Barnhart Kurt, Hummel Amy C, Sammel Mary D, Menon Seema, Jain John, Chakhtoura Nahida
Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and Infertility, University of Pennsylvania Medical Center, Philadelphia, Pennsylvania 19104, USA.
Fertil Steril. 2007 Feb;87(2):250-6. doi: 10.1016/j.fertnstert.2006.06.054. Epub 2006 Nov 13.
To evaluate the safety and acceptability of a novel dosing regimen of methotrexate to treat ectopic pregnancy.
Prospective study.
Three academic medical centers.
PATIENT(S): One hundred one patients with ectopic pregnancy who elected to have medical therapy.
INTERVENTION(S): Intramuscular methotrexate 50 mg/m(2) was administered on days 0 and 4; additional doses of methotrexate were given on day 7 and/or day 11 if hCG levels did not decrease by 15% during the follow-up period.
MAIN OUTCOME MEASURE(S): Adverse events, acceptability, and resolution of pregnancy without surgical treatment.
RESULT(S): With this protocol, 87% of patients were treated successfully. Of those protocols that were considered failures, only 3% of patients experienced rupture of ectopic pregnancy. Treatment was well-tolerated; most side effects were reported as mild and transient. Ninety-one percent of the 61.5% of patients who responded to the satisfaction questionnaire reported satisfaction with this regimen.
CONCLUSION(S): This "2-dose" protocol minimizes the number of injections and surveillance visits, compared with the "multiple dose" regimen, and methotrexate is administered more frequently than with the "single dose" regimen. The protocol may optimize the balance between convenience and efficacy. In a limited number of women, no safety concerns were noted with up to 4 doses of methotrexate in a 2-week period without leucovorin rescue.
评估一种新型甲氨蝶呤给药方案治疗异位妊娠的安全性和可接受性。
前瞻性研究。
三个学术医疗中心。
101例选择药物治疗的异位妊娠患者。
在第0天和第4天肌内注射甲氨蝶呤50mg/m²；如果在随访期间hCG水平未下降15%，则在第7天和/或第11天给予额外剂量的甲氨蝶呤。
不良事件、可接受性以及无需手术治疗的妊娠结局。
采用该方案，87%的患者治疗成功。在那些被认为治疗失败的方案中，只有3%的患者发生异位妊娠破裂。治疗耐受性良好；大多数副作用报告为轻度且短暂。在对满意度问卷作出回应的患者中，61.5%的患者中有91%报告对该方案满意。
与“多剂量”方案相比，这种“2剂量”方案减少了注射次数和监测就诊次数，且甲氨蝶呤的给药频率高于“单剂量”方案。该方案可能优化了便利性和疗效之间的平衡。在少数女性中，在2周内给予多达4剂甲氨蝶呤且未进行亚叶酸解救时，未发现安全问题。
