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米非司酮口腔含服联合米索前列醇用于澳大利亚临床环境下早期药物流产的疗效与安全性。

Efficacy and safety of mifepristone-buccal misoprostol for early medical abortion in an Australian clinical setting.

作者信息

Goldstone Philip, Walker Clara, Hawtin Katherine

机构信息

Marie Stopes International in Australia, Melbourne, Victoria, Australia.

MS Health, Melbourne, Victoria, Australia.

出版信息

Aust N Z J Obstet Gynaecol. 2017 Jun;57(3):366-371. doi: 10.1111/ajo.12608. Epub 2017 Mar 17.

DOI:10.1111/ajo.12608
PMID:28303569
Abstract

BACKGROUND

In 2014, a composite pack containing mifepristone-buccal misoprostol, indicated for use to 63 days gestation replaced the existing regimen for early medical abortion (EMA) in Australia.

AIMS

To provide updated efficacy and safety information for the use of mifepristone-buccal misoprostol for EMA in Australia, and assess the effect of patient age and gestational age on efficacy.

MATERIALS AND METHODS

Observational cohort study of 15 008 women attending one of 16 Marie Stopes International clinics in Australia for an EMA (gestational age ≤ 63 days) between 1 March 2013 and 30 September 2015. Administration of 200 mg oral mifepristone in-clinic was followed 24-48 h later by 800 μg buccal misoprostol self-administered at home. Method success was defined as complete abortion not requiring surgical intervention.

RESULTS

Follow-up information was available for 87.14% (13 078/15 008) of women. Likelihood of follow-up was significantly lower for women from rural or remote locations (adjusted odds ratio, 0.47; P < 0.001). Medical abortion was successful in 95.16% (12 445/13 078) of women with follow-up. Higher patient and gestational ages were associated (P < 0.001) with a slight increase in method failure. There were 674 serious adverse events (5.15%), mainly due to method failure. Infection (15; 0.11%) and haemorrhage (17; 0.13%) were rare. One death was recorded (<0.01%); however, an association between EMA and cause of death, necrotising pneumonia, was not established.

CONCLUSION

Mifepristone-buccal misoprostol is an effective and safe alternative to surgical termination of pregnancy up to 63 days gestation.

摘要

背景

2014年,一种含米非司酮-口腔用米索前列醇的复合包装药物在澳大利亚被用于妊娠63天内的早期药物流产,取代了现有的早期药物流产方案。

目的

提供澳大利亚使用米非司酮-口腔用米索前列醇进行早期药物流产的最新疗效和安全性信息,并评估患者年龄和孕周对疗效的影响。

材料与方法

对2013年3月1日至2015年9月30日期间在澳大利亚16家玛丽斯特普国际诊所之一进行早期药物流产(孕周≤63天)的15008名女性进行观察性队列研究。在诊所口服200mg米非司酮,24 - 48小时后在家自行口服800μg口腔用米索前列醇。方法成功定义为无需手术干预的完全流产。

结果

87.14%(13078/15008)的女性有随访信息。来自农村或偏远地区的女性随访可能性显著较低(调整优势比,0.47;P < 0.001)。有随访的女性中95.16%(12445/13078)药物流产成功。患者年龄和孕周越大,方法失败率略有增加(P < 0.001)。有674例严重不良事件(5.15%),主要是由于方法失败。感染(15例;0.11%)和出血(17例;0.13%)罕见。记录到1例死亡(<0.01%);然而,未证实早期药物流产与死因坏死性肺炎之间存在关联。

结论

米非司酮-口腔用米索前列醇是妊娠63天内手术终止妊娠的一种有效且安全的替代方法。

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