今日の臨床サポート

異所性妊娠

著者: 明樂重夫 明理会東京大和病院

監修: 金山尚裕 静岡医療科学専門大学校

著者校正済:2022/09/14
現在監修レビュー中
患者向け説明資料

概要・推奨   

薬剤監修について:
オーダー内の薬剤用量は日本医科大学付属病院 薬剤部 部長 伊勢雄也 以下、林太祐、渡邉裕次、井ノ口岳洋、梅田将光による疑義照会のプロセスを実施、疑義照会の対象については著者の方による再確認を実施しております。
※薬剤中分類、用法、同効薬、診療報酬は、エルゼビアが独自に作成した薬剤情報であり、 著者により作成された情報ではありません。
尚、用法は添付文書より、同効薬は、薬剤師監修のもとで作成しております。
※同効薬・小児・妊娠および授乳中の注意事項等は、海外の情報も掲載しており、日本の医療事情に適応しない場合があります。
※薬剤情報の(適外/適内/⽤量内/⽤量外/㊜)等の表記は、エルゼビアジャパン編集部によって記載日時にレセプトチェックソフトなどで確認し作成しております。ただし、これらの記載は、実際の保険適応の査定において保険適応及び保険適応外と判断されることを保証するものではありません。また、検査薬、輸液、血液製剤、全身麻酔薬、抗癌剤等の薬剤は保険適応の記載の一部を割愛させていただいています。
(詳細はこちらを参照)
著者のCOI(Conflicts of Interest)開示:
明樂重夫 : 特に申告事項無し[2022年]
監修:金山尚裕 : 特に申告事項無し[2022年]

改訂のポイント:
  1. 定期レビューを行った(変更なし)。

病態・疫学・診察

疾患情報(疫学・病態)  
  1. 妊卵が子宮内腔以外の場所に着床して起こる妊娠をいい、全妊娠の約1.5~2%に発生をみる。
  1. 妊卵の着床部位により、卵管(采部、膨大部、峡部、間質部)、卵巣、腹腔、頸管に分類される。図にそれぞれの部位と全異所性妊娠に対する頻度を示す。
 
異所性妊娠の妊卵着床部位による分類とその頻度

異所性妊娠は着床部位により分類される。なかでも卵管膨大部妊娠が最も多い。

 
  1. 超音波検査で、妊娠にもかかわらず子宮内に胎嚢が認められないことで見つかることが多い。
  1. 初期は無症状だが、多くは妊娠5~8週頃までに流産または破裂の転機をとり、性器出血や下腹部痛が出現する。
  1. 進行すると急性腹症、出血性ショックを呈し、妊娠初期にみられる代表的な緊急疾患の1つである
  1. 女性が腹痛や不正出血を訴える場合、あるいは一般状態不良で救急搬送されてきた場合はまず本症を疑い、妊娠反応を行う。
  1. 診断には経腟エコーと血中ヒト絨毛性ゴナドトロピン(human chorionic gonadotropin、hCG)の組み合わせが有用である。
  1. 外科的治療、特に腹腔鏡手術が有効だが、初期にはメトトレキサート(MTX)も用いられる。
  1. 症状、妊娠部位、妊娠週数、血中hCG値により、治療方針を決定する。
問診・診察のポイント  
問診:
  1. 妊娠の有無、性器出血や下腹部痛の有無と程度を確認する。

