Obstetrical & Gynecological Survey最新文献_第9页

An Update on Human Papillomavirus Vaccination in the United States 美国人乳头瘤病毒疫苗接种的最新进展

4区医学 Q1 OBSTETRICS & GYNECOLOGY

Obstetrical & Gynecological Survey

Pub Date : 2023-08-01 DOI: 10.1097/ogx.0000000000001184

Teresa K. L. Boitano, Peter W. Ketch, Isabel C. Scarinci, Warner K. Huh

ABSTRACT Human papillomavirus (HPV) is the most common sexually transmitted infection in the United States in adults, and although most cases are transient, 10%–20% of infections can persist and progress to various forms of cancer. The HPV vaccine prevents more than 90% of HPV infections and HPV-associated cancers. The vaccine is most effective at preventing all types of HPV-related dysplasia in patients with no prior exposure to HPV. Reasons for decreased compliance include parent-specific factors such as education, safety concerns, absence of professional recommendation, and apprehension about supporting sexual behavior, whereas professional-level barriers include lack of time to discuss vaccination, knowledge gaps, vaccine access, and financial concerns. This clinical expert series highlights the evidence supporting the HPV vaccine as a safe and effective way to prevent cervical cancer. Most HPV infections are acquired in individuals aged 14–24 years with increasing prevalence with each year. Shared decision-making should be used for patients aged 27–45 years, in whom the vaccine has been demonstrated to be safe and effective, but the population advantage of vaccination is expected to be limited. Unvaccinated health care workers exposed to the virus in their practices should be vaccinated between the ages of 27 and 45 years. A previous HPV infection should not be a reason to not receive the vaccine, and it is not necessary to screen individual patients before vaccination. The vaccine is efficacious against other HPV types regardless of which HPV strain an individual may be positive for at the time of vaccination. Regarding women with HPV-related dysplasia such as high-grade squamous intraepithelial lesions that undergo excisional procedures, up to 15% will experience persistent or recurrent disease, and these women are at higher risk of developing a new HPV-associated lesion. Therefore, vaccination may provide a significant reduction in future disease in this patient population. The World Health Organization Strategic Advisory Group of Experts on Immunization recently evaluated the current scheduling regimens for the HPV vaccine and concluded that a single dose may provide enough protection in individuals younger than age 21; however, the Centers for Disease Control and Prevention is yet to comment. An ongoing large randomized, controlled, double-blinded, noninferiority trial (ESCUDDO) is currently evaluating a single-dose versus 2-dose regimen that will help elucidate whether vaccine scheduling in the United States may change to a single-dose paradigm. The strongest predictor of vaccine uptake is health care professional recommendation, and patients with prior infection or excision should still be offered the vaccine. Finally, although vaccination national guidelines are in place for individuals aged 9–26 years, certain patient populations older than 26 years may benefit from the vaccine.

人乳头瘤病毒(HPV)是美国成年人中最常见的性传播感染，尽管大多数病例是短暂的，但10%-20%的感染可以持续并发展为各种形式的癌症。HPV疫苗可以预防90%以上的HPV感染和HPV相关的癌症。该疫苗在预防未接触过HPV的患者发生所有类型的HPV相关发育不良方面最为有效。依从性下降的原因包括家长特定因素，如教育、安全问题、缺乏专业建议和对支持性行为的担忧，而专业层面的障碍包括缺乏时间讨论疫苗接种、知识差距、疫苗获取和财务问题。本临床专家系列强调了支持HPV疫苗是一种安全有效的预防宫颈癌的方法的证据。大多数人乳头瘤病毒感染发生在14-24岁的人群中，患病率每年都在增加。对于27-45岁的患者，应采用共同决策，疫苗已被证明是安全有效的，但预计疫苗接种的人群优势有限。未接种疫苗的卫生保健工作者应在27岁至45岁之间接种疫苗。以前的HPV感染不应该成为不接种疫苗的理由，在接种疫苗之前没有必要对个别患者进行筛查。该疫苗对其他HPV类型有效，无论个体在接种疫苗时可能对哪种HPV毒株呈阳性。对于患有hpv相关发育不良的妇女，如接受切除手术的高级别鳞状上皮内病变，高达15%的妇女将经历持续或复发性疾病，这些妇女发展为新的hpv相关病变的风险更高。因此，疫苗接种可能会显著减少这一患者群体未来的疾病。世界卫生组织免疫战略咨询专家组最近评估了目前的人乳头瘤病毒疫苗接种方案，并得出结论认为，单剂疫苗可为21岁以下的个人提供足够的保护;然而，美国疾病控制与预防中心尚未对此发表评论。一项正在进行的大型随机、对照、双盲、非劣效性试验(ESCUDDO)目前正在评估单剂量与2剂量方案，这将有助于阐明美国的疫苗计划是否可能改为单剂量方案。疫苗接种的最强预测因子是卫生保健专业人员的建议，既往感染或切除的患者仍应提供疫苗。最后，尽管针对9-26岁的个体制定了疫苗接种国家指南，但某些26岁以上的患者群体可能受益于疫苗。

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引用次数: 0

Unindicated Cervical Cancer Screening in Adolescent Females Within a Large Healthcare System in the United States 在美国的一个大型医疗保健系统中，青少年女性的无指征宫颈癌筛查

4区医学 Q1 OBSTETRICS & GYNECOLOGY

Obstetrical & Gynecological Survey

Pub Date : 2023-08-01 DOI: 10.1097/ogx.0000000000001179

Hillary Hosier, Sangini S. Sheth, Carlos R. Oliveira, Lauren E. Perley, Alla Vash-Margita

