【摘要】 目的：系统评价阿美替尼治疗晚期非小细胞肺癌(NSCLC)的临床有效性和安全性。方法：对中英文主要数据库进行系统检索，包括中国知网、万方数据库、维普数据库、中国生物医学文献数据库、Web of Science、Embase、PubMed及the Cochrane Library等，检索时间为建库至2026年2月2日。按照纳入与排除标准收集阿美替尼治疗NSCLC的随机对照试验(RCT,研究组患者采用阿美替尼单药治疗；对照组患者采用非阿美替尼类靶向药物、常规化疗或其他治疗方式),并进行质量评价和资料提取，使用Stata 12.0软件进行Meta分析和发表偏倚评估。结果：最终纳入14篇RCT研究，共涉及1 810例患者。Meta分析结果显示，在临床有效性方面，研究组患者的客观缓解率(RR=1.23,95%CI=1.04～1.46,P=0.018)、疾病控制率(RR=1.12,95%CI=1.02～1.24,P=0.022)均高于对照组，差异均有统计学意义。在安全性方面，两组患者≥3级药品不良反应发生率(RR=0.90,95%CI=0.72～1.12,P=0.347)、皮疹发生率(RR=0.96,95%CI=0.62～1.50,P=0.864)、恶心呕吐发生率(RR=0.90,95%CI=0.53～1.50,P=0.676)的差异均无统计学意义；研究组患者的腹泻发生率低于对照组，差异有统计学意义(RR=0.66,95%CI=0.54～0.81,P=0.000)。漏斗图显示，存在一定的发表偏倚。结论：阿美替尼治疗晚期NSCLC患者疗效确切，安全、可靠。更多还原

【Abstract】 OBJECTIVE: To systematically review the clinical efficacy and safety of almonertinib in the treatment of advanced non-small cell lung cancer(NSCLC). METHODS: A systematic retrieval was conducted across major Chinese and English databases including CNKI, Wanfang Data, VIP, CBM, Web of Science, Embase, PubMed and the Cochrane Library, the retrieval time was from database establishment to Feb. 2nd, 2026. According to the inclusion and exclusion criteria, randomized controlled trials(RCT, the research group was given almonertinib alone, the control group received non-almonertinib targeted drugs or conventional chemotherapy or other treatments) on almonertinib in the treatment of NSCLC were collected for quality evaluation and data extraction, Stata 12.0 software was used to conduct Meta-analysis and publication bias evaluation. RESULTS: A total of 14 RCT were enrolled, involving 1 810 patients. Meta-analysis indicated that in terms of clinical efficacy, the objective remission rate(RR=1.23,95%CI=1.04-1.46,P=0.018) and disease control rate(RR=1.12,95%CI=1.02-1.24,P=0.022) of the research group were significantly higher than those of the control group, with statistically significant differences. In terms of safety, the differences in incidences of grade ≥3 adverse drug reactions(RR=0.90,95%CI=0.72-1.12,P=0.347), rash(RR=0.96,95%CI=0.62-1.50,P=0.864), nausea and vomiting(RR=0.90,95%CI=0.53-1.50,P=0.676) between two groups were not statistically significant; the incidence of diarrhea of the research group was lower than that of the control group, with statistically significant difference(RR=0.66,95%CI=0.54-0.81,P=0.000). Funnel plot indicated the presence of publication bias. CONCLUSIONS: Almonertinib has significant efficacy in the treatment of advanced NSCLC, which is safe and reliable.更多还原