Darai E, Benifla J L, Naouri M, Pennehouat G, Guglielmina J N, Deval B, Filippini F, Crequat J, Madelenat P
Department of Obstetrics and Gynaecology, Hôpital Bichat, Paris, France.
Hum Reprod. 1996 Feb;11(2):420-4. doi: 10.1093/humrep/11.2.420.
Between November 1988 and December 1993, 100 patients with a common, unruptured ectopic pregnancy were treated with 1 mg/kg injection of intratubal methotrexate under transvaginal sonographic control. Patients were not excluded from this series on the basis of the size of the adnexal mass, the term of ectopic pregnancy or initial beta-human chorionic gonadotrophin (HCG) concentrations. Patients were excluded following uncertain diagnosis, signs of a ruptured ectopic pregnancy, or a significant haemoperitoneum on ultrasound scans. The mean age of the patients was 29.5 years (range 20-41). The mean gestational age and initial HCG concentration were 7.5 weeks (5-11) and 11,614 mIU/ml (192-105,000 respectively). Of the 100 patients, 22 (22%) had an ectopic pregnancy with active cardiac activity. Complete resolution was obtained in 78 out of these 100 ectopic pregnancies. Of these, 66 patients (85%) needed only one intratubal methotrexate injection, and 12 patients (15%) required a second i.m. methotrexate injection of 1 mg/kg. In this study, local treatment with one single intratubal methotrexate injection was successful in only 66% of patients. The mean resolution time for reduction of beta-HCG concentrations was 23.5 days (range 7-40). There was no statistically significant correlation between initial beta-HCG concentrations and outcomes after methotrexate treatment of ectopic pregnancy in our study. Where embryonal heart beats were observed, the success rate of the procedure was 40.9% (nine out of 22 cases). In the absence of cardiac activity, or when ultrasound examination showed no embryo, the success rate achieved was 84.6% (66 out of 78 cases) (P < 0.01). In all, 34 patients were considered to be incompletely cured after only one intratubal methotrexate injection: 12 patients required a second i.m. injection, a stagnation of beta-HCG concentrations was observed in 15 patients, abdominal pain occurred in six patients, and one patient suffered tubal rupture with haemoperitoneum. A total of 22 patients required secondary surgical management (salpingectomy). No biochemical or clinical side-effects of methotrexate treatment occurred. Tubal alteration ascribable to methotrexate injection occurred in one patient in our study. Out of 75 patients in this series who wished to conceive, 21 (28%) became pregnant within 1 year with the following outcomes: 11 pregnancies at term, three miscarriages, one induced abortion and six recurrent ectopic pregnancies (four occurred on the same side). Our findings suggest that treatment of common unruptured ectopic pregnancy without prior selection of patients, by a single intratubal methotrexate administration was associated with a 66% success rate. This was dependent only on the presence of embryonal heart beats and there was no correlation between the success rate and initial beta-HCG concentrations. Successful outcome after methotrexate administration for ectopic pregnancy could be perfected by way of an improved selection of patients based on inactive embryonal hearts and absence of a visualized embryo.
1988年11月至1993年12月期间,100例常见的未破裂异位妊娠患者在经阴道超声引导下接受了1mg/kg输卵管内注射甲氨蝶呤治疗。本研究系列未根据附件包块大小、异位妊娠孕周或初始β-人绒毛膜促性腺激素(HCG)浓度排除患者。诊断不明确、有异位妊娠破裂体征或超声检查发现大量腹腔积血的患者被排除在外。患者的平均年龄为29.5岁(范围20 - 41岁)。平均孕周和初始HCG浓度分别为7.5周(5 - 11周)和11,614mIU/ml(192 - 105,000)。在这100例患者中,22例(22%)异位妊娠伴有胎心活动。这100例异位妊娠中有78例完全消退。其中,66例患者(85%)仅需一次输卵管内甲氨蝶呤注射,12例患者(15%)需要第二次1mg/kg的肌肉注射甲氨蝶呤。在本研究中,单次输卵管内注射甲氨蝶呤局部治疗仅在66%的患者中成功。β-HCG浓度降低的平均消退时间为23.5天(范围7 - 40天)。在我们的研究中,异位妊娠甲氨蝶呤治疗后初始β-HCG浓度与治疗结果之间无统计学显著相关性。观察到有胚胎心跳时,该治疗方法的成功率为40.9%(22例中的9例)。在无心跳活动或超声检查未显示胚胎时,成功率为84.6%(78例中的66例)(P < 0.01)。总共有34例患者在仅一次输卵管内甲氨蝶呤注射后被认为未完全治愈:12例患者需要第二次肌肉注射,15例患者观察到β-HCG浓度停滞,6例患者出现腹痛,1例患者发生输卵管破裂并伴有腹腔积血。共有22例患者需要二次手术治疗(输卵管切除术)。未发生甲氨蝶呤治疗的生化或临床副作用。在本研究中,1例患者出现了归因于甲氨蝶呤注射的输卵管改变。在本系列75例希望怀孕的患者中,21例(28%)在1年内怀孕,结果如下:11例足月妊娠,3例流产,1例人工流产,6例复发性异位妊娠(4例发生在同一侧)。我们的研究结果表明,对常见的未破裂异位妊娠患者不进行预先筛选,单次输卵管内注射甲氨蝶呤治疗的成功率为66%。这仅取决于胚胎心跳的存在,成功率与初始β-HCG浓度之间无相关性。基于胚胎心跳不活跃和未可视化胚胎对患者进行改进筛选,可提高甲氨蝶呤治疗异位妊娠的成功结局。