He Wei, Cheng Miao
School of Basic Medical Sciences，Shaanxi University of Chinese Medicine, Xianyang 712046, China.
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing 100700, China.
Zhongguo Zhong Yao Za Zhi. 2017 Jul;42(13):2591-2598. doi: 10.19540/j.cnki.cjcmm.20170523.005.
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.
评估中药联合第一代表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）治疗晚期非小细胞肺癌（NSCLC）的疗效和安全性。检索中国生物医学文献数据库（CBM）、中国期刊全文数据库（CNKI）、维普资讯（VIP）、PubMed、Cochrane图书馆、EMbase等中英文数据库，查找中药联合第一代EGFR-TKI治疗晚期NSCLC的随机和临床对照试验。基于总缓解率、疾病控制率、生活质量、一年生存率和不良反应/事件等结局指标，采用Revman 5.3.5测量统计效应。同时，用Stata12.0进行偏倚风险评估。共纳入17项研究，涉及1391例患者，治疗组706例，对照组685例。这些研究方法学质量低、同质性高、发表偏倚风险低。Meta分析显示，中药联合第一代EGFR-TKI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）]、生活质量改善率[RR = 1.28，95%CI（1.17，1.41）]、一年生存率[RR = 1.27，95%CI（1.01，1.61）]等疗效指标均优于单纯第一代EGFR-TKI，差异有统计学意义（P < 0.05）。同时，中药联合第一代EGFR-TKI组的皮肤毒性反应[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/事件发生率低于第一代EGFR-TKI组,差异有统计学意义（P < 0.01）。根据Begg秩相关检验，无发表偏倚。总之，中药联合第一代EGFR-TKI治疗晚期NSCLC的疗效和安全性优于单纯EGFR-TKI。然而，由于样本量小且纳入论文的方法学质量低，该结论仍需高质量、大样本随机对照试验进一步验证。
