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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)
【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.
【Key words】 breast cancer; letrozole; aminoglutethimide; estrad iol; postmenopause;
- 【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