一氧化二氮(N2O2)的使用和\'痛苦\'的复合材料。
    结果:在诊断宫腔镜检查期间,平均差为11.5mm/100(95%置信区间(CI)0.08-22.95),P=0.05,病例得分较低,与对照组相比。在随后的手术过程中,平均差异为15mm/100(95%CI2.71-28.22),P=0.02,病例疼痛评分较低,与对照组相比。术后15分钟疼痛无显著差异,参与者和临床医生报告的不良反应和事件,程序可接受性和“遇险”复合。
    结论:与安慰剂相比,甲氧氟烷可显著减轻OPH期间的疼痛,用于诊断和手术程序。此外,甲氧氟烷耐受性良好,没有不良事件。
    BACKGROUND: Despite clinical and economic benefits, pain during outpatient hysteroscopy (OPH) remains a barrier to use. There is a lack of evidence to support routine use of one analgesic over another versus no analgesic.
    OBJECTIVE: To study the efficacy and safety of methoxyflurane analgesia during OPH.
    METHODS: A single-centre, randomised, double-blind, placebo-controlled experiment was performed; 90 patients were randomly assigned (1:1). Participants allocated to the treatment group (cases) received 3 mL of methoxyflurane through an inhaler. The control group received a placebo. The primary outcome was a mean difference in pain, via a change in Visual Analog Scale (VAS) score from baseline at diagnostic hysteroscopy. Secondary outcomes were a mean difference in VAS score with any subsequent operative procedures; a mean difference in VAS score at 15 min post-procedure; participant and clinician-reported adverse effects and events; and participant-reported procedure acceptability, adjuvant nitrous oxide (N2O2) use and a composite of \'distress\'.
    RESULTS: During diagnostic hysteroscopy, there was a mean difference of 11.5 mm/100 (95% confidence interval (CI) 0.08-22.95), P = 0.05, with the lower score in the cases, compared with controls. During subsequent operative procedures, there was a mean difference of 15 mm/100 (95% CI 2.71-28.22), P = 0.02, with the lower pain score in the cases, compared with controls. There was no significant difference in pain 15 min post-procedure, participant- and clinician- reported adverse effects and events, procedure acceptability and the \'distress\' composite.
    CONCLUSIONS: Methoxyflurane significantly reduced pain during OPH compared with placebo, for diagnostic as well as operative procedures. Furthermore, methoxyflurane was well tolerated, with no adverse events.
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  • 文章类型: Journal Article
    目的:为了比较去除时间,技术,以及将IUD错位到未错位的IUD的成功。
    方法:我们在2014年7月至2017年7月期间在一个医疗系统内对宫内节育器使用者进行了一项回顾性队列研究。我们使用Fisher精确和Wilcoxon秩和检验来比较IUD错位和非错位患者的临床特征和IUD移除细节。
    结果:在报告存在宫内节育器的1,759次超声报告中,436描述了宫内节育器错位。其中,150将宫内节育器描述为嵌入式,16将其描述为部分穿孔。与非错位宫内节育器相比,错位的患者更有可能被移除和更快地移除宫内节育器(281/436vs.545/1323,p<0.001,中位数为17天从指数超声检查236天,p<0.001)。大多数宫内节育器,错位和非错位,在第一次尝试时被移除(82%,85%),由通才OBGYN(75%,70%),使用环形镊子(73%,65%)。大多数嵌入和部分穿孔的宫内节育器被移除(68%,69%),使用环形镊子(59%,67%),第一次尝试(84%,91%)。
    结论:与未定位的宫内节育器相比,定位错误的宫内节育器更有可能被移除和更快地移除。大多数宫内节育器,甚至是标记为部分穿孔或嵌入的宫内节育器,被一个通才OBGYN带走了,使用环形镊子,第一次尝试。
    结论:宫内节育器错位的超声发现与难以取出宫内节育器无关。
    OBJECTIVE: This study aimed to compare removal timing, techniques, and success of malpositioned intrauterine device (IUDs) to nonmalpositioned IUDs.
    METHODS: We performed a retrospective cohort study of IUD users with ultrasound performed between July 2014 and July 2017 within one medical system. We used Fisher exact and Wilcoxon rank-sum tests to compare clinical characteristics and IUD removal details between patients with malpositioned and nonmalpositioned IUDs.