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文献 

P J Hajenius, F Mol, B W J Mol, P M M Bossuyt, W M Ankum, F van der Veen
Interventions for tubal ectopic pregnancy.
Cochrane Database Syst Rev. 2007 Jan 24;(1):CD000324. doi: 10.1002/14651858.CD000324.pub2. Epub 2007 Jan 24.
Abstract/Text BACKGROUND: Treatment options for tubal ectopic pregnancy are; (1) surgery, e.g. salpingectomy or salpingo(s)tomy, either performed laparoscopically or by open surgery; (2) medical treatment, with a variety of drugs, that can be administered systemically and/or locally by various routes and (3) expectant management.
OBJECTIVES: To evaluate the effectiveness and safety of surgery, medical treatment and expectant management of tubal ectopic pregnancy in view of primary treatment success, tubal preservation and future fertility.
SEARCH STRATEGY: The Cochrane Menstrual Disorders and Subfertility Group's Specialised Register, Cochrane Controlled Trials Register (up to February 2006), Current Controlled Trials Register (up to October 2006), and MEDLINE (up to October 2006) were searched.
SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing treatments in women with tubal ectopic pregnancy.
DATA COLLECTION AND ANALYSIS: Data extraction and quality assessment was done independently by two reviewers. Differences were resolved by discussion with all reviewers.
MAIN RESULTS: Thirty five studies have been analysed on the treatment of tubal ectopic pregnancy, describing 25 different comparisons.
SURGERY: Laparoscopic salpingostomy is significantly less successful than the open surgical approach in the elimination of tubal ectopic pregnancy (2 RCTs, n=165, OR 0.28, 95% CI 0.09, 0.86) due to a significant higher persistent trophoblast rate in laparoscopic surgery (OR 3.5, 95% CI 1.1, 11). However, the laparoscopic approach is significantly less costly than open surgery (p=0.03). Long term follow-up (n=127) shows no evidence of a difference in intra uterine pregnancy rate (OR 1.2, 95% CI 0.59, 2.5) but there is a non significant tendency to a lower repeat ectopic pregnancy rate (OR 0.47, 95% 0.15, 1.5). Salpingostomy alone is significantly less successful than when combined with a prophylactic single shot methotrexate (2 RCTs, n=163, OR 0.25, 95% CI 0.08-0.76) to prevent persistent trophoblast.
MEDICAL TREATMENT: Systemic methotrexate in a fixed multiple dose intramuscular regimen has a non significant tendency to a higher treatment success than laparoscopic salpingostomy (1 RCT, n=100, OR 1.8, 95% CI 0.73, 4.6). No significant differences are found in long term follow-up (n=74): intra uterine pregnancy (OR 0.82, 95% CI 0.32, 2.1) and repeat ectopic pregnancy (OR 0.87, 95% CI 0.19, 4.1). One single dose intramuscular methotrexate is significantly less successful than laparoscopic salpingostomy (4 RCTs, n=265, OR 0.38, 95% CI 0.20, 0.71). With a variable dose regimen treatment success rises, but shows no evidence of a difference compared to laparoscopic salpingostomy (OR 1.1, 95% CI 0.52, 2.3). Long term follow-up (n=98) do not differ significantly (intra uterine pregnancy OR 1.0, 95% CI 0.43, 2.4, ectopic pregnancy OR 0.54, 95% CI 0.12, 2.4). The efficacy of systemic single dose methotrexate alone is significantly less successful than when combined with mifepristone (2 RCTs, n=262, OR 0.59, 95% CI 0.35, 1.0). The same goes for the addition of traditional Chinese medicine (1 RCT, n=78, OR 0.08, 95% CI 0.02, 0.39). Local medical treatment administered transvaginally under ultrasound guidance is significantly better than a 'blind' intra-tubal injection under laparoscopic guidance in the elimination of tubal ectopic pregnancy (1 RCT, n=36, methotrexate OR 5.8, 95% CI 1.3, 26; 1 RCT, n=80, hyperosmolar glucose OR 0.38, 95% CI 0.15, 0.93). However, compared to laparoscopic salpingostomy, local injection of methotrexate administered transvaginally under ultrasound guidance is significantly less successful (1 RCT, n=78, OR 0.17, 95% CI 0.04, 0.76) but with positive long term follow up (n=51): a significantly higher intra uterine pregnancy rate (OR 4.1, 95% CI 1.3, 14) and a non significant tendency to a lower repeat ectopic pregnancy rate (OR 0.30, 95% CI 0.05, 1.7). EXPECTANT MANAGEMENT: Expectant management is significantly less successful than prostaglandin therapy (1 RCT, n=23, OR 0.08, 95% CI 0.02-0.39).
AUTHORS' CONCLUSIONS: In the surgical treatment of tubal ectopic pregnancy laparoscopic surgery is a cost effective treatment. An alternative nonsurgical treatment option in selected patients is medical treatment with systemic methotrexate. Expectant management can not be adequately evaluated yet.

PMID 17253448
F Mol, B W Mol, W M Ankum, F van der Veen, P J Hajenius
Current evidence on surgery, systemic methotrexate and expectant management in the treatment of tubal ectopic pregnancy: a systematic review and meta-analysis.
Hum Reprod Update. 2008 Jul-Aug;14(4):309-19. doi: 10.1093/humupd/dmn012. Epub 2008 Jun 2.
Abstract/Text BACKGROUND: To evaluate the effectiveness of surgery, medical treatment and expectant management of tubal ectopic pregnancy (EP) in terms of treatment success (i.e. complete elimination of trophoblast tissue), financial costs and future fertility.
METHODS: We searched for randomized controlled trials which described treatment interventions that have been widely adopted in clinical practice. A systemic literature search identified 15 trials.
RESULTS: Laparoscopic salpingostomy was significantly less successful than the open surgical approach (relative risk, RR 0.9, 95% CI 0.82-0.99) due to a higher persistent trophoblast rate, but was significantly less costly. A prophylactic single shot methotrexate (MTX), given intramuscularly (i.m.) immediately post-operatively, significantly reduced persistent trophoblast after laparoscopic salpingostomy (RR 0.89, 95% CI 0.82-0.98, number needed to treat of 10). With systemic MTX in a fixed multiple dose i.m. regimen the likelihood of treatment success was higher than with laparoscopic salpingostomy (RR 1.15, 95% CI 0.93-1.43), but the difference was not significant. Systemic MTX in a fixed multiple dose i.m. regimen was only cost-effective if serum human chorionic gonadotrophin (hCG) concentrations were <3000 IU/l. If serum hCG concentrations were <1500 IU/l, then the single-dose MTX i.m. regimen-if necessary with additional MTX injections-was also cost-effective. Expectant management could not be evaluated yet. Subsequent fertility did not differ between the interventions studied.
CONCLUSIONS: This meta-analysis shows that laparoscopic surgery is the most cost-effective treatment for tubal EP. Systemic MTX is a good alternative in selected patients with low serum hCG concentrations.

