米非司酮配伍米索前列醇用作黄体晚期生育调节的临床研究

目的 :探讨米非司酮配伍米索前列醇黄体晚期用作生育调节的有效性、安全性和可接受性。方法 :预期月经来潮前 5日～月经来潮当日开始口服米非司酮 ,2 5 mg,q1 2 h× 4次 ,并于首次用药后48h口服米索前列醇 40 0μg。结果 :共接纳了 61名对象 ,服药周期为 2 67个。共有 1 3个周期妊娠 ,其中 7个周期完全流产 ,6个周期继续妊娠 ,故总妊娠率为 4.87% ( 1 3 / 2 67) ,服药后继续妊娠率为2 .2 5 % ( 6/ 2 67) ,妊娠周期的服药失败率为 46.1 5 % ( 6/ 1 3 )。用药期间 ,月经周期与经期长度均无明显变化。2 67个服药周期中有 1 94个周期按照科研设计服药 ,占 72 .66%。结论 :米非司酮配伍米索前列醇黄体晚期用作生育调节有一定效果 ,但有效性、依从性与可接受性有待进一步提高     

米非司酮配伍米索前列醇用于黄体期避孕的研究

目的　探讨在黄体期无保护性生活后 ,使用米非司酮配伍米索前列醇避孕的效果、副反应和对月经的影响。方法　对因多次无保护性生活或无保护性生活结束超过 12 0h要求紧急避孕的69 9例妇女 ,于预期月经来潮前 10d内服用米非司酮 10 0mg ,并于服用米非司酮 48h后加服米索前列醇 40 0 μg。观察是否妊娠和下次月经的情况。 结果　 699例妇女中失访 1例 ,妊娠 2 5例 ,妊娠率 (即失败率 )为 3 6%。妊娠危险性随性生活次数的增多而增加。 673例妇女月经来潮 ,其中 3 81例( 56 6% )在预期月经日± 3d来潮 ,月经提前或延迟超过 7d者分别占 2 2 %和 8 5%。服药后 1周内的主要副反应为腹泻、腹痛 ( 3 1 1% )和恶心、呕吐 ( 2 0 4% )。结论　在黄体期使用米非司酮配伍米索前列醇 ,是一种可选择的避孕补救方法     

延长米非司酮配伍米索前列醇序贯用药时间预防流产后出血的研究

目的　探讨米非司酮配伍米索前列醇终止早孕的最佳剂量方案 ,以预防流产后出血。方法　对 16 12例妊娠≤ 49天 ,要求药物终止妊娠的妇女 ,按 2∶1随机分为观察组、对照组。观察组1118例 ,米非司酮首次剂量 5 0mg ,继后每 12h 1次 ,每次 2 5mg(共 6d) ,总剂量 30 0mg ,于用药第 3天晨加用米索前列醇 6 0 0 μg,第 4～ 6天晨各加服 2 0 0 μg,总量 12 0 0 μg。对照组 494例 ,米非司酮首次剂量 5 0mg ,继后每 12h 1次 ,每次 2 5mg ,总剂量 15 0mg ,于用药第 3天晨加服米索前列醇 6 0 0 μg。 结果　观察组与对照组完全流产率分别为 98 39%和 88 0 6 % ;不全流产率 1 43 %和 10 73 % ,流产失败率为 0 18%和 1 2 1% (P <0 0 0 0 1)。两组出血时间分别为 (8 2± 2 8)d和 (12 3± 3 9)d(P <0 0 0 1) ,10d内止血率为 87 45 %和 5 7 47% (P <0 0 0 0 1) ,两组副反应比较 ,差异无显著性 (P >0 0 5 )。结论　低剂量分次服用并延长米非司酮并米索前列醇用药时间可提高完全流产率 ,缩短药物流产后出血时间 ,且不增加副反应     

复方米非司酮配伍米索前列醇终止10-16周妊娠的临床疗效比较研究

目的:比较复方米非司酮和米非司酮配伍米索前列醇终止10-16周妊娠的临床疗效。方法:将152例妊娠10-16周因非意愿妊娠要求药物流产的妇女随机分成2个不同的治疗组:单方组76例,米非司酮晨服50mg,晚服25mg,连服2d。d3晨服米索600μg。复方组76例,晨服复方米非司酮片1片(米非司酮30mg/片,双炔失碳酯5mg/片),连服2d,米索服法同单方组。结果:复方组和单方组流产成功率分别为92.10%和89.48%;完全流产率分别为82.89%和78.95%。结论:复方米非司酮配伍米索前列醇口服能安全有效地终止10-16周的妊娠,疗效好,有减少流产后子宫出血量的趋势。且有服药方法简便,米非司酮剂量小等优点。     