    RESULTS: Of 1759 ultrasounds reporting the presence of an IUD, 436 described IUD malposition. Of these, 150 described the IUD as embedded and 16 as partially perforated. IUDs were more likely to be removed and removed sooner for patients with malpositioned compared with nonmalpositioned IUDs (281/436 vs 545/1323, p < 0.001 and median 17 days vs 236 days from the index ultrasound, p < 0.001). Most IUDs, malpositioned and nonmalpositioned, were removed on the first attempt (82%, 85%), by a generalist obstetrician and gynecologist (75%, 70%), using a ring forceps (73%, 65%). Most embedded and partially perforated IUDs were removed (68%, 69%), using a ring forceps (59%, 67%), on the first attempt (84%, 91%).
    CONCLUSIONS: Malpositioned IUDs were more likely to be removed and removed sooner than nonmalpositioned IUDs. Most IUDs, even IUDs labeled as partially perforated or embedded, were removed by a generalist obstetrician and gynecologist, using ring forceps, on first attempt.
    CONCLUSIONS: Ultrasound findings of IUD malposition are not associated with difficult IUD removal.
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  • 文章类型: Journal Article
    目的:自2020年以来,FDA已批准多次延长使用左炔诺孕酮(LNG)52-mg宫内节育器(IUD)预防妊娠超过五年。对于致电生殖健康诊所安排更换的患者,此信息的可及性仍然未知。我们评估了患者通过电话访问有关LNG52mgIUD预防妊娠持续时间的信息的经验。
    方法:我们在2022年扩展之前和之后利用了一个神秘的客户研究设计,以询问超过五年的LNG52-mgIUD使用情况。有目的的采样确保了临床多样性。
    结果:2022年6月,18家(32%)诊所提供了超过五年的延长使用,25(44%)建议在五年内更换,和14(25%)无法提供信息。提供延长LNG52毫克宫内节育器使用的诊所数量在2023年8月没有显著增加(n=22,39%,p=0.27)。
    结论:计划更换LNG52-mg宫内节育器的患者可能无法获得超过五年的使用信息。生殖健康诊所的调度人员需要对更新的指南进行进一步的培训。
    OBJECTIVE: Since 2020, the Food and Drug Administration has approved multiple extensions to the use of the levonorgestrel (LNG) 52-mg intrauterine device (IUD) for pregnancy prevention beyond 5 years. The accessibility of this information to patients calling a reproductive health clinic to schedule replacement remains unknown. We assess the patient experience in accessing information via phone call on the duration of pregnancy prevention for LNG 52-mg IUD.
    METHODS: We utilized a mystery client study design to inquire about LNG 52-mg IUD use beyond 5 years. Purposeful sampling ensured clinic diversity.
    RESULTS: In June 2022, 18 (32%) clinics offered extended use beyond 5 years, 25 (44%) recommended replacement at 5 years, and 14 (25%) could not provide information. The number of clinics offering extended LNG 52-mg IUD use did not significantly increase in August 2023 (n = 22, 39%, p = 0.27).
    CONCLUSIONS: Patients scheduling a replacement of the LNG 52-mg IUD may not receive information about use beyond 5 years.
    CONCLUSIONS: Reproductive health clinics scheduling staff need further training on updated guidelines.
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  • 文章类型: Journal Article
    为了检查高危型人乳头瘤病毒(HPV)感染和宫颈发育不良的患病率,和HPV感染的清除率,在不同类型的宫内节育器(宫内节育器)和其他避孕方法的使用者中。
    一项基于注册的横断面研究,包括2017-2018年在瑞典县参加宫颈癌筛查计划的16,181名30-49岁女性。来自筛查记录的避孕数据与HPV检测结果配对,细胞学和组织学随访试验以及随后的HPV检测。
    HPV阳性的风险没有差异,或组织学HSIL+,含铜宫内节育器使用者与未报告使用避孕药具的妇女之间的关系。使用左炔诺孕酮宫内系统和激素避孕与年龄校正模型(aOR1.21;95%CI1.04-1.41和aOR1.41;95%CI1.22-1.63)和HSIL+(aOR1.45;95%CI1.02-2.06和aOR1.56;95%CI1.13-2.16)的HPV感染几率较高。HPV清除率无显著差异。
    报告使用左炔诺孕酮宫内节育系统和激素避孕,但不使用铜宫内节育器,与未报告使用避孕药相比,HPV感染和组织学HSIL+的患病率更高。
    在横断面研究中,使用铜宫内节育器的妇女与未使用避孕药的妇女相比,HPV或宫颈发育不良的患病率没有差异。
    UNASSIGNED: To examine the prevalence of infections with high-risk human papillomavirus (HPV) and cervical dysplasia, and the clearance rate of HPV infections, in users of different kinds of intrauterine devices (IUDs) and other contraceptive methods.