ABSTRACT The increasingly complicated nature of screening guidelines for cervical cancer includes multiple component tests (cytology, genotyping, and high-risk human papilloma virus [HPV] testing) and evolving recommendations. The aim of this study was assessing single-large-healthcare-system trends over time associated with adolescent females and unindicated cervical cancer screening tests. This repeated cross-sectional study analyzed electronic medical records of provider- and patient-specific variables from the Yale New Haven Health System. Included in the study were all 13- to 20-year-old Yale New Haven Health System patients who underwent screening for cervical cancer via either HPV testing or cytology between January 1, 2012 and December 31, 2018. Age, medical histories, surgical histories, self-reported race and ethnicity, and prescribed medications were all patient-specific variables. Provider-specific variables included clinical practice affiliation, clinical degree, and adolescent patient volume (number of medical visits completed by a patient less than 21 every 6 months). In terms of this study, definition of practice setting was either academic (low-income teaching hospitals) or community-based (private practice setting with primarily insured women). Cytologies were categorized as either unindicated or indicated, based on cervical cancer screening guidelines from 2012 (recorded as unindicated for index specimens collected before the 21st birthday in patients lacking immunocompromised conditions). Should an HPV test be performed, any results other than “atypical squamous cells of undetermined significance” received an unindicated status. The final sample size in the study included 794 women from 118 providers (53% community setting and 47% academic setting). Results from analysis of 900 cervical cancer screenings demonstrated that unindicated tests made up the majority of tests (90%), with 87% of these being unindicated cytology testing only and 14% with unindicated HPV testing as well. Reasons for obtaining unindicated tests as recorded in the original clinical history were lacking, as 62% had no justification listed for testing, and those with reasons failed current guideline compliance. The incidence rate (IR) of adolescent unindicated tests decreased by 33% between 2012 and 2018. Although a significantly lower IR of unindicated screening existed in the academic setting, the rate of decline in the IR of unindicated screening during this period was significantly greater in the community than in the academic setting by 11%. A strength of the study included its ability to calculate IRs in all encounters, including sexually transmitted infection or contraception screenings. Limitations included utilization of hospital system cytology reports for obtaining data, thereby hindering any access to data necessary for validation of screening or surveillance indications from previously performed antecedent cytology. Furthermore, the study faile

宫颈癌筛查指南日益复杂，包括多组分检测(细胞学、基因分型和高危人乳头瘤病毒[HPV]检测)和不断发展的建议。本研究的目的是评估单一大型医疗保健系统随时间推移与青春期女性和未指明的宫颈癌筛查测试相关的趋势。这项重复的横断面研究分析了来自耶鲁大学纽黑文卫生系统的提供者和患者特定变量的电子医疗记录。该研究纳入了2012年1月1日至2018年12月31日期间通过HPV检测或细胞学筛查接受宫颈癌筛查的13至20岁耶鲁纽黑文健康系统患者。年龄、病史、手术史、自我报告的种族和民族以及处方药物都是患者特有的变量。提供者特定变量包括临床实践隶属关系、临床学位和青少年患者数量(每6个月少于21名患者完成的就诊次数)。在本研究中，实践环境的定义要么是学术(低收入教学医院)，要么是社区(以参保妇女为主的私人实践环境)。根据2012年的宫颈癌筛查指南，细胞学检查分为无指征和有指征两类(在没有免疫功能低下的患者中，在21岁生日之前收集的指数标本记录为无指征)。如果进行HPV检测，除了“意义不确定的非典型鳞状细胞”之外的任何结果都将被视为未指明的状态。该研究的最终样本量包括来自118个提供者的794名妇女(53%的社区环境和47%的学术环境)。对900例宫颈癌筛查的分析结果表明，无指征检测占大多数(90%)，其中87%仅为无指征细胞学检测，14%也有未指征的人乳头瘤病毒检测。缺乏原始临床病史中记录的未指示检测的原因，因为62%的患者没有列出检测的理由，而有理由的患者未能遵守现行指南。2012年至2018年期间，青少年无指征检测的发病率下降了33%。虽然在学术环境中存在明显较低的无指筛检IR，但在此期间，社区中无指筛检IR的下降率明显高于学术环境，下降率为11%。该研究的一个优势在于，它能够计算所有接触的风险系数，包括性传播感染或避孕筛查。限制包括利用医院系统细胞学报告来获取数据，从而阻碍了对先前进行的细胞学检查的筛查或监测适应症验证所需数据的任何访问。此外，该研究未能收集到另一个指南依从性指标的信息:21岁开始的患者的指示指数宫颈癌筛查数量。根据Becerra-Culqui对21岁及以上的女性进行的一项调查，65%的女性错过了筛查的机会。最后，作者无法评论免疫功能低下的女性和由于通过病理报告而不是正常女性检查收集数据而错过指示筛查的符合条件的年轻女性。尽管21岁及以下女性的未指明筛查显著减少，但仍有改进的领域。由于最近的指南更新可能会给提供者和患者带来更大的挑战，因此在指南的遵守和传播方面，循证策略比以往任何时候都更加重要。

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引用次数: 0

Association Between Enlarged Genital Hiatus and Composite Surgical Failure After Vaginal Hysterectomy With Uterosacral Ligament Suspension 阴道子宫切除术合并子宫骶韧带悬吊术后生殖器裂孔扩大与复合手术失败的关系

