目的:探讨来曲唑治疗前是否优于米非司酮治疗前,其次是米索前列醇,在早期妊娠流产的医疗治疗中完全撤离。
方法:前瞻性开放标签非劣效性随机对照试验。
方法:大学附属医院。
方法:我们招募了294名被诊断为妊娠早期流产的妇女,他们选择了药物治疗。
方法:参与者被随机分配到:(i)米非司酮组,口服200mg米非司酮,然后在24-48小时后阴道接受800μg米索前列醇;或(ii)来曲唑组,每天一次口服10毫克来曲唑,持续3天,随后在来曲唑施用的第三天(即最后一天)阴道施用800μg米索前列醇。
方法:主要结果是治疗后42天无手术干预的完全疏散率。次要结果包括诱导至驱逐间隔,不利影响,妇女的满意度,所需米索前列醇的剂量数,阴道出血的持续时间,米索前列醇给药当天的疼痛评分和其他不良事件。
结果:来曲唑和米非司酮组的完全疏散率为97.8%(95%CI95.1%-100%)和97.2%(95%CI94.4%-99.9%),分别(非劣效性p≤0.001)。与米非司酮组相比,来曲唑组的平均诱导至组织排出间隔更长(15.4vs9.0h)(p=0.03)。来曲唑组治疗后出血较轻,月经恢复较早。所需的米索前列醇的剂量数量没有统计学上的显着差异,阴道出血的持续时间,两组患者服用米索前列醇当天的疼痛评分和其他不良事件发生率.大多数妇女(来曲唑和米非司酮组中分别为91.2%和93.9%,分别)对他们的治疗选择感到满意。
结论:来曲唑治疗前不劣于米非司酮,其次是米索前列醇,用于治疗妊娠早期流产。
OBJECTIVE: To investigate whether letrozole pre-treatment is non-inferior to mifepristone pre-treatment, followed by
misoprostol, for complete evacuation in the medical treatment of first-trimester missed miscarriage.
METHODS: Prospective open-label non-inferiority randomised controlled trial.
METHODS: A university-affiliated hospital.
METHODS: We recruited 294 women diagnosed with first-trimester missed miscarriage who opted for medical treatment.
METHODS: Participants were randomly assigned to: (i) the mifepristone group, who received 200 mg mifepristone orally followed 24-48 h later by 800 μg
misoprostol vaginally; or (ii) the letrozole group, who received 10 mg letrozole orally once-a-day for 3 days, followed by 800 μg misoprostol vaginally on the third (i.e. last) day of letrozole administration.
METHODS: The primary outcome was the rate of complete evacuation without surgical intervention at 42 days post-treatment. Secondary outcomes included induction-to-expulsion interval, adverse effects, women\'s satisfaction, number of doses of misoprostol required, duration of vaginal bleeding, pain score on the day of
misoprostol administration and other adverse events.
RESULTS: The complete evacuation rates were 97.8% (95% CI 95.1%-100%) and 97.2% (95% CI 94.4%-99.9%) in the letrozole and mifepristone groups, respectively (p ≤ 0.001 for non-inferiority). The mean induction-to-tissue expulsion interval in the letrozole group was longer compared with the mifepristone group (15.4 vs 9.0 h) (p = 0.03). The letrozole group had less heavy post-treatment bleeding and an earlier return of menses. There were no statistically significant differences in the number of doses of
misoprostol required, the duration of vaginal bleeding, the pain score on the day of
misoprostol administration and the rate of other adverse events between the two groups. The majority of the women (91.2% and 93.9% in the letrozole and mifepristone groups, respectively) were satisfied with their treatment option.
CONCLUSIONS: Letrozole is non-inferior to mifepristone as a pre-treatment, followed by misoprostol, for the medical treatment of first-trimester missed miscarriage.