    UNASSIGNED: A cross-sectional register-based study including 16,181 women aged 30-49 years participating in the screening programme for cervical cancer in a Swedish County in 2017-2018. Data on contraception from screening records was paired with the HPV test results, cytological and histological follow-up tests and subsequent HPV test.
    UNASSIGNED: There was no difference in the risk of being HPV positive, or histological HSIL+, between users of copper-containing IUDs and women with no reported use of contraception. Use of levonorgestrel intrauterine system and hormonal contraception were associated with higher odds for HPV infection in age-adjusted models (aOR 1.21; 95% CI 1.04-1.41, and aOR 1.41; 95% CI 1.22-1.63, respectively) and for HSIL+ (aOR 1.45; 95% CI 1.02-2.06, and aOR 1.56; 95% CI 1.13-2.16, respectively). No significant differences were found in HPV clearance rates.
    UNASSIGNED: Reported use of levonorgestrel intrauterine system and hormonal contraception, but not use of copper IUD, was associated with a higher prevalence of HPV infections and histological HSIL + compared to no reported use of contraception.
    Women using copper IUD showed no difference in prevalence of HPV or cervical dysplasia compared to women not using contraception in cross-sectional study.
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  • 文章类型: Journal Article
    背景:大量月经出血的症状对专业人士有重大影响,物理,和社会功能。2021年,发表了一项随机对照试验的结果,该试验比较了52mg左炔诺孕酮释放宫内节育器系统和射频非电切镜下子宫内膜消融术作为大量月经出血妇女的治疗方法。在2年的随访中,两种治疗策略在治疗大量月经出血方面同样有效。然而,长期结果也与患者和医疗保健提供者相关。
    目的:本研究旨在评估根据从52mg左炔诺孕酮宫内节育系统或射频非电切下子宫内膜消融术开始治疗的重度月经出血症状的女性的再干预风险和月经失血的长期差异。
    方法:本研究是一项多中心随机对照试验(MIRA试验)的长期随访研究,其中女性被分配到52mg左炔诺孕酮宫内节育器(n=132)或射频非电切镜下子宫内膜消融术(n=138).与原始试验的妇女联系以填写6份问卷。主要结果是分配治疗后的再干预率。次要结果包括手术再干预率,通过图片失血评估图表测量的月经出血,(疾病特异性)生活质量,性功能,患者满意度。
    结果:从最初试验中随机分配的270名女性中,196(52mg左炔诺孕酮宫内缓释系统组:n=94;射频非切除子宫内膜消融术组:n=102)参加了这项长期随访研究。平均随访时间为7.4年(范围,6-9年)。52mg左炔诺孕酮宫内节育系统组的累积再干预率(包括药物和手术再干预)为40.0%(34/85),射频非电切镜下子宫内膜消融术组为28.7%(27/94)(相对风险,1.39;95%置信区间,0.92-2.10)。与射频非切除子宫内膜消融术(35.3%[30/85]vs19.1%[18/94]相比,仅采用52mg左炔诺孕酮宫内节育系统开始治疗的患者的手术再干预累积率显著较高;相对风险,1.84;95%置信区间,1.11-3.10)。然而,子宫切除率相似(52mg左炔诺孕酮宫内缓释系统组11.8%[10/94]和射频非切除子宫内膜消融术组18.1%[17/102];相对风险,0.65;95%置信区间,0.32-1.34)。大多数再干预发生在随访的前24个月。总共171个图片失血评估图表得分显示中位出血得分为0.0。在生活质量方面没有发现临床相关的差异,性功能,患者满意度。
    结论:长期随访后再干预的总体风险在按照52mg左炔诺孕酮宫内节育器开始治疗的妇女和采用射频非电切镜下子宫内膜消融术开始治疗的妇女之间没有差异。然而,从52mg左炔诺孕酮释放宫内节育器系统开始接受治疗的女性接受手术再干预的风险较高,这是由随后的子宫内膜消融增加驱动的。两种治疗策略在长期内有效降低月经失血。这项长期随访研究的结果可以支持医生优化月经大出血女性的咨询,从而促进有关治疗选择的知情决策。
    The symptom of heavy menstrual bleeding has a substantial impact on professional, physical, and social functioning. In 2021, results from a randomized controlled trial comparing a 52-mg levonorgestrel-releasing intrauterine system and radiofrequency nonresectoscopic endometrial ablation as treatments for women with heavy menstrual bleeding were published. Both treatment strategies were equally effective in treating heavy menstrual bleeding during 2-year follow-up. However, long-term results are also relevant for both patients and healthcare providers.