4区医学 Q1 OBSTETRICS & GYNECOLOGY

Obstetrical & Gynecological Survey

Pub Date : 2023-08-01 DOI: 10.1097/ogx.0000000000001187

Megan S. Bradley, Amaanti Sridhar, Kimberly Ferrante, Uduak U. Andy, Anthony G. Visco, Maria E. Florian-Rodriguez, Deborah Myers, Edward Varner, Donna Mazloomdoost, Marie G. Gantz

ABSTRACT Commonly performed at the time of total vaginal hysterectomy to combat uterovaginal prolapse, uterosacral ligament suspension and sacrospinous ligament fixation are native tissue apical suspensions. Because recurrent pelvic organ prolapse increases over time after apical suspensions, nonmodifiable and modifiable risk factors have been explored. It is suggested by numerous studies that 1 risk factor for recurrent prolapse is an enlarged preoperative and postoperative genital hiatus (GH). An enlarged GH may be indicative of a caudal shift in pelvic viscera, increasing stress on vaginal supports. However, short-term follow-up, retrospective design, and lack of patient perspectives on prolapse outcomes limited the overall impact of those findings. The SUPeR trial (Study of Uterine Prolapse Procedures-Randomized) compared vaginal mesh hysteropexy with vaginal hysterectomy with uterosacral ligament suspension in a randomized trial design with long-term follow-up postoperatively. Postoperative assessments included the patient’s assessment of prolapse symptoms. The primary objective of this manuscript was to evaluate the efficacy of the vaginal hysterectomy with uterosacral ligament suspension amidst groups defined by surgical changes in GH size. The hypothesis predicted higher prolapse recurrence proportions for those with persistently enlarged GH size at 4–6 weeks postoperatively, compared with those with smaller preoperative and postoperative GH sizes. SUPeR participants included in this ancillary analysis underwent vaginal hysterectomy with uterosacral ligament suspension and then completed a 2-year follow-up. Based on preoperative to postoperative GH measurement changes, participants were divided into 3 groups. These groups were (1) persistently enlarged GH (“persistently enlarged”), (2) improved GH (“improved”), and (3) stable or normal GH preoperatively and postoperatively (“stably normal”). Prolapse was defined as any compartment with prolapse 1 cm or more beyond the hymen. The primary aim was comparison of composite surgical failure across the GH groups at 24 months, defined by any of the following conditions: anatomic failure, retreatment for prolapse, or symptoms of bothersome vaginal bulge. Secondary outcomes included the composite surgical failure components, postoperative complications, POP-Q measurements, and pain during intercourse. A total of 81 women were included in this secondary analysis. Predominant characteristics included a median age of 65.6 years, with 50 patients in the “improved group,” 14 patients in the “persistently enlarged” group, and 17 patients in the “stably normal” group. Notably, the prevalence of advanced anterior prolapse at baseline was greatest in the persistently enlarged group compared with that of both the improved and stably normal groups. Also, the prevalence of posterior colporrhaphy during the index procedure varied across groups and was more common in the improved group than the stably normal gro

在阴道全子宫切除术中，子宫骶韧带悬吊术和骶棘韧带固定术通常采用原生组织顶端悬吊术。由于复发性盆腔器官脱垂在根尖悬吊后随着时间的推移而增加，不可改变和可改变的危险因素已被探讨。许多研究表明，复发性脱垂的一个危险因素是术前和术后生殖器裂孔(GH)的扩大。生长激素增大可能表明盆腔脏器的尾端移位，增加对阴道支撑物的压力。然而，短期随访、回顾性设计和缺乏患者对脱垂结果的看法限制了这些研究结果的总体影响。超级试验(研究子宫脱垂手术-随机)比较阴道网状子宫切除术和阴道子宫切除术合并子宫骶韧带悬吊的随机试验设计，术后长期随访。术后评估包括患者对脱垂症状的评估。本文的主要目的是评估阴道子宫切除术合并子宫骶韧带悬吊术在GH大小改变组中的疗效。该假说预测，与术前和术后GH尺寸较小的患者相比，术后4-6周GH尺寸持续增大的患者脱垂复发率更高。这项辅助分析的超级参与者接受阴道子宫切除术和子宫骶韧带悬吊，然后完成了2年的随访。根据术前至术后GH测量变化，将参与者分为3组。这些组是(1)持续增大的GH(“持续增大”)，(2)改善的GH(“改善”)，(3)术前和术后稳定或正常的GH(“稳定正常”)。脱垂被定义为脱垂超过处女膜1厘米的任何隔室。主要目的是比较GH组在24个月时的复合手术失败，其定义为以下任何一种情况:解剖失败，脱垂的再治疗，或令人烦恼的阴道隆起症状。次要结局包括复合手术失败因素、术后并发症、POP-Q测量和性交疼痛。共有81名女性被纳入这一次要分析。主要特征包括中位年龄65.6岁，“改善组”50例，“持续扩大组”14例，“稳定正常”组17例。值得注意的是，与改善组和稳定正常组相比，持续扩大组在基线时晚期前脱垂的患病率最高。此外，在指数手术过程中，后阴道破裂的发生率在各组之间有所不同，改善组比稳定正常组更常见。几乎所有患者的手术都是阴道子宫切除术和子宫骶韧带悬吊。研究发现，阴道子宫切除术后，在调整晚期前脱垂的患病率后，4-6周生长激素持续增大的女性术后2年的复合手术失败发生率与其他组相比并不高。与稳定正常组相比，持续扩大组复合手术失败的校正优势比为6.0(95%可信区间，1.0-37.5;P = 0.06)。最终，基线生长激素大小不是一个可改变的危险因素;然而，在进行术前和术后正常生长激素测量比较时，阴道后子宫切除术和阴道前壁脱垂之间确实存在关联。尽管如此，这项研究不能证实复发性脱垂的风险与按生长激素大小分组的患者之间的显著关系。

