摘要
目的探讨氟脲苷+放线菌素D+依托泊苷+长春新碱(FAEV)方案相比依托泊苷+甲氨蝶呤+放线菌素D/环磷酰胺+长春新碱(EMA/CO)方案用于有高危因素的妊娠滋养细胞肿瘤(gestational trophoblastic neoplasm,GTN)患者初始治疗的疗效和安全性。方法采用前瞻性随机对照研究,2015年5月1日至2016年12月31日期间在北京协和医院纳入39例GTN初治患者,其中FAEV组18例,EMA/CO组21例,随访至2017年6月1日,比较两组患者的治疗结局、随访结局和副反应。结果两组患者的基线特征差异无统计学意义。FAEV组患者达到完全缓解(CR)所需疗程数[(3.72±1.93)个]和总疗程数[(6.28±1.41)个]均少于EMA/CO组[(6.04±2.16)、(8.52±1.99)个](P均<0.001)。两组患者初始治疗CR率(94.4%vs.81.0%,P=0.349)、包含挽救化疗后CR率(94.4%vs.95.2%,P=1.000)及化疗总周数(18.22周vs.17.67周,P=0.747)差异无统计学意义。两组副反应及严重程度差异无统计学意义。结论 FAEV方案可以作为GTN患者尤其是有高危因素GTN患者的一线治疗方案选择之一。
Objective To compare the efficacy and safety between FAEV (floxuridine, actinomycin D, etoposide, and vincristine) regimen and EMA/CO (etoposide, methotrexate, actinomyein D/cyclophosphamide, vincristine) regimen using as primary chemotherapy for patients with gestational trophoblastic neoplasm (GTN)with high-risk factors.Methods In this randomized controlled trial, we enrolled 39 patients with GTN who had no chemotherapy history in Peking Union Medical College Hospital from May 1st, 2015 to December 31st, 2016.Patients were randomly assigned to take FAEV (n=18)or EMA/CO (n=21)regimen.The follow-up lasted until June 1st, 2017, and treatment outcome, follow-up outcome and adverse event of two groups were compared.Results There was no statistical difference in baseline characteristics of patients between FAEV and EMA/CO group.Treatment courses needed to achieve complete remission (CR) (3.72± 1.93) and total treatment courses (6.28± 1.41) of FAEV group were both fewer than those of EMA/CO group [ (6.04±2.16) and ( 8.52±1.99), both P〈0.001 ].CR rates of primary treatment (94.4% vs. 81.0%, P=0.349), CR rates of treatment including salvage therapy (94.4% vs. 95.2%, P= 1.000)and total chemotherapy weeks (18.22 weeks vs. 17.67 weeks, P=0.747)of FAEV and EMA/CO group had no statistical difference.There was no statistical difference in adverse event or severity between FAEV and EMA/CO group.Conclusion FAEV regimen could be a first-line choice for patients with GTN, especially for high-risk patients.
作者
计鸣良
蒋诗阳
赵峻
向阳
万希润
冯凤芝
任彤
杨隽钧
JI Ming-liang;JIANG Shi-yang;ZHAO Jun;XIANG Yang;IVAN Xi-run;FENG Feng-zhi;REN Tong;YANG Jun-jun.(Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Beijing 100730, China)
出处
《中国实用妇科与产科杂志》
CAS
CSCD
北大核心
2018年第4期419-424,共6页
Chinese Journal of Practical Gynecology and Obstetrics