Lecuru F, Robin F, Bernard J P, Maizan de Malartic C, Mac-Cordick C, Boucaya V, Taurelle R
Service de Gynécologie-Obstétrique, Hôpital Boucicaut, Paris, France.
Int J Gynaecol Obstet. 1998 Jun;61(3):253-9. doi: 10.1016/s0020-7292(98)00038-1.
To compare the effectiveness of single-dose methotrexate (MTX) and laparoscopic salpingostomy in the treatment of unruptured ectopic pregnancy (UEP).
75 patients entered a prospective non-randomized study. Thirty-seven women were submitted to a single-dose methotrexate (Group 1) and 38 underwent laparoscopic salpingostomy (Group 2). Methotrexate (1 mg/kg) was given intramuscularly on an out-patient basis if the beta-hCG level was < 5000 IU/I and the hematosalpinx diameter was < 3 cm and the peritoneal fluid < 300 cm3 on TVS. The follow-up consisted of serial clinical examinations, beta-hCG assays, liver tests and blood cell counts. Laparoscopic salpingostomy was decided in other cases of UEP or when patients refused or could not comply with the follow-up.
Group 1 patients (91.8%) were cured with 1-3 doses of MTX, the remainder required a laparoscopy. Seventy-three percent of them were treated on an out-patient basis. The mean time to resolution of hCG was 26.7 days. The initial beta-hCG level significantly correlated with the necessity of a surgical option and the time to resolution of beta-hCG. Whenever beta-hCG was < 3600 IU/l, all patients were cured with a single injection, without hospitalization and with a follow-up of < 27 days. Group 2 patients (81.6%) were cured with laparoscopy and 15.8% required a MTX injection for persistent EP. The mean hospital stay was significantly longer than for those that required the MTX injection (2.7 vs. 0.6; P = 0.0001), but the follow-up was shorter and required significantly less clinical examinations, sonograms and biologic tests. Finally the effectiveness of single-dose MTX and laparoscopic salpingostomy were similar (P = 0.2, 95% CI of the difference: -0.15-0.04).
Single-dose MTX was as effective as laparoscopy in the treatment of UEP. A rigorous selection of the patients for the treatment option is mandatory to guarantee high success rates, in an out-patient basis and a short follow-up.
比较单剂量甲氨蝶呤(MTX)与腹腔镜输卵管造口术治疗未破裂异位妊娠(UEP)的效果。
75例患者进入一项前瞻性非随机研究。37名女性接受单剂量甲氨蝶呤治疗(第1组),38名接受腹腔镜输卵管造口术(第2组)。如果β - hCG水平<5000 IU/I,输卵管积血直径<3 cm,经阴道超声检查(TVS)显示腹腔积液<300 cm³,则在门诊给予甲氨蝶呤(1 mg/kg)肌内注射。随访包括系列临床检查、β - hCG检测、肝功能检查和血细胞计数。其他UEP病例或患者拒绝或无法配合随访时则决定行腹腔镜输卵管造口术。
第1组患者中91.8%经1 - 3剂MTX治愈,其余患者需要进行腹腔镜检查。其中73%在门诊接受治疗。hCG降至正常的平均时间为26.7天。初始β - hCG水平与手术治疗的必要性及β - hCG降至正常的时间显著相关。当β - hCG<3600 IU/l时,所有患者单次注射即可治愈,无需住院,随访时间<27天。第2组患者中81.6%经腹腔镜检查治愈,15.8%因持续性异位妊娠需要注射MTX。平均住院时间明显长于接受MTX注射的患者(2.7天对0.6天;P = 0.0001),但随访时间较短,所需的临床检查、超声检查和生物学检测明显较少。最后,单剂量MTX与腹腔镜输卵管造口术的效果相似(P = 0.2,差异的95%可信区间:-0.15 - 0.04)。
单剂量MTX在治疗UEP方面与腹腔镜检查效果相同。为保证高成功率,必须对治疗方案的患者进行严格筛选,在门诊治疗并缩短随访时间。