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引用次数: 0

Extended Use of Levonorgestrel-Releasing Intrauterine System (LNG-IUS) 52 mg: A Population Pharmacokinetic Approach to Estimate In Vivo Levonorgestrel Release Rates and Systemic Exposure Including Comparison With Two Other LNG-IUSs 长期使用左炔诺孕酮宫内释放系统(LNG-IUS) 52 mg:用群体药代动力学方法评估体内左炔诺孕酮释放率和全身暴露，包括与其他两种LNG-IUS的比较

4区医学 Q1 OBSTETRICS & GYNECOLOGY

Obstetrical & Gynecological Survey

Pub Date : 2023-08-01 DOI: 10.1097/01.ogx.0000967032.19580.48

Jeffrey T. Jensen, Isabel Reinecke, Teun M. Post, Eeva Lukkari-Lax, Birte M. Hofmann

ABSTRACT With over 30 years of use, levonorgestrel-releasing intrauterine systems (LNG-IUSs) have proven to be highly effective methods of contraceptives. The active ingredient in LNG-IUS, levonorgestrel (LNG), is released directly into the uterine cavity, which causes suppression of endometrial maturation and thickened cervical mucus. A variety of LNG-IUS options exhibit well-established safety profiles and efficacy, providing anywhere between 2 and 18 times lower systemic exposure when compared with LNG-containing pills or implants. Patient-centered decision-making regarding product choice may be encouraged through standardized comparisons of LNG release and exposure during the time of their respective usage periods. Evaluation of the efficacy, safety, and PK of extended Mirena use from beyond 5 years to the conclusion of 8 years was designed in the Mirena Extension Trial (MET), thereby facilitating comparisons with LNG-IUS 19.5 mg and LNG-IUS 13.5 mg. Using validated liquid chromatography-tandem mass spectrometry methods and SHBG concentrations, the authors determined concentrations of plasma LNG levels. Dichloromethane was used for extracting residual LNG from the elastomer material from removed IUS devices, which was then quantified via liquid chromatography and external calibration on a reversed-phase column. Although previous models used measured LNG and SHBG (serum) concentrations, the population pharmacokinetics (popPK) allows for a uniform method of comparison among different pharmacologic studies. The popPK approach allows for a reliable estimates of in vivo LNG exposure and release during the entirety of the 8-year use period. The MET enrolled premenopausal women aged 18–35 years for a multicenter, single-arm study regarding patients who had used LNG-IUS 52 mg for the last 4.5–5 years for up to 8 years. The study took place from December 22, 2016 to May 28, 2021 throughout 54 US centers, with the primary outcome of contraceptive efficacy and failure rate. Participants each provided written, informed consent. Study strengths of the popPK approach included its robust methodology, its ability to provide in vivo release rate estimates, a stepwise demo of model suitability from use years 6 to 8, model-based estimation of unbound LNG, and the ability to provide estimates for both population and individual PK profiles from sparse available sampling. Limitations include the possibility of findings being group effects possibly inapplicable to all LNG-IUS users. In addition, the data fail to provide local endometrial and cervical LNG concentrations due to the systemic nature of the LNG exposure. Finally, the popPK Mondale should not be used for theoretical question addressing (such as creating rate release estimates outside of available data sets). In conclusion, a broad data set indicates that reliable LNG exposure is delivered by 8-year popPK and release models for up to 7 years of LNG-IUs 52 mg use. Efficacy is data-supported for 6–8 years o

经过30多年的使用，左炔诺孕酮释放宫内系统(LNG-IUSs)已被证明是非常有效的避孕方法。LNG- ius的有效成分左炔诺孕酮(LNG)直接释放到子宫腔内，导致子宫内膜成熟受到抑制，宫颈粘液增厚。与含lng的药片或植入物相比，各种LNG-IUS选择具有良好的安全性和有效性，可将全身暴露降低2至18倍。通过在各自的使用期间对液化天然气释放和暴露进行标准化比较，可以鼓励以患者为中心的产品选择决策。在menrena延长试验(MET)中，设计了延长menrena使用5年以上至8年的疗效、安全性和PK的评估，从而促进了LNG-IUS 19.5 mg和LNG-IUS 13.5 mg的比较。使用经过验证的液相色谱-串联质谱法和SHBG浓度，作者确定了血浆LNG水平的浓度。使用二氯甲烷从移除的IUS装置中提取弹性体材料中的残余LNG，然后通过液相色谱法和反相柱上的外部校准进行定量。虽然以前的模型使用测量的LNG和SHBG(血清)浓度，但群体药代动力学(popPK)允许在不同的药理学研究之间进行统一的比较方法。popPK方法允许在整个8年的使用期内对体内LNG暴露和释放进行可靠的估计。MET招募了年龄在18-35岁的绝经前妇女，进行了一项多中心单臂研究，研究对象是在过去4.5-5年使用LNG-IUS 52毫克至8年的患者。该研究于2016年12月22日至2021年5月28日在美国54个中心进行，主要结局是避孕效果和失败率。参与者都提供了书面的知情同意书。popPK方法的研究优势包括其稳健的方法，提供体内释放率估计的能力，从使用第6年到第8年的模型适用性逐步演示，基于模型的未绑定液化天然气估计，以及从稀疏可用样本中提供总体和个体PK概况估计的能力。局限性包括研究结果可能是群体效应，可能不适用于所有LNG-IUS用户。此外，由于LNG暴露的全身性，数据未能提供局部子宫内膜和宫颈LNG浓度。最后，popk Mondale不应该用于理论问题的处理(例如在可用数据集之外创建速率释放估计)。综上所述，一组广泛的数据表明，可靠的LNG暴露是由8年的popPK和释放模型提供的，最长可达7年的LNG- ius 52毫克使用。数据支持6-8年的使用效果，在此期间持续释放LNG。52mg LNG- iud的全身LNG暴露与其他LNG- ius装置相当，且显著低于口服和植入的含LNG避孕药。

