每周奈达铂对比每周顺铂用于宫颈癌术后同步放化疗的随机对照试验  

Weekly nedaplatin versus weekly cisplatin as postoperative concurrent chemoradiotherapy after radical surgery for cervical cancer: a randomized controlled trial

作　　者：肖丽华[1] 黄碧芬 郑建清[1] 陈明芬[1] 苏菁菁[1] 吴敏[1] XIAO Lihua;HUANG Bifen;ZHENG Jianqing;CHEN Mingfen;SU Jingjing;WU Min(Department of Radiation Oncology, the Second Affiliated Hospital of Fujian Medical University, Quanzhou, 362000, P.R.China;Department of Obstetrics and Gynecology, Quanzhou Medical College People's Hospital Affiliated, Quanzhou, 362000, P.R.China)

机构地区：[1]福建医科大学附属第二医院放射治疗科,福建泉州362000 [2]福建泉州医学高等专科学校附属人民医院妇产科,福建泉州362000

出　　处：《中国循证医学杂志》2019年第4期381-386,共6页Chinese Journal of Evidence-based Medicine

基　　金：福建医科大学附属第二医院苗圃基金(编号:2013MP16)

摘　　要：目的 探讨每周奈达铂同步化疗对比每周顺铂用于宫颈癌术后辅助治疗的疗效和安全性。方法 本研究自2013年6月至2017年1月在福建医科大学附属第二医院放疗科实施,在取得知情同意后将200例ⅠB1～ⅡB期术后宫颈癌患者随机分为奈达铂组和顺铂组。奈达铂和顺铂化疗用量均为35～40 mg/m^2,每周1次,共5次。放疗技术采用调强放射治疗技术或三维适形放射治疗技术,比较两组的无进展生存率、总生存率和不良反应情况。统计分析采用SPSS 24.0软件进行。结果 奈达铂组入组105例,顺铂组95例。奈达铂组和顺铂组3年无进展生存率为80.5%vs. 79.5%,差异无统计学意义(χ~2=0.198,P=0.656)。奈达铂组和顺铂组3年总生存率分别为72.5%vs. 69.9%,差异无统计学意义(χ~2=0.261,P=0.609)。奈达铂组3/4级恶心呕吐发生率为6.67%,显著低于顺铂组的15.79%,差异有统计学意义(χ~2=2.555,P=0.011);但奈达铂组3/4级血小板减少发生率为9.52%,显著高于顺铂组的3.15%,差异有统计学意义(χ~2=1.985,P=0.047)。两组贫血、白细胞减少、放射性直肠炎等不良反应发生率无统计学差异。结论 基于奈达铂的同步放化疗用于宫颈癌术后的辅助治疗,其疗效不劣于顺铂,且奈达铂组的消化道反应明显减少,可作为顺铂的替代药物。Objectives To compare the efficacy and safety of weekly nedaplatin compared with weekly cisplatin as postoperative concurrent chemoradiotherapy scheme for cervical cancer patients.Methods This trial was performed in the Department of Radiation Oncology in the Second Affiliated Hospital of Fujian Medical University from June2016to January2017.A total of200patients with stageⅠB1-ⅡB cervical cancer were randomly assigned to the nedaplatin group and the cisplatin group after signing informed content.The dose of nedaplatin or cisplatin ranged35to40mg/m^2,once a week for5weeks.Intensity-modulated radiation therapy or three-dimensional conformal radiation therapy were used for patients.The progression-free survival,overall survival and adverse reactions were compared between two groups.Statistical analysis was performed by SPSS24.0software.Results A total of105patients were enrolled in the nedaplatin group,and95patients were in cisplatin group.The three-year progression-free survival rate was80.5%vs.79.5%in the nedaplatin group and the cisplatin group,respectively;and no statistical significant difference was found(χ^2=0.198,P=0.656)between two groups.The3-year overall survival rates were72.5%and69.9%for the nedaplatin group and the cisplatin group,respectively,and there was no significant difference between the two groups(χ^2=0.261,P=0.609).The incidence of grade3/4nausea and vomiting in the nedaplatin group was6.67%,which was significantly lower than that of15.79%in the cisplatin group,and statistical significant difference was found(χ^2=2.555,P=0.011);however,the incidence of grade3/4thrombocytopenia in the nedaplatin group was9.52%,which was significantly higher than that in the cisplatin group(3.15%);and the difference was statistically significant(χ^2=1.985,P=0.047).There was no difference in the incidence of adverse reactions such as anemia,neutropenia,and radiological proctitis in both groups.Conclusions Nedaplatin-based concurrent chemoradiotherapy has similar efficacy compared to cisplatin-based concur

关 键 词：宫颈癌 化学治疗 奈达铂 随机对照试验 

分 类 号：R737.33[医药卫生—肿瘤]