Comparison of three single doses of mifepristone as emergency contraception: a randomised controlled trial

BACKGROUND: This is an analysis of the Australian component of a large World Health Organization multicentre dose-finding study of mifepristone for emergency contraception and the first clinical study of this controversial drug in Australia. AIMS: To compare the effectiveness and side-effects of three single doses of mifepristone taken within 120 h after unprotected coitus as emergency contraception. DESIGN: Double-blind, randomised controlled trial. SUBJECTS AND METHODS: One hundred fifty healthy women with regular menstrual cycles who requested emergency contraception. Participants were allocated randomly to one of the three doses (10, 50 and 600 mg). The primary outcome was confirmed pregnancy, and secondary outcome measures included side-effects and delay in the onset of the next menses. RESULTS: Pregnancy rates for mifepristone 10, 50 and 600 mg were 2.0, 2.1 and 2.1%, respectively, with no significant difference between groups. No major side-effects occurred, except an unpredictable delay in the onset of the next menses. Mifepristone 600 mg caused a significantly longer delay in the onset of the next menses than either the 10 or the 50 mg dose. CONCLUSION: Lowering the dose of mifepristone from 600 to 10 mg did not significantly impair its effectiveness as an emergency contraceptive, and caused less delay in the onset of the next menses. Therefore, a dose as low as 10 mg may be preferable to 600 mg for emergency contraception. This is very much lower than the dose required to terminate a pregnancy.     

First trimester abortion with mifepristone and three doses of sublingual misoprostol: a pilot study

OBJECTIVE: To evaluate the efficacy and safety of a medical abortion regimen with multiple doses of sublingual misoprostol 24 h after mifepristone. METHODS: The regimen was designed on the basis of pharmacokinetics of various routes of administration of misoprostol. Forty women < or = 8 weeks' gestation were given mifepristone 200 mg orally, followed 24 h later by three doses of misoprostol 200 microgm sublingually 6 h apart. They were followed up on day 3 and day 14 with transvaginal ultrasound. Pain and bleeding were assessed using a visual analogue scale and acceptability, by a questionnaire. RESULTS: Abortion outcome was assessed in terms of onset of pain and vaginal bleeding, time of expulsion of products and duration of vaginal bleeding. Seventy-five per cent of women experienced pain within 2 h after first dose of misoprostol. Bleeding began at a mean of 1.41 h after pain and expulsion at a mean of 6.1 h after first dose of misoprostol. Complete expulsion was confirmed in all women (100%) by ultrasound on day 14. The longest duration of bleeding was 12 days (mean 7.2 days) with 87.5% bleeding for < 10 days. Acceptability was 100% but 70% perceived pain to be moderate and 67.5% bleeding to be light or slightly more than menses. CONCLUSIONS: Medical abortion using three doses of sublingual misoprostol administered 24 h after mifepristone appears to be the most appropriate in terms of pharmacokinetics of the drugs. This pilot study associates the regimen with a short abortion process, which appears to be safe, highly efficacious and acceptable.     

Early medical abortion: a new regimen up to 49 days' gestation

AIM: To evaluate a new regimen of mifepristone and misoprostol in early medical abortion up to 49 days of amenorrhoea. METHODS: One hundred healthy women requesting pregnancy termination up to 49 days gestation received 200 mg mifepristone followed by 800 microg misoprostol orally 24 h later. Statistical analysis was carried out by unpaired t-test. RESULTS: Ninety-six percent of patients aborted completely 4.3 h after they were given misoprostol. No significant side-effects were noted. The duration of bleeding correlated with gestational age (P-value 0.009). CONCLUSION: This new regimen of mifepristone-misoprostol is effective in terminating early pregnancy, with shorter induction to abortion interval and greater acceptability.     

Mifepristone (RU486) and therapeutic late pregnancy termination: a double-blind study of two different doses

An antiprogesterone, mifepristone (RU486), was administeredto 35 patients undergoing a therapeutic interruption of pregnancyduring the second and third trimester for maternal or fetalindications. A randomized double-blind study test was perfonnedusing 150 and 450 mg of mifepristone as pretreatment prior toprostaglandins. No toxicity or maternal morbidity were recorded.In three patients the onset of labour occurred spontaneouslybefore prostaglandin administration. Mifepristone produced amodification in the consistency of the cervix with a statisticalimprovement in cervical calibration in the two groups, but thecervical effect was independent of the dose.     