PMID 18522946
Lars Bo Krag Moeller, Charlotte Moeller, Sten Grove Thomsen, Lars Franch Andersen, Lene Lundvall, Øejvind Lidegaard, Jens Joergen Kjer, Jens Lindgren Ingemanssen, Vibeke Zobbe, Charlotte Floridon, Janne Petersen, Bent Ottesen
Success and spontaneous pregnancy rates following systemic methotrexate versus laparoscopic surgery for tubal pregnancies: a randomized trial.
Acta Obstet Gynecol Scand. 2009;88(12):1331-7. doi: 10.3109/00016340903188912.
Abstract/Text OBJECTIVE: To determine which treatment should be offered to women with a non-ruptured tubal pregnancy: a single dose of methotrexate (MTX) or laparoscopic surgery.
DESIGN: Prospective, randomized, open multicenter study.
SETTING: Seven Danish departments of obstetrics and gynecology.
SAMPLE: A total of 106 women diagnosed with ectopic pregnancy (EP).
METHODS: Between March 1997 and September 2000, 1,265 women were diagnosed with EP, 395 (31%) were eligible, 109 (9%) were randomized of whom 106 had an EP. The study was originally powered to a sample size of 422 patients. The women were randomized to either medical (MTX; 53) or surgical (laparoscopic salpingotomy; 53) treatment. Follow-up by questionnaire and through national patient databases for a maximum of 10 years.
MAIN OUTCOME MEASURES: Uneventful decline of plasma-human chorionic gonadotropin to less than 5 IU/L, rates of spontaneous, subsequent intrauterine, and recurrent ectopic pregnancies.
RESULTS: The success rates were 74% following MTX treatment and 87% after surgery (n.s.); the subsequent spontaneous intrauterine pregnancy rate was 73% after MTX and 62% after surgery; and the EP rate was 9.6% after MTX and 17.3% following surgery (n.s.).
CONCLUSIONS: In women with an EP, who are hemodynamically stable and wishing to preserve their fertility, medical treatment with single dose MTX tends to be equal to treatment with laparoscopic surgery regarding success rate, complications, and subsequent fertility. Although the two treatment modalities seemed to be similar in outcome, it is crucial that the diagnosis is based on a high-quality ultrasonographic evaluation, as two patients had intrauterine pregnancies despite fulfilling the diagnostic algorithm for EP.

PMID 19961341
G H Lipscomb, M L McCord, T G Stovall, G Huff, S G Portera, F W Ling
Predictors of success of methotrexate treatment in women with tubal ectopic pregnancies.
N Engl J Med. 1999 Dec 23;341(26):1974-8. doi: 10.1056/NEJM199912233412604.
Abstract/Text BACKGROUND: The use of methotrexate for the treatment of women with tubal ectopic pregnancies is now common practice. However, the clinical and hormonal determinants of the success of this treatment are not known.
METHODS: We studied 350 women with tubal ectopic pregnancies who were treated with methotrexate intramuscularly according to a single-dose protocol. Pretreatment serum concentrations of human chorionic gonadotropin and progesterone, the size and volume of the gestational mass, fetal cardiac activity, and the presence of fluid (presumably blood) in the peritoneal cavity were correlated with the efficacy of therapy, as defined by resolution of the ectopic pregnancy without the need for surgical intervention.
RESULTS: There was no relation between the women's age or parity, the size or volume of the conceptus, or the presence of fluid in the peritoneal cavity and the efficacy of treatment. Among the 320 women in whom treatment was successful (91 percent), the mean (+/-SD) serum chorionic gonadotropin and progesterone concentrations were 4019+/-6362 mIU per milliliter and 6.9+/-6.7 ng per milliliter (21.9+/-21.3 nmol per liter), respectively, as compared with 13,420+/-16,590 mIU per milliliter and 10.2+/-5.5 ng per milliliter (32.4+/-17.5 nmol per liter) (P<0.001 and P=0.02) in the 30 women in whom treatment was not successful. Fetal cardiac activity was present in 12 percent of the successfully treated cases and 30 percent of those in which treatment was not successful (P=0.01). Regression analysis revealed the pretreatment serum chorionic gonadotropin concentration to be the only factor that contributed to the failure rate.
CONCLUSIONS: Among women with tubal ectopic pregnancies, a high serum chorionic gonadotropin concentration is the most important factor associated with failure of treatment with a single-dose methotrexate protocol.

PMID 10607814

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