米非司酮药物流产中米索前列醇两种不同口服途径：一项随机对照试验。
Two distinct oral routes of misoprostol in mifepristone medical abortion: a randomized controlled trial.
作者信息
Winikoff Beverly, Dzuba Ilana G, Creinin Mitchell D, Crowden William A, Goldberg Alisa B, Gonzales Juliana, Howe Michelle, Moskowitz Jeffrey, Prine Linda, Shannon Caitlin S
机构信息
From the Gynuity Health Projects, New York, New York; Magee Womens Hospital/University of Pittsburgh, Pittsburgh, Pennsylvania; Planned Parenthood of Waco, Waco, Texas; Planned Parenthood League of Massachusetts, Boston, Massachusetts; Whole Woman's Health, Austin, Texas; Family Planning Associates Medical Group, Chicago, Illinois; Parkmed, New York, New York; and Institute for Urban Family Health, New York, New York.
出版信息
Obstet Gynecol. 2008 Dec;112(6):1303-1310. doi: 10.1097/AOG.0b013e31818d8eb4.
OBJECTIVE
To study the efficacy, safety, and acceptability of oral immediately swallowed and buccal misoprostol 800 mcg after mifepristone 200 mg for terminating pregnancy through 63 days since the last menstrual period (LMP).
METHODS
This seven-site study randomly assigned 966 women seeking abortions to oral or buccal misoprostol 800 mcg 24-36 hours after mifepristone 200 mg with 7-14-day follow-up.
RESULTS
Success rates in the oral and buccal groups were 91.3% (389 of 426) and 96.2% (405 of 421), respectively (P=.003; relative risk [RR] 0.95, 95% confidence interval [CI] 0.92-0.98). Ongoing pregnancy occurred in 3.5% (15 of 426) of women who took oral misoprostol compared with 1.0% (4 of 421) of women in the buccal group (P=.012; RR 3.71, 95% CI 1.24-11.07). Through 49 days since the LMP, oral and buccal regimens performed similarly, but success with oral misoprostol decreased as pregnancy advanced. In pregnancies of 57-63 days since the LMP, success with oral misoprostol fell below 90%, whereas that with buccal remained high (oral 85.1% [97 of 114], buccal 94.8% [109 of 115], P=.015, RR 0.90, 95% CI 0.82-0.98). Furthermore, in this gestational age group, there were significantly more ongoing pregnancies among women who took misoprostol orally (7.9% [9 of 114]) compared with buccally (1.7% [2 of 115]; P=.029, RR 4.54, 95% CI 1.0-20.55). Adverse effect profiles were similar, although fever and chills were reported approximately 10% more often among women who took buccal misoprostol. Satisfaction and acceptability were high for both methods.
CONCLUSION
Buccal misoprostol 800 mcg after mifepristone 200 mg is a good option for medical abortion through 63 days since the LMP. Oral misoprostol 800 mcg is also a safe and effective alternative, although success rates diminish with increasing gestational age.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00386867
LEVEL OF EVIDENCE
I.
目的
研究在末次月经（LMP）后63天内，服用200mg米非司酮后口服即刻吞咽及口腔含服800μg米索前列醇终止妊娠的有效性、安全性及可接受性。
方法
这项在七个地点开展的研究将966名寻求堕胎的女性随机分为两组，在服用200mg米非司酮24 - 36小时后，分别给予口服或口腔含服800μg米索前列醇，并进行7 - 14天的随访。
结果
口服组和口腔含服组的成功率分别为91.3%（426例中的389例）和96.2%（421例中的405例）（P = 0.003；相对危险度[RR]0.95，95%置信区间[CI]0.92 - 0.98）。口服米索前列醇的女性中有3.5%（426例中的15例）持续妊娠，而口腔含服组为1.0%（421例中的4例）（P = 0.012；RR 3.71，95%CI 1.24 - 11.07）。在LMP后的49天内，口服和口腔含服方案效果相似，但随着孕周增加，口服米索前列醇的成功率下降。在LMP后57 - 63天的妊娠中，口服米索前列醇的成功率低于90%，而口腔含服的成功率仍较高（口服85.1%[114例中的97例]，口腔含服94.8%[115例中的109例]，P = 0.015，RR 0.90，95%CI 0.82 - 0.98）。此外，在这个孕周组中，口服米索前列醇的女性中持续妊娠的比例显著高于口腔含服者（7.9%[114例中的9例]对比1.7%[115例中的2例]；P = 0.029，RR 4.54，95%CI 1.0 - 20.55）。不良反应情况相似，尽管报告显示口腔含服米索前列醇的女性出现发热和寒战的频率约高10%。两种方法的满意度和可接受性都很高。
结论
在LMP后63天内，服用200mg米非司酮后口腔含服800μg米索前列醇是药物流产的一个好选择。口服800μg米索前列醇也是一种安全有效的替代方法，尽管成功率会随着孕周增加而降低。
临床试验注册
ClinicalTrials.gov，www.clinicaltrials.gov，NCT00386867
证据级别
I
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