米非司酮合并米索前列醇终止10～16周妊娠的疗效

目的：观察口服米非司酮合并米索前列醇终止１０～１６ｗｋ妊娠的临床疗效。方法：１７５例妊娠１０～１６ｗｋ妇女用２种不同剂量米非司酮（组Ⅰ２５ｍｇｂｉｄ×３ｄ，总量１５０ｍｇ；组Ⅱ２００ｍｇ单次用药），合并米索前列醇（最大剂量不超过１．６ｍｇ）口服。结果：２组流产成功率分别为８９％和８４％，Ｐ＞０．０５。组Ⅰ胎儿排出时间（７ｈ）明显短于组Ⅱ（９ｈ），Ｐ＜０．０１。组Ⅰ米索前列醇用量（０．７ｍｇ）明显少于组Ⅱ（１．０ｍｇ），Ｐ＜０．０１。结论：口服米非司酮合并米索前列醇终止１０～１６ｗｋ妊娠是安全有效的；给药方法以米非司酮小剂量多次给药法更可取。     

米非司酮治疗围绝经期子宫内膜异症的临床观察与分析

[目的]探讨米非司酮治疗围绝经期子宫内膜异位症(EMT)的临床疗效以及安全性。[方法]将我院2010年1月到2011年5月收治的60例围绝经期EMT患者随机分为对照组与观察组,每组30例,对照组给予孕三烯酮治疗,观察组给予米非司酮治疗。评价临床疗效、两组不良反应发生情况,测定两组患者治疗前后的血清CA-125含量。[结果]观察组的显效率和总有效率均明显高于对照组,两组比较差异具有统计学意义(P0.05);观察组不良反应发生率明显低于对照组,两组比较具有显著性差异(P0.05);治疗后,观察组的CA-125含量明显低于对照组(P0.05)。[结论]米非司酮临床治疗围绝经期EMT的疗效确切。     

65例异位妊娠保守治疗的临床观察

目的 比较MTX单独用药及MTX加米非司酮联合用药治疗异位妊娠疗效的差异.方法 65例确诊为异位妊娠患者,对照组30例和观察组35例.对照组给予MTX单次肌肉注射,观察组给予MTX单次肌肉注射并口服米非司酮50mg,q12h共3d,定期测定血β-hCG及B超,对用药后疗效进行分析比较.结果 对照组成功率73.3％,观察组成功率91.4％,差异有统计学意义(P＜0.05).结论 MTX联合米非司酮治疗异位妊娠是一种简单、安全、有效的治疗方法,更适合于年轻、有生育要求的患者.     

米非司酮对子宫内膜异位症大鼠内膜OPN及MMP-9表达的影响

目的探讨米非司酮对大鼠子宫内膜异位症(Endometriosis,EMS)模型在位及异位内膜中骨桥蛋白(OPN)及金属蛋白酶9(MMP-9)表达的影响。方法取建模成功的13只大鼠随机分为米非司酮组(7只),对照组(6只),药物干预4周后开腹取材,通过免疫组织化学法及RT-PCR法测定药物干预前、后在位及异位内膜中MMP-9及OPN的表达。结果干预后米非司酮组在位内膜和异位内膜中OPN及MMP-9的表达均较干预前表达明显降低(P<0.05);对照组干预后异位内膜中OPN的表达强于在位内膜,而米非司酮组干预后异位内膜及在位内膜中OPN表达差异无统计学意义(P=0.113);对照组干预后异位内膜中MMP-9的表达强于在位内膜,且干预后米非司酮组异位内膜中MMP-9的表达也较在位内膜中表达增强(P=0.011);对照组干预后异位内膜中OPNmRNA表达较干预前明显减低,且在位内膜及异位内膜的表达差异无统计学意义。结论米非司酮可降低大鼠EMS模型在位、异位内膜中OPN及MMP-9的表达,对异位内膜中OPN的抑制作用要强于在位内膜;对在位内膜中MMP-9的抑制作用不弱于对异位内膜。米非司酮可能通过抑制病灶局部OPN、MMP-9的表达而降低细胞的黏附和侵袭能力。