    This study aimed to assess long-term differences in reintervention risk and menstrual blood loss in women with the symptom of heavy menstrual bleeding treated according to a strategy starting with a 52-mg levonorgestrel-releasing intrauterine system or radiofrequency nonresectoscopic endometrial ablation.
    This study was a long-term follow-up study of a multicenter randomized controlled trial (MIRA trial), in which women were allocated to either a 52-mg levonorgestrel-releasing intrauterine device (n=132) or radiofrequency nonresectoscopic endometrial ablation (n=138). Women from the original trial were contacted to fill out 6 questionnaires. The primary outcome was the reintervention rate after allocated treatment. Secondary outcomes included surgical reintervention rate, menstrual bleeding measured by the Pictorial Blood Loss Assessment Chart, (disease-specific) quality of life, sexual function, and patient satisfaction.
    From the 270 women who were randomized in the original trial, 196 (52-mg levonorgestrel-releasing intrauterine system group: n=94; radiofrequency nonresectoscopic endometrial ablation group: n=102) participated in this long-term follow-up study. Mean follow-up duration was 7.4 years (range, 6-9 years). The cumulative reintervention rate (including both medical and surgical reinterventions) was 40.0% (34/85) in the 52-mg levonorgestrel-releasing intrauterine system group and 28.7% (27/94) in the radiofrequency nonresectoscopic endometrial ablation group (relative risk, 1.39; 95% confidence interval, 0.92-2.10). The cumulative rate of surgical reinterventions only was significantly higher among patients with a treatment strategy starting with a 52-mg levonorgestrel-releasing intrauterine system compared with radiofrequency nonresectoscopic endometrial ablation (35.3% [30/85] vs 19.1% [18/94]; relative risk, 1.84; 95% confidence interval, 1.11-3.10). However, the hysterectomy rate was similar (11.8% [10/94] in the 52-mg levonorgestrel-releasing intrauterine system group and 18.1% [17/102] in the radiofrequency nonresectoscopic endometrial ablation group; relative risk, 0.65; 95% confidence interval, 0.32-1.34). Most reinterventions occurred during the first 24 months of follow-up. A total of 171 Pictorial Blood Loss Assessment Chart scores showed a median bleeding score of 0.0. No clinically relevant differences were found regarding quality of life, sexual function, and patient satisfaction.
    The overall risk of reintervention after long-term follow-up was not different between women treated according to a treatment strategy starting with a 52-mg levonorgestrel-releasing intrauterine system and those treated using a strategy starting with radiofrequency nonresectoscopic endometrial ablation. However, women allocated to a treatment strategy starting with a 52-mg levonorgestrel-releasing intrauterine system had a higher risk of surgical reintervention, which was driven by an increase in subsequent endometrial ablation. Both treatment strategies were effective in lowering menstrual blood loss over the long term. The results of this long-term follow-up study can support physicians in optimizing the counseling of women with heavy menstrual bleeding, thus promoting informed decision-making regarding choice of treatment.
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  • 文章类型: Randomized Controlled Trial
    目的:该试验旨在比较妇女在宫内节育器(IUD)插入过程中所感受到的疼痛,有或没有虚拟现实(VR)治疗。此外,插入过程中的焦虑,插入后疼痛,并对插入的满意度进行了比较。
    方法:该试验设计为前瞻性,双中心,随机化,开放标签介入试验。所有在避孕咨询期间选择宫内节育器的成年女性,提供知情同意书的人符合资格.法律监护下的妇女,不隶属于国家社会保障体系,并伴有预先存在的头晕,严重的面部伤口,或癫痫不合格。符合条件的妇女被随机分配没有VR治疗的标准护理(对照组)或VR治疗(实验组)。疼痛,焦虑,满意度是用10厘米的数字量表测量的。
    结果:在2020年9月至2022年4月之间,100名妇女被随机分配:每组50名。对照组插入IUD期间的平均疼痛评分为5.4cm,实验组为5.1cm(p=0.54)。插入期间的平均焦虑在对照组中为4.8cm,而在实验组中为4.2cm(p=0.13)。而插入后感觉到的平均疼痛对照组为2.4cm,实验组为2.4cm(p=0.98)。两组对插入的平均满意度为9.6cm(p=0.87)。宫内节育器插入前的焦虑,以及预期的疼痛,与插入过程中感知到的疼痛显着相关。
    结论:在手术期间进行VR治疗并不能减轻接受宫内节育器插入的女性的感觉疼痛。
    OBJECTIVE: The trial aimed to compare the pain perceived by women during intrauterine device (IUD) insertion, with or without virtual reality (VR) therapy. Furthermore, anxiety during the insertions, pain after the insertions, and satisfaction with the insertions were compared.
