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稽留流产中与米非司酮和米索前列醇药物治疗成功相关的因素:一项回顾性病例对照研究

Factors related to successful medication management with mifepristone and misoprostol in missed miscarriage: a retrospective case-control study.

作者信息

Wang Huiyuan, He Yuheng, Gao Gao, Zhou Jingwei, Ye Xingrong, Tan Rongrong, Pu Danhua, Wu Jie, Lu Jing

机构信息

State Key Laboratory of Reproductive Medicine and Offspring Health, Department of Obstetrics and Gynecology, The First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital/Jiangsu Women and Children Health Hospital, Nanjing, 210000, China.

Nanjing Meteorological Observation Centre, Nanjing, 210000, China.

出版信息

BMC Pregnancy Childbirth. 2025 May 10;25(1):554. doi: 10.1186/s12884-025-07662-5.

Abstract

BACKGROUND

Treatment with mifepristone in combination with misoprostol may be a safe and less expensive option compared with surgical management in missed miscarriage, but the efficacy of medication management varies in clinical practice. This study aims to identify the risk factors related to successful medical management using mifepristone and misoprostol for missed miscarriage.

METHODS

We carried out a retrospective case-control study in the First Affiliated Hospital with Nanjing Medical University from January 1, 2023 to December 31, 2023. Patients were recruited into this study if they were aged 16 years and older, diagnosed with a missed miscarriage by pelvic ultrasound scan in the first 13 weeks of pregnancy (by last menstrual period), and chose to have medication management. Women who failed to spontaneously pass the gestational sac within 24 h of the oral misoprostol dose were included in the case group, while women who had complete gestational sac expulsion within 24 h of the oral misoprostol dose were defined as controls. The baseline characteristics of the patients were collected in the electronic medical record system and the meteorological data were obtained from the Nanjing Meteorological Observation Centre. Logistic regression analysis was used to identify the risk factors which affected medication management efficacy.

RESULTS

A total of 163 patients met inclusion criteria, including 60 patients in the case group and 103 patients in the control group. Our results showed that the history of gravidity, history of parity, history of miscarriage, history of caesarean section, prior uterine surgery, and the use of supplemental vaginal misoprostol could be potential risk factors, while the remaining variables showed no significant differences between the two groups. The univariable logistic regression model demonstrated that the risk of unsuccessful medication management was increased 3.67-fold in patients who had been pregnant more than 3 times (95% CI: 1.66, 8.08; p = 0.001); increased 2.29-fold in parous women (95% CI: 1.13, 4.62; p = 0.021); and increased 2.09-fold in patients who had previous miscarriages (95% CI: 1.10, 4.00; p = 0.026). Additionally, prior uterine surgery was related to the outcomes of medication management (OR: 2.94; 95% CI: 1.46, 5.93; p = 0.003), especially caesarean section (OR: 2.09; 95% CI: 1.13, 4.62; p = 0.021). Interestingly, the repeated vaginal administration of misoprostol was not associated with an increased success rate (OR: 3.65; 95% CI: 1.76, 7.56; p = 0.001). Moreover, we evaluated the effect of meteorological factors on which the exposure of 4 days average visibility emerged as a statistically significant risk factor (OR: 1.13, 95% CI: 1.01, 1.27; p = 0.036). Multivariable logistic regression model showed that the history of parity, prior uterine surgery, use of supplemental vaginal misoprostol and 4 days average visibility were still independently associated with the outcomes of medication management, while the gestational age by ultrasound was no longer related.

CONCLUSIONS

The missed miscarriage patients who are parous or have uterine surgery history may suffer from a higher risk of unsuccessful medication management. The exposure to reduced visibility had a significant influence on the efficacy of mifepristone and misoprostol, while the supplementary administration of vaginal misoprostol could not increase the chance of successful miscarriage management.

摘要

背景

与稽留流产的手术治疗相比,米非司酮联合米索前列醇治疗可能是一种安全且成本较低的选择,但药物治疗的疗效在临床实践中存在差异。本研究旨在确定与米非司酮和米索前列醇药物治疗成功相关的危险因素。

方法

我们于2023年1月1日至2023年12月31日在南京医科大学第一附属医院进行了一项回顾性病例对照研究。纳入年龄16岁及以上、妊娠前13周(根据末次月经)经盆腔超声检查诊断为稽留流产且选择药物治疗的患者。口服米索前列醇24小时内未能自然排出妊娠囊的女性纳入病例组,口服米索前列醇24小时内完全排出妊娠囊的女性定义为对照组。在电子病历系统中收集患者的基线特征,并从南京气象观测中心获取气象数据。采用Logistic回归分析确定影响药物治疗疗效的危险因素。

结果

共有163例患者符合纳入标准,其中病例组60例,对照组103例。结果显示,妊娠史、分娩史、流产史、剖宫产史、既往子宫手术史以及补充阴道用米索前列醇可能是潜在危险因素,而其余变量在两组间无显著差异。单因素Logistic回归模型显示,妊娠3次以上的患者药物治疗失败风险增加3.67倍(95%CI:1.66,8.08;P=0.001);经产妇增加2.29倍(95%CI:1.13,4.62;P=0.021);有既往流产史的患者增加2.09倍(95%CI:1.10,4.00;P=0.026)。此外,既往子宫手术与药物治疗结局相关(OR:2.94;95%CI:1.46,5.93;P=0.003),尤其是剖宫产(OR:2.09;95%CI:1.13,4.62;P=0.021)。有趣的是,重复阴道给予米索前列醇与成功率增加无关(OR:3.65;95%CI:1.76,7.56;P=0.001)。此外,可以评估气象因素的影响,其中4天平均能见度的暴露是一个具有统计学意义的危险因素(OR:1.13,95%CI:1.01,1.27;P=0.036)。多因素Logistic回归模型显示,分娩史、既往子宫手术史、补充阴道用米索前列醇和4天平均能见度仍与药物治疗结局独立相关,而超声检查的孕周不再相关。

结论

经产妇或有子宫手术史的稽留流产患者药物治疗失败风险可能更高。能见度降低对米非司酮和米索前列醇的疗效有显著影响,而补充阴道用米索前列醇并不能增加流产成功治疗的机会。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/59cb/12065209/f950cdfc539c/12884_2025_7662_Fig1_HTML.jpg

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