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首页> 外文期刊>BJOG: an international journal of obstetrics and gynaecology >A randomised trial comparing single dose systemic methotrexate and laparoscopic surgery for the treatment of unruptured tubal pregnancy.
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A randomised trial comparing single dose systemic methotrexate and laparoscopic surgery for the treatment of unruptured tubal pregnancy.

机译：一项随机试验比较了单剂量全身性甲氨蝶呤和腹腔镜手术治疗不破裂输卵管妊娠的疗效。

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OBJECTIVE: To compare single dose systemic methotrexate (50 mg/m2) with laparoscopic surgery for the treatment of unruptured tubal pregnancy. DESIGN: An open, pragmatic, prospective randomised trial. SETTING: Departments of obstetrics and gynaecology at three hospitals in Auckland, New Zealand. PARTICIPANTS: Clinically stable women with an unruptured tubal pregnancy diagnosed by transvaginal ultrasound and quantitative serum beta-hCG measurement. Inclusion criteria included a serum beta-hCG concentration < 5,000 IU/L, and a tubal pregnancy of < 3.5 cm diameter. MAIN OUTCOME MEASURES: Treatment success, physical and psychological functioning, side effects, and subsequent ipsilateral tubal patency. RESULTS: Two hundred and eighteen women with ectopic pregnancies were seen at the three hospitals. 79 women (36% eligibility rate) were eligible for trial entry and 62 women (78% recruitment rate) were recruited. Twenty-six of the 28 women (93%) randomised to laparoscopic surgery required no further treatment, compared with 22 of the 34 women (65%) randomised to methotrexate (95% CI of difference in success rate 10 - 47%; P < 0.01). Two women (7%) in the laparoscopic surgery group had persistent trophoblast. Nine women (26%) in the methotrexate group required more than one dose of methotrexate and five women (15%) underwent laparoscopy during follow up. In the laparoscopy group three women (11%) had negative laparoscopies and two women (7%) had were found to have a ruptured fallopian tube at the time of surgery. Women treated with methotrexate had significantly better objective physical functioning scores but there were no differences in any other psychological outcomes. Women treated with methotrexate experienced greater and more prolonged vaginal bleeding. The likelihood of methotrexate treatment failure was greater at higher serum beta-hCG concentrations. Ipsilateral tubal patency rates were similar in each group. CONCLUSION: This trial shows that in the treatment of tubal pregnancy single dose systemic methotrexate is a less effective treatment than laparoscopic salpingotomy. It is well tolerated, but should only be offered as an alternative to surgery to women who have mild symptoms and present at low serum beta-hCG concentrations. In our population this likely to be no more than a quarter of women presenting with a tubal pregnancy.
机译：目的：比较单剂量全身性甲氨蝶呤（50 mg / m2）与腹腔镜手术治疗不破裂输卵管妊娠的疗效。设计：一项开放，务实，前瞻性随机试验。地点：新西兰奥克兰的三家医院的妇产科。研究对象：经阴道超声和定量血清β-hCG测定诊断为输卵管妊娠未破裂的临床稳定妇女。纳入标准包括血清β-hCG浓度<5,000 IU / L，输卵管妊娠直径<3.5 cm。主要观察指标：治疗成功，生理和心理机能，副作用以及随后的同侧输卵管通畅。结果：在三家医院中发现了218名异位妊娠妇女。有79名妇女（合格率36％）有资格参加试验，并招募了62名妇女（合格率78％）。随机分组接受腹腔镜手术的28名女性中有26名（93％）无需进一步治疗，而随机分组接受甲氨蝶呤的34名女性中有22名（65％）的成功率差异为10％-47％; P <95 0.01）。腹腔镜手术组中有两名妇女（7％）患有持续性滋养细胞。甲氨蝶呤组中有9名妇女（占26％）需要多于一剂甲氨蝶呤，随访期间有5名妇女（占15％）接受了腹腔镜检查。在腹腔镜检查组中，三名女性（11％）腹腔镜检查阴性，而两名女性（7％）在手术时发现输卵管破裂。接受甲氨蝶呤治疗的女性的客观身体机能得分明显更高，但其他任何心理结果均无差异。接受甲氨蝶呤治疗的女性阴道流血的时间越来越长。在较高的血清β-hCG浓度下，甲氨蝶呤治疗失败的可能性更大。每组同侧输卵管通畅率相似。结论：该试验表明，在输卵管妊娠的治疗中，单剂量全身性甲氨蝶呤的治疗效果不及腹腔镜输卵管切开术。它具有良好的耐受性，但仅应作为症状较轻且血清β-hCG浓度低的女性的手术替代品。在我们的人口中，这可能不超过出现输卵管妊娠的妇女的四分之一。

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