不同剂量米非司酮配伍米索前列醇药物流产的研究

目的　探讨米非司酮配伍米索前列醇药物流产的方法 ,以提高药物流产的完全流产率。方法　 2 0 0 0年 7月 1日至 2 0 0 3年 12月 31日解放军 2 0 5医院将 2 0 32例早孕 35～ 4 9d行药物流产的妇女随机分为 4组 :即观察 1组、观察 2组、观察 3组和对照组。对照组 30 0例 ,米非司酮每日 5 0mg顿服连用 3d ,第 3次服药后 2 4h服米索前列醇 6 0 0 μg ;观察 1组 30 0例 ,观察 2组 82 4例 ,观察 3组 6 0 8例 ,米非司酮常规服药 2 4h后分别加服 5 0、75和 10 0mg ,米索前列醇用法同对照组。结果　按照观察 1组、观察 2组、观察 3组及对照组的顺序 ,完全流产率分别为 90 6 7%、99 88%、99 5 1%和 80 6 7%。胎囊排出时间分别为 (5 0 6± 1 5 6 )h、(2 74± 1 2 1)h、(2 6 9±1 19)h和 (6 4 5± 1 36 )h。阴道流血时间分别为 (10 80± 4 2 3)d、(7 81± 3 2 2 )d、(7 90± 2 91)d和 (13 90±5 4 2 )d。观察组完全流产率较高 ,胚囊排出时间和阴道流血时间较短 ,差异有显著性意义 (P <0 0 1)。观察 1组分别与观察 2组、观察 3组比较 ,完全流产率较低 ,胚囊排出时间和阴道流血时间较长 ,差异有显著性意义 (P <0 0 1)。观察 2组与观察 3组相近 ,差异无显著性意义 (P >0 0 5 )。 4组副反应及月经复潮时间     

复方米非司酮配伍米索前列醇终止8-12周妊娠的临床疗效比较研究

目的:探讨复方米非司酮配伍米索前列醇终止8-12周妊娠的临床疗效。方法:将要求终止105例孕8-12周正常或合并高危因素妊娠的早孕妇女随机分为两组:复方组53例,晨服复方米非司酮片1片,qd×2次(总量:米非司酮60mg,双炔失碳酯10mg);单方组52例,口服米非司酮2片,bid×3次(总量:米非司酮150mg),两组均首次服药后48h加服米索前列醇。结果:复方组和单方组流产成功率分别为90.57%(48/53)和86.54%(45/52);完全流产率分别为81.13%(43/53)和75%(39/52)。结论:复方米非司酮配伍喜克馈能安全有效终止8-12周正常或合并高危因素的妊娠,疗效较好,具有米非司酮剂量小,服药简便等优点。     

米非司酮合并米索前列醇催经止孕的临床研究

米非司酮合并米索前列醇催经止孕的临床研究钱美玲，陶承洁，周美蓉（上海市卢湾区妇幼保健院，上海，２０００２０）本研究旨在了解小剂量米非司酮配伍米索前列醉于预期月经来潮前４天至预期月经来潮日及月经延期４天之内口服，用于催经止孕的临床效果及副反应。对象与方...     

降低米非司酮和米索前列醇剂量催经止孕效果观察

目的：观察降低米非司酮与米索前列醇剂量催经止孕的临床效果。方法：将120例闭经时间≤37 d的妇女随机分为2组（各60例）。低剂量组：给予米非司酮100 mg口服,米索前列醇400 μg舌下含服;常规剂量组：给予米非司酮150 mg,米索前列醇600 μg口服。比较给药后2组的完全流产率、出血时间、平均流产时间和不良反应的程度。结果：测定血清人绒毛膜促性腺激素β亚单位（β-hCG）诊断低剂量和常规剂量组分别有3例和2例未妊娠,给药后均引发阴道出血（即月经来潮）。2组完全流产率、出血时间差异无统计学意义（P ＞0.05）;常规剂量组平均流产时间短于低剂量组（P ＜0.05）;低剂量组不良反应发生率低于常规剂量组 （P ＜0.05）。结论：降低米非司酮和米索前列醇剂量用于闭经≤37 d催经止孕可行,且不良反应少。     

