中药联合第一代EGFR-TKI治疗中晚期非小细胞肺癌有效性及安全性的Meta分析

为评价中药联合第一代EGFR-TKI治疗中晚期非小细胞肺癌的有效性及安全性,检索中国生物医学文献数据库(CBM)、中国期刊全文数据库(CNKI)、维普期刊全文数据库(VIP)、Pubmed、Cochrane Library、EMbase等中英文数据库,纳入中药联合第一代EGFR-TKI治疗中晚期非小细胞肺癌的随机对照临床试验研究,结局指标为总缓解率、疾病控制率、生活质量评分、1年生存率、不良反应/事件,采用Revman 5.3.5合并统计效应量,采用Stata 12.0分析潜在文献发表偏倚。共纳入17篇文献,计1 391例患者,试验组706例,对照组685例。研究质量较低,同质性较好,发表偏倚风险较小。Meta分析结果显示,中药联合第一代EGFR-TKI治疗中晚期非小细胞肺癌的总缓解率RR=1.33,95%CI(1.17,1.51)]、疾病控制率RR=1.21,95%CI(1.13,1.29)]、生活质量改善RR=1.28,95%CI(1.17,1.41)]、1年生存率RR=1.27,95%CI(1.01,1.61)]等有效性指标,优于单用第一代EGFR-TKI,均具有统计学差异(P0.05)。且其皮肤毒性反应RR=0.74,95%CI(0.63,0.86)]、胃肠道反应RR=0.54,95%CI(0.41,0.71)]、肝功能损害RR=0.41,95%CI(0.26,0.67)]等不良反应/事件的发生率,低于单用第一代EGFR-TKI,具有显著统计学差异(P0.01)。Begg秩相关法检验显示不存在文献发表偏倚。总之,与单用第一代EGFR-TKI比较,联合中药治疗具有更好的有效性及安全性,但由于纳入研究样本量小,低质量多,研究结论仍需大样本高质量研究进一步验证。

Meta-analysis on effectiveness and safety of traditional Chinese medicine combined with first-generation EGFR-TKI in treating advanced non-small cell lung cancer

To evaluate the efficacy and safety of traditional Chinese medicine combined with first-generation EGFR-TKI in treating advanced non-small cell lung cancer (NSCLC). China biomedical literature database (CBM), China Journal Full-text Database (CNKI), VIP, PubMed, CochraneLibrary, EMbase and other Chinese and English databases were searched for randomized and clinical controlled trials of traditional Chinese medicine combined with first-generation EGFR-TKI in treating advanced NSCLC. The statistical effect was measured by Revman 5.3.5 based on the outcome indexes of total response rate, disease control rate, quality of life, one-year survival rate, and adverse reactions/events. Meanwhile, a bias risk assessment was conducted by Stata12.0. A total of 17 studies were included, involving 1 391 cases, with 706 cases in the treatment group and 685 cases in the control group. The studies featured a low methodological quality, high homogeneity and low publication bias risk. The meta-analysis showed that total response rate RR=1.33, 95%CI (1.17, 1.51)], disease control rate RR=1.21, 95%CI (1.13, 1.29)], quality of life improvement rate RR=1.28, 95%CI (1.17, 1.41)], one-year survival rate RR=1.27, 95%CI (1.01, 1.61)], and other indexes of effectiveness of Chinese medicine combined with first-generation EGFR-TKI were all superior to those of first-generation EGFR-TKI alone, with significant differences (P<0.05). Meanwhile, the incidence of adverse reaction/events, such as the skin toxic response RR=0.74,95%CI (0.63, 0.86)], gastrointestinal reaction RR=0.54,95%CI (0.41, 0.71)], damage to hepatic function RR=0.41, 95%CI (0.26, 0.67)] in Chinese medicine combined with first-generation EGFR-TKI group were lower than those in first-generation EGFR-TKI group, with significant differences (P<0.01). There was no publication bias according to Begg Rank correlation test. In short, traditional Chinese medicine combined with first-generation EGFR-TKI had a better efficacy and safety in treating advanced NSCLC than EGFR-TKI alone. However, due to the small sample size and the low methodological quality of included papers, the conclusion still needs to be further proved by high-quality, large-sample randomized controlled trials.