胸腺五肽、甲地孕酮配合EP方案与单纯EP方案治疗晚期非小细胞肺癌的对比研究

Comparative Study of Timoepntin and Megestrol Acetate P1us EP Regimen with EP Regimen Alone in the Treatment Of Advanced Non-small Cell Lung Cancer

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 effect,toxicity and quality of life（QOL） between IM-EP regimen and EP regimen alone in primary patients with advanced non-small cell lung cancer （ NSCLC, stage IIIb-IV） , Methods Group A（33 cases） were treated with TM-EP regimen and group B （35cases）were treated with EP regimen. Both regimens were reepated every 4 weeks for three cycles, Objective tumor response and eytotoxic re- actions were assessed by WHO criteria. QOL was evaluated by clinical benefit response. Results The objective response rate（ CR ＋ PR） was 27,3 % in group A compared to 22.9 % in group B （ P 〉 0.05）. The median sur- vival time was 32 weeks in group A eompared to 27 weeks in group B（P 〈0. 01 ）. Leukovenia,nausea and vom- iting in group B were more serious than those in group A （ P 〈 0. 01 ） , but transient fever and chill were much more common in group A.