黄体早期短程口服小剂量米非司酮用于常规避孕效果及机制分析

目的:研究黄体早期短程小剂量米非司酮用于常规避孕方法的可靠性。方法:选取86例月经周期一贯基本正常,且有正常性生活者,于月经第15天开始口服米非司酮片剂或胶囊试验避孕。以总剂量15~31.25mg为试验剂量,分次服用。分组:6.25mg/d×5d(A组,4例,受试5周期);6.25mg/d×4d(B组,12例,受试54周期);6.25mg/d×3d(C组,10例,受试43周期);5mg/d×3d(D组,60例,受试254周期)。观察避孕效果,并对可能月经滞迟延后者行HCG、B超等检查。结果:A组中,4例次月经推迟7~10天,HCG、B超等检查阴性,有效率100%,月经不正常率80%;B组中,5例次月经推迟5~7天,HCG、B超等检查阴性,有效率100%,月经不正常率9.26%;C组中,全部正常月经周期,月经正常率及避孕成功率均100%;D组中,2例次月经推迟5~7天,HCG、B超等检查阴性,有效率100%,月经不正常率0.78%。4组共获356个受试周期,避孕效果相同,因C、D组对月经几无影响,方案优于A、B组。结论:规律月经黄体早期(分泌期早期)短程小剂量米非司酮(如:5~6.25mg/d×3d)方法有希望试用于常规避孕。     

复方米非司酮与米非司酮用于药物流产临床分析

目的:探讨复方米非司酮用于药物流产的效果。方法:因非意愿妊娠要求行药物流产者随机分为3组,A组:口服复方米非司酮(米非司酮30 mg+双炔失碳酯5 mg),1片/d,qd×2 d,第3日口服米索前列醇0.6 mg;B组:服米非司酮(25 mg/片)1片,bid×3 d,第4日口服米索前列醇0.6 mg;C组:口服米非司酮2片,qd×3 d,第4日口服米索前列醇0.6 mg。结果:A组完全流产率高于B组和C组,孕囊排出时间和完全流产者出血时间A组较B组、C组缩短,差异均有统计学意义(P<0.05)。结论:复方米非司酮用于药物流产成功率高,出血时间短,值得临床广泛使用。     

Efficacy of mifepristone followed on the same day by misoprostol for early termination of pregnancy: report of a randomised trial

Objective To examine the clinical efficacy of mifepristone 600 mg followed on the same day or two days later by misoprostol 400μg orally in women undergoing medical termination of pregnancy whose pregnancies have a gestational age up to 49 days.
Design Prospective, randomised trial.
Setting Clinical research office.
Participants Eighty-six women, requesting elective termination of a pregnancy which has a gestational age of  ≤ 49  days.
Methods After administration of mifepristone 600 mg, participants were randomised to take misoprostol six to eight hours later (Group 1) or 48 hours later (Group 2). Women returned for a follow up evaluation  24±1  hours after taking the misoprostol. Participants in Group 1 who had not aborted received a second dose of misoprostol to take 48 hours after the mifepristone. All women returned approximately two weeks after receiving mifepristone. If termination of pregnancy had still not occurred and the pregnancy was non-viable, the woman returned again in three weeks.
Main outcome measures Rate of complete abortion 24 hours after administration of misoprostol.
Results At 24 hours after receiving misoprostol, 21/42 (50%, 95% CI 35%, 65%) women in Group 1 and 40/44 (91%, 95% CI 82%, 99%) women in Group 2 had complete abortions. By follow up two weeks later after the administration of mifepristone, 40/42 (95%, 95% CI 89%, 100%) women in Group 1 and 43/44 (98%, 95% CI 93%, 99%) women in Group 2 were known to have complete abortions. Nausea, vomiting or diarrhoea in women using the standard regimen (Group 2) occurred in 68%, 36%, and 20%, respectively.
Conclusions After treatment with mifepristone 600 mg, administration of misoprostol  400 μg  orally on the same day is not as effective at causing abortion within the first 24 hours compared with the standard time interval of 48 hours between medications.     

