【摘要】 背景与目的:多西紫杉醇已成为临床上治疗晚期非小细胞肺癌的主要药物之一。国外报道单药一线治疗晚期非小细胞肺癌的有效率20%,其主要毒性是骨髓抑制。本研究观察易优瑞康!(Euruikang,国产多西紫杉醇)治疗晚期初治非小细胞肺癌的疗效和毒性。方法:共77例患者入组,随机分组,试验组38例,对照组39例。试验组接受易优瑞康75mg/m2,对照组接受艾素75mg/m2,1小时输注,两组均联合顺铂70mg/m2,每3周重复疗程。在多西紫杉醇给药前1天开始口服地塞米松7.5mg,每天2次,连服3天预防过敏反应。所有患者均接受两个疗程以上的化疗。结果:试验组可评价37例,PR15例,SD16例,PD6例,总有效率40.54%。33例4周后再次复查评价,确认有效率为28.95%。对照组可评价疗效37例,PR13例,SD16例,PD8例,总有效率35.14%。34例4周后再次复查评价疗效,确认有效率为27.03%。两组疗效差异无统计学意义。易优瑞康主要的毒副作用为Ⅱ～Ⅲ度骨髓抑制,Ⅰ～Ⅱ度脱发、乏力和消化道反应,未见严重的过敏反应发生。结论:本研究所用的易优瑞康注射液是一种治疗晚期非小细胞肺癌安全有效的药物,与国内已上市的同类产品艾素疗效、毒副作用相当。更多还原

【Abstract】 BACKROUND & OBJECTIVE: Docetaxel is one of the major drugs for advanced non-small cell lung cancer(NSCLC) treatment in clinical use. It is reported that the response rate of docetaxel alone is about 20% and its major toxicity is myelosupression. The study was to evaluate the efficacy and tolerability of docetaxel (made in Beijing) in the treatment of advanced NSCLC. METHODS: 77 patients were randomized into two groups. In the study group, patients were received docetaxel (made in Beijing) 75 mg/m2 in one hour plus cisplatin 70 mg/m2; while in the control group, docetaxel (made in Jiangsu) 75 mg/m2 plus cisplatin 70 mg/m2 were administrated. Treatment in the two groups was repeated every 3 weeks. All patients had to receive at least two cycles of chemotherapy. RESULTS: The objective responses in the study and control group were 28.95% and 27.03% respectively, with no statistical difference (P>0.5). Common toxicities of docetaxel (made in Beijing) were grade Ⅱ～Ⅲ myelosupression, grade I～II transaminase elevation, alopecia and hypodynamia. CONCLUSION: Docetaxel (made in Beijing) is an effective chemotherapy drug in advanced NSCLC treatment, which has the similar efficacy and toxicity to docetaxel (made in Jiangsu).更多还原