紫杉醇脂质体联合铂类同步放化疗治疗宫颈癌的随机对照研究  

A randomized controlled trial of two chemotherapy regimens （paclitaxel liposome combined with platinum and paclitaxel combined with platinum ）in concurrent chemoradiotherapy for cervical carcinoma

作　　者：曾四元[1] 李凌[1] 钟美玲[1] 江维[1] 吴云燕[1] 刘毅[1] 

机构地区：[1]江西省妇幼保健院肿瘤科,南昌330006

出　　处：《中华肿瘤杂志》2011年第7期517-519,共3页Chinese Journal of Oncology

摘　　要：目的评价紫杉醇脂质体联合铂类同步放化疗治疗宫颈癌的疗效和安全性。方法对162例Ⅱa～Ⅳ期宫颈癌患者进行随机对照研究。紫杉醇联合铂类组（对照组）71例，紫杉醇135mg／m2，第1天；顺铂80my／m2或卡铂[曲线下面积（AUC）取值4～6]，第2天。紫杉醇脂质体联合铂类组（试验组）91例，紫杉醇脂质体135mg／m2，第1天；顺铂80mg／m2或卡铂（AUC取值4～6），第2天。两组均3周为1个疗程，共治疗2～3个疗程。两组均同期予以根治性放疗。同步放化疗结束后6个月，根据肿瘤退缩情况判定疗效，并持续进行随访。结果试验组和对照组的有效率分别为89．0％和90．1％，差异无统计学意义（P〉0．05）。试验组和对照组的1年累积生存率分别为89．2％和91．4％，差异亦无统计学意义（P〉0．05）。试验组的胃肠道反应、骨髓抑制、肌肉和关节酸痛、皮疹发生率分别为49．6％、78．0％、26．3％和4．4％，显著低于对照组（63．3％、81．6％、53．5％和12．6％，均P〈0．05），而脱发、肝功能损害、外周神经炎等方面差异并不明显（P〉0．05）。结论紫杉醇脂质体联合铂举同痔前化疗治疗TTa～Ⅳ朔官衙瘵寄仝右撕沅朔疗村右待讲一彤观瘩．Objective To compare the efficacy, side effects and influence of two chemotherapy regimens, paclitaxel liposome combined with platinum and paclitaxel combined with platinum, on the survival rate in patients with cervical carcinoma receiving concurrent chemoradiotherapy. Methods One hundred and sixty two cases with primary cervical carcinoma diagnosed and treated in the Jiangxi Maternal and Children Hospital between January 2008 and November 2009 were enrolled in this randomized controlled trial. Seventy one cases were included in the paclitaxel group and 91 in the paclitaxel liposome group. The chemotherapy doses were as followings： paclitaxel liposome and paclitaxel 135 mg/m2 ; cisplatin 80 mg/m2 or carboplatin AUC 4-6, repeated every 21 days for two or three times. Radical radiotherapy was given to both groups at the same time. The efficacy was evaluated by the tumor regression and the patients were followed-up for six months. Results The overall response rates of paclitaxel group and paclitaxel liposome group were 90.1% and 89.0% , respectively （P 〉0.05）. The 1-year cumulative survival rate was 91.4% for the paclitaxel group and 89.2% for the paclitaxel liposom group （ P 〉 0.05 ）. The incidence rate of adverse effects such as rash, gastrointestinal toxicity, bone marrow suppression and muscle/joint pain in the paclitaxel liposome group was significantly lower than that in the paclitaxel group （ P 〈 0.05 ）, while there was no significant difference regarding the hair loss, liver damage, and peripheral neuritis （ P 〉 0.05 ）. Conclusions Paclitaxel liposome plus platinum is a safe and effective therapeutic regimen for stage Ⅱa～Ⅳ cervical carcinoma. However, the long-term efficacy of this regimen should be further observed.

关 键 词：宫颈肿瘤 紫杉醇脂质体 紫杉醇 顺铂 卡铂 同步放化疗 

分 类 号：R737.33[医药卫生—肿瘤]