米非司酮配伍米索前列醇终止畸形子宫早孕63例临床分析

目的 :探讨米非司酮配伍米索前列醇终止畸形子宫早孕的临床疗效。方法 :对 6 3例早孕合并畸形的流产病例均采用药物流产方法 ,即 :米非司酮 75mg× 2 (早 50 mg,晚 2 5mg)口服 ,d 3晨空腹服米索前列醇 6 0 0μg。结果 :完全流产率 44 /6 3(6 9.8% ) ,不全流产率 1 7/6 3(2 7.6 % ) ,失败 2 /6 3(3.2 % )。对 1 7例不全流产、2例失败者行刮宫及吸宫术 ,手术操作容易 ,穿孔率及漏吸率为 0。B超用于诊断畸形子宫正确率高。结论 :米非司酮配伍米索前列醇终止畸形子宫早孕的方法较理想 ,B超是诊断子宫畸形较理想的手段     

早孕7-9周药物流产的临床观察

目的:探讨提高孕7-9周药物流产的有效性药物剂量。方法:因非意愿妊娠要求终止早孕的孕7-9周妇女256例,随机分为二组,A组(109例)和B组(147例)。d1-2分别分次口服米非司酮150mg或200mg;d3口服米索前列醇600μg,4h后无论胚囊是否排出,均加服米索400μg。结果:A组完全流产率为91.2%,B组为92.5%,P>0.05。药物流产后阴道出血时间、出血量、转经时间、经期及经量二组均无统计学差异。结论:两种方法的完全流产率均达到90%以上,200mg米非司酮配伍米索前列醇,可能减少孕囊排出时的出血量,对孕7-9周的妇女不失为一种安全的药物流产手段。     

A randomized comparison of mifepristone and self-administered oral or vaginal misoprostol for early abortion

In France, mifepristone in association with orally administered misoprostol is widely used for the early termination of pregnancy (up to 49 days' gestation). In other centers, mifepristone in association with vaginally administered misoprostol has also been used. The aim of the present study was to compare the efficacy and tolerance of mifepristone in association with misoprostol administered orally or vaginally for the termination of pregnancy of up to 49 days' gestation.

A total of 237 women were enrolled in the study. All women received 600 mg mifepristone administered orally and 400 μg misoprostol administered either orally (n = 119) or vaginally (n = 118). A second dose of 400 μg misoprostol was administered if women had not expelled the pregnancy within 3 h. Women were randomized into treatment groups according to the day of their admission.

The overall success rate was 98.7% and there was no significant difference in efficacy between the two groups. There was one treatment failure in the group in which misoprostol was administered orally. Of those women who aborted within 3 h of administration of the first dose of misoprostol, the route of administration of misoprostol did not influence the time to abortion. Of the women who received a second dose of misoprostol, the time to abortion was shorter in those who received misoprostol orally (52 min versus 77 min).

Tolerance was assessed by visual analog scales and was similar for both groups. In both groups, women preferred the oral route of administration.     

Regimens of misoprostol with mifepristone for early medical abortion: a randomised trial

OBJECTIVE: To compare the efficacy, adverse effects and acceptability of the three most common misoprostol regimens used with mifepristone for medical abortion. DESIGN: Randomised nonblinded trial. SETTING: Three clinics associated with major research universities in Canada; two in major urban areas and one in a periurban area. POPULATION: Women of reproductive age. METHODS: Consenting women presenting for abortion services with gestations less than 56 days and who met inclusion criteria were given 200 mg mifepristone orally and then randomised into three misoprostol study groups: (group I) 400 micrograms of oral misoprostol, (group II) 600 micrograms of oral misoprostol, and (group III) 800 micrograms of vaginal misoprostol. Misoprostol was self-administered at home 24-48 hours following mifepristone, and participants were instructed to take a second similar misoprostol dose at 24 hours after the initial dose if bleeding was less than a normal menstrual period. MAIN OUTCOME MEASURES: Successful abortion without surgery was 94.1%, with no significant differences across the three study groups (94.7% in group I, 93.4% in group II, and 94.3% in group III; P= 0.975). RESULTS: Efficacy and adverse effects did not differ significantly across the three study groups. Pain increased significantly across the study and the gestational age groups and was associated with lower acceptability. CONCLUSIONS: There appears to be a range of safe and effective options for early medical abortion with mifepristone including a choice between oral and vaginal administration of misoprostol.     

