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目的 :研究米非司酮用于晚期妊娠引产对新生儿的影响 ,评价其对母婴的安全性。方法 :采用高效液相色谱法测定产妇及新生儿血浆中的米非司酮浓度。结果 :服药组产妇产程活跃期血浆中的米非司酮浓度为 ( 3 2 3± 13 7)ng·mL-1、脐血浓度为 ( 95 9± 5 1 0 )ng·mL-1,其新生儿出生后 2 4h的血药浓度为 ( 3 9 8± 2 0 7)ng·mL-1,均与对照组有显著差异 (P <0 0 5 ) ,且脐血浓度与产妇产程活跃期血浆中的米非司酮浓度成正相关 ,相关系数为 0 72 ,脐 /母血药浓度比值为 0 3 0。出生后 72h血药浓度 ( 2 7 7± 9 9)ng·mL-1与对照组比无显著差异 (P >0 0 5 )。结论 :该研究为米非司酮用于晚期妊娠引产的安全性提供一定的科学依据
Objective: To study the effect of mifepristone on newborn infants in late pregnancy and to evaluate the safety of mifepristone in maternal and infant. Methods: The concentrations of mifepristone in maternal and neonatal plasma were determined by high performance liquid chromatography. Results: The plasma concentration of mifepristone in the medication group was (32 3 ± 13 7) ng · mL-1 and the cord blood concentration was (95 9 ± 5 1 0) ng · mL-1 The plasma concentration of newborns at 24 hours after birth was (398 ± 277) ng · mL-1, which was significantly different from the control group (P <0.05), and the cord blood concentration was positively correlated with the active stage of labor Plasma concentrations of mifepristone were positively correlated, with a correlation coefficient of 0 72 and a navel / maternal serum concentration ratio of 0 30. The plasma concentration at 72h after birth (2 7 7 ± 9 9 ng · mL -1) was not significantly different from that of the control group (P 0 05). Conclusions: This study provides a scientific basis for the safety of mifepristone in induction of labor during late pregnancy