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来曲唑治疗绝经后妇女晚期乳腺癌临床研究

Clinical study of letrozole in the treatment of postmeno pausal women with advanced breast cancer(ABC)

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【作者】 徐兵河; 孙燕; 宋恕平; 盛立军; 张沂平; 崔树千; 熊建萍; 侯媛淑; 王萍辉; 刘少华; 胡春宏; 陈颖; 高亚杰; 韩丽; 郑秀立; 陆禹溶;

【Author】 XU Bing he 1,SUN Yan 1,SONG Shu ping 1,SHENG Li jun 2,ZHANG Yi pi ng 3,CUI Shu qian 4, XIONG Jian ping 5,HOU Yuan shu 6,WANG Ping hui 6, LIU Shao hua 7,HU Chun hong 8, CHEN Ying 9,GAO Ya jie 10 ,HAN Li 11 ,ZHENG Xiu li

【机构】 中国医学科学院中国协和医科大学肿瘤医院; 山东省肿瘤医院; 浙江省肿瘤医院; 河南省肿瘤医院; 江西省肿瘤医院; 湖南省肿瘤医院; 湖南医科大学附属二院; 湖南医科大学附属一院; 吉林省肿瘤医院; 大连医科大学附?;

【摘要】 目的 :研究来曲唑治疗绝经后妇女晚期乳腺癌的临床疗效和不良反应。方法 :采用多中心随机对照方法。 10 1例和 31例分别口服来曲唑 2 .5mg ,qd与氨鲁米特 (AG) 2 5 0mg ,tid~qid及泼尼松 10mg ,qd。连服 4~ 6周 ,疗前 2周内及治疗 4周后的 3d内检测血中雌二醇 (E2 )水平 ,同时评价疗效和不良反应。结果 :来曲唑组和AG组分别有 98例和 2 9例可评价疗效和不良反应。有效率分别为 2 7.6 %与 2 0 .7% ,绝经时间长者疗效明显优于绝经时间短者 ,雌激素受体 (ER)阳性疗效较阴性好 ,软组织和骨转移的疗效亦明显优于肝转移的疗效。疗后对E2 的平均有效抑制率分别为 5 7%与 5 4%。来曲唑组乏力、头晕等不良反应显著低于AG组。结论 :来曲唑对E2 的抑制作用和对绝经后晚期乳腺癌疗效肯定 ,不良反应轻微 ,值得临床推广应用。

【Abstract】 Objective:To study the efficacy and adverse reacti on of letrozole in the treatment of postmenopausal women with ABC.Methods:A multicenter,randomized clinical trial on the effects of letr ozole was conducted.101 and 31 patients were randomly assigned to receive letroz ole 2.5 mg,qd or aminoglutethimide(AG) 250 mg,tid~qid,respectively.Each patient received 4~6 weeks of the treatment.Plasma estradiol concentrations were deter mined 2 weeks before the treatment and within 3 days after the treatment discont inued.The effects and adverse reaction were evaluated.Results:98 and 29 patients were evaluable finally treated with letrozo le or AG.The response rate was 27.6% and 20.7%, respectively.The effect was c orrelated with postmen opausal time and ER/PR status.The plasma level of estradiol was suppressed by 57 % and 54%,respectively.The drug related adverse events(fatigue and dizziness) w ere higher in AG than in letrozole group.Conclusion:Letrozole is an effective and safe agent for treatment of p ostmenopausal women with ABC.

  • 【文献出处】 中国新药杂志 ,Chinese New Drugs Journal , 编辑部邮箱 ,2001年10期
  • 【分类号】R737.9
  • 【被引频次】31
  • 【下载频次】290
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