口服米非司酮预防早孕人流不全的临床研究

目的:探讨早孕人流负压吸引术后口服米非司酮对减少人流不全的作用。方法:3634例因早期妊娠要求行负压吸引术的健康妇女分为对照组1878例,常规负压吸宫;米非司酮组1756例,常规负压吸宫术后当天开始口服米非司酮25mg/×6d。结果:①人流术后再次行刮宫术共26例,发生率为0.72%。其中对照组19例(1.01%);米非司酮组7例(0.39%),组间有显著性差异(P<0.05)。②对照组复刮时刮出物病理检查,可见"绒毛、蜕膜和其他组织,如退变组织、增生期或分泌期内膜组织",但米非司酮组中刮出物未见残留的绒毛组织。③对26例人工不全流产作进一步分析,提示重复人流者有增加人流不全发生的趋势;普通人流者比术中应用麻醉者更易发生人流不全。结论:人流手术最好在孕6-8周进行,尽可能采用无痛人流,术后给予米非司酮口服可预防人流不全,尤其适用于伴有高危因素的人流手术妇女。     

A woman's choice

Abortion is now the most common gynaecological operation in New Zealand and Australia. Early legal abortion is a safe procedure whether carried out surgically or medically. In contrast, the traditional use of abortifacients has been mostly unscientific, illegal and shrouded in secrecy. Mifepristone as an option for induced abortion has only recently become available in New Zealand and is not yet available in Australia. The reasons for the delay in introducing a significant new abortion technique are political, professional, legal, socioeconomic and commercial. Istar, a not-for-profit company, was formed in New Zealand in 1999 to import mifepristone. The drug was approved for use in New Zealand on 30 August 2001. It was first used in October 2001 in Wellington for mid-trimester abortions and in April 2002 for early medical abortions. Legal ambiguities were clarified in a High Court Judgment on 10 April 2003. The experience with mifepristone raises concerns about the introduction of new drugs for reproductive health care, given the commercial risks associated with their development. The Royal Australian and New Zealand College of Obstetricians and Gynaecologists has a role to play in ensuring that safe abortion services are available for women. Advocates of women's rights in reproductive health care have made a significant impact in the last three decades and the conclusion that abortion must be the woman's choice is strongly supported.     

Clinical uses of mifepristone: an update for women's health practitioners

In September 2000, the U.S. Food and Drug Administration (FDA) approved the use of mifepristone for the provision of medical abortion. Although mifepristone was developed and marketed because of its potential to effect early first-trimester medical abortion, it has additional applications to health care, including the treatment of gynecologic conditions, cancer, and Cushing's disease. The controversial nature of abortion has dominated the publicity about mifepristone. The evidence for the safety and efficacy of mifepristone in medical abortion has been overshadowed, and many clinicians are unaware of the other potential uses of the drug. This article provides a discussion of background information on the pharmacology, development of, and research on mifepristone and an update on current and potential uses in health care today. Information on the FDA-approved regimen and alternative protocols for management of mifepristone in its use in abortion care are presented.     

Medical Abortion

Objective: to review medical abortion with emphasis on studies using methotrexate and misoprostol.Data Sources: a MEDLINE search and bibliographies from relevant articles were used. Only studies in English and French with medical abortion using mifepristone, methotrexate and misoprostol were reviewed.Data selection: only studies using mifepristone with 100 or more women were included. All studies using methotrexate and misoprostol alone or in combination were reviewed.Results: in early pregnancy, combinations of mifepristone with prostaglandin or methotrexate with misoprostol are effective for pregnancy termination. When misoprostol is used to augment mifepristone or methotrexate, its vaginal application appears to be superior to the oral route. Vaginal misoprostol (800 μg) is more effective applied five to seven days after the methotrexate than three days after. For inevitable or incomplete abortions, misoprostol alone may be used effectively to avoid surgery. When surgical abortion fails, medical abortion is an excellent back-up treatment.Conclusion: medical abortion with mifepristone or methotrexate plus misoprostol is a safe and effective method of pregnancy termination. Because the complete abortion rate with medical abortion is less than with vacuum aspiration, surgery cannot be completely avoided. Commitment on behalf of both physician and patient is necessary to ensure safety. If mifepristone becomes available in Canada, studies comparing its use to methotrexate will be of paramount importance to help to determine the best method. Further research into medical abortion is important to women’s health as this method is highly acceptable and has the potential to increase access to safe abortion.     