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引用次数: 0

A Systematic Review and Meta-analysis of Cell-Free DNA Testing for Detection of Fetal Sex Chromosome Aneuploidy 无细胞DNA检测检测胎儿性染色体非整倍体的系统综述和荟萃分析

4区医学 Q1 OBSTETRICS & GYNECOLOGY

Obstetrical & Gynecological Survey

Pub Date : 2023-08-01 DOI: 10.1097/ogx.0000000000001188

Matthew A. Shear, Kate Swanson, Ria Garg, Angie C. Jelin, John Boscardin, Mary E. Norton, Teresa N. Sparks

ABSTRACT Noninvasive prenatal screening has become a valuable tool in detecting a variety of disorders and abnormalities, including sex chromosome aneuploidies (SCAs). The test uses cell-free DNA (cfDNA) analysis to identify risk for chromosomal abnormalities, which can then be more fully investigated using other tests. Much of previous research focused on cfDNA has assessed autosomal aneuploidies, but few studies have specifically focused on SCAs. The aim of this systematic review and meta-analysis was to assess the accuracy of cfDNA testing in identifying SCAs in singleton pregnancies. Studies were identified by keywords associated with cfDNA, SCA, and noninvasive prenatal testing, and studies were included based on relevance. Inclusion criteria were limited to singleton pregnancies that underwent cfDNA testing with confirmation by diagnostic genetic testing between January 1, 2010 and December 1, 2021. A total of 21 articles were selected for the final meta-analysis. All included studies reported results for monosomy X (45,X), representing nearly 13,000 tests with 254 confirmed positive results, 133 false-positives, and 18 false-negatives. Estimated sensitivity based on this sample was 98.8%, with specificity of 99.4%. Positive and negative predictive values were 14.5% and 100%, respectively. Of the 21 included studies, 16 also reported results for Klinefelter syndrome (47,XXY), representing just over 11,000 tests with 62 confirmed positive results, 10 false-positives, and 11 false-negatives. Estimated sensitivity was 100% and specificity was 100%, with positive predictive value of 97.7% and negative predictive value of 100%. Thirteen of 21 studies included reported results for triple X syndrome (47,XXX), representing roughly 10,000 tests with 38 confirmed positive results, 18 false-positives, and 1 false-negative. This showed an estimated sensitivity of 100% and specificity of 99.9%, with positive predictive value of 61.6% and negative predictive value of 100%. Finally, 9 of the studies included in this meta-analysis reported results for Jacobs syndrome (47,XYY), representing approximately 8500 tests with 22 confirmed positive results, 2 false-positives, and no false-negatives. This led to an estimated sensitivity and specificity of 100%, with positive and negative predictive values also 100%. These results provide evidence that cfDNA testing is effective in identification of SCAs in pregnancies at high risk. This particular population limits the generalizability of the findings but adds to the literature surrounding the effectiveness and accuracy of this method. The analysis used strict criteria to define the studies that were included, yet still included a large sample of tests (12,000), which adds to the statistical and practical significance of the analysis. Generalizing the findings of this study is difficult based on both the fact that the sample did not include low-risk individuals and that positive predictive values varied greatly wit

无创产前筛查已成为检测各种疾病和异常的宝贵工具，包括性染色体非整倍体(SCAs)。该测试使用无细胞DNA (cfDNA)分析来确定染色体异常的风险，然后可以使用其他测试更全面地调查。以前的许多研究都集中在cfDNA上，评估了常染色体非整倍体，但很少有研究专门关注sca。本系统综述和荟萃分析的目的是评估cfDNA检测在单胎妊娠中识别sca的准确性。通过与cfDNA、SCA和无创产前检测相关的关键词识别研究，并根据相关性纳入研究。纳入标准仅限于2010年1月1日至2021年12月1日期间接受cfDNA检测并经诊断性基因检测确认的单胎妊娠。总共选择了21篇文章进行最终的meta分析。所有纳入的研究报告了X单体的结果(45,X)，涉及近13,000次检测，其中254次确认阳性结果，133次假阳性结果和18次假阴性结果。该样本的敏感性为98.8%，特异性为99.4%。阳性预测值为14.5%，阴性预测值为100%。在纳入的21项研究中，16项也报告了Klinefelter综合征的结果(47,XXY)，代表超过11,000项测试，其中62例确诊阳性结果，10例假阳性结果，11例假阴性结果。估计敏感性100%，特异性100%，阳性预测值97.7%，阴性预测值100%。在21项研究中，有13项研究报告了triple X综合征的结果(47,XXX)，约10000例检测中有38例确诊阳性结果，18例假阳性结果，1例假阴性结果。估计敏感性为100%，特异性为99.9%，阳性预测值为61.6%，阴性预测值为100%。最后,在这个荟萃分析中9的研究报道结果雅各布斯综合症(47岁,XYY),代表约8500测试22证实了积极的结果,2假阳性,不误报警。这导致估计的敏感性和特异性为100%，阳性和阴性预测值也为100%。这些结果提供了证据，证明cfDNA检测在识别高危妊娠sca方面是有效的。这种特殊的人群限制了研究结果的普遍性，但增加了围绕这种方法的有效性和准确性的文献。该分析使用严格的标准来定义纳入的研究，但仍然包括大量的测试样本(12,000)，这增加了分析的统计和实际意义。由于样本不包括低风险个体，且阳性预测值随患病率变化很大，影响了临床意义，因此很难概括本研究的结果。总体而言，cfDNA检测SCA具有很高的敏感性和特异性，并且对每个检查的SCA具有99.99%或更高的阴性预测值。需要进一步的研究来证实这些发现，并将知识扩展到更多样化的人群。

