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目的：评价重组人血管内皮抑制素注射液郁期临床试验中对非小细胞肺癌的有效性和安全性。方法：入组恩度郁期临床试验的2725例人群中,我院42例患者接受恩度联合标准一、二线含铂化疗方案,恩度静脉滴注,7.5mg/㎡/天,连续给药14天,21天为一周期重复给药。结果：可评价疗效的38例患者客观反应率为28.6%,疾病控制率为73.8%,42例患者中位无疾病进展生存时间5.3个月,中位总生存时间为8.0个月,1、2、3年生存率分别为40.5%、18.8%及10.7%。 PS 评分良好(0~1分)、近期疗效评价临床有效组(CR+PR)患者及恩度使用≥4周期的患者具有更长的无疾病进展生存时间,分别是5.6月、7.4月和7.0月(P<0.05),PS评分是患者的唯一独立预后因素。发生芋/Ⅳ度不良反应主要为化疗相关的胃肠道反应9.5%,白细胞减少38.1%,贫血26.2%,血小板减少2.4%。结论：恩度联合化疗治疗晚期非小细胞肺癌在我院的郁期临床试验数据显示恩度联合化疗可以在毒副作用可耐受的情况下,使患者的临床受益增加,近期的肿瘤控制转换为生存的获益,且治疗效果与恩度使用周期数、患者一般状况相关。“,”[ Abstract] Objective: To evaluate the toxicities and clinical benefits of Endostar combined with platinum-based doublet chemotherapy for treating advanced non-small cell lung cancer ( NSCLC) in our center in a phase IV study. Meth-ods:Of the 2 725 cases in this phase IV study, 42 patients in our hospital were administered with platinum-based doublet chemotherapy and endostatin at a dose of 7. 5 mg/m2 daily for consecutive 14 days, every 21days as a cycle. Results:Of 38 assessable patients, objective response rate was 28. 6%. Disease control rate was 73. 8%. Median progression-free sur-vival time and median overall survival for 42 patients were 5. 3 months and 8. 0 months, respectively. The 1, 2, 3 year sur-vival rates were 40. 5%, 18. 8% and 10. 7%, respectively. Patients with good ECOG PS score (0~1 points), good clinic effect (CR+PR) and ≥ 4 treatment cycles with Endostar had a longer progression-free survival time, which were 5. 6 months, 7. 4 months, and 7. 0 months, respectively(P<0. 05). ECOG PS score was the only independent prognostic fac-tor . The grade III / Ⅳadverse reactions included mainly chemotherapy-related gastrointestinal reactions (9. 5%), leuko-penia(38. 1%), anemia (26. 2%), and thrombocytopenia (2. 4%). Conclusion: The research data in this phase IV study in our hospital show that Endostar combined with chemotherapy is tolerable and is associated with clinical benefit. The short-time tumor control is converted into survive benefits. In addition, the therapeutic efficacy is related to the cycle number of Endostar and good ECOG PS scores.