紫草对药物流产临床效果的影响

我们对600例停经42天内的早孕妇女分两组分别应用米非司酮联合紫草配伍米索前列醇及米非司酮配伍米索前列醇进行药物流产,结果表明米非司酮联合紫草组的完全流产率(99.00%)明显高于米非司酮组(92.33%)(P<0.01).前者用米非司酮和紫草后孕囊排出时间(54.01±7.55小时)及服用米索前列醇后6小时内的孕囊排出率(82.33%)较后者(56.41±9.93小时、72.67%)明显缩短和升高(P均小于0.05),且出血时间(7.01±3.11天)和出血时间超过10天的发生率(12.46%)亦较后者(8.09±5.63天,24.91%)明显缩短和减少(P值分别小于0.05和0.01).两组流产后月经转复天数无明显差别(P>0.05).由此可见,紫草可提高米非司酮药物流产的成功率、缩短出血时间,因此有必要对其提高药物流产效果的作用进行进一步的探讨.     

The relationship between spontaneous and induced abortion and the occurrence of second-trimester abortion in subsequent pregnancies

In part I of the present paper an analytic review is presented of the literature on the possible harmful influence of a spontaneous or induced abortion on the course of a subsequent pregnancy.Lack of unanimity proved the most striking result of the analysis. One part of the authors concluded to a relationship between second-trimester abortion and a preceding spontaneous or induced abortion, whereas the others reached a negative result.Since it was thought that the design of all the investigations reviewed showed minor or major deficiencies it was decided to formulate the conditions that must be fulfilled in order to be able to draw valid conclusions on the possible relationship between a second-trimester abortion and a preceding spontaneous or induced first-trimester abortion and to carry out a study that fulfilled the necessary criteria. (The authors should like to stress that the conditions formulated can serve as a model for all investigations that aim at studying the possible relationship between a gestational derangement and a specific disturbance occurring during a preceding pregnancy.) The conditions are that a distinct definition of the disturbances and derangements should be given and strictly adhered to; that the index cases and their controls should be consecutively collected from a clearly defined population; that the induced or spontaneous abortion should immediately precede the second-trimester abortion and that the index cases and their controls should be matched as far as possible (pregnancy order, age at parturition, period of parturition) with exclusion of possible other causes of immature delivery (severe congenital malformations, multiple births, intrauterine infection, uterine anomalies) from the index cases and the controls.After completion of the study a posteriori matching should be carried out to establish whether the frequency of other possible relevant factors differed between index pregnancies and controls.The second part of the present study consists of the investigation of all 87 cases of second-trimester abortion (deliveries at a duration of 112–197 days and/or a birth-weight of less than 1000g) that occurred during a 5-yr period (1973–1977) in the Amsterdam department. Of these 87 deliveries 59 belonged to the category in which the outcome of the delivery under investigation was considered to be related to disturbances observed in the pregnancy itself and not to the preceding pregnancy. In 6 cases the second-trimester abortion was preceded by an induced abortion and in 13 cases by a spontaneous abortion. In 19 cases out of the remaining 28 cases an anomaly in the preceding pregnancy was detected.A control group of 56 pregnancies was composed. Each index case was matched with 2 patients with a similar rank of gestation and with the same maternal age. One of these controls had delivered as near as possible prior to the date of immature delivery of the index case and the other as near as possible after that date. In the control group 3 patients had an induced abortion and 8 a spontaneous abortion in the preceding pregnancy. The difference between the index group and the control group is significant (P < 0.001).Since the possibility had to be taken into account that the relationship between a spontaneous abortion and an induced abortion and the outcome of a subsequent pregnancy are not similar, both groups were separately investigated with the exclusion of the other index cases and their controls. Of 15 second-trimester abortions not preceded by a spontaneous abortion 6 underwent an induced abortion prior to the pregnancy as compared to 3 in the 30 controls (P 0.04). Of the 22 pregnancies not preceded by an induced abortion, 13 had had a spontaneous abortion prior to the present pregnancy as compared to 8 in the 44 controls (P 0.003).It is concluded that a relationship, presumably of a cause-effect nature, exists between an induced abortion and a second-trimester abortion in a subsequent pregnancy. The relationship between a spontaneous abortion and a second-trimester abortion in a subsequent pregnancy is far more significant. In the latter cases an inherent fetal, idiopathic wastage syndrome is thought to be present causing both the first- and the second-trimester abortion.     