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引用次数: 0

The Evolving Landscape of Genetic Carrier Screening: Clinical Considerations and Challenges. 基因携带者筛查的发展前景:临床考虑和挑战。

IF 6.2 4区医学 Q1 OBSTETRICS & GYNECOLOGY

Obstetrical & Gynecological Survey

Pub Date : 2023-08-01 DOI: 10.1097/OGX.0000000000001168

Lauren E Buckley, Maeve K Hopkins, Jeffrey A Kuller

Importance: Genetic carrier screening is performed to identify carriers of rare genetic diseases. Identification of carriers allows patients to make informed reproductive health choices and can decrease the incidence of genetic disorders with serious medical implications.

Objective: This review aims to provide an overview of the history of prenatal genetic screening and the various forms of carrier screening, a synopsis of recent changes in society recommendations and current practice guidelines, and discussion of clinical challenges associated with carrier screening.

Evidence acquisition: Published practice guidelines from relevant professional societies were reviewed and synthesized. PubMed search was performed for relevant history and clinical considerations of carrier screening.

Results: Information and evidence summarized in this review include professional society practice guidelines, review articles, and peer-reviewed research articles.

Conclusions and relevance: Current practice guidelines differ between stakeholder professional organizations. Expanded carrier screening offers increased identification of rare disease carriers allowing for more informed reproductive choices. However, there are several barriers to the implementation of expanded carrier screening for all patients.

重要性:基因携带者筛查用于鉴定罕见遗传病的携带者。确定携带者可使患者作出知情的生殖健康选择，并可减少具有严重医疗影响的遗传疾病的发生率。目的:本文综述了产前遗传筛查的历史和各种形式的携带者筛查，概述了社会建议和现行实践指南的最新变化，并讨论了与携带者筛查相关的临床挑战。证据获取:审查和综合相关专业协会出版的实践指南。PubMed检索携带者筛查的相关病史和临床考虑。结果:本综述总结的信息和证据包括专业学会实践指南、综述文章和同行评议的研究文章。结论和相关性:当前的实践指南在利益相关者专业组织之间有所不同。扩大携带者筛查提供了更多的罕见疾病携带者的识别，允许更知情的生殖选择。然而，在所有患者中实施扩大的携带者筛查存在一些障碍。

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引用次数: 0

CenteringPregnancy: A Review of Implementation and Outcomes. 妊娠中心:实施和结果综述。

IF 6.2 4区医学 Q1 OBSTETRICS & GYNECOLOGY

Obstetrical & Gynecological Survey

Pub Date : 2023-08-01 DOI: 10.1097/OGX.0000000000001169

Julia M Moyett, Khaila Ramey-Collier, Linda M Zambrano Guevara, Amy MacDonald, Jeffrey A Kuller, Sarahn M Wheeler, Sarah K Dotters-Katz

Importance: CenteringPregnancy (CP) is a model for group prenatal care associated with improved perinatal outcomes for preterm birth and low birthweight, increased rates of breastfeeding, and higher rates of patient and clinician satisfaction.

Objective: The study aims to review the literature related to perinatal outcomes associated with CP, benefits and barriers to implementation, and utility of the model.

Evidence: An electronic-based search was performed in PubMed using the search terms "CenteringPregnancy" OR "Centering Pregnancy," revealing 221 articles.

Results: The CP model improves patient centeredness, efficiency, and equality in prenatal care. Challenges include administrative buy-in, limited resources, and financial support. Multisite retrospective studies of CP demonstrate improved maternal, neonatal, postpartum, and well-being outcomes, especially for participants from minority backgrounds; however, prospective studies had mixed results. CenteringPregnancy is feasibly implemented with high tenet fidelity in several low- and middle-income settings with improved perinatal outcomes compared with traditional care.

Conclusions: CenteringPregnancy is feasible to implement, largely accepted by communities, and shows positive qualitative and quantitative health outcomes. This body of literature supports CP as a potential tool for decreasing racial inequalities in prenatal access, quality of care, and maternal mortality. Further investigation is necessary to inform obstetric clinicians about the potential outcome differences that exist between group and traditional prenatal care.

