恩度注射液联合NP方案治疗晚期NSCLC临床研究

目的：评价恩度（endostar YH-16）联合长春瑞滨和顺铂（NP）治疗晚期非小细胞肺癌（NSCLC）的疗效和安全性。方法：选择非小细胞肺癌患者486例,分为恩度注射液联合化疗组322例及单纯化疗组164例。研究的目标是有效率（RR）、临床受益率（CBR）、肿瘤进展时间（TTP）、生活质量（QOL）及安全性。结果：试验组和对照组的总RR分别为35.4%和19.5%（P=0.0003）,总CBR分别为73.3%和64.0%（P=0.035）,总的中位TTP分别为6.3个月和3.6个月（P=0.0000）。试验组的临床症状缓解率较对照组略高,有统计学差异（P=0.015）。试验组与对照组不良反应的发生率差异均无统计学意义。结论：YH-16与NP方案联合,能明显提高晚期NSCLC的RR及中位TTP,且安全性较好,具有较好的临床前景。

Clinical study of endu injection with NP chemotherapy in the treatment of advanced NSCLC

Objective To evaluate the efficacy and security of combined endu injection with NP chemotherapy for the treatment of advanced non-small cell lung cancer(NSCLC).Method 486 cases with advanced non-small cell lung cancer were divided into two groups,322 patients of test group were treated with combination of endu injection and chemotherapy,and 164 patients of control group only received chemotherapy.The aim of the study is the response rate(RR),the clinical benefit rate(CBR) and the time to progression(TTP).Results The total response rate in two groups were 35.4% and 19.5%(P=0.0003).The total clinical benefit rate were 73.3% and 64.0%(P=0.035),The total time to progression were 6.3 months and 3.6 months(P=0.0000).The clinical laxation rate of patients in test group was superior to the patients in control group,but no apparent difference(P>0.05).The incidence rates of the side effect in test group was superior to the patients in control group,showed apparent difference(P=0.015).Conclusion Combined endu injection and chemotherapy can improve the curative effect(RR and median TTP)of advancednon NSCLC,as well as enhancing the safety factor.