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目的：比较环磷酰胺（CTX）、阿霉素（ADM）、氟尿嘧啶（5FU）及大剂量氨甲喋呤（HD-MTX）组成的CAF-HD-MTX方案与CTX、ADM及5FU组成的CAF方案治疗晚期乳腺癌的疗效．方法：90例晚期乳腺癌随机分成两组，每组均为45例．结果：CAF-HD-MTX组完全缓解率20.0％（9/45），总有效率80.0％（36／45）；CAF组完全缓解率13．3％（6/45），总有效率46．7％（21／45）．统计学分析，完全缓解率没有显著差异（P＞0．05）．总有效率有非常显著差异（P＜0．01）．主要毒副反应，其中CAF-HD-MTX组的肝功损害及口腔炎较CAF组有明显差异（前者P＜0.01，后者P＜0．05）.而骨髓抑制及胃肠道反应两组均无显著差异（P＞0．05）．结论：CAF-HD-MTX方案治疗晚期乳腺癌有效率高，病人可耐受，可在临床上进一步观察使用．
OBJECTIVE: To compare CAF-HD-MTX regimen consisting of cyclophosphamide (CTX), adriamycin (ADM), fluorouracil (5FU) and high dose methotrexate (HD-MTX) with advanced CAF regimen consisting of CTX, ADM and 5FU The efficacy of breast cancer. Methods: Ninety patients with advanced breast cancer were randomly divided into two groups, 45 cases in each group. Results: The complete remission rate of CAF-HD-MTX group was 20.0% (9/45), the total effective rate was 80.0% (36/45); the complete remission rate of CAF group was 13.3% (6/45), and the total effective rate was 46. 7% (21/45). Statistical analysis showed that there was no significant difference in complete remission rate (P>0.05). The total effective rate has a very significant difference (P<0.01). Main toxicities and side effects, including liver function damage and stomatitis in the CAF-HD-MTX group, were significantly different from those in the CAF group (P<0.01 for the former, P<0.05 for the latter). The myelosuppression and gastrointestinal reactions There was no significant difference (P>0.05). Conclusion: The CAF-HD-MTX regimen is effective in patients with advanced breast cancer and can be tolerated by patients. It can be further observed in clinical practice.