Sang G, Shao Q, Wu Y
Zhejiang Academy of Medical Sciences, Hangzhou.
Zhonghua Yi Xue Za Zhi. 1996 May;76(5):325-30.
To compare use-effectiveness and side-effects of medical termination of early pregnancy by oral administration of separated doses of mifepristone 150 mg or single dose of mifepristone 200 mg followed by PG05 1 mg vaginally in 4500 healthy pregnant women with amenorrhea < or = 49 days in a phase I multicentre study.
All subjects were recruited in 30 clinics after obtaining informed consents.
The complete, incomplete abortion and continuous pregnancy rates were 88.6%, 8.1%, 1.7% and 92.0%, 5.8%, 0.8% in single dose and separated doses groups, respectively. The efficacy of termination of early pregnancy by mifepristone 150 mg in separated doses was higher than that in single dose of mifepristone 200 mg when both in combination with PG05 1 mg (P < 0.01). One case of allergic rash was noted after administration of mifepristone. No severe side-effects were observed except bleeding problems. 65 cases received emergency vacuum aspiration and 7 of them received blood transfusion due to heavy bleeding. In addition, 2 cases of ectopic pregnancies required blood transfusion as heavy bleeding caused by exfetation disruption. There was no significant difference in to the time to start bleeding and the days of bleeding lasted between two treatment groups. However, there was a significant positive correlation (P < 0.001) between diameters of SAC and the days of bleeding lasted.
Logistic regression analysis suggested that subject's age, gravidity and days of amenorrhea have significant effects on abortion efficacy. 75.2% of subjects are satisfactory in self-assessment of the treatment, and 81.8% of subjects will choose medical abortion method in case they need to terminate undesired early pregnancy in the future.
在一项I期多中心研究中，比较4500例月经停止≤49天的健康孕妇口服150mg米非司酮分剂量给药或200mg米非司酮单剂量给药后阴道给予1mg卡前列甲酯栓进行早期妊娠药物流产的使用效果和副作用。
所有受试者在获得知情同意后于30家诊所招募。
单剂量组和分剂量组的完全流产率、不完全流产率和持续妊娠率分别为88.6%、8.1%、1.7%和92.0%、5.8%、0.8%。米非司酮150mg分剂量给药联合PG05 1mg时早期妊娠终止效果高于米非司酮200mg单剂量给药联合PG05 1mg时（P<0.01）。服用米非司酮后有1例出现过敏性皮疹。除出血问题外未观察到严重副作用。65例接受了急诊吸宫术，其中7例因出血过多接受输血。此外，2例异位妊娠因妊娠物破裂出血过多需要输血。两组开始出血时间和出血持续天数无显著差异。然而，妊娠囊直径与出血持续天数之间存在显著正相关（P<0.001）。
Logistic回归分析表明，受试者年龄、孕次和停经天数对流产效果有显著影响。75.2%的受试者对治疗自我评估满意，81.8%的受试者若未来需要终止意外早期妊娠会选择药物流产方法。
