CAJ | 학술논문

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AJCC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800 mg/m2溶于100 ml生理盐水30 min内静脉滴注后30 ～60 min完成放疗,B组用安慰剂放疗.放疗总剂量66 Gy(1.8 ～2.0 Gy/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％(x2=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％(x2 =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.
목적 평개방사증민제감안쌍서납재흉단식관린암방료중적료효화불량반응.방법 2008-2009년간채용다중심、수궤、쌍맹방법대불내수혹거절동기방화료Ⅱa～Ⅲ기화부쇄골상림파결전이Ⅳ기(제6판AJCC분기)환자진행림상시험,경병리증실적흉단식관린암66례환자수궤분위A、B조.A조용감안쌍서납800 mg/m2용우100 ml생리염수30 min내정맥적주후30 ～60 min완성방료,B조용안위제방료.방료총제량66 Gy(1.8 ～2.0 Gy/차,5차/주,6.6～7.2주완성).A조척제1례,B조척제3례,가분석병례량조각31례.결과 수방솔위97％.A、B조환자근기총유효솔분별위93.5％、67.7％(x2=6.61,P=0.01),2년총생존솔,무진전생존솔,종류특이생존솔분별위39.9％、29.9％,30.1％、27.9％,43.1％、26.8％(x2 =0.62、0.02、0.30,P=0.433、0.878、0.586).소유환자내수량호,미발현엄중불량반응.결론 연구현시,감안쌍서납작위방사증민제,재근기료효상량조환자차이유통계학의의,차환자내수성량호.본차수방기내,생존솔미견명현개선.
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.