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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、Pub Med、Embase、Sino Med、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Rev Man 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。
Objective: To evaluate the efficacy and safety of Shenmai injection in the treatment of acute leukemia by meta-analysis. Methods: Computer search of the Cochrane library, Pub Med, Embase, Sino Med, China Knowledge Network, VIP Journal database and Wanfang Database. Randomized controlled clinical trials of Shenmai injection in the treatment of acute leukemia. The search time limit for each database was built until 2016. September 1st of this year. The Cochrane risk assessment table was used to evaluate the quality of the study, and the extracted data were used for meta-analysis using Rev Man 5.3 software. Results: A total of 12 randomized controlled trials were included and 775 patients were cumulative. Meta-analysis showed that compared with the control group treated with chemotherapeutic drugs only, Shenmai injection-assisted chemotherapeutic treatment can increase the total clinical efficiency (RR=1.15, 95% CI: 1.06 to 1.25, P=0.001); The wheat injection adjuvant chemotherapy drug can also alleviate the adverse reactions caused by chemotherapeutic drugs, such as nausea and vomiting (RR=0.63, 95%CI: 0.49~0.81, P=0.0004), neutropenia (RR=0.58, 95%CI: 0.41). The incidence of ~ 0.82, P = 0.002) and cardiotoxicity (RR = 0.36, 95% CI: 0.22 ~ 0.60, P <0.0001) was lower than that of the control group. Conclusion: Shenmai injection adjuvant chemotherapy for acute leukemia has a good effect, and can alleviate the adverse reactions caused by chemotherapy, it is worthy of clinical promotion. However, subject to the limitations of the methodological quality of the included literature, the conclusion of this study needs to be further verified by a large sample, multi-center randomized controlled trial.