摘要
目的新型重组人血管内皮抑制素(rh-endostatin)的Ⅰ期、Ⅱ期、Ⅲ期临床试验证明该药临床应用安全有效。本研究旨在评价rh-endostatin联合长春瑞滨和顺铂(NP)、吉西他滨和顺铂(GP)两种化疗方案治疗晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)的临床近期疗效和不良反应。方法采用前瞻性开放性随机对照临床研究,将129例晚期NSCLC患者随机分到NP+rh-endostatin组和GP+rh-endostatin组,对其临床近期疗效和不良反应进行组间比较。结果 NP+rh-endostatin组和GP+rh-endostatin组总有效率(response rate,RR)分别是29.09%和36.36%;临床受益率(clinical benefit response,CBR)分别是70.91%和81.82%;中位肿瘤进展时间(time to progression,TTP)分别为6.3个月和6.4个月,组间无统计学差异。初复治患者、病理类型、临床分期和用药周期各因素对RR、CBP和中位TTP影响的比较显示,两组化疗方案间差异亦无统计学意义。两组患者的不良反应方面,NP+rh-endostatin组白细胞减少发生率较高,GP+rh-endostatin组血小板减少发生率较高,组间有统计学差异。NP+rh-endostatin组静脉炎的发生率显著高于GP+rh-endostatin组,差异有统计学意义。结论重组人血管内皮抑制素联合NP或GP方案临床近期疗效相当,均能提高晚期NSCLC患者的治疗效果,然而不良反应并无增加,安全性较好。
[Objective] Rh-endostatin is a new recombinant human endostatin, Phase Ⅰ ,Phase Ⅱand Phase Ⅲ studies revealed that it was effective and tolerant in clinical use. To observe the efficaeies and toxicities of rh-endostatin combined with NP or GP regimen in patients with advanced non-small cell lung cancer. [Methods] 129 cases were enrolled in a randomized, opening, prospective trial, and were administrated with rh-endostatin plus NP or GP regimen, Effieacies and adverse reactions were analyzed and compared in two groups. [Results] The response rate was 29.09% in NP plus rh-endostatin, 36.36% in GP plus rh-endostatin; and clinical benefit rate was 70.91%, 81.82% respectively, the median TIP was 6.3months,6.4 months respectively, there was no significant difference in two groups. Some factors compacted on RR, CBR, median TIP of NSCLC patients, such as primary/secondary treatment history, pathology types, and clinical stage and cycles of treatment, there were no statistic difference in two groups for several of factors. In the major adverse reactions, there was highest incidence of leucopenia （75.1%） in NP plus rh-endostatin, highest incidence of thrombocytopenia （53.0%） in GP plus rh-endostatin, with significant difference. NP plus rh-endostatin group the incidence of phlebitis was significantly higher than GP ＋ rh-endostatin group, the difference was statistically significant. [Conclusion ] The regimen of rh-endostatin combined with NP or GP is similar in the clinical efficacy, results in significantly meaningful improvement in the treatment of advanced NSCLC patients, but adverse reactions didn＇t increase between two regimens.
出处
《中国现代医学杂志》
CAS
CSCD
北大核心
2011年第30期3811-3815,3818,共6页
China Journal of Modern Medicine
