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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。
BACKGROUND & AIM: Docetaxel has become one of the main drugs in the clinical treatment of advanced non-small cell lung cancer. Foreign reports first-line treatment of advanced non-small cell lung cancer effective rate of 20%, the main toxicity is myelosuppression. This study was to evaluate the efficacy and toxicity of Euruikang (docetaxel) in the treatment of advanced non-small cell lung cancer (NSCLC). Methods: A total of 77 patients were enrolled and randomly divided into experimental group (38 cases) and control group (39 cases). The experimental group received Yiyouikang 75mg / m2, the control group received Ad Su 75mg / m2, 1 hour infusion, both groups were combined with cisplatin 70mg / m2, repeated every 3 weeks. One day prior to docetaxel, dexamethasone was administered orally at 7.5 mg twice daily for 3 days to prevent allergic reactions. All patients received more than two courses of chemotherapy. Results: The experimental group could evaluate 37 cases, PR15 cases, SD16 cases and PD6 cases, the total effective rate was 40.54%. 33 cases of 4 weeks after the re-evaluation, confirmed that the effective rate was 28.95%. The control group could evaluate the efficacy of 37 cases, PR13 cases, SD16 cases, PD8 cases, the total effective rate was 35.14%. 34 cases were reviewed again after 4 weeks to evaluate the efficacy, to confirm the effective rate was 27.03%. No significant difference between the two groups. The main toxic and side effects of Yiyouikang Ⅱ ~ Ⅲ degree myelosuppression, Ⅰ ~ Ⅱ degree hair loss, fatigue and gastrointestinal reactions, no serious allergic reactions. Conclusion: The Yiyouruikang injection used in this study is a safe and effective drug for the treatment of advanced non-small cell lung cancer. It has the same side effects as the Alzheimer’s product already on the market in China.