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目的:临床随机性研究诺维本(NAVELBINE)联合氟脲嘧啶(5-FU)加醛氢叶酸(CF)方案A组与联合表阿霉素(E-ADM)加氨甲喋呤(MTX)方案B组治疗晚期转移性乳腺癌的疗效与毒副反应。方法:入组晚期转移性乳腺癌40例临床完全随机分为A组与B组。分别予相应联合化疗至少两个疗程疗效及毒性判定按照WHO标准。结果:A组CR 15%,PR 45%,CR+PR 60%;B组CR 20%,PR 45%,CR+PR 65%。两组之间统计学无差异。毒副反应,B组表现的心律失常症状显著高于A组,统计学存在显著性差异(P=0.001 6)。而白细胞下降、血小板下降、肝功能损害也提示B组高于A组。结论:本项研究提示诺维本联合氟脲嘧啶加醛氢叶酸方案与联合表阿霉素加氨甲喋呤方案治疗晚期转移性乳腺癌均有较高疗效,但联合氟脲嘧啶组的毒副作用更为温和,患者更易接受。
OBJECTIVE: In a randomized clinical trial of NAVELBINE combined with 5-fluorouracil and alduronic acid (CF) regimen in combination with epirubicin (E-ADM) plus methotrexate (MTX) B group treatment of advanced metastatic breast cancer efficacy and side effects. Methods: Forty patients with advanced metastatic breast cancer were randomly divided into A group and B group. Respectively to the corresponding combination chemotherapy at least two courses efficacy and toxicity in accordance with WHO standards. Results: Group A CR 15%, PR 45%, CR + PR 60%; Group B CR 20%, PR 45%, CR + PR 65%. No statistical difference between the two groups. Toxic and side effects, the symptoms of arrhythmia manifested in group B were significantly higher than those in group A, there was a significant statistical difference (P = 0.001 6). The leukopenia, thrombocytopenia, liver dysfunction also prompted B group was higher than A group. CONCLUSIONS: This study suggests that combination of nocetin plus fluorouracil and aldofen folate has a higher efficacy in combination with epirubicin plus methotrexate in the treatment of advanced metastatic breast cancer, but the toxic side effects of combination with fluorouracil are more Gentle, patients are more receptive.