Department of Obstetrics and Gynecology, Hvidovre Hospital, Hvidovre, Denmark.
Acta Obstet Gynecol Scand. 2009;88(12):1331-7. doi: 10.3109/00016340903188912.
To determine which treatment should be offered to women with a non-ruptured tubal pregnancy: a single dose of methotrexate (MTX) or laparoscopic surgery.
Prospective, randomized, open multicenter study.
Seven Danish departments of obstetrics and gynecology.
A total of 106 women diagnosed with ectopic pregnancy (EP).
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.
Uneventful decline of plasma-human chorionic gonadotropin to less than 5 IU/L, rates of spontaneous, subsequent intrauterine, and recurrent ectopic pregnancies.
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.).
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.
确定应向未破裂输卵管妊娠（EP）的妇女提供哪种治疗方法：单次甲氨蝶呤（MTX）或腹腔镜手术。
前瞻性、随机、开放的多中心研究。
丹麦 7 个妇产科部门。
共 106 名诊断为异位妊娠（EP）的妇女。
1997 年 3 月至 2000 年 9 月，共诊断出 1265 名 EP 妇女，其中 395 名（31%）符合条件，109 名（9%）被随机分配，其中 106 名患有 EP。该研究最初的样本量为 422 名患者。妇女被随机分为药物（MTX；53 例）或手术（腹腔镜输卵管切开术；53 例）治疗组。通过问卷调查和国家患者数据库进行为期最长 10 年的随访。
人绒毛膜促性腺激素（hCG）血浆水平降至 5IU/L 以下，自发、随后的宫内和复发性 EP 的发生率。
MTX 治疗后成功率为 74%，手术治疗后成功率为 87%（无统计学差异）；MTX 治疗后自发宫内妊娠率为 73%，手术治疗后为 62%；MTX 治疗后 EP 发生率为 9.6%，手术治疗后为 17.3%（无统计学差异）。
对于血流动力学稳定且希望保持生育能力的 EP 妇女，单次剂量 MTX 药物治疗在成功率、并发症和随后的生育能力方面与腹腔镜手术治疗相当。虽然这两种治疗方法的结果似乎相似，但关键是诊断基于高质量的超声评估，因为有两名患者尽管符合 EP 的诊断算法，但仍发生了宫内妊娠。
