甘氨双唑钠胸段食管鳞癌放射增敏作用——Ⅲ期多中心随机对照研究  

作　　者：秦尚彬[1] 王雅棣[3] 杨俊泉[4] 王小虎[5] 李海滨[6] 杨志勇[7] 于洪[8] 李雪迎 高献书[1] 

机构地区：[1]北京大学第一医院放疗科,北京100034 [2]医学统计室 [3]河北医科大学第四医院放疗科 [4]唐山市人民医院放疗科 [5]甘肃省肿瘤医院放疗科 [6]河北工程大学附属医院放疗科 [7]邯郸市中心医院放疗科 [8]辽宁省肿瘤医院放疗科

出　　处：《中华放射肿瘤学杂志》2012年第5期426-429,共4页Chinese Journal of Radiation Oncology

基　　金：中国国家自然科学基金（30670619）;中国国家自然科学基金（81072017）

摘　　要：目的评价放射增敏剂甘氨双唑钠在胸段食管鳞癌放疗中的疗效和不良反应。方法2008-2009年间采用多中心、随机、双盲方法对不耐受或拒绝同期放化疗Ⅱa～Ⅲ期和仅锁骨上淋巴结转移Ⅳ期（第6版MCC分期）患者进行临床试验，经病理证实的胸段食管鳞癌66例患者随机分为A、B组。A组用甘氨双唑钠800mg／m。溶于100ml生理盐水30min内静脉滴注后30～60min完成放疗，B组用安慰剂放疗。放疗总剂量66Gy（1．8～2．0Gy／次，5次／周，6．6～7．2周完成）。A组剔除1例，B组剔除3例，可分析病例两组各31例。结果随访率为97％。A、B组患者近期总有效率分别为93．5％、67．7％（χ^2=6．61，P=0．01），2年总生存率，无进展生存率，肿瘤特异生存率分别为39．9％、29．9％，30．1％、27．9％，43．1％、26．8％（χ2=0．62、0．02、0．30，P=0．433、0．878、0．586）。所有患者耐受良好，未发现严重不良反应。结论研究显示，甘氨双唑钠作为放射增敏剂，在近期疗效上两组患者差异有统计学意义，且患者耐受性良好。本次随访期内，生存率未见明显改善。Objective To evaluate the efficacy and clinical safety of sodium glycididazole (CMNa)in thoracic esophageal squamous carcinoma.Methods From June 1,2008 to October 13,2009,66pathologically proved thoracic esophageal squamous carcinoma (stage Ⅱa-Ⅲ,stage Ⅳ with metastases only in supraclavicular lymph nodes,by AJCC 6th ed) were randomized into radiotherapy plus CMNa (A) or radiotherapy plus placebo (B) group.Radiotherapy was given by conventional schedule:1.8-2.0 Gy per fraction,5 times per week to a total dose of 66 Gy/6.6-7.2w.CMNa was given intravenously 800 mg/m2 3 times a week in solution of 100 ml saline within 30 minutes.Radiotherapy was started 30-60 minutes after completion of infusion.Patients of Group B received placebo in saline solution.A total of 66 patients were enrolled ( Group A:32 ; Group B:34 ),and four patients were unanalyzable,remaining 31 patients in each Group.Baseline factors were balanced.Results Follow-up rate was 97％.Group A vs.Group B:the overall response rate was 93.5％ vs.67.7％ ( x2 =6.61,P =0.01 ),2-year overall survival was 39.9％ vs.29.9％ ( x2 =0.62,P =0.433 ),2-year cancer specific survival was 43.1％ vs.26.8％ ( x2 =0.30,P =0.878),and 2-year progression-free survival was 30.1％ vs.27.9％ ( x2 =0.02,P =0.586).No severe side effects observed.All patients tolerated CMNa infusion well.Conclusions CMNa is tolerable and effective as a hypoxic radiosensitizer,and its combination with radiotherapy can improve short term effect.However,survival is not improved within our follow-up period.

关 键 词：甘氨双唑钠 放射增敏剂 食管肿瘤 

分 类 号：R735.1[医药卫生—肿瘤]