Current and potential methods for second trimester abortion

Medical and surgical methods can both be recommended for second trimester abortion (after 12-weeks of gestational age). Induced abortion with a mifepristone and misoprostol regimen is the preferred approach; where mifepristone is not available, misoprostol alone for medical abortion is also effective. Dilation and evacuation (D&E) is the procedure of choice for surgical abortions, and adequate cervical preparation contributes significantly to safety. Availability of drugs and instruments, ability to provide pain control, provider skill and comfort, client preference, cultural considerations, and local legislation all influence the method of abortion likely to be performed in a given setting. Both surgical and modern medical methods are safe and effective when provided by a trained, experienced provider.     

Accounting for time: insights from a life-table analysis of the efficacy of medical abortion

OBJECTIVE: Previously published analyses have ignored the temporal nature of medical abortion and calculated effectiveness as the proportion of abortions that succeed. By using life tables, we incorporate the important element of time to produce unbiased efficacy rates as well as afford insight into the medical abortion process. STUDY DESIGN: Using data on 6568 women from 6 previously published mifepristone-misoprostol medical abortion studies, we generated multidecrement life table efficacy curves and evaluated the cumulative probability of successful medical abortion. RESULTS: Efficacy rates calculated using proportions are biased because of loss to follow-up. Compliance with the medical abortion regimen was high. More than 80% of abortions were complete within a week of receiving mifepristone. Success continued to improve thereafter. Most surgical interventions were unnecessary. CONCLUSION: Follow-up visits can be scheduled within a week of receiving mifepristone; however, aspirations should not be performed routinely if the abortion is not complete.     

Mifepristone followed by home administration of buccal misoprostol for medical abortion up to 70 days of amenorrhoea in a general practice in Curaçao

Objective?To evaluate the efficacy and safety of home administration of buccal misoprostol after mifepristone for medical abortion up to 70 days' gestation in a general practice in Curaçao, where induced abortion is severely restricted by law.

Methods?In a prospective study 330 women received 200?mg mifepristone and were instructed to take four tablets (800?μg) of misoprostol via the buccal route 24–36?h later, at home. One week later, follow-up took place.

Results?The outcome could be evaluated in 307 of the 330 women. The efficacy of the mifepristone-buccal misoprostol procedure was 97.7% (300/307). In seven women vacuum aspirations for continuing pregnancy or incomplete abortion following treatment were required. Success rates at 64–70 days' gestation were the same as for gestations of less than 64 days duration. The main adverse effects were nausea and diarrhoea.

Conclusion?Home administration of buccal misoprostol 24–36?h after mifepristone is a safe and effective method of medical abortion up to 70 days. It could be applied in a general practice in Curaçao, where induced abortion is legally restricted.     

Home abortion implies radical changes for women

Objective?To gain knowledge about women's experiences, views and reactions regarding having a home abortion (medical abortion with the use of misoprostol at home).

Methods?One hundred women were interviewed one week post-abortion; this yielded both quantitative and qualitative data.

Results?The overwhelming majority of the women experienced wellbeing and were satisfied with their choice of abortion method. They appreciated the privacy and the comfort of being at home which also allowed the presence of a partner. The intake of mifepristone at the clinic was described by many in existential terms as an emotionally charged act, experienced by some as more difficult than expulsion at home. However, relief was the predominant emotional feeling during the expulsion day. Most women did not find it especially dramatic to see and handle the products of conception although some felt uncomfortable at the sight.

