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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

DOI：

中文关键词: 参芪扶正注射剂大肠癌随机对照试验 Meta分析

英文关键词:Shenqifuzheng injection Colorectal carcinoma Randomized controlled trial Meta analysis

基金项目:国家自然科学基金项目（编号：81473547、81673829）

作者	单位
张丹^① 吴嘉瑞^① 刘施^① 张冰^① 崔盈盈^① 王凯欢^① 段笑娇^①	①北京中医药大学中药学院（北京 100102）

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中文摘要:

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、PubMed、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（SinoMed）、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RevMan 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。

英文摘要:

ABSTRACT 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 systematic 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 11 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 total 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 gastrointestinal 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: 0.37 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.

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