重要性:中心妊娠(CP)是一种群体产前护理模式，可改善早产儿和低出生体重儿的围产期结局，提高母乳喂养率，提高患者和临床医生的满意度。目的:本研究旨在回顾与CP相关的围产期结局、实施的益处和障碍以及该模型的实用性相关文献。证据:在PubMed中使用搜索词“CenteringPregnancy”或“CenteringPregnancy”进行电子搜索，显示221篇文章。结果:CP模式提高了产前护理的以患者为中心、效率和公平性。挑战包括行政支持、有限的资源和财政支持。多地点回顾性研究表明，CP改善了产妇、新生儿、产后和健康状况，特别是对少数民族背景的参与者;然而，前瞻性研究的结果喜忧参半。与传统护理相比，妊娠在一些低收入和中等收入环境中以高宗旨保真度实施是可行的，可改善围产期结局。结论:以怀孕为中心是可行的，在很大程度上被社区接受，并显示出积极的定性和定量的健康结果。这些文献支持CP作为减少产前机会、护理质量和孕产妇死亡率方面的种族不平等的潜在工具。进一步的调查是必要的，以告知产科临床医生关于群体产前护理和传统产前护理之间存在的潜在结果差异。

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引用次数: 0

Reclassification of the Etiology of Infant Mortality With Whole-Genome Sequencing 用全基因组测序重新分类婴儿死亡的病因

4区医学 Q1 OBSTETRICS & GYNECOLOGY

Obstetrical & Gynecological Survey

Pub Date : 2023-08-01 DOI: 10.1097/01.ogx.0000967016.12085.9e

Mallory J. Owen, Meredith S. Wright, Sergey Batalov, Yonghyun Kwon, Yan Ding, Kevin K. Chau, Shimul Chowdhury, Nathaly M. Sweeney, Elizabeth Kiernan, Andrew Richardson, Emily Batton, Rebecca J. Baer, Gretchen Bandoli, Joseph G. Gleeson, Matthew Bainbridge, Christina D. Chambers, Stephen F. Kingsmore

ABSTRACT Infant mortality rates are quite high even in developed countries; in the United States, infant deaths occur approximately 1 in 200 live births. The leading cause of infant mortality is congenital malformation or chromosomal abnormality, which cause roughly 20% of infant deaths, followed by other causes such as pregnancy complications, preterm birth or low birth weight, and sudden infant death syndrome. Improvements in treatments for certain conditions such as pregnancy complications or prematurity have previously resulted in a reduction in mortality due to these causes. Although the same may be true of congenital malformations or chromosomal abnormalities, the relationship between these factors and infant mortality has not been closely examined. Previous studies have largely been retrospective in nature and varied greatly among method and records used, perpetuating inaccuracies and imprecision. This study aimed to clarify and add to previous literature by examining the relationship between single-locus genetic disease (Mendelian genetic disease) and overall infant mortality. This study applied diagnostic whole-genome sequencing (WGS) to infants in intensive care to diagnose diseases of unknown etiology in a single hospital system between 2015 and 2020. The study was retrospective and included review of medical records and death certificates, as well as results from WGS. Where possible, WGS information was obtained on living infants and their parents, and where that was not possible, it was obtained postmortem. Death certificates and causes of death were also examined and compared with WGS results. In the final sample, 112 infants who died underwent WGS either premortem or postmortem. WGS identified genetic diseases in 46 (41%) of these infants. Of the genetic diseases identified, 83% had previous evidence supporting an association with childhood mortality, and evidence was gathered from previous literature that could improve outcomes for 30%. Death certificate comparisons showed that of 45 infants where WGS showed underlying genetic disease, 62% were not reported on the certificate or attributed to the cause of death. In addition to the 112 infants who died, the study population included 434 infants who survived and also had WGS performed. No significant differences were found between the groups in sex, race, or ethnicity. Types of genetic disease varied between infants who died and those who survived, with only 4% being found in both. Certain diseases were more likely to occur in infants who survived, and others were more likely to occur in infants who died. Specific etiology had some prognostic value, positively predicting either death or survival. These results indicate that first, after examination of WGS in comparison with death certificates, genetic diseases are chronically underreported. In addition, WGS showed that etiology of leading causes of infant mortality could be fundamentally different than previously thought. WGS is als

即使在发达国家，婴儿死亡率也相当高;在美国，每200个活产婴儿中就有1个死亡。婴儿死亡的主要原因是先天性畸形或染色体异常，约占婴儿死亡的20%，其次是其他原因，如妊娠并发症、早产或出生体重过低，以及婴儿猝死综合症。对某些疾病，如妊娠并发症或早产的治疗方法的改进，以前曾导致这些原因造成的死亡率下降。虽然先天性畸形或染色体异常可能也是如此，但这些因素与婴儿死亡率之间的关系尚未得到仔细研究。以前的研究在很大程度上是回顾性的，在使用的方法和记录之间差异很大，使不准确性和不精确性永久化。本研究旨在通过检查单位点遗传病(孟德尔遗传病)与总体婴儿死亡率之间的关系来澄清和补充先前的文献。本研究将诊断性全基因组测序(WGS)应用于2015年至2020年单一医院系统重症监护婴儿诊断病因不明的疾病。这项研究是回顾性的，包括对医疗记录和死亡证明的审查，以及WGS的结果。在可能的情况下，获取在世婴儿及其父母的WGS信息，如果不可能，则在死后获得。还检查了死亡证明和死亡原因，并与WGS结果进行了比较。在最后的样本中，112名死亡的婴儿在死前或死后进行了WGS。WGS在这些婴儿中发现了46例(41%)遗传疾病。在已确定的遗传疾病中，有83%的人先前有证据支持与儿童死亡率有关，并且从先前的文献中收集的证据可以改善30%的结果。死亡证明比较显示，在45名WGS显示潜在遗传疾病的婴儿中，62%没有在证明上报告或归因于死亡原因。除了死亡的112名婴儿外，研究人群还包括434名幸存的婴儿，他们也进行了WGS。在性别、种族或民族方面，各组之间没有发现显著差异。在死亡和存活的婴儿中，遗传疾病的类型各不相同，两者中只有4%被发现。某些疾病更可能发生在存活下来的婴儿身上，而另一些疾病更可能发生在死亡的婴儿身上。特定病因有一定的预后价值，对死亡或生存有积极的预测作用。这些结果表明，首先，在将WGS与死亡证明进行比较后，遗传疾病的报告长期偏低。此外，WGS表明，婴儿死亡的主要原因的病因学可能与以前认为的根本不同。WGS目前也不是一种广泛的治疗方法，尽管正在采取措施使其更广泛地可获得，但仍有许多需要做出的改变。这项研究的局限性在于其规模小，并且可能对其他患者群体的推广作用有限。未来的研究应该确定WGS测试和实施的最佳广度，以及WGS通过识别可治疗的疾病来降低婴儿死亡率的潜力。

