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目的:观察抗肿瘤新药重组人血管内皮抑素(恩度)联合NP方案化疗在晚期NSCLC一线化疗中的近期疗效和安全性。方法:经组织病理学或细胞学检查确诊的Ⅲ/Ⅳ期NSCLC78例。分别接受NP(对照组)或NP+重组人血管内皮抑素(试验组)方案治疗,其中重组人血管内皮抑素15mg加入0.9%氯化钠溶液500mL匀速缓慢静脉滴注,d1～14连续给药,间歇7d重复。按RECIST标准评价近期疗效,按NCICTC3.0版标准评价毒性反应。结果:78例可评价疗效的患者中,试验组、对照组的客观有效率(RR)分别是47.4%和25.0%(P=0.04)。两组在血液学和非血液学毒性方面,中、重度不良反应率均无统计学差异。结论:NP+重组人血管内皮抑素能明显提高晚期NSCLC患者的有效率,且安全性较好。
Objective: To observe the short-term efficacy and safety of anti-tumor drug recombinant human endostatin (Endostar) combined with NP regimen in first-line chemotherapy of advanced NSCLC. Methods: A total of 78 patients with stage Ⅲ / Ⅳ NSCLC confirmed by histopathology or cytology were included. They were treated with NP (control group) or NP + recombinant human endostatin (experimental group) respectively. The recombinant human endostatin 15 mg was added into 500 mL of 0.9% sodium chloride solution for uniform and slow intravenous infusion, and d1 to 14 , Intermittent 7d repeat. According to RECIST standard evaluation of recent efficacy, according to NCICTC3.0 version of the standard evaluation of toxic reactions. Results: The objective and effective rates (RR) of the 78 evaluable patients were 47.4% and 25.0%, respectively (P = 0.04). There was no significant difference in the hematological and non-hematological toxicity between the two groups in the rate of moderate and severe adverse reactions. Conclusion: NP + recombinant human endostatin can significantly improve the efficiency of patients with advanced NSCLC, and the safety is better.