ve In this double-blind randomized trial, we compare the effect of 75 mg mifeprostone in capsules on termination of early pregnancy was compared with that of 150 mg in tablets combined with misoprostol.
Twenty-four healthy female volunteers with amenorrhea for seven weeks or less.asking for legal termination of pregnancy were recruited and divided into 4 groups (6 each). The subjects were orally administered with RU4...Twenty-four healthy female volunteers with amenorrhea for seven weeks or less.asking for legal termination of pregnancy were recruited and divided into 4 groups (6 each). The subjects were orally administered with RU486 of 50mg (Group Ⅰ). 50mg Q12hx 6 (GrouP Ⅱ),200mg(GrouP Ⅲ)or 600mg(Group Ⅳ).Vacuum aspiration(GrouP Ⅰ)or Methyl Carprost Suppository(PGOS 1.0mg)(GrouP Ⅱ-Ⅳ)was given 72h after the firsl dose followed by a 6--hour medl'cal survel'llance.Blood samples were collected on day 1-6,8,15,43 to measure the serum levels of β-hCG,E2,P,PRL,ACTH, Cortisol,T3,T4 and TSH in each subject.The results showed that no significant dose-effect relationship was observed in terms of clinical efficacy,vaginal bleeding or side effects.All four groups shared the same tendency of changes in serum levels of β-hCG,E2 and P.β-hCG levels increased by 50-100% (P<0.01)24h prior to treatment,and continued ic ipcrease following lreatment until the sac expulsion.EZ levels l'n each group reinal'ned higher than pre-treatment values with the gradual decline in P levels.β-hCG,E2 and P decreased drastically after abortion,levels of β-hCG,E2,P on day 5 were only 35-60% (P<0.01),32-46%(P<0.01)and 30-56%(P<0.01)of those on day 4 respectively.The mean PRL levels on day 2-4 in each group increased obviously but declined gradually following the sac ex.pulsion.During treatment,the respective cortisol levels increased dramatically,the average levels ofcortisol on day 2-4 were 30-40%(P<0.05) l'n GrouP Ⅰ-Ⅲ and 60%(P< 0.01) in Group Ⅳ higher as compared with day 1 values, while decreased rapidly af ter termination of pregnancy as indicated that cortisol levels on day 5 were only 67-81%(P<0.05) of those on day 4.The changes in ACTH,T3,T4,TSH levels were of no statistic sigulAance(P>0.05).This study indicated that RU486 has no dose-effect relationship when used for interruption of early pregnancy and its main action site seems neither in ovary nor in villi.It has some effects on pituitary-adrenal axis,especially in large dosage,however,it has no obvious impact on pituilary-thyroid axis.It seems that the changes in PRL serum levels were directly due to the drug itsed ifs clinical significance should be further studied.展开更多
文摘ve In this double-blind randomized trial, we compare the effect of 75 mg mifeprostone in capsules on termination of early pregnancy was compared with that of 150 mg in tablets combined with misoprostol.
文摘Twenty-four healthy female volunteers with amenorrhea for seven weeks or less.asking for legal termination of pregnancy were recruited and divided into 4 groups (6 each). The subjects were orally administered with RU486 of 50mg (Group Ⅰ). 50mg Q12hx 6 (GrouP Ⅱ),200mg(GrouP Ⅲ)or 600mg(Group Ⅳ).Vacuum aspiration(GrouP Ⅰ)or Methyl Carprost Suppository(PGOS 1.0mg)(GrouP Ⅱ-Ⅳ)was given 72h after the firsl dose followed by a 6--hour medl'cal survel'llance.Blood samples were collected on day 1-6,8,15,43 to measure the serum levels of β-hCG,E2,P,PRL,ACTH, Cortisol,T3,T4 and TSH in each subject.The results showed that no significant dose-effect relationship was observed in terms of clinical efficacy,vaginal bleeding or side effects.All four groups shared the same tendency of changes in serum levels of β-hCG,E2 and P.β-hCG levels increased by 50-100% (P<0.01)24h prior to treatment,and continued ic ipcrease following lreatment until the sac expulsion.EZ levels l'n each group reinal'ned higher than pre-treatment values with the gradual decline in P levels.β-hCG,E2 and P decreased drastically after abortion,levels of β-hCG,E2,P on day 5 were only 35-60% (P<0.01),32-46%(P<0.01)and 30-56%(P<0.01)of those on day 4 respectively.The mean PRL levels on day 2-4 in each group increased obviously but declined gradually following the sac ex.pulsion.During treatment,the respective cortisol levels increased dramatically,the average levels ofcortisol on day 2-4 were 30-40%(P<0.05) l'n GrouP Ⅰ-Ⅲ and 60%(P< 0.01) in Group Ⅳ higher as compared with day 1 values, while decreased rapidly af ter termination of pregnancy as indicated that cortisol levels on day 5 were only 67-81%(P<0.05) of those on day 4.The changes in ACTH,T3,T4,TSH levels were of no statistic sigulAance(P>0.05).This study indicated that RU486 has no dose-effect relationship when used for interruption of early pregnancy and its main action site seems neither in ovary nor in villi.It has some effects on pituitary-adrenal axis,especially in large dosage,however,it has no obvious impact on pituilary-thyroid axis.It seems that the changes in PRL serum levels were directly due to the drug itsed ifs clinical significance should be further studied.