    METHODS: The trial was designed as a prospective, bi-centric, randomized, open-label interventional trial. All adult women that chose an IUD during a contraceptive consultation, and who provided informed consent were eligible. Women under legal guardianship, not affiliated to a national social security system, and with pre-existing dizziness, severe facial wounds, or epilepsy were not eligible. Eligible women were randomly allocated either standard care without VR therapy (Control group) or with VR therapy (Experimental group). Pain, anxiety, and satisfaction were measured using a 10-cm numerical scale.
    RESULTS: Between September 2020 and April 2022, 100 women were randomized: 50 to each group. The mean pain scores during IUD insertion were 5.4 cm in the Control group versus 5.1 cm in the Experimental group (p = 0.54). Mean anxiety during insertion were 4.8 cm in the Control group versus 4.2 cm in the Experimental group (p = 0.13). While mean pain perceived after insertions were 2.4 cm in the Control Group and 2.4 cm in the Experimental group (p = 0.98). Mean satisfaction with the insertions was 9.6 cm in both groups (p = 0.87). Anxiety before IUD insertion, as well as anticipated pain, were significantly correlated with pain perceived during insertions.
    CONCLUSIONS: VR therapy performed during the procedure did not alleviate perceived pain in women undergoing IUD insertions.
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  • 文章类型: Journal Article
    目的:比较和评估左炔诺孕酮宫内缓释系统(LNG-IUD)和电切镜术重塑手术治疗与既往剖宫产瘢痕缺损(PCDS)相关的经期出血的疗效。
    方法:对接受LNG-IUD(左炔诺孕酮20μg/24h,N=33)或切除镜检查重塑(N=27)。比较1、6和12个月的治疗结果。子宫大小逆行或大的患者的结局,缺陷尺寸,和局部血管化也进行了评估。
    结果:治疗后12个月,两组之间的有效率没有显着差异;然而,LNG-IUD组的经期出血天数减少高于电切镜组(13.6vs.8.5天,p=0.015)。第一年内,两组出血天数都减少了,但液化天然气宫内节育器组的下降幅度更大。与切除镜组相比,LNG-IUD组缺损部位局部血管形成增加的个体获得了更有利的结果(p=0.016),在LNG-IUD组中,反应不佳的人倾向于子宫明显更大(p=0.019)。两组子宫逆行或大缺损患者的治疗结果均无明显差异。
    结论:我们的研究结果支持LNG-IUD在减少PCDS相关的经期出血天数方面与电切镜检查一样有效,并且可以安全地应用于没有近期生育愿望的患者。在宫腔镜检查期间观察到的局部血管化增加的患者可能从LNG-IUD干预中比电切镜检查受益更多。
    OBJECTIVE: To compare and evaluate the efficacy of the levonorgestrel-releasing intrauterine system (LNG-IUD) and resectoscopy remodeling procedure for intermenstrual bleeding associated with previous cesarean delivery scar defect (PCDS).
    METHODS: A retrospective comparative study was conducted on patients with PCDS receiving LNG-IUD (levonorgestrel 20 μg/24 h, N = 33) or resectoscopy remodeling (N = 27). Treatment outcomes were compared over 1, 6, and 12 months. Outcomes in patients with a retroverted or large uterus size, defect size, and local vascularization also were evaluated.
    RESULTS: At 12 months post-treatment, there were no significant differences between groups in efficacy rate; however, the reduction of intermenstrual bleeding days was higher in the LNG-IUD group than in the resectoscopy group (13.6 vs. 8.5 days, p = 0.015). Within the first year, both groups experienced a reduction in bleeding days, but the decrease was greater in the LNG-IUD group. Individuals exhibiting increased local vascularization at the defect site experienced more favorable outcomes in the LNG-IUD group than the resectoscopy group (p = 0.016), and who responded poorly tended to have a significantly larger uterus in the LNG-IUD group (p = 0.019). No significant differences were observed in treatment outcomes for patients with a retroverted uterus or large defect in either group.
