中药汤剂联合FOLFOX方案治疗Ⅲ~Ⅳ期胃癌疗效和安全性的Meta分析  

Meta-analysis of Clinical Efficacy and Safety of Chinese Medicine Decoction Combined with FOLFOX Chemotherapy in the Treatment of StageⅢ-ⅣGastric Cancer

作　　者：吴坚伟 龚红卫 秦丹梅[2] 李成银[2] 杨星[1] 杨杰 田昊 WU Jian-wei;GONG Hong-wei;QIN Dan-mei;LI Cheng-yin;YANG Xing;YANG Jie;TIAN Hao(Hubei University of Chinese Medicine,Wuhan 430061 Hubei,China;Department of Oncology,Hubei Provincial Hospital of Traditional Chinese Medicine,Wuhan 430061 Hubei,China)

机构地区：[1]湖北中医药大学,湖北武汉430061 [2]湖北省中医院肿瘤科,湖北武汉430061

出　　处：《中医肿瘤学杂志》2021年第5期67-77,共11页Journal of Oncology in Chinese Medicine

基　　金：2019国家中医药管理局《中医循证能力建设项目》(编号:2019XZZX-ZL002)。

摘　　要：目的评价中药汤剂联合FOLFOX化疗方案治疗Ⅲ~Ⅳ期胃癌的疗效和安全性。方法通过计算机检索各数据库建库至2021年4月1日公开发表的关于中药汤剂联合FOLFOX方案化疗治疗Ⅲ~Ⅳ期胃癌的随机对照试验(randomized controlled trial,RCT)。数据库包括:中国知网(China nationalknowledgeinfrastructure,CNKI)、维普(VIP)、万方、中国生物医学文献服务系统(China biologymedicine,CBM),PubMed、Embase、The CochraneLibrary;对纳入的RCT进行筛选、提取数据和偏倚风险评价,再应用RevMan 5.3进行Meta分析。结果最终纳入23篇RCT,共1339例患者。Meta分析结果显示,与单纯化疗比较,中药联合化疗的有效率[OR=1.67,95%CI(1.24,2.26),P=0.0008]与KPS改善率更佳[OR=4.75,95%CI(2.87,7.86),P<0.00001];中医临床症状得到改善[OR=3.99,95%CI(2.74,5.80),P<0.00001];消化道反应发生率[OR=0.32,95%CI(0.24,0.42),P<0.00001],白细胞减少发生率[OR=0.52,95%CI(0.36,0.74),P=0.0003],神经毒性发生率[OR=0.48,95%CI(0.31,0.75),P=0.001]均降低;此外,中药联合化疗后的CD3^(+)[WMD=11.68,95%CI(8.77,14.58),P<0.00001]与CD4^(+)[WMD=6.35,95%CI(3.71,8.98),P<0.00001]得到提升;CD4^(+)/CD8^(+)[WMD=0.35,95%CI(0.15,0.56),P=0.0005]比例提高;而CD8^(+)[WMD=0.99,95%CI(-1.69,3.67),P=0.47]在两组之间无统计学意义。结论相较于单纯化疗,中药汤剂联合FOLFOX方案化疗治疗Ⅲ~Ⅳ期胃癌的疗效和安全性更好。Objective To evaluate the clinical efficacy and safety of Chinese medicine decoction combined with FOLFOX chemotherapy in the treatment of stageⅢ-Ⅳgastric cancer.Methods Literature retrieval was performed in the 7 databases of China Knowledge Network(CNKI),VIP,Wanfang,China Biomedical Documentation Service System(CBM),PubMed,Embase,the Cochrane Library from the establishment to April 1,2021.The randomized controlled trials(RCTs)of Chinese medicine decoction combined with FOLFOX regimen chemotherapy for the treatment of stageⅢ-Ⅳgastric cancer were searched.After the screening of the included RCTs,we performed data extraction and individual study quality assessment.The meta-analysis was performed using RevMan 5.3.Results Twenty-three RCTs were finally included,involving a total of 1339 patients.The results of meta analysis showed that compared with chemotherapy alone,Chinese medicine combined chemotherapy had the high effective rate[OR=1.67,95%CI(1.24,2.26),P=0.0008]and Karnofsky Performance Status(KPS)improvement rate[OR=4.75,95%CI(2.87,7.86),P<0.00001],and can effectively relieve the clinical symptoms of traditional Chinese medicine[OR=3.99,95%CI(2.74,5.80),P<0.00001],reduce the incidence of gastrointestinal reactions[OR=0.32,95%CI(0.24,0.42),P<0.00001],leukopenia incidence rate[OR=0.52,95%CI(0.36,0.74),P=0.0003]and incidence rate of neurotoxicity[OR=0.48,95%CI(0.31,0.75),P=0.001].Furthermore,the combined therapy can increase the levels of CD3^(+)[WMD=11.68,95%CI(8.77,14.58),P<0.00001]and CD4^(+)[WMD=6.35,95%CI(3.71,8.98),P<0.00001],and increase the CD4^(+)/CD8^(+)ratio[WMD=0.35,95%CI(0.15,0.56),P=0.0005].However,the difference of CD8^(+)level[WMD=0.99,95%CI(-1.69,3.67),P=0.47]between the two groups was not statistically significant.Conclusion Our finding revealed that the efficacy and safety of Chinese medicine decoction combined with FOLFOX regimen in the treatment of stageⅢ-Ⅳgastric cancer may be better than chemotherapy alone.

关 键 词：中药 联合化疗 胃癌 FOLFOX META分析 

分 类 号：R273[医药卫生—中西医结合] R730.52[医药卫生—中医肿瘤科]