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)、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(P<0.05)。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(P<0.01)。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。
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,Pub Med,Cochrane Library,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 EGFRTKI 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.
出处
《中国中药杂志》
CAS
CSCD
北大核心
2017年第13期2591-2598,共8页
China Journal of Chinese Materia Medica
