机构地区:[1]东南大学医学院附属徐州市中心医院放疗科,江苏221009
出 处:《中华妇幼临床医学杂志(电子版)》2016年第6期644-650,共7页Chinese Journal of Obstetrics & Gynecology and Pediatrics(Electronic Edition)
基 金:江苏省自然科学基金项目(BK20151157);江苏省"六大人才高峰"高层次人才选拔培养资助项目(2014-WSN-069)~~
摘 要:目的探讨雷替曲塞联合顺铂同步放化疗,治疗中晚期宫颈癌的临床疗效和安全性。方法选择2011年1月至2012年12月,东南大学医学院附属徐州市中心医院放疗科收治的80例中晚期宫颈癌患者为研究对象。采用信封法,将其随机分为RP组(n=40,接受雷替曲塞联合顺铂同步放化疗方案治疗)与TP组(n=40,接受紫杉醇联合顺铂同步放化疗方案治疗)。RP组具体化疗方案为:雷替曲塞3mg/m^2,静脉滴注15min,d1;顺铂60mg/m^2,静脉滴注60min,d1。TP组具体化疗方案为:紫杉醇135mg/m^2,静脉滴注180min,d1;顺铂60mg/m^2,静脉滴注60min,d2。统计学比较2组患者治疗有效率、不良反应率、总生存(OS)率及无病生存(DFS)率。本研究经过本院伦理委员会审核通过,所有患者均签署知情同意书。结果①2组患者的年龄、Karnofsky行为状态(KPS)评分、体重下降百分比、肿瘤最大直径、病理类型、国际妇产科联盟(FIGO)临床分期等基本临床资料比较,差异均无统计学意义(P>0.05)。②RP组和TP组治疗有效率分别为92.5%(38/40)与90.0%(36/40),二者比较,差异无统计学意义(χ2=0.734,P=0.675)。③RP组骨髓抑制、皮疹、脱发、肌肉和关节酸痛、外周神经炎发生率分别为62.5%(25/40)、12.5%(5/40)、30.0%(12/40)、5.0%(2/40)、10.0%(4/40),均分别显著低于TP组的82.5%(33/40)、35.0%(14/40)、80.0%(32/40)、25.0%(10/40)、32.5%(13/40),并且差异均有统计学意义(χ~2=4.013,P=0.045;χ~2=5.591,P=0.018;χ~2=20.202,P<0.001;χ~2=6.275,P=0.012;χ~2=6.050,P=0.014)。2组患者恶心、呕吐、腹泻、食欲下降、肝功能损害发生率比较,差异均无统计学意义(P>0.05)。④2组患者OS曲线、DFS曲线分别比较,差异无统计学意义(χ~2=0.930,P=0.330;χ~2=0.780,P=0.380)。结论雷替曲塞联合顺铂同步放化疗,治疗中晚期宫颈癌安全、有效,其疗效与紫杉醇联合顺铂同步放化疗疗效相近,但导致的不良反应更少。Objective To investigate the efficacy and safety of concurrent chemoradiatherapy with raltitrexed and cisplatin in treatment of patients with moderate and advanced cervical cancer. Methods From January 2011 to December 2012, a total of 80 patients with moderate and advanced cervical cancer were selected as research subjects and they were randomly assigned to RP group (n= 40, received concurrent chemoradiatherapy with raltitrexed and cisplatin treatment) and TP group (n=40, received concurrent chemoradiatherapy with paclitaxel and cisplatin treatment) by envelope method. The chemotherapy regimen of RP group was as follows., raltitrexed 3 mg/m2 intravenous drip 15 min on day 1, and cisplatin 60 mg/m2 intravenous drip 60 min on day 1. The chemotherapy regimen of TP group was as follows: paclitaxel 135 mg/m2 intravenous drip 180 min on day 1, and cisplatin 60 mg/m2 intravenous drip 60 min on day 2. The effective rate, adverse reactions rate, and overall survival (OS) rate and disease free survival (DFS) rate were observed and compared by statistical methods between two groups. This study was approved by the ethics committee of our hospital, and all patients signed the informed consent. Results (1) There were no significant differences between two groups in the age, Karnofsky performance status (KPS) score, body weight loss ratio, the maximum diameter of tumor, pathological type, Federation International of Gynecology and Obstetrics (FIGO) stage (P〉0.05).(2)The effective rates in RP group and TP group were 92.5% (38/40) and 90% (36/40), respectively, and there was no significant difference between them (x2=0. 734, P=0. 675). (3)The incidences of myelosuppression, rash, alopecia, muscle and joint pain, peripheral neuritis in RP group were 62.5% (25/40), 12.5% (5/40), 30.0% (12/40), 5.0% (2/40), 10. 0% (4/40), respectively, and they were significantly lower than those in TP group 82.5% (33/40), 35.0% (14/40), 80.0% (32/40), 25.0%
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