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米非司酮联合米索前列醇与单独应用米索前列醇治疗早期妊娠丢失的结局比较。

Outcomes After Early Pregnancy Loss Management With Mifepristone Plus Misoprostol vs Misoprostol Alone.

机构信息

Department of Obstetrics and Gynecology, University of Washington School of Medicine, Seattle.

Department of Urology, University of Washington School of Medicine, Seattle.

出版信息

JAMA Netw Open. 2024 Oct 1;7(10):e2435906. doi: 10.1001/jamanetworkopen.2024.35906.

Abstract

IMPORTANCE

Medication management of early pregnancy loss (EPL), or miscarriage, typically involves the administration of misoprostol with or without pretreatment with mifepristone. Combination treatment with mifepristone plus misoprostol is more effective than misoprostol alone but is underutilized in the US.

OBJECTIVE

To describe differences in clinical outcomes after EPL management with mifepristone plus misoprostol vs misoprostol alone using commercial claims data.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study used national insurance claims data from the IBM MarketScan Research Database. Participants included pregnant people (aged 15-49 years) with private insurance who presented with an initial EPL diagnosis between October 1, 2015, and December 31, 2022.

EXPOSURES

The primary exposure was the medication used to manage EPL (ie, mifepristone plus misoprostol or misoprostol alone). Other exposures of interest included demographic characteristics and location of service.

MAIN OUTCOMES AND MEASURES

The primary outcome was subsequent procedural management (eg, uterine aspiration) after EPL diagnosis and medication management. Other outcomes of interest included return visits, hospitalizations, and complications occurring in the subsequent 6 weeks. Descriptive statistics and bivariate analyses were used, and a multivariable logistic regression model was created to examine factors associated with subsequent procedural management.

RESULTS

This study included 31 977 patients (mean [SD] age, 32.7 [5.6] years) with claims for EPL who received medication management. Of these patients, 3.0% received mifepristone plus misoprostol and 97.0% received misoprostol alone. Patients who received misoprostol with pretreatment with mifepristone were less likely to have subsequent uterine aspiration (10.5% vs 14.0%; P = .002), and they were also less likely to have subsequent emergency department (ED) visits for EPL (3.5% vs 7.9%; P < .001). In multivariable analysis, use of mifepristone plus misoprostol was associated with decreased odds of subsequent procedural management (adjusted odds ratio, 0.71 [95% CI, 0.57-0.87]).

CONCLUSIONS AND RELEVANCE

The findings of this study suggest that mifepristone is underutilized for the medication management of EPL, but its use is associated with a lower need for subsequent uterine aspiration and a decrease in the number of subsequent visits to an ED. Increasing access to mifepristone for EPL management may decrease health care utilization and expenditures.

摘要

重要性

早期妊娠丢失(EPL)或流产的药物管理通常涉及米索前列醇的给药,无论是否预先使用米非司酮。米非司酮联合米索前列醇联合治疗比单用米索前列醇更有效,但在美国的应用不足。

目的

使用商业索赔数据描述 EPL 管理中使用米非司酮加米索前列醇与单用米索前列醇的临床结局差异。

设计、设置和参与者:这是一项回顾性队列研究,使用 IBM MarketScan Research Database 中的国家保险索赔数据。参与者包括有私人保险的 15-49 岁孕妇,他们在 2015 年 10 月 1 日至 2022 年 12 月 31 日期间首次出现 EPL 诊断。

暴露

主要暴露因素是用于管理 EPL 的药物(即米非司酮加米索前列醇或单用米索前列醇)。其他感兴趣的暴露因素包括人口统计学特征和服务地点。

主要结果和措施

主要结果是 EPL 诊断和药物管理后随后的程序管理(例如,子宫抽吸术)。其他感兴趣的结果包括随访、住院和随后 6 周内发生的并发症。使用描述性统计和双变量分析,并创建多变量逻辑回归模型来检查与随后的程序管理相关的因素。

结果

本研究纳入了 31977 名接受 EPL 药物管理的患者(平均[SD]年龄 32.7[5.6]岁)。其中 3.0%接受米非司酮加米索前列醇治疗,97.0%接受米索前列醇单独治疗。接受米非司酮预处理米索前列醇的患者随后进行子宫抽吸术的可能性较低(10.5%比 14.0%;P = .002),随后因 EPL 就诊急诊部的可能性也较低(3.5%比 7.9%;P < .001)。多变量分析显示,使用米非司酮加米索前列醇与随后进行程序管理的几率降低相关(调整后的优势比,0.71[95%CI,0.57-0.87])。

结论和相关性

这项研究的结果表明,米非司酮在 EPL 的药物管理中应用不足,但它的使用与随后子宫抽吸术的需求降低以及随后到急诊部就诊的次数减少有关。增加米非司酮在 EPL 管理中的应用可能会降低医疗保健的利用和支出。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a8f/11581616/2edd817c478d/jamanetwopen-e2435906-g001.jpg

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