目的:系统评价重组人血管内皮抑制素联合吉西他滨、顺铂治疗非小细胞肺癌(NSCLC)的疗效和安全性,为临床用药提供循证参考。方法:计算机检索Cochrane 图书馆、PubMed、Embase、ClinicalTrials、中国知网数据库、万方数据库、维普数据库等,收集重组人血管内皮抑制素联合吉西他滨、顺铂(试验组)对比吉西他滨联合顺铂(对照组)治疗NSCLC的随机对照试验(RCT)。筛选文献、提取资料后采用Cochrane 5.1.0偏倚风险评估工具和Jadad量表对文献质量进行评价,采用Rev Man 5.3软件进行Meta分析。结果:最终纳入27项RCT,共计1 646例患者。Meta分析结果显示,试验组患者有效率[RR=1.67,95%CI(1.48,1.89),P<0.000 01]、临床受益率[RR=1.26,95%CI(1.20,1.33),P<0.000 01]均显著高于对照组;两组患者白细胞下降发生率[RR=0.98,95%CI(0.88,1.11),P=0.79]、血小板下降发生率 [RR=1.07,95%CI(0.91,1.26),P=0.39]、胃肠道反应发生率[RR=1.01,95%CI(0.90,1.14),P=0.85]比较差异均无统计学意义。结论:重组人血管内皮抑制素联合吉西他滨、顺铂可提高NSCLC患者的疗效,且未增加不良反应的发生。
Abstract
OBJECTIVE: To systematically evaluate the efficacy and safety of Endostar combined with gemcitabine and cisplatin in the treatment of non-small cell lung cancer (NSCLC), and to provide evidence-based reference for clinical drug use. METHODS: Retrieved from Cochrane Library, PubMed, Embase, ClinicalTrials, CNKI, Wanfang and VIP database, randomized controlled trials (RCT) about Endostar combined with gemcitabine and cisplatin(trial group) vs. gemcitabine combined with cisplatin (control group) for NSCLC were collected. After literature screening, data extraction and quality evaluation with Cochrane 5.1.0 bias risk evaluation tool and Jadad scale, Meta-analysis was performed by using Rev Man 5.3 software. RESULTS: A total of 27 RCTs were included, involving 1 646 patients. Results of Meta-analysis showed that response rate [RR=1.67, 95%CI(1.48,1.89),P<0.000 01] and clinical benefit rate [RR=1.26, 95%CI (1.20, 1.33),P<0.000 01] of trial group were significantly higher than those of control group. There was no statistical significance in the incidence of leucopenia [RR=0.98,95%CI(0.88, 1.11),P=0.79], thrombocytopenia [RR=1.07, 95%CI(0.91, 1.26),P=0.39] and gastrointestinal reaction [RR=1.01, 95%CI(0.90, 1.14),P=0.85] between 2 groups. CONCLUSIONS: Endostar combined with gemcitabine and cisplatin can improve therapeutic efficacy of NSCLC patients, without increasing the incidence of ADR.