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目的:系统评价复方苦参注射液联合FOLFOX化疗方案治疗大肠癌临床疗效及安全性。方法:EMBASE、Pub Med、Cochrane Library、Cancer Lit、中国期刊全文数据库(CNKI)、中文科技期刊全文数据库(VIP)、中国生物医学文献数据库(Sino Med)、万方数据库等数据库1979~2016年文献,全面搜集复方苦参注射液联合FOLFOX化疗方案治疗大肠癌的随机对照试验,对纳入文献进行质量评价,提取资料并通过Rev Man 5.3软件进行数据分析。结果:共纳入26篇文献,累计2 269例受试者。Meta分析结果显示:在FOLFOX化疗方案基础上联用复方苦参注射液治疗大肠癌的临床疗效优于对照组仅用FOLFOX化疗方案(RR=1.35,95%CI:1.23~1.40,P<0.000 01),生存质量明显改善(RR=1.58,95%CI:1.37~1.83,P<0.000 01)。此外,复方苦参注射液还可降低化疗引起的不良反应的发生率,如白细胞减少(RR=0.62,95%CI:0.42~0.93,P=0.02),恶心呕吐(RR=0.63,95%CI:0.50~0.80,P=0.000 2)。结论:复方苦参注射液联合FOLFOX化疗方案在治疗大肠癌方面具有较好的疗效。
Objective: To systematically evaluate the clinical efficacy and safety of compound Kushen injection combined with FOLFOX chemotherapy in the treatment of colorectal cancer. METHODS: The databases of EMBASE, Pub Med, Cochrane Library, Cancer Lit, Chinese Journal Full-text Database (CNKI), Chinese Science and Technology Periodicals VIP database, Sino Med, Wanfang Database etc. from 1979 to 2016 , A comprehensive randomized controlled trial of compound Kushen injection combined with FOLFOX chemotherapy in the treatment of colorectal cancer was conducted. The quality of the included literature was evaluated and the data were extracted and analyzed by Rev Man 5.3 software. RESULTS: A total of 26 articles were included, with a total of 2,269 subjects. The results of Meta analysis showed that the clinical efficacy of Compound Kushen Injection in treating colorectal cancer was better than that of the control group only treated with FOLFOX chemotherapy (RR = 1.35, 95% CI: 1.23-1.40, P <0.000 01 ), Quality of life improved significantly (RR = 1.58, 95% CI: 1.37-1.83, P <0.000 01). In addition, compound Kushen injection can reduce the incidence of adverse reactions caused by chemotherapy, such as leukopenia (RR = 0.62,95% CI: 0.42-0.93, P = 0.02), nausea and vomiting (RR = 0.63,95% CI : 0.50 to 0.80, P = 0.000 2). Conclusion: Compound Kushen injection combined with FOLFOX chemotherapy has good curative effect in the treatment of colorectal cancer.