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

发布时间：2018-10-30 07:23

【摘要】：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)、相关期刊论文(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。
[Abstract]:In order to evaluate the efficacy and safety of Chinese herbal medicine combined with first-generation EGFR-TKI in the treatment of intermediate and advanced non-small cell lung cancer (NSCLC), the Chinese Biomedical Literature Database (CBM), the full text Database of Chinese Journal (CNKI),) and the full text Database (VIP),) of Chinese Journal were searched. Pubmed,Cochrane Library,EMbase and other Chinese and English databases were included in the randomized controlled clinical trial of Chinese herbal medicine combined with first-generation EGFR-TKI in the treatment of intermediate and advanced non-small cell lung cancer. The outcome indicators were total remission rate, disease control rate, quality of life score. 1 year survival rate, adverse reaction / event, Revman 5.3.5 combined with statistical effect, Stata 12.0 were used to analyze the potential publication bias. A total of 17 articles were included, including 1 391 patients, 706 cases in the trial group and 685 cases in the control group. The quality of the study was lower, the homogeneity was better, and the risk of publication bias was lower. The results of Meta analysis showed that the total remission rate of Chinese herbal medicine combined with first-generation EGFR-TKI in the treatment of intermediate and advanced non-small cell lung cancer [RR=1.33,95%CI (1.17 ~ 1.51)], The rate of disease control [RR=1.21,95%CI (1.131.29)], the improvement of quality of life (RR=1.28,95%CI (1.171.41), the 1-year survival rate [RR=1.27,95%CI (1.01 卤1.61)], etc. Compared with the first generation EGFR-TKI, alone, there was statistical difference (P0.05). The incidence of adverse reactions / events in patients with skin toxicity [RR=0.74,95%CI (0.63U 0.86)], gastrointestinal reaction (RR=0.54,95%CI (0.41 卤0.71), liver function damage (RR=0.41,95%CI (0.260.67)], etc. Compared with the first generation EGFR-TKI, alone, there was significant statistical difference (P0.01). Begg rank correlation test showed that there was no publication bias. In a word, compared with the first-generation EGFR-TKI alone, the combined Chinese medicine therapy has better efficacy and safety, but because of the small sample size and the low quality, the conclusion of the study still needs to be further verified by the large sample and high quality research.
【作者单位】：陕西中医药大学基础医学院;北京中医药大学东直门医院;
【分类号】：R734.2

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