    CONCLUSIONS: Our findings support that the LNG-IUD is as effective as resectoscopy in reducing intermenstrual bleeding days associated with PCDS and can be safely applied to patients without recent fertility aspirations. Patients with increased local vascularization observed during hysteroscopy may benefit more from LNG-IUD intervention than resectoscopy.
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  • 文章类型: Journal Article
    目的:先前的研究发现,左炔诺孕酮宫内节育器(LNG52mg宫内节育器)使用者的头发皮质醇浓度(下丘脑垂体肾上腺轴激活的替代指标)增加。我们评估了启动铜(CuT380IUD)或LNG52mgIUD的女性的头发皮质醇和心理测验的变化。
    方法:我们前瞻性招募健康女性开始使用LNG52mgIUD或CuT380IUD。参与者提供了头发和血液样本,并完成了心理测量清单[患者健康问卷-9;积极和消极的影响时间表;IUD插入后以及6个月和12个月的心理总体幸福感指数]。我们使用液相色谱和串联质谱来测量头发皮质醇浓度。我们使用独立的双样本t检验比较了从基线到6个月和12个月的头发皮质醇浓度和心理测验变化。
    结果:我们招募了目标86名参与者中的39名(LNG52mgIUD26,CuT380IUD13)。38名受试者(LNG52mgIUD25,CuT380IUD13)完成了六个月的随访。我们发现六个月时毛发皮质醇浓度的平均变化在队列之间没有差异[LNG52mgIUDn=21(-0.01pg/mg(95%置信区间-1.26,1.23);CuT380IUDn=13(-1.31pg/mg(-3.36,0.73))]。虽然心理测量库存结果仍在正常范围内,LNG52mg宫内节育器用户报告说,随着时间的推移,有更有利的变化趋势。
    结论:我们没有发现CuT380宫内节育器或LNG52mg宫内节育器开始后头发皮质醇浓度的临床重要差异;心理测量清单显示激素宫内节育器对情绪没有不利影响。
    结论:我们发现LNG52mgIUD或CuT380IUD开始后毛发皮质醇浓度相似,这表明激素IUD不会增加皮质醇浓度或改变应激反应性。和对心理测量库存的有利影响进一步保证,LNG52mg宫内节育器对情绪没有不利影响。
    背景:ClinicalTrials.govNCT03499379。
    Prior studies found increased hair cortisol concentration (a surrogate marker for hypothalamic-pituitary-adrenal axis activation) in users of the levonorgestrel intrauterine device (LNG 52 mg IUD). We evaluated change in hair cortisol and psychometric tests in women initiating a copper (CuT380 IUD) or LNG 52 mg IUD.
    We prospectively enrolled healthy women initiating an LNG 52 mg IUD or CuT380 IUD. Participants provided hair and blood samples and completed psychometric inventories (Patient Health Questionnaire-9, Positive and Negative Affect Schedule, and Psychological General Well-Being Index) after IUD insertion and at 6 and 12 months. We used liquid chromatography with tandem mass spectrometry to measure hair cortisol concentrations. We compared hair cortisol concentrations and psychometric test changes from baseline to 6 and 12 months using independent two-sample t tests.
    We enrolled 39 of our targeted 86 participants (LNG 52 mg IUD 26, CuT380 IUD 13). Thirty-eight subjects (LNG 52 mg IUD 25, CuT380 IUD 13) completed 6 months of follow-up. We found no difference between cohorts in the mean change in hair cortisol concentrations at 6 months (LNG 52 mg IUD n = 21 [-0.01 pg/mg (95% CI -1.26, 1.23); CuT380 IUD n = 13 [-1.31 pg/mg (-3.36, 0.73)]). While psychometric inventory results remained within normal ranges, LNG 52 mg IUD users reported a trend toward more favorable changes over time.
    We did not find clinically important differences in hair cortisol concentrations following initiation of a CuT380 IUD or LNG 52 mg IUD; psychometric inventories demonstrated no adverse effect of hormonal IUDs on mood.
    Our findings of similar hair cortisol concentrations following the initiation of either the LNG 52 mg IUD or CuT380 IUD suggest that hormonal IUDs do not increase cortisol concentrations or alter stress reactivity, and favorable effects on psychometric inventories provide further reassurance that the LNG 52 mg IUD has no adverse impact on mood.
    ClinicalTrials.gov NCT03499379.
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