复方苦参注射液联合NP方案治疗晚期非小细胞肺癌的临床研究

  目的 比较复方苦参注射液（岩舒）联合NP方案与NP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（34例）接受复方苦参注射液联合NP方案治疗；B组（36例）接受NP方案治疗。两组均以4周为1周期，重复3个周期。客观疗效与不良反应按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26.5 %及22.2 %（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）；两组均未发现其他严重的不良反应。临床受益疗效A组高于B组（P＜0.05）。结论 复方苦参注射液联合NP方案与单纯NP方案治疗晚期NSCLC的客观疗效差异无统计学意义，但A组患者不良反应小，中位生存期长，患者生活质量改善明显。

Clinical study of the combination of Yanshui injection and NP regimen in patients with advanced non-small cell lung cancer (NSCLC)

Objective To compare the effect, toxicity and quality of life(QOL) between Yanshu-NP regimen and NP regimen alone in primary patients with advanced non-small cell lung cancer(NSCLC, stage Ⅲb~Ⅳ). Methods Group A(34 cases) were treated with Yanshu-NP regimen and group B(36 cases) were treated with NP regimen. Both regimens were repeated every 4 weeks for three cycles. Objective tumor re－sponse and cytotoxic reactions were assessed by WHO criteria. QOL was evaluated by clinical benefit re－sponse. Results The objective response rate(CR+PR) was 26.5 % in group A compared to 22.2 % in group B(P >0.05). The median survival time was 32 weeks in group A compared to 27 weeks in group B(P <0.01). Leukopenia, nausea and vomiting in group B were more serious than those in group A(P <0.01). No other seri－ous adverse reactions occurred in either group. Clinical benefit response in group A was higher than that in group B(P <0.05). Conclusion The present study indicated that Yanshu-NP regimen had lower toxicity,longer median survival time and better QOL than NP regimen alone for advanced NSCLC, however there was no significant statistical difference in the objective response rate between the two groups.