Lertkhachonsuk Arb-Aroon, Israngura Nathpong, Wilailak Sarikapan, Tangtrakul Somsak
Department of Obstetrics and Gynaecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
Int J Gynecol Cancer. 2009 Jul;19(5):985-8. doi: 10.1111/IGC.0b013e3181a8333d.
This study is to compare the remission and complication rates of actinomycin D (Act-D) and methotrexate-folinic acid (MTX-FA) as single-agent treatments of stage I, low-risk gestational trophoblastic neoplasia (GTN). From 1994 to 2005, all women with International Federation of Gynecology and Obstetrics stage I, low-risk GTN were randomly assigned to received either intravenous Act-D 10 microg/kg per day for 5 days every 2 weeks or intramuscular methotrexate 1 mg/kg per day on days 1, 3, 5, and 7 with intramuscular folinic acid 0.1 mg/kg per day on days 2, 4, 6, and 8 every 2 weeks. Forty-nine women met the eligibility criteria. Age, human chorionic gonadotropin level, and International Federation of Gynecology and Obstetrics score were similar in both treatment groups. Of the 22 women who received Act-D, 2 were lost to follow-up. Among the 27 women who received MTX-FA, 2 were lost to follow-up, and 6 had to switch to Act-D because of the rising levels of liver enzymes. All 20 women (100%) in the Act-D arm achieved remission compared with 14 (73.6%) in 19 women in the MTX-FA arm (P = 0.02). Mucositis and alopecia were reported more frequently in the Act-D group, whereas elevations of liver enzyme levels were more frequent in the MTX-FA group. Actinomycin D seems to be more effective than MTX-FA in the treatment of stage I, low-risk GTN. Larger multicenter randomized controlled trials should be conducted to establish the most appropriate regimen for these patients.
本研究旨在比较放线菌素D(Act-D)与甲氨蝶呤-亚叶酸(MTX-FA)作为单药治疗Ⅰ期低危妊娠滋养细胞肿瘤(GTN)的缓解率和并发症发生率。1994年至2005年,所有国际妇产科联盟(FIGO)Ⅰ期低危GTN患者被随机分配,每2周接受一次以下治疗:静脉注射Act-D,每日10μg/kg,共5天;或在第1、3、5和7天肌肉注射甲氨蝶呤,每日1mg/kg,同时在第2、4、6和8天肌肉注射亚叶酸,每日0.1mg/kg。49名女性符合入选标准。两个治疗组的年龄、人绒毛膜促性腺激素水平和FIGO评分相似。在接受Act-D治疗的22名女性中,2名失访。在接受MTX-FA治疗的27名女性中,2名失访,6名因肝酶水平升高而不得不改用Act-D。Act-D组的所有20名女性(100%)均实现缓解,而MTX-FA组19名女性中的14名(73.6%)实现缓解(P = 0.02)。Act-D组黏膜炎和脱发的报告更为频繁,而MTX-FA组肝酶水平升高更为频繁。放线菌素D在治疗Ⅰ期低危GTN方面似乎比MTX-FA更有效。应开展更大规模的多中心随机对照试验,以确定这些患者最合适的治疗方案。