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目的系统评价术后辅助化疗对于Ⅰ期非小细胞肺癌的临床疗效。方法计算机检索Pubmed、Embase、Cochrane Library、中国知网、维普等数据库,收集符合纳入标准的随机对照试验,质量评价后提取数据,采用RevMan 5.0软件进行Meta分析。结果纳入5个RCT研究,包含1 839例Ⅰ期非小细胞肺癌患者,所有研究均采用了随机分组方法,但均未详细报道随机方案的隐藏及是否采用盲法。Meta分析结果显示,采用辅助化疗的患者5年生存期明显高于对照组(RR:0.83,95%CI:0.70~0.98,P=0.03),5年复发情况相似,差异无统计学意义(RR:0.65,95%CI:0.39~1.07,P=0.09),ⅠB期患者的5年总生存没有显著差异(RR:0.90,95%CI:0.74~1.08,P=0.26)。结论术后辅助化疗可以提高Ⅰ期非小细胞肺癌患者的总生存,但无进展生存及亚组分析优势不明显。由于纳入的研究存在偏倚,没有进行充足的亚组分析,会影响结果的论证程度,期待高质量的双盲随机对照试验提供更确切的证据。
Objective To evaluate the clinical effect of postoperative adjuvant chemotherapy on stage Ⅰ non-small cell lung cancer. Methods The databases of Pubmed, Embase, Cochrane Library, CNKI and VIP were searched by computer, and randomized controlled trials were collected to meet the inclusion criteria. The data were extracted after the quality evaluation. Meta-analysis was performed using RevMan 5.0 software. Results Five RCTs were enrolled in this study, including 1 839 patients with stage I non-small cell lung cancer. All the patients were randomized into groups. However, none of the RCTs covered the randomization and blindness. Meta-analysis showed that the 5-year survival of patients receiving adjuvant chemotherapy was significantly higher than that of the control group (RR: 0.83, 95% CI: 0.70-0.98, P = 0.03). The 5-year recurrence was similar with no significant difference : 0.65, 95% CI: 0.39-1.07, P = 0.09). There was no significant difference in 5-year overall survival between patients with stage IB (RR: 0.90; 95% CI: 0.74-1.08, P = 0.26). Conclusion Postoperative adjuvant chemotherapy can improve the overall survival of patients with stage I non-small cell lung cancer, but the progression-free survival and subgroup analysis advantages are not obvious. Because of the biased nature of the included studies, insufficient subgroup analysis is not conducted, the degree of justification of the results will be affected and high-quality, double-blind, randomized controlled trials are expected to provide more precise evidence.