Conclusion?Given that they choose this method themselves and are well informed, women are able to handle the abortion process by themselves outside a clinical setting. The option to choose home abortion implies a radical change in empowerment for women. Also allowing them the possibility to take mifepristone at home would increase their privacy and personal integrity even more.     

Acceptability and feasibility of 400 μg buccal misoprostol after 200 mg mifepristone for early medical abortion in Georgia

Objectives: The aim of the study was to examine the acceptability and feasibility of early medical abortion using 200?mg mifepristone and 400?μg buccal misoprostol in Georgia, outside the capital city of Tbilisi.

Methods: A total of 622 women in four regions of western and eastern Georgia who presented for termination of pregnancy at up to 63?d of gestation were enrolled in the study. In the western regions, women took one 200?mg pill of mifepristone in the clinic and were given the option of administering 400?μg misoprostol buccally, either at the clinic or at home, 24–48?h later. In the eastern region, women were given the option to take both drugs at home. Abortion status was determined 2 weeks after mifepristone administration.

Results: Ninety-five percent of participants had a successful abortion. Twenty-one percent of women in the eastern region elected to take mifepristone at home; nearly all participants in both regions (98%) chose to take misoprostol at home. Ninety-five percent of women were very satisfied or satisfied with the method, and 95% said they would prefer medical abortion for a future procedure.

Conclusions: Medical abortion with mifepristone and 400?μg buccal misoprostol is an acceptable and feasible option for women in Georgia, outside the capital city of Tbilisi.     

米非司酮配伍米索前列醇治疗稽留流产的疗效分析

目的 探讨米非司酮配伍米索前列醇治疗稽留流产的临床疗效.方法 选取66例稽留流产患者,采用随机数字表法分为对照组与试验组,各33例.对照组给予米非司酮50 mg治疗3 d后配伍米索前列醇600 μg治疗,试验组给予米非司酮50 mg治疗1d后,增加75 mg米非司酮用药1 d后配伍米索前列醇600 μg治疗.比较两组临...     

剖宫产后早孕药流及重复药流213例临床分析

研究目的 :研究停经 70 d以内的剖宫产后早孕药流及重复药流的安全性、有效性。对象和方法 :剖宫产后早孕对象 2 1 3例 ,其中 6 3例为剖宫产后第 2次要求药流的早孕对象 ,停经 34～ 6 9d,口服米非司酮 2 5 mg q1 2 h× 5次 ,首次计量 5 0 mg(总量 1 5 0 mg) ,d3上午来院加服米索前列醇 6 0 0μg。结果 :完全流产率 92 .5 % ,不全流产率 4.7% ,失败率2 .8%。结论 :口服米非司酮合并米索前列醇能有效地终止剖宫产后早孕包括重复药流对象的早孕 ,其效果与一般人群药流效果相似 ,其安全性、有效性令人满意。此外 ,由于用药后宫颈软化 ,宫口扩张 ,即使药流失败 ,也易于吸宫术的施行 ,减轻受术者的痛苦     

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.     

剖宫产后早孕药物流产加服米非司酮的临床观察

目的:探讨剖宫产后早孕药物流产加服米非司酮是否能提高完全流产率。方法:剖宫产后再次妊娠(停经≤49 d)行药物流产的孕妇240例,随机分为研究组和对照组。对照组120例,米非司酮75 mg/d(早50 mg,晚25 mg)连用2 d,第3日口服米索前列醇600μg;研究组120例,在对照组的基础上,服用米索前列醇后加服米非司酮25 mg,bid×3 d。结果:研究组和对照组的完全流产率分别为92.50%和73.33%,差异有统计学意义(P<0.01),阴道流血时间分别为11.0±4.0 d和14.7±5.4 d,差异有统计学意义(P<0.01)。结论:剖宫产后早孕药物流产加服米非司酮25 mg,bid×3 d,可提高完全流产率,缩短阴道流血时间。     

