Background and objective In recent years, there has been a large number of studies and reports about the efficacy and safety of recombinant human endostatin (rh-endostatin), an anti-angiogenic drug, in treatment of advanced lung cancer.Authentic assessment of th-endostatin treatment in lung cancer is important.The aim of this study is to assess the clinical eflicacy and safety of th-endostatin combined with chemotherapy in the treatment of patients with non-small cell lung cancer (NSCLC).Methods Cochrane systematic review methods were used in the data selection, and data were selected from the Cochrane Library, EMBASE, Medline, SCI, CBM, CNKI, and etc electronic database to get all clinical controlled trials.The retrieval time was March 2010.The objects of these randomized controlled trials were advanced NSCLC patients and in the experimental group was th-endostatin combination chemotherapy, in the control group was chemotherapy alone to compare the efficacy of two groups.The quality of included trials were evaluated by two reviewers independently The software RevMan 5.0 was used for meta-analyses.Results Fifteen trials with 1,326 patients were included according to the including criterion.All trials were randomized controlled trials, and two trials were adequate in reporting randomization.Thirteen trials didn't mention the blinding methods.Meta analysis indicated that the NPE arm (Vinorelbine+cisplatin+rh-endostatin) had a different response rate compared with NP (Vinorelbine+cisplatin) arm (OR=2.16, 95％CI: 1.57-2.99).The incidences of severe leukopenia (OR=0.94, 95％CI: 0.66-1.32) and severe thrombocytopenia (OR=1.00, 95％CI: 0.64-1.57) and nausea and vomiting (OR=0.85, 95％ CI: 0.61-1.20) were similar in the NPE arm compared with those in the NP arm.The NPE plus radiotherapy (RT) arm had a similar response rate compared with NP plus RT arm (OR=2.39, 95％CI: 0.99-5.79).The incidences ofleukopenia (OR=0.83, 95％CI: 0.35-1.94) and thrombocytopenia (OR=0.78, 95％CI: 0.19-3.16) and radiation esophagitis (OR=1.00, 95％CI: 0.40-2.49) were similar in the NPE plus RT arm compared with those in the NP plus RT arm.Conclusion In the treatment of advanced NSCLC, th-endostatin in combination with platinum-based chemotherapy improve the response rate without obviously raised side effects, however, when radiotherapy are added to NPE arm or NP arm, the response rates have a similar outcome.Owing to the small sample size and poor quality of included trials, more well-designed double-blinded randomized controlled trials should be performed.%背景与目的近年来已有大量有关抗血管生成药物重组人血管内皮抑素(恩度,rh-endostatin)在肺癌治疗中有效性和安全性的研究与报道,真实评价重组人血管内皮抑素对肺癌的治疗效果具有重要意义,本文将系统评价重组人血管内皮抑素联合化疗与单纯化疗在晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)治疗中的疗效与安全性.方法采用Cochrane系统评价方法,对Embase、Medline、SCI、Cochrane图书馆、中国生物医学文献数据库、中文科技期刊全文数据库、中国期刊全文数据库等数据库进行计算机检索,检索时间截止至2010年3月.纳入标准为研究对象为晚期NSCLC病例,实验组为重组人血管内皮抑素联合化疗,对照组为单独使用化疗,研究内容为比较两组治疗疗效的随机对照试验.纳入研究的质量由两名研究者评估.采用RevMan S.0软件对研究进行meta分析.结果按照标准共纳入15篇文献,1,326例病例.15项研究均为临床随机对照试验,其中2项对随机方法进行了详细描述,13项未对盲法进行描述.Meta分析表明,长春瑞滨+顺铂+重组人血管内皮抑素方案(NPE)与长春瑞滨+顺铂方案(NP)比较反应率差异有统计学意义(OR=2.1 6,95%CI:1.57.2.99),NPE方案治疗后重度白细胞减少(OR=0.94,95%CI:0.66-1.32)、重度血小板下降(OR=1.00,95%CI:0.64-1.57)和恶心呕吐(OR=0.85,95%CI:0.61.1.20)发生率均与NP方案比较无显著性差异(P>0.05).NPE+放疗方案与NP+放疗方案的反应率相似(OR=2.39,95%CI:0.99.5.79),NPE+放疗方案治疗后白细胞减少(OR=0.83,95%CI:0.35-1.94)、血小板下降(OR=0.78,95%CI:0.19.3.16)和放射性食管炎(OR=1.00,95%CI:0.40-2.49)发生率均与NP+放疗方案比较无显著性差异(P>0.05).结论在晚期NSCLC的治疗中,重组人血管内皮抑素与以铂类为基础的化疗方案联用可提高治疗反应率,同时毒副作用增加不明显,但在此基础上再与放疗联用并不能提高治疗反应率.由于本文纳入的研究较少,发生偏倚可能性较大,从而影响到结论的论证强度,尚需更多高质量的双盲随机对照研究提供证据.
展开▼
