Actinomycin D Versus Methotrexate-Folinic Acid as the Treatment of Stage I, Low-Risk Gestational Trophoblastic Neoplasia A Randomized Controlled Trial
Actinomycin D Versus Methotrexate-Folinic Acid as the Treatment of Stage I, Low-Risk Gestational Trophoblastic Neoplasia A Randomized Controlled Trial
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DOI：
10.1111/igc.0b013e3181a8333d
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发表时间：
2009-07-01
影响因子：
4.8
通讯作者：
Tangtrakul, Somsak
中科院分区：
文献类型：
--
作者：
Lertkhachonsuk, Arb-aroon;Israngura, Nathpong;Tangtrakul, Somsak
本研究旨在比较放线菌素 D (Act-D) 和甲氨蝶呤-亚叶酸 (MTX-FA) 单药治疗 I 期低危妊娠滋养细胞肿瘤 (GTN) 的缓解率和并发症率。从1994年到2005年，所有国际妇产科联合会I期、低风险GTN的女性被随机分配接受静脉注射Act-D 10 μg/kg每天，每两周5天，或在第1、3、5和7天肌肉注射甲氨蝶呤1 mg/kg每天，并在第2天肌肉注射亚叶酸0.1 mg/kg每天，每两周 4、6 和 8 次。四十九名女性符合资格标准。两个治疗组的年龄、人绒毛膜促性腺激素水平和国际妇产科联合会评分相似。在接受 Act-D 的 22 名女性中，有 2 名失访。在接受 MTX-FA 的 27 名女性中，有 2 名患者失访，6 名患者由于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%) 均获得缓解，而 MTX-FA 组的 19 名女性中有 14 名 (73.6%) 获得缓解 (P = 0.02)。 Act-D 组更常见粘膜炎和脱发，而 MTX-FA 组更常见肝酶水平升高。放线菌素 D 在治疗 1 期低风险 GTN 方面似乎比 MTX-FA 更有效。应进行更大规模的多中心随机对照试验，以确定最适合这些患者的治疗方案。
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 mu g/kg per day for 5 days every 2 weeks or intramuscular methotrexate 1 mg/kg per day oil days 1, 3, 5, and 7 with intramuscular folinic acid 0.1 mg/kg per day oil 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 1, low-risk GTN. Larger Multicenter randomized controlled trials Should be conducted to establish the most appropriate regimen for these patients.