[摘要] 目的: Meta分析雷莫芦单抗（ramucirumab）治疗晚期非小细胞肺癌（non-small cell lung cancer, NSCLC）的有效性及安全性。方法: 计算机检索Cochrane 图书馆（2017 年第8 期）、Web of Science、Pubmed、EMbase、万方数据库、中国期刊全文数据库(CNKI)、中国生物医学文献数据库（CBM）、中国科技期刊数据库和ASCO、ESMO主要会议数据库，检索时限均从建库至2017 年9 月1 日。收集雷莫芦单抗治疗晚期NSCLC的临床随机对照试验, 由2 位评价员独立筛选文献、提取数据并评估纳入研究的质量后,采用RevMan5.3 软件进行的实验组与对照组雷莫芦单抗治疗后NSCLC患者的无进展生存期（PFS）、总生存期（OS）、客观反应率（ORR）及不良反应等Meta 分析。结果：最终纳入3 项RCT进行Meta 分析，共计1 545 例NSCLC患者，其中雷莫芦单抗组777例，对照组768 例。试验组NSCLC患者的PFS 和OS均优于对照组[HR=0.77, 95%CI(0.69~0.85), P<0.01; HR=0.88, 95%CI(0.78~0.99), P<0.05]；但雷莫芦单抗组和对照组ORR比较差异无统计学意义[RR=1.33, 95%CI(0.68~2.61), P>0.05]。雷莫芦单抗联合多西他赛对比多西他赛单药二线治疗可延长晚期NSCLC患者的PFS 和OS [HR=0.77, 95%CI(0.69~0.86), P<0.01 ; HR=0.86, 95%CI(0.76, 0.98), P<0.05]；雷莫芦单抗试验组最严重的不良反应为高血压[RR=3.33，95%CI(1.83~6.05), P<0.01], 而恶心、呕吐、腹泻、食欲减退、疲劳、蛋白尿、中性粒细胞减少、白细胞减少、血小板减少、出血事件等两组差异均无统计学意义（均P>0.05）。结论：雷莫芦单抗治疗可延长晚期NSCLC患者的PFS和OS，其最主要的不良反应为高血压。

[Abstract] Objective: To systematically evaluate the efficacy and safety of ramcircumab in the treatment of advanced non-small cell lung cancer (NSCLC) by a Meta-analysis. Methods: The randomized controlled clinical trials of ramcircumab in the treatment of advanced non-small cell lung cancer were retrieved from Cochrane Library (2017, Issue 8), Web of Science, Pubmed, EMbase, Wanfang Database, CNKI, CBM, Chinese Science and Technology Academic Journal and ASCO, ESMO main conference database, with the enddate of September 1, 2017. Two independent reviewers selected the literatures, extracted the data, and assessed the quality of the included studies. The progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and adverse reactions in NSCLC patients of ramcircumab group and control group were analyzed by RevMan5.3 software. Results: Three RCTs were finally included in this meta-analysis. A total of 1 545 NSCLC patients were enrolled, including 777 in ramcircumab group and 768 in control group. The PFS and OS of NSCLC patients in the ramcircumab group were all better than those of the control group (HR=0.77,95%CI[0.69-0.85],P<0.01; HR=0.88, 95%CI[0.78-0.99], P<0.05). However, there was no statistically significant difference in the ORR between the ramcircumab group and the control group (RR=1.33, 95%CI[0.68-2.61], P>0.05). Compared with docetaxel single-agent second-line treatment,Ramcircumab combined with docetaxel can prolong PFS and OS of advanced NSCLC patients (HR=0.77, 95%CI[0.69-0.86], P<0.01; HR=0.86, 95%CI [0.76-0.98], P<0.05). The most serious adverse reaction in the ramcircumab group was hypertension (RR=3.33,95%CI[1.83-6.05], P<0.01); whereas the incidences of nausea, vomiting, diarrhea, loss of appetite, fatigue, proteinuria, neutropenia,leukopenia, thrombocytopenia, and bleeding etc. showed no significant differences between the two groups (all P>0.05). Conclusion:Ramcircumab can prolong PFS and OS of patients with advanced NSCLC. The main adverse reaction is hypertension.

国家自然科学基金资助项目（No.81460754）