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目的评价重组人血管内皮抑制素YH-16治疗复治的晚期非小细胞肺癌的有效率、肿瘤进展时间(TTP)、对生活质量的影响及不良反应,并为临床确定合适的用药剂量。方法本研究为随机对照多中心试验。患者随机分为7.5mg/m2或15mg/m2两个剂量组,均采用静脉滴注YH-163h,每天1次,连续给药28d。结果共入组68例,可评价疗效的患者60例。7.5mg/m2剂量组和15mg/m2剂量组有效率均为3.0%(P>0.05);中位TTP在意向治疗(ITT)人群分别为60d和71d(P>0.05),对生活质量的影响以及不良事件发生率分别为48.6%和38.7%(P>0.05)。无预期以外的不良事件发生。结论YH-16对多程化疗后复发的非小细胞肺癌显示出一定的抗肿瘤活性,安全性较好,临床受益率高;建议采用7.5mg/m2作为临床常规使用剂量。
Objective To evaluate the effectiveness of recombinant human endostatin YH-16 in the treatment of advanced non-small cell lung cancer (NSCLC), the time to tumor progression (TTP), quality of life and adverse reactions, and to determine the appropriate dose for clinical use. Methods This study was a randomized controlled multicenter trial. Patients were randomly divided into two doses of 7.5mg / m2 or 15mg / m2, were used intravenous infusion of YH-163h, once daily, continuous administration of 28d. Results A total of 68 patients were enrolled in the study, and 60 patients were evaluated. The effective rates of both 7.5 mg / m2 and 15 mg / m2 were 3.0% (P> 0.05). The median TTP was 60 days and 71 days (P> 0.05) respectively in the intention-to-treat (ITT) And the incidence of adverse events were 48.6% and 38.7% (P> 0.05). Unexpected adverse events occurred. Conclusion YH-16 shows some antitumor activity in non-small cell lung cancer after recurrent chemotherapy. It has good safety and high clinical benefit rate. It is recommended that 7.5 mg / m 2 be used as routine dose in clinic.