米非司酮配伍前列腺素抗早孕效果影响因素的探讨

目的:探讨国产米非司酮配伍前列腺素抗早孕效果的影响因素。方法:将500例分为两组,一组用米非司酮25mg,每日2次,连服3d,第4天上午阴道塞卡前列腺素栓(15-甲基PGF_(2a)酸)1mg(简称卡前列素栓组)。另一组米非司酮的用法及剂量与前一组同,第4天上午口服米索前列醇0.6mg(简称米索组)。结果:米索组完全流产率为93.2%,明显高于卡前列素栓组的88.4%(P<0.05)。米索组的流产效果受服药者年龄、既往人工流产次数、用药前胚囊平均直径与血β-hCG水平的影响较卡前列素栓组小。结论:米非司酮配伍米索前列醇是方便、有效、副作用小的抗早孕方法。用药后2w测定β-hCG值结合B超检查可用于监测药物流产效果,有实用价值。     

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.     

米非司酮配伍米索前列醇终止10～16周妊娠的临床多中心随机比较性研究

目的探索米非司酮合并米索前列醇（米索）终止１０～１６周妊娠最佳剂量及最佳给药途径。方法将来自上海２４所医院的２００７例孕１０～１６周要求药物终止妊娠的妇女,随机分成４种不同的治疗组。组Ⅰ：５１１例,米非司酮７５ｍｇ每天１次,连服２天（总量１５０ｍｇ）,第３天晨口服米索０．６ｍｇ,每３～４小时重复１次,最多３次;组Ⅱ：４９１例,米非司酮１００ｍｇ每天１次,连服２天（总量２００ｍｇ）,米索用法同组Ⅰ;组Ⅲ：５１９例,米非司酮用法同组Ⅰ,第３天晨阴道内放置米索０．６ｍｇ,每１２小时重复１次,最多３次;组Ⅳ：４８６例,米非司酮用法同组Ⅱ,米索用法同组Ⅲ。结果４组２４小时内的流产成功率分别为８８．６％、８９．４％、９０．９％和９４．０％。组Ⅳ的成功率明显高于组Ⅰ和组Ⅱ。２４小时内流产成功者米索的用量,阴道给药者比口服给药者明显减少（Ｐ＜０．００１）,胃肠道副反应发生率也明显降低（Ｐ＜０．０５）。结论口服米非司酮２００ｍｇ合并阴道放置米索,是较好的药物终止１０～１６周妊娠的方法,可作为一种常规方法推荐在临床应用。     

Early IUD insertion after medically induced abortion

Objective: There is insufficient evidence on the continuation, safety and acceptability of immediate insertion of the intrauterine device (IUD) after medical abortion. The objective of the present study was to evaluate clinical outcomes of early IUD insertion, compared with those of delayed IUD insertion, following medical abortion.

Methods: Women undergoing medical abortion with mifepristone and misoprostol up to 49 days’ gestation and opting for Copper T 380A IUD contraception underwent early (5–14 days after mifepristone) or delayed insertion (3–4 weeks after mifepristone). The primary outcome measure was 6 month IUD continuation rate after medical abortion. Secondary outcome measures included user acceptability and safety.

Results: Between October 2015 and October 2016, post-medical abortion IUD insertion was performed in 120 eligible women fulfilling the inclusion and exclusion criteria. There was no statistically significant difference in the continuation rates of the early and delayed IUD insertion groups at 6 months (76.7 versus 83.3%, p?=?.75). The 6 month IUD expulsion rates were 6.7 and 3.3% in the early and delayed insertion groups, respectively (p?=?.56). There were 10 (16.7%) removals in the early and eight (13.3%) in the delayed insertion groups (p?=?.77). Level of satisfaction with postabortal IUD use was comparable in both groups. Adverse events were rare and did not differ significantly between the two groups.

Conclusion: We demonstrated high continuation rates, safety and acceptability of early IUD insertion after medical abortion.