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引用次数: 0

The Risks and Benefits of Monoclonal Antibody Therapy During Pregnancy and Postpartum: Maternal, Obstetric, and Neonatal Considerations. 单克隆抗体治疗在妊娠和产后的风险和益处：产妇、产科和新生儿的考虑因素。

IF 6.2 4区医学 Q1 OBSTETRICS & GYNECOLOGY

Obstetrical & Gynecological Survey

Pub Date : 2023-07-01 DOI: 10.1097/OGX.0000000000001155

Natalie E Wickenheisser, Amanda M Craig, Jeffrey A Kuller, Sarah K Dotters-Katz

Importance: Autoimmune and rheumatologic conditions can lead to multiple adverse maternal, obstetric, and neonatal outcomes, especially if they flare during pregnancy. Although many medications to control these conditions exist, concerns regarding their safety often unnecessarily limit their use.

Objective: We aim to review the current evidence available describing the use of monoclonal antibody (mAb) therapeutics in pregnancy and postpartum and understand the impact of their use on the developing fetus and neonate.

Evidence acquisition: Original research articles, review articles, case series and case reports, and pregnancy guidelines were reviewed.

Results: Multiple retrospective (including 1924 patients) and prospective studies (including 899 patients) of anti-tumor necrosis factor (TNF) agent use in pregnancy found no significant increase in rates of miscarriage, preterm birth, or congenital anomalies compared with controls. Most societies, including American College of Obstetricians and Gynecologists and Society for Maternal-Fetal Medicine, recommend initiation or continuation of TNF-α inhibitors during pregnancy for patients with autoimmune diseases. An increased risk of mild infections in newborns has been reported, although infections requiring hospitalizations are rare. Data suggest that breastfeeding while taking anti-TNF agents is safe for neonates. Less data exist for the use of other mAbs including anticytokine, anti-integrin, and anti-B-cell agents during pregnancy and postpartum.

Conclusions and relevance: Current evidence suggests that the use of mAbs, particularly anti-TNF agents, is safe in pregnancy and postpartum, without significant adverse effects on the pregnant patient or infant. The benefits of ongoing disease control in pregnant patients result in favorable maternal and neonatal outcomes.

重要性：自身免疫和风湿病会导致多种不利的孕产妇、产科和新生儿结局，尤其是在怀孕期间。尽管存在许多控制这些情况的药物，但对其安全性的担忧往往不必要地限制了它们的使用。目的：我们旨在回顾目前描述单克隆抗体（mAb）治疗在妊娠和产后使用的证据，并了解其使用对发育中的胎儿和新生儿的影响。证据获取：回顾了原始研究文章、综述文章、病例系列和病例报告以及妊娠指南。结果：妊娠期使用抗肿瘤坏死因子（TNF）药物的多项回顾性（包括1924名患者）和前瞻性研究（包括899名患者）发现，与对照组相比，流产、早产或先天性畸形的发生率没有显著增加。包括美国妇产科学会和母婴医学会在内的大多数学会都建议患有自身免疫性疾病的患者在怀孕期间开始或继续使用TNF-α抑制剂。据报道，新生儿轻度感染的风险增加，尽管需要住院治疗的感染很少。数据表明，母乳喂养同时服用抗TNF药物对新生儿是安全的。关于在妊娠和产后使用其他单克隆抗体，包括抗细胞因子、抗整合素和抗B细胞剂的数据较少。结论和相关性：目前的证据表明，单克隆抗体，特别是抗TNF药物，在妊娠期和产后是安全的，对孕妇或婴儿没有显著的不良影响。对孕妇进行持续疾病控制的好处是有利于产妇和新生儿的预后。

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引用次数: 0

Rate of Manifesting Carriers and Other Unexpected Findings on Carrier Screening 载明携带者的比率及其他在携带者筛查中意外发现

4区医学 Q1 OBSTETRICS & GYNECOLOGY

Obstetrical & Gynecological Survey

Pub Date : 2023-07-01 DOI: 10.1097/01.ogx.0000947136.14734.37

Sydney K. Clevenger, Justin S. Brandt, Shama P. Khan, Pranali Shingala, Jillian Carrick, Ruchi Aluwalia, Gary A. Heiman, Elena Ashkinadze

(Abstracted from Prenat Diagn 2023;43:117–125) Obstetric care includes many types of assessment of both mother and baby, including screening for genetic conditions. This can be done through genetic tests referred to as carrier screening, which detect carriers at risk to have children with autosomal recessive and X-linked recessive conditions.

(摘自prennat Diagn 2023;43:11 17 - 125)产科护理包括对母亲和婴儿的多种评估，包括遗传病筛查。这可以通过被称为携带者筛查的基因测试来完成，这种测试可以检测出有可能患有常染色体隐性遗传病和x连锁隐性遗传病的携带者。

引用次数: 0