Torky Haitham A, Marie Heba, ElDesouky ElSayed, Gebreel Samy, Raslan Osama, Moussa Asem A, Ahmad Ali M, Zain Eman, Mohsen Mohamed N
Department of Obstetrics & Gynecology, October 6th University & As-Salam International Hospital, Cairo, Egypt.
Department of Obstetrics & Gynecology, Cairo University, Cairo, Egypt.
Geburtshilfe Frauenheilkd. 2018 Jan;78(1):63-69. doi: 10.1055/s-0043-122499. Epub 2018 Jan 22.
Misoprostol is used for the medical management of miscarriage as it is more effective in the early stages of pregnancy. Letrozole has an anti-estrogen effect and is used for the pretreatment of miscarriage with misoprostol.
The aim of this study was compare the efficacy and safety of letrozole with placebo pretreatment in the medical management of first trimester missed miscarriage.
This was a prospective randomized case-control study.
Four hundred and thirty-eight women were randomly divided into two groups of 219; the placebo group received placebo tablets twice daily for 3 days, followed by 800 micrograms of misoprostol vaginally on the fourth day of enrolment, while the letrozole group received letrozole 10 mg twice daily for three days followed by 800 micrograms misoprostol administered vaginally. Symptoms and side effects were recorded, and the women advised to return to hospital if they experienced severe pain or bleeding or intolerable side effects and to report to hospital for a check-up one week after misoprostol administration. Ultrasound was done seven days after misoprostol administration to monitor outcomes. Surgical evacuation was carried out if medical management failed.
There were significant differences between the two groups, with better outcomes found for the letrozole group in terms of rates of complete miscarriage, onset of vaginal bleeding, and interval between induction and onset of expulsion (p < 0.001). A higher rate of nausea and vomiting was reported for the letrozole group (p = 0.002). Differences between groups with regard to pre- and post-termination hemoglobin levels, fever, severe pain and severe bleeding needing evacuation were not statistically significant.
Adding letrozole to misoprostol improves the success rate and decreases the interval between induction and expulsion in cases of first trimester miscarriage; however, nausea and vomiting is higher with letrozole.
米索前列醇用于流产的药物治疗，因为它在妊娠早期更有效。来曲唑具有抗雌激素作用，用于米索前列醇流产预处理。
本研究的目的是比较来曲唑与安慰剂预处理在孕早期稽留流产药物治疗中的疗效和安全性。
这是一项前瞻性随机病例对照研究。
438名妇女被随机分为两组，每组219人；安慰剂组每天服用两次安慰剂片，共3天，在入组第4天阴道给予800微克米索前列醇，而来曲唑组每天服用两次10毫克来曲唑，共3天，随后阴道给予800微克米索前列醇。记录症状和副作用，建议妇女如果出现严重疼痛、出血或无法耐受的副作用，返回医院，并在米索前列醇给药一周后到医院进行检查。米索前列醇给药7天后进行超声检查以监测结局。如果药物治疗失败，则进行手术清宫。
两组之间存在显著差异，来曲唑组在完全流产率、阴道出血开始时间以及引产与排出开始之间的间隔方面效果更好（p<0.001）。来曲唑组报告的恶心和呕吐发生率更高（p=0.002）。两组在终止妊娠前后血红蛋白水平、发热、严重疼痛和需要清宫的严重出血方面的差异无统计学意义。
在米索前列醇中添加来曲唑可提高孕早期流产病例的成功率并缩短引产与排出之间间隔；然而，来曲唑组恶心和呕吐发生率更高。
