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中絶問題研究者~中絶ケア・カウンセラーの塚原久美のブログです

ゲメプロスト(プレグランディン)は頸管拡張においてもミソプロストールに劣る

Cochrane Database Syst Rev. 2010 Feb 17;(2):CD007207.

Cervical preparation for first trimester surgical abortion

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Cochrane Database Syst Rev
. 2010 Feb 17;(2):CD007207. doi: 10.1002/14651858.CD007207.pub2.
Cervical preparation for first trimester surgical abortion
Nathalie Kapp 1, Patricia A Lohr, Thoai D Ngo, Jennifer L Hayes
Affiliations expand
PMID: 20166091 DOI: 10.1002/14651858.CD007207.pub2
Abstract
Background: Preparing the cervix prior to surgical abortion is intended to make the procedure both easier and safer. Options for cervical preparation include osmotic dilators and pharmacologic agents. Many formulations and regimens are available, and recommendations from professional organizations vary for the use of preparatory techniques in women of different ages, parity or gestational age of the pregnancy.

Objectives: To determine whether cervical preparation is necessary in the first trimester, and if so, which preparatory agent is preferred.

Search strategy: We searched Cochrane, Popline, Embase, Medline and Lilacs databases for randomised controlled trials investigating the use of cervical preparatory techniques prior to first trimester surgical abortion. In addition, we hand-searched key references and contacted authors to locate unpublished studies or studies not identified in the database searches.

Selection criteria: Randomised controlled trials investigating any pharmacologic or mechanical method of cervical preparation, with the exception of nitric oxide donors (the subject of another Cochrane review), administered prior to first trimester surgical abortion were included. Outcome measures must have included the amount of cervical dilation achieved, the procedure duration or difficulty, side-effects, patient satisfaction or adverse events to be included in this review.

Data collection and analysis: Trials under consideration were evaluated by considering whether inclusion criteria were met as well as methodologic quality. Fifty-one studies were included, resulting in 24 different cervical preparation comparisons. Results are reported as odds ratios (OR) for dichotomous outcomes and weighted mean differences for continuous data.

Main results: When compared to placebo, misoprostol (400-600 microg given vaginally or sublingually), gemeprost, mifepristone (200 or 600 mg), prostaglandin E and F(2alpha) (2.5 mg administered intracervically) demonstrated larger cervical preparation effects. When misoprostol was compared to gemeprost, misoprostol was more effective in preparing the cervix and was associated with fewer gastrointestinal side-effects. For vaginal administration, administration 2 hours prior was less effective than administration 3 hours prior to the abortion. Compared to oral misoprostol administration, the vaginal route was associated with significantly greater initial cervical dilation and lower rates of side-effects; however, sublingual administration 2-3 hours prior to the procedure demonstrated cervical effects superior to vaginal administration.When misoprostol (600 microg oral or 800 microg vaginal) was compared to mifepristone (200 mg administered 24 hours prior to procedure), misoprostol had inferior cervical preparatory effects. Compared to day-prior laminaria tents, 200 or 400 microg vaginal misoprostol showed no differences in the need for further mechanical dilation or length of the procedure; similarly, the osmotic dilators Lamicel and Dilapan showed no differences in cervical ripening when compared to gemeprost, although gemeprost had cervical effects which were superior to laminaria tents. Older prostaglandin regimens (sulprostone, prostaglandin E(2) andF(2alpha)) were associated with high rates of gastrointestinal side-effects and unplanned pregnancy expulsions. Few studies reported women's satisfaction with cervical preparatory techniques.

Authors' conclusions: Modern methods of cervical ripening are generally safe, although efficacy and side-effects between methods vary. Reports of adverse events such as cervical laceration or uterine perforation are uncommon overall in this body of evidence and no published study has investigated whether cervical preparation impacts these rare outcomes. Cervical preparation decreases the length of the abortion procedure; this may become increasingly important with increasing gestational age, as mechanical dilation at later gestational ages takes longer and becomes more difficult. These data do not suggest a gestational age where the benefits of cervical dilation outweigh the side-effects, including pain, that women experience with cervical ripening procedures or the prolongation of the time interval before procedure completion. Mifepristone 200 mg, osmotic dilators and misoprostol, 400microg administered either vaginally or sublingually, are the most effective methods of cervical preparation.

仮訳

主な結果
 プラセボと比較すると、ミソプロストール(400~600μgを経膣または舌下投与)、ゲメプロストミフェプリストン(200または600mg)、プロスタグランジンEおよびF(2α)(2.5mgを静脈内投与)はより大きな子宮頚管準備効果を示した。ミソプロストールとゲメプロストを比較すると、ミソプロストールは子宮頸管の準備効果が高く、胃腸の副作用が少なかった。経膣投与の場合、中絶の2時間前の投与は、3時間前の投与よりも効果が低くなっています。ミソプロストールの経口投与と比較して、経膣投与は初期子宮頸管拡張が有意に大きく、副作用の発生率が低いことに関連しています。しかし、手術の2〜3時間前に舌下投与すると、経膣投与よりも優れた子宮頸管効果を示しました。ミソプロストール(600μg経口または800μg膣)とミフェプリストン(200mg、手続きの24時間前に投与)を比較すると、ミソプロストールには子宮頸管準備作用が劣ることがわかりました。前日のラミナリアテントと比較して、ミソプロストール200または400マイクログラム膣剤は、さらなる機械的拡張の必要性や手術の長さに差がありませんでした。同様に、浸透圧拡張剤のラミセルとディラパンは、ゲメプロストと比較して、子宮頸部成熟に差がありませんでしたが、ゲメプロストはラミナリアテントよりも優れた子宮頸部作用を有しています。古いプロスタグランジンレジメン(スルプロストン、プロスタグランジンE(2)、F(2α))は、胃腸の副作用と計画外妊娠排出率が高いことと関連していた。子宮頸管準備手技に対する女性の満足度を報告した研究はほとんどない。


著者らの結論
 現代の子宮頸管熟成法は、方法によって効果や副作用が異なるが、一般的に安全である。子宮頸管裂傷や子宮穿孔などの有害事象の報告は、この一連のエビデンスでは全体的にまれであり、子宮頸管準備術がこれらのまれな結果に影響するかどうかを調べた発表研究はない。子宮頸管準備によって中絶手術の時間が短くなります。妊娠期間が長くなると機械的な拡張に時間がかかり、難しくなるため、このことは妊娠期間が長くなるにつれてますます重要になる可能性があります。これらのデータは、子宮頸管拡張の利点が、女性が子宮頸管熟成術で経験する痛みなどの副作用や処置完了までの時間間隔の延長を上回る妊娠年齢を示唆するものではありません。ミフェプリストン200mg、浸透圧性拡張剤、ミソプロストール400μgを経膣または舌下投与することが、子宮頸管準備の最も効果的な方法とされています。