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目的 :研究来曲唑一线治疗绝经后妇女晚期乳腺癌的临床疗效和不良反应。方法 :采用多中心协作开放临床试验 ,入组患者共 32例 ,口服来曲唑 2 .5mg ,qd ,共服 4~ 6周 ,疗前 2周内及治疗 6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 :入组 32例均可评价疗效 ,CR 1例 ,PR 14例 ,有效率为 4 6 .9%。其中 ,绝经时间 <5年与≥ 5年者的有效率分别 33.3%及 5 5 .0 % ;ER与PR均阳性、ER或PR阳性、受体未测者的有效率分别为 75 .0 % (3 4 ) ,6 6 .7% (4 6 )与 36 .4 % (8 2 2 ) ;表明绝经时间长的患者疗效优于绝经时间短者 ;ER与PR均阳性的疗效好 ,而受体未测者疗效较差的原因可能是这部分患者中有一部分为受体阴性 ;另外 ,皮肤、淋巴结与软组织转移的疗效亦优于实质器官转移的疗效。疗后对E2的平均有效抑制率为 6 6 .7%。主要不良反应为乏力、头晕。结论 :来曲唑作为一线药物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。
Objective: To study the clinical efficacy and side effects of letrozole in the treatment of advanced breast cancer in postmenopausal women. Methods: In a multicenter clinical trial, 32 patients were enrolled in the study. Letrozole 2.5 mg qd was given orally for 4-6 weeks. Blood samples were taken within 2 weeks before treatment and after 6 weeks of treatment Estradiol (E2) levels, while evaluating the efficacy and adverse reactions. Results: All the 32 cases were eligible for evaluation of CR, 1 case of CR and 14 cases of PR, the effective rate was 46.9%. Among them, the menopausal time of <5 years and ≥ 5 years were 33.3% and 55.0%, ER and PR were positive, ER or PR were positive, the receptor unmeasured efficiency was 75.0% (34), 66.7% (46) and 36.4% (82.2), respectively. The results showed that the patients with long history of menopause had better curative effect than those with short menopause. The positive results of ER and PR were good, Body unmeasured efficacy of the poor may be part of this part of patients with receptor negative; In addition, the skin, lymph node and soft tissue metastasis is also superior to the efficacy of parenchymal organ metastases. After treatment, the average effective inhibition rate of E2 was 66.7%. The main adverse reactions are fatigue, dizziness. Conclusion: Letrozole, as a first-line drug, has definite curative effect on postmenopausal women with advanced breast cancer and has mild adverse reactions. It is worthy of clinical application.