中医药联合EGFR-TKIs治疗ⅢA-Ⅳ期非小细胞肺癌的系统评价和Meta分析

Combination of traditional Chinese medicine and EGFR-TKIs in treating phase ⅢA-Ⅳnon-small cell lung cancer:A systemic review and Meta-analysis

目的:中医药联合表皮生长因子酪氨酸激酶受体抑制剂(EGFR-TKIs)治疗ⅢA-Ⅳ期非小细胞肺癌的有效性和安全性。方法:计算机检索Pub Med、Medline、EMbase、Cochrane Library中国生物医学文献数据库、中国知网、万方数据资源、维普数据资源等数据库,纳入中医药联合EGFR-TKIs单药治疗ⅢA-Ⅳ期非小细胞肺癌的随机对照试验。由两名评价者独立评价并交叉核对纳入研究质量,对纳入的同质研究采用Rev Man 5.2统计软件进行Meta分析。结果:共纳入15项研究,合计977例患者。Meta分析结果显示,与EGFR-TKIs单药相比,中医药联合EGFR-TKIs能改善疾病的控制率(RR=1.26,P<0.01,95%CI[1.15,1.39])、生活质量(RR=1.35,P<0.01,95%CI[1.21,1.52]),并减轻EGFR-TKIs单药治疗中皮疹、腹泻、恶心呕吐的不良反应。结论:中医药联合EGFRTKIs治疗ⅢA-Ⅳ期非小细胞肺癌比EGFR-TKIs单药有效。由于纳入研究较少,质量不高,该结论尚待更大规模的多中心的随机对照研究进一步验证。

Objective：To evaluate the effectiveness and safety of traditional Chinese medicine（TCM） combined with epidermal growth factor receptor-tyrosine kinase inhibitors（EGFR-TKIs） in treating phase ⅢA-Ⅳ non-small cell lung cancer（NSCLC）.Methods：The randomized controlled trials（RCTs） about treating phase ⅢA-Ⅳ NSCLC with combination of TCM and EGFR-TKIs were retrieved from PubMed,Medline,EMbase,Cochrane Library,China Biology Medicine disc,China National Knowledge Infrastructure,Wanfang database and VIP database by using computer.The quality of RCTs was evaluated independently and checked crossways by two evaluators,and the homogeneous researches were analyzed by using RevMan 5.2software.Results：15 RCTs with 977 patients were included.Mete-analysis results indicated that combination of TCM and EGFRTKIs could improve disease control rate（RR=1.26,P〈0.01,95%Cl[1.15,1.39]） and life quality（RR=1,35,P〈0.01,95%Cl[1.21,1.52]）,and reduce adverse reactions as rashes,diarrhea,nausea and vomiting caused by EGFR-TKIs.Conclusion：The curative effect of combination of TCM and EGFR-TKIs in treating phase ⅢA-Ⅳ NSCLC is superior to that of EGFR-TKIs alone,and the superiority is mainly embodied in improving short term effective rate,life quality and security,and alleviating rashes,diarrhea,nausea and vomiting caused by EGFR-TKIs.Because the number of RCTs included is few,and the quality is not high,the conclusion needs to be verified by large sample,multicenter,randomized,double-blind controlled clinical trials which are designed properly and scientifically.