Division of Obstetrics and Gynecology, Department of Women's and Children's Health, Karolinska Institutet/Karolinska University Hospital, 17176 Stockholm, Sweden.
Hum Reprod. 2012 Feb;27(2):388-93. doi: 10.1093/humrep/der407. Epub 2011 Nov 28.
Misoprostol has been shown to be an effective agent for cervical ripening and termination of early pregnancy especially when administered vaginally. Our objective was to evaluate whether bacterial vaginosis (BV) affected the pharmacokinetics of vaginally administered misoprostol during early pregnancy.
Ten women with BV and 10 healthy women requesting medical abortion up to 9 weeks of pregnancy were administered 200 mg mifepristone followed 24-48 h later by a single dose of 800 µg misoprostol vaginally. Blood samples were taken before (0 h) and 0.5, 1, 2, 3 and 4 h after misoprostol administration. Misoprostol acid was determined in serum samples using liquid chromatography/tandem mass spectrometry.
All women with BV had a vaginal pH > 4.7. The mean bioavailability measured as the area under the curve (AUC) and maximum concentration (C(max)) appeared higher in the control than in the BV group (1458.7 versus 878.1 pg h/ml) and (630.7 versus 342.5 pg/ml), respectively, but did not achieve statistical significance and there was no other significant difference in the pharmacokinetics between the two groups. However, if two women with vaginal pH > 4.7 were excluded from the control group the difference in AUC₂₄₀ (1359 versus 878.1 pgh/ml) reached statistical significance (P = 0.048).
BV had an effect on pharmacokinetics of vaginally administered misoprostol in early pregnancy. However, the results should be interpreted with caution due to the small sample size and marked individual variations.
米索前列醇已被证明是一种有效的宫颈成熟和终止早孕的药物，尤其是经阴道给药时。我们的目的是评估细菌性阴道病（BV）是否会影响早期妊娠经阴道给予米索前列醇的药代动力学。
10 名患有 BV 的妇女和 10 名要求在怀孕 9 周内进行药物流产的健康妇女在服用米非司酮 200mg 后 24-48 小时，单次阴道给予 800µg 米索前列醇。在给药前（0 小时）和给药后 0.5、1、2、3 和 4 小时采集血样。采用液相色谱/串联质谱法测定血清中米索前列醇酸的含量。
所有患有 BV 的妇女阴道 pH 值均>4.7。以曲线下面积（AUC）和最大浓度（C(max))表示的生物利用度在对照组中均高于 BV 组（1458.7 比 878.1 pg h/ml）和（630.7 比 342.5 pg/ml），但未达到统计学意义，两组间药代动力学无其他显著差异。然而，如果将阴道 pH 值>4.7 的两名妇女从对照组中排除，AUC₂₄₀的差异（1359 比 878.1 pgh/ml）达到统计学意义（P=0.048）。
BV 对早期妊娠经阴道给予米索前列醇的药代动力学有影响。然而，由于样本量小且个体差异明显，结果应谨慎解释。
