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目的:评价国产多西他赛(深圳万乐医药公司产品)单药以及多西他赛+顺铂联合化疗方案对乳腺癌和非小细胞肺癌的临床疗效和安全性,并以进口多西他赛(安万特公司)+顺铂联合化疗方案作对照。方法:1)单药治疗分为2组:多西他赛(万乐)75mg/m2第1天静脉滴注,21天为一周期,治疗乳腺癌(A组)和非小细胞肺癌(B组);2)联合治疗分为4组:乳腺癌患者随机分为多西他赛(万乐)70mg/m2+顺铂80mg/m2(C组),或泰索帝(进口)70mg/m2+顺铂80mg/m2(D组),21天为一周期;肺癌患者随机分为多西他赛(万乐)+顺铂(E组)或泰索帝(进口)+顺铂(F组),方案与乳腺癌相同。结果:147例患者中138例可评价疗效,141例可评价不良反应,单药有效率乳腺癌(A组)21.7%,单药非小细胞肺癌(B组)6.1%,联合治疗组有效率C组60.0%,D组35.0%,E组23.8%,F组28.6%。不良反应主要为骨髓抑制、恶心呕吐、脱发。联合治疗方案多西他赛(万乐)组与泰索帝(安万特)组比较,疗效和不良反应相似。结论:多西他赛(万乐)单药及联合顺铂方案治疗乳腺癌和非小细胞肺癌安全有效,耐受性好,与进口泰索帝疗效和不良反应相似。
OBJECTIVE: To evaluate the clinical efficacy and safety of domestic single-drug combination of docetaxel (Shenzhen Wanle Pharmaceutical Co., Ltd.) and docetaxel + cisplatin combined chemotherapy on breast cancer and non-small cell lung cancer, and to import docetaxel Race (Aventis) + cisplatin combination chemotherapy regimen. Methods: 1) Monotherapy was divided into two groups: Docetaxel (Wan Le) 75mg / m2 intravenous drip on the first day, a cycle of 21 days, the treatment of breast cancer (A group) and non-small cell lung cancer Group); 2) combination therapy was divided into 4 groups: patients with breast cancer were randomly divided into docetaxel (Wan Le) 70mg / m2 + cisplatin 80mg / m2 Platinum 80mg / m2 (D group), 21 days for one cycle; patients with lung cancer were randomly divided into docetaxel (cisplatin) (E group) or taxotere (import) The same scheme and breast cancer. RESULTS: Of the 147 patients, 138 were evaluable, 141 were evaluable for adverse reactions, 21.7% for single-agent effective breast cancer (group A) and 6.1% for single-agent non-small cell lung cancer (group B) Group C 60.0%, Group D 35.0%, Group E 23.8%, Group F 28.6%. Adverse reactions mainly bone marrow suppression, nausea and vomiting, hair loss. Combination therapy docetaxel (million music group) and Taxotere (aventis) group, the efficacy and adverse reactions were similar. CONCLUSION: Docetaxel alone and combined with cisplatin are safe and effective in the treatment of breast cancer and non-small cell lung cancer with similar efficacy and side effects to imported taxotere.