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尿多酸肽联合NP与NP方案化疗在晚期非小细胞肺癌的随机对照临床研究 被引量:12

A randomized clinical trial of Uroacitides combined with NP and NP regimen alone for advanced non-small cell lung cancer
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摘要 背景与目的尿多酸肽是从健康人尿中分离提取、纯化的一组细胞分化诱导剂。临床前实验表明,尿多酸肽对多种肿瘤具有抑制生长、诱导分化凋亡的作用。本研究拟比较尿多酸肽联合NP方案(长春瑞滨NVB、顺铂DDP)化疗与单纯NP方案治疗晚期非小细胞肺癌(NSCLC)的疗效、生存期及毒性。方法42例晚期NSCLC病例被随机分入尿多酸肽联合NP化疗组与NP化疗组。NP方案NVB25mg/m2静脉滴注第1、8天,DDP75mg/m2静脉滴注第1天,21天为一个周期,化疗2周期。尿多酸肽联合NP化疗尿多酸肽注射液300mL锁骨下静脉置管给药,每天1次,于化疗前7天开始用药,再与NP方案联合治疗2周期,化疗药使用当日停用尿多酸肽。结果尿多酸肽联合NP化疗组有效率为44.4%,NP化疗组有效率为20.0%(P>0.05);尿多酸肽联合NP化疗组中位生存期为9个月,NP化疗组为6个月(P=0.0287)。毒副反应主要为骨髓抑制、胃肠道反应和脱发,二组间差异无统计学意义。结论尿多酸肽联合NP化疗治疗晚期复治NSCLC疗效肯定,毒性可耐受,尤其在延长患者中位生存期方面具有一定优势。 Background and objective Uroacitides is a group of cell differentiation inducers, which is purified from fresh human urine. Preclinical studies of Uroacitides have showed that cancer cells could be induced to differentiate, and the growth of cancer cells could be inhibited by Uroacitides. The aim of this study is to compare the efficacy and toxicity between Uroacitides combined with NP regimen and NP alone in treatment of advanced non-small cell lung cancer (NSCLC). Methods Forty-two cases of advanced NSCLC were randomized into Uroacitides+NP and NP groups. NP group: NVB 25 mg/m^2 on days 1 and 8, DDP 75 mg/m^2 on day 1. Uroacitides combined with NP group : Uroacitides of 300 mL was given through subclavian catheter daily for 7 days prior to the NP chemotherapy, then concurrently with NP regimen for 2 cycles, except the days of administration of chemotherapy. Results In the Uroacitides+NP group, the overall response rate was 44.4%, and 20.0% in the NP group (P〉0.05). The median survival time was 9 months in the Uroacitides+ NP group and 6 months in the NP group (P=0. 0287). The main toxicities were myelosuppression, gastrointestinal reaction and alopecia, and there was no significant difference in incidences of toxicities between the two groups (P〉0.05). Conclusion Uroacitides combined with NP regimen shows a good curative effect and low toxicity, and may significantly prolong the median survival time for advanced NSCLC.
出处 《中国肺癌杂志》 CAS 2006年第6期536-539,共4页 Chinese Journal of Lung Cancer
关键词 非小细胞肺癌 化疗 尿多酸肽 长春瑞滨 顺铂 Non-small cell lung cancer Chemotherapy Uroacitides Vinorelbine Cisplatin
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