| Background:Medical abortion using mifepristone combined with misoprostol, which has a very mature scheme,has been widely applied in the early termination of pregnancy up to49days and the success rate reached more than95%that made it popular clinically acceptable to the early pregnant woman. The traditional surgical methods for termination of pregnancy usually used at8-16weeks of gestation were vacuum aspiration,dilatation and evacuation and ethacridine amnioticcavity intracavitary administration. In these methods, the serious complications such as cervical trauma,uterine perforation, organ injury and amnionic fluid embolism would occur at times,even lead to death. Furthermore the long time of the operation procedure and the severe pain of patient's suffering would't be conducive to woman's physical and mental health. For these reasons, the domestic and abroad researchs about using mifepristone in combination with misoprostol to terminate pregnancy beyond49days were increasing. The studies on efficacy and safety about medical abortion were always the focus of clinical research. Medical abortion in pregnancies up to63days has been approved in European,but not approved beyond63days. At present, only in the Shanghai area through multicenter study, there had been instituted the conventional operation in clinical application of medical abortion for terminate pregnancy10-16W, but there was no corresponding technical operation routine in our country. However, no unified, efficient, standardized medication regimen is available for termination of pregnancy8-16weeks now. Therefore, it is necessary for us to further study the effectiveness, safety of medical abortion and to offer reliable clinical evidence for clinical drug development of conventional.Objective:To evaluate the cinical efficacy and safety of mifepristone in combinnation with misoprostol in the termination of8-16weeks pregnancy by standard clinical study. To offer reliable clinical evidence for instituting medication routine of mifepristone in combinnation with misoprostol in the termination of8-16weeks pregnancy.Methods:60women of8-16weeks gestation in Women'Hospital of Zhejiang University School of Mdeicine were divided into two groupes per their gestational weeks from Octuber to Dcember in2010.30women of8-10weeks pregnancy(Group A) were administered out-patient and the other who were at10-16weeks of gestation (Group B) were administered in-hospital. The two groups were given the same regimen which were took100mg mifeprisitone once at9:00am in the first day and the second day respectively, and administered600ug misoprostol vaginally at7:00-8:00am in the third day. The administration of misoprostol was repeated every3or4hours orally, to a maximum of four doses if needed and stopped after the delivery of the fetus and placenta. Meanwhile,the followed indexs were observed:side effect, the time of vaginal bleeding and abdominal pain,inducing time to abortion, dosages of misoprostol, efflux time of the fetus and placenta, The amount of vaginal bleeding within2hours and from2hours to24hours after abortion, success rate. All women were requested to follow up the day after abortion and2weeks and1month later or the first menses recovery. A clinical examination including blood routine and B ultrasonography and serum beta-HCG level was performed at follow up. On the other side, influence factors which could lead to surgical intervention in medical abortion were analyzed.Results:Part one Efficacy and safety In60cases the total success rate was98.3%and the failure rate was1.7%. The success abortion rate was96.7%in group A and100%in group B. The incomplete abortion rate was26.7%in group A and36.7%in group B. The failure rate was3.3%in groupA and no failure in group B. There was no statistical difference between the two groups. The start time of vaginal bleeding40%in service with mifepristone after an average of35.69±6.05hours and60%in the use of misoprostol after a mean of1.83±0.65hours in group A, but26.7%in service with mifepristone after an average of37.15±7.10hours and73.3%in the use of misoprostol after a mean of3±1.96hours in group B..There was no statistical difference in vaginal bleeding average time after taking mifepristone but there was significant in vaginal bleeding average time after taking misoprostol between the two groups, and the vaginal bleeding appearance earlier in group A. The degree of abdominal pains were following in group A:mild20cases(66.7%), moderate10cases(33.3%), no severe pain or need painkillers and were following in group B:mild9cases(30%),moderate18cases(60%), severe3cases(10%) including two cases with analgesics. There were significant difference between the two groups and the degree of pains in group B was significantly heavier than that in group A. Inducing time to abortion was2.9±1.16hours in group A and4.88±3.48hours in group B, there was significant difference between the two groups. The amount of vaginal bleeding within2hours and from2hours to24hours after abortion were30±21.68ml and30±25.34ml respectively in group A and were72.5±85.44ml and35±17.16ml respectively in group B. There was significant statistical difference in the amount of vaginal bleeding within2hours after abortion between the two groups and no obvious difference in the amount of vaginal bleeding from2hours to24hours after abortion. The amount of vaginal bleeding in group B was more than that in group A.The hemoglobin(HGB) at1-2days after abortion was significantly decreased than that before the abortion, there was a statistically significant difference. The hemoglobin after1month had been largely restored to the original level;The dosages of misoprostol were600±428ug in group A and1200+586ug in group B.There was significant difference between the two groups and the more amount of misoprostol was used in group B. The vaginal bleeding and staxis after abortion lasted6±8.25d and10±7.14d in group A but lasted6±3.75d and7.5±6.23d in group B. The total time of vaginal bleeding and staxis after abortion lasted20±8.92d in group A and16±7.29d in group B. There were no statistical differences between the two groups. After2weeks of the abortion,the serum human chorionic gonadotrophin (β-HCG) levels in group A slower down than that in group B, but after one month the serum β-HCG level almost returned to normal. The resumption of menstruation after abortion was38±14.79d in group A and41.50±21.77d in group B. There was no difference between the two groups. Adverse drug reaction occured slightly and no serious complications and rare complication occured. Part two Surgical intervention and analysis of related factors In60cases there were21cases (35%) to be carried out the surgical intervention. The related factors which could lead to surgical intervention by univariate analysis were as follows: previous Gravidity, the times of previous abortion, the results of cavitas pelvis B ultrasound examination and serum β-HCG level2weeks after abortion, serum β-HCG decline rate2weeks and1month after abortion, the resumption of menstruation days after abortion. And Multivariate analysis found that the more numbers of previous abortions (≥3times) and the higher of the serum β-HCG level2weeks after abortion and the more intrauterine residues in tissues hinted by B ultrasound examination (the largest diameter>20mm), then the risk of surgical intervention was greater.Conclusion:1,Effects of mifepristone200mg combined with misoprostol vaginal and orally in the termination of8-16weeks of pregnancy were safe and feasible with high success rate and less side reaction.2,The risk factors of surgical intervention were as follows:previous abortion (≥3times), the serum β-HCG level2weeks after abortion, the result of B ultrasound examination (the largest diameter of intrauterine residues in tissues>20mm)... |
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