目的 系统评价甲磺酸阿帕替尼治疗晚期非小细胞肺癌（NSCLC）的有效性和安全性。方法 计算机检索Cochrane图书馆、Embase、PubMed、中国生物医学文献数据库（CBM）、中国期刊全文数据库（CNKI）、维普数据库（VIP）、万方数据库等关于甲磺酸阿帕替尼治疗晚期NSCLC的临床随机对照试验（RCT），检索时间均从各数据库创建至2021年6月。由两名评价员独立评价文献质量、提取资料并交叉核对，并进行方法学质量评价，采用RevMan 5.2软件进行Meta分析。结果 共纳入17项RCTs，包括1 263例患者，其中治疗组638例、对照组625例。Meta分析结果显示：甲磺酸阿帕替尼组总有效率[RR=1.48，95% CI （1.36，1.62）]，细胞角蛋白19片段[RR=-1.50，95% CI （-1.75，-1.25）]、血清癌胚抗原[RR=-4.05，95% CI （-4.30，-3.80）]、基质金属蛋白酶-9[RR=-401.98，95% CI （-438.82，-365.13）]、血管内皮生长因子[RR=-192.54，95% CI （-211.55，-173.53）]，与对照组比较均有显著性差异（P<0.000 01）；治疗组消化道不适、蛋白尿、白细胞降低以及口腔黏膜炎的发生危险度高于对照组，但差异无统计学意义。结论 基于现有临床证据，甲磺酸阿帕替尼治疗晚期NSCLC较对照组疗效更为显著，是一种较为理想的用药方案。

Objective To systematically evaluate efficacy and safety of apatinib mesylate for advanced non-small cell lung cancer (NSCLC), for which to provide scientific proofs for clinical decision making. Methods The databases including: The Cochrane Library, Embase, PubMed, CNKI, CBM, VIP, Wanfang Data were searched from the inception to Jun 2021 to collect the randomized controlled trials (RCTs) related to the safety and efficacy of apatinib mesylate for the treatment of advanced NSCLC. Quality assessment and data extraction were conducted by two reviewers independently. Disagreement was resolved through discussion. and data analyses were performed with RevMan 5.2 software. Results A total of 17 RCTs were included, including 1 263 patients. There were 638 patients in treatment groups and 625 patients in the control group. The Meta-analysis results showed, compared with the control group, the total effective rate [RR = 1.48, 95%CI (1.36, 1.62)], cytokeratin-19-fragment [RR = -1.50, 95%CI (-1.75, -1.25)], carcinoembryonic antigen [RR=-4.05,95%CI(-4.30,-3.80)],matrix metalloproteinase-9 [RR = -401.98, 95%CI (-438.82, -365.13)], vascular endothelial growth factor [RR = -192.54, 95%CI (-211.55, -173.53)] were significantly different in apatinib mesylate group (P < 0.000 01). The risk of gastrointestinal discomfort, proteinuria, leukopenia and oral mucositis in the treatment group was higher than that in the control group, but the difference was not statistically significant. Conclusion Based on the present clinical evidence, the Meta-analysis results indicate that the treatment efficacy of apatinib mesylate group is better than control group on treating advanced NSCLC, which is a standard treatment of advanced non-small cell lung cancer.

R979.1

战略支援部队特色医学中心医药卫生基础研究探索课题（19ZX63）