基于Meta分析的参芪扶正注射剂辅助治疗大肠癌临床评价研究  

Meta-analysis on the Randomized Controlled Trials of Shenqifuzheng Injection in the Treatment of Colorectal Carcinoma

作　　者：张丹[1] 吴嘉瑞[1] 刘施[1] 张冰[1] 崔盈盈[1] 王凯欢 段笑娇 

机构地区：[1]北京中医药大学中药学院,北京100102

出　　处：《药物流行病学杂志》2017年第10期683-688,共6页Chinese Journal of Pharmacoepidemiology

基　　金：国家自然科学基金项目(编号:81473547;81673829)

摘　　要：目的:采用Meta分析方法评价参芪扶正注射剂联合FOLFOX化疗方案治疗大肠癌临床疗效及安全性。方法:计算机检索Embase、Pub Med、the Cochrane Library、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)、万方数据库有关参芪扶正注射剂联合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11篇文献,累计943例受试者。Meta分析结果显示:在FOLFOX化疗方案基础上,联用参芪扶正注射剂可以提高临床总有效率(RR=1.40,95%CI:1.21~1.61,P=0.000 01),改善患者生存质量(RR=1.76,95%CI:1.40~2.23,P<0.000 01),此外,参芪扶正注射剂还可改善化疗引起的不良反应,如消化道反应(RR=0.61,95%CI:0.51~0.74,P<0.000 01),白细胞减少(RR=0.60,95%CI:0.49~0.74,P<0.000 01),血小板减少(RR=0.51,95%CI:0.37~0.71,P<0.000 01),肝功能异常(RR=0.54,95%CI:0.36~0.80,P=0.002)。结论:参芪扶正注射剂联合FOLFOX化疗方案在治疗大肠癌方面具有较好的疗效,但本研究结论还需要进一步大样本严格的随机对照试验来证实。Objective：To systematically assess the clinical effectiveness and safety of Shenqifuzheng injection combined with FOLFOX chemotherapy regimen in the treatment of colorectal carcinoma. Methods ： A thorough and system- atic retrieval of randomized controlled trials （RCTs） which regarding Shenqifuzheng injection combined with FOLFOX chemotherapy regimen for treating colorectal carcinoma was conducted by using literature databases. The methodological quality of the included RCTs was evaluated, and then the data were analysed by RevMan 5.3 software. Results：A total of I 1 RCTs with 943 participants were included. In the Meta-analysis, Shenqifuzheng injection plus FOLFOX chemotherapy regimen could be better than FOLFOX chemotherapy regimen alone in the treatment of colorectal carcinoma in respect of to- tal effective rate （RR = 1.40, 95% CI： 1.21-1.61, P = 0.000 01 ）, and improvement of life quality （ RR = 1.76, 95% CI： 1.40-2.23, P 〈 0.000 01 ）. In addition, Shenqifuzhneg injection can reduce the adverse reactions, such as gastroin- testinal reaction （ RR = 0.61,95 % CI： 0.51-0.74, P 〈 0. 000 01 ）, aleucocytosis （RR = 0.60, 95 % CI： 0.49-0.74, P 〈 0.000 01 ）, thrombocytopenia （RR = 0.51, 95% CI： O. 37-0.71, P 〈 0.000 01 ）, abnormal liver function （ RR = 0.54, 95% CI： 0. 36-0.80, P = 0. 002）. Conclusion： Shenqifuzheng injection combined with FOLFOX chemotherapy regimen is beneficial in the treatment of colorectal carcinoma, while our findings should be comfirmed by more large-size RCTs.

关 键 词：参芪扶正注射剂 大肠癌 随机对照试验 META分析 

分 类 号：R283.611[医药卫生—中药学]