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目的比较TM-NP方案[Timoepntin(胸腺五肽)、MA(megestrol acetate,甲地孕酮)、与DDP联合的生物化疗方案]与EP方案(即VP16加DDP的单纯化疗方案)对初治Ⅲb-Ⅳ期非小细胞肺癌(NSCLC)患者的疗效、毒性及生活质量的改善情况。方法 A组(33例)接受TM-NP方案治疗;B组(35例)接受EP方案治疗。两组均以4周为1周期,重复3个周期。客观疗效与毒性反应按WHO标准进行评价,生活质量根据临床受益疗效来评价。结果 A、B两组客观疗效(CR+PR)分别为27.3%及22.9%,P>0.05;中位生存期A组32周,B组27周(P<0.01);白细胞减少及恶心呕吐反应B组均较A组明显(P<0.01);短暂性寒战、发热症状多见于A组(P<0.01);两组均未发现其他严重的毒性反应。临床受益疗效A组高于B组(P<0.05)。结论胸腺五肽、甲地孕酮配合NP方案与单纯EP方案治疗晚期NSCLC的客观疗效无明显差异性,但前者毒副反应小,中位生存期长,患者生活质量改善明显。
Objective To compare the efficacy and safety of TM-NP regimen [Timoepntin, MA (megestrol acetate), biochemotherapy with DDP] and EP regimen (ie, chemotherapy alone with VP16 plus DDP) -Ⅳ stage non-small cell lung cancer (NSCLC) patients with efficacy, toxicity and quality of life improvement. Methods Group A (33 cases) received TM-NP regimen; Group B (35 cases) received EP regimen. Both groups were 4 cycles for 1 cycle, repeat 3 cycles. Objective efficacy and toxicity response to WHO standards for evaluation, quality of life based on clinical benefit evaluation. Results The objective response (CR + PR) in group A and group B were 27.3% and 22.9%, respectively, P> 0.05. The median survival time was 32 weeks in group A and 27 weeks in group B (P <0.01). The leukopenia and nausea and vomiting responses (P <0.01). The symptoms of transient shivering and fever were more common in group A (P <0.01). No other serious toxicity was found in both groups. The clinical benefit of group A was higher than that of group B (P <0.05). Conclusion The objective efficacy of thymopentin, megestrol combined with NP and simple EP regimen in the treatment of advanced NSCLC is no significant difference, but the former has small toxic side effects, long median survival and significant improvement in quality of life.