复方米非司酮对人早孕蜕膜组织雌孕激素受体的影响

观察服用复方米非司酮片 (米非司酮 + AF-5 3)后早孕妇女蜕膜组织雌孕激素受体的变化。 6 0名孕 6～ 7周的妇女被随机分为 6组 ,A组 :对照组 ;B组 :米非司酮 40 mg/次 ;C组 :米非司酮 75 mg/次 ;D组 :复方米非司酮 1片 (米非司酮 2 0 mg+ AF-5 35 mg) ;E组 :复方米非司酮 1片 (米非司酮 30 mg+ AF-5 35 mg) ;F组 :复方米非司酮 1片 (米非司酮40 mg+ AF-5 35 mg)。以上各服药组 ,均为上述剂量每日 1次 ,连服 2日。服药 48h后手术终止妊娠 ,取蜕膜组织 ,放射性配体结合试验测定其胞浆、胞核雌、孕激素受体浓度。结果显示 :复方米非司酮各配伍组均显著降低孕激素受体 (PR) ,升高雌激素受体 (ER) ,改变 ER/PR,促进流产发生。 E组使胞浆雌激素受体 (Ec R)显著高于其它各用药组 ,可能有利于流产后雌激素尽快作用于 ER,促进内膜恢复。结论提示复方米非司酮中米非司酮与AF-5 3配伍具有协同作用 ,改变了雌孕激素受体比例 ,促进流产的发生 ,E组有利于子宫内膜的恢复     

Mifepristone and misoprostol in the induction of labor at term.

OBJECTIVE: To assess the ability of mifepristone to prime the cervix adequately and induce labor in pregnant women at term; and when mifepristone alone proves insufficient, to determine whether oral misoprostol taken 48 h following mifepristone administration is effective in inducing labor. METHODS: In this prospective study 50 pregnant women at term with an unfavorable cervix were given 400 mg of mifepristone orally and allowed to return home. If labor did not start within 48 h, the women were admitted and induction was continued with 50 mug of misoprostol, a prostaglandin (PG) E1 analogue, taken orally every 4 h. The 50 controls, who were matched prospectively for parity and pregnancy duration, underwent labor induction according to the routine administration of 3-mg tablets of PGE2 vaginally. RESULTS: In the study group, 66% of the women entered labor spontaneously or had a sufficiently ripened cervix within 48 h of taking mifepristone. However, there was no difference in time between prostaglandin administration and delivery between the control group and the 34% of women who required misoprostol in the study group. In the study group, the cesarean section rate was significantly lower among the women whose labor was induced with mifepristone alone than among those who required misoprostol. There were no differences overall in obstetric or neonatal outcomes between the study and control groups. CONCLUSIONS: In this pilot sample, 400 mg of mifepristone was effective in inducing cervical changes and labor. Although there were no adverse effects using oral misoprostol in combination with mifepristone, labor was more difficult to induce in the women who did not respond to mifepristone alone, and these women had a higher operative delivery rate.     

Efficacy of concurrent administration of mifepristone and misoprostol for termination of pregnancy

In this prospective randomized parallel group study, subjects with a pregnancy of less than 63 d were randomized to receive either (i) 200?mg oral mifepristone plus 400?μg misoprostol per vaginally concurrently (group A); (ii) or the administration of misoprostol after 48?h (group B). Transvaginal sonography was performed on the 14th day of misoprostol administration to confirm complete abortion. The primary outcome was to compare the rates of complete abortion in two groups. Secondary outcomes were to compare induction abortion interval, side effects and compliance. A total of 200 subjects included in the study were randomized into groups A and B (100 each). Both the groups were comparable for age, parity, gestational age and history of previous abortion. The complete expulsion rate in group A was 96% (95% confidence interval (CI) 95.1–98.2%) and group B was 95% (95% CI 93.0–96.8%) (p?>?0.100). A gestational age of more than 56 d was found to predict failure of treatment in both groups. The adverse effect profile in the two groups was the same. Efficacy of concurrent mifepristone and misoprostol in combination is similar to that when misoprostol is given 48?h later (ctri.nic.in CTRI/2010/091/001422).     

Contragestion with late luteal administration of RU 486 (Mifepristone)

The efficacy and tolerance of RU 486 prescribed as a late luteal contragestive agent have been evaluated in 139 women at risk of pregnancy. They were given 400 or 600 mg of RU 486 once on the day before the expected menses. Among these women, 48 (34.5%) were pregnant (positive plasma beta-human chorionic gonadotropin, [beta-hCG]) at the time of RU 486 intake. Bleeding occurred in all but six women. An ongoing pregnancy after treatment was found in nine cases (failure rate, 9/48, 18.8%), which was subsequently terminated by surgical procedure in all cases. There was no disturbance in the menstrual cycle, and the tolerance was very satisfactory. In conclusion, this method is acceptable for women at risk of pregnancy in whom other usual postcoital contraceptive methods cannot be prescribed.