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基于Meta分析的参麦注射剂辅助治疗急性白血病临床评价研究

Meta analysis on Randomized Controlled Trials of Shenmai Injection in Adjuvant Treatment of Acute Leukemia

DOI：

中文关键词: 参麦注射剂急性白血病 Meta分析

英文关键词:Shenmai injection Acute leukemia 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	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分析方法评价参麦注射剂辅助化疗药物治疗急性白血病的有效性及安全性。方法：计算机检索the Cochrane library、PubMed、Embase、SinoMed、中国知网、维普期刊数据库和万方数据库有关参麦注射剂治疗急性白血病的随机对照临床试验文献，检索时限为各数据库建库至2016年9月1日。采用Cochrane风险评价表评价其研究质量，提取资料通过RevMan5.3软件进行Meta分析。结果：共纳入12个随机对照试验，累计患者775例。Meta分析结果显示，与仅采用化疗药物治疗的对照组比较，参麦注射剂辅助化疗药物治疗可提高临床总有效率（RR=1.15，95% CI：1.06~1.25，P=0.001）；此外，参麦注射剂辅助化疗药物治疗还可以缓解化疗药物引起的不良反应，如恶心呕吐（RR=0.63，95%CI：0.49~0.81，P=0.000 4）、白细胞减少（RR=0.58，95%CI：0.41~0.82，P=0.002）及心脏毒性（RR=0.36，95%CI：0.22~0.60，P<0.0001）的发生率低于对照组。结论：参麦注射剂辅助化疗药物治疗急性白血病具有较好的疗效，且能缓解化疗引起的不良反应，值得临床推广。但受纳入文献方法学质量的限制，本研究结论有待大样本、多中心的随机对照试验进一步验证。

英文摘要:

ABSTRACT Objective:To evaluate systematically the clinical effectiveness and safety of Shenmai injection adjuvant chemotherapy in treatment of acute leukemia. Methods:Randomized controlled trials (RCTs) regarding acute leukemia treated by Shenmai injection combined with chemotherapy were searched in the China National Knowledge Infrastructure Database, China Science and Technology Journal Database, Wanfang Database, Chinese Biomedical Literature Database, PubMed and Cochrane Library up to September 1st, 2016. Two reviewers independently retrieved RCTs and extracted information. The Cochrane risk of bias method was used to assess the quality of included studies, and the Meta analysis was conducted with RevMan 5.3 software.Results:12 RCTs involving 775 participants were included. The results of Meta analysis showed that Shenmai injection combined with chemotherapy group was significantly superior to the chemotherapy group in the total effective rates (RR=1.15, 95%CI: 1.06 1.25, P=0.001). Furthermore, compared with receiving chemotheapy alone, Shenmai injection combined with chemothrapy had significant benefits of relieving neusea and vomiting（RR=0.63，95%CI：0.49 0.81，P=0.000 4）,leucopenia（RR=0.58，95%CI：0.41 0.82，P=0.002）and cardiotoxicity（RR=0.36，95%CI：0.22 0.60，P<0.000 1）. Conclusion:Shenmai injection combined with chemotherapy could be beneficial to patients with acute leukemia, and it worthwhile for spreading in clinical practice.

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