摘要
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.
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.
