黄芪注射液结合化疗对儿童急性淋巴细胞白血病疗效的Meta分析

Meta-Analysis of Efficacy of Astragalus Injection Combined with Chemotherapy in the Treatment of Children with Acute Lymphoblastic Leukemia

目的:系统评价黄芪注射液结合化疗对儿童急性淋巴细胞白血病(ALL)的疗效,为临床提供循证参考。方法:计算机检索PubMed、EMBase、the Cochrane Library、CBM、CNKI、VIP、Wanfang数据库,收集有关应用黄芪注射液治疗急性白血病的随机对照试验(RCT),并追踪纳入文献的参考文献,检索时限均为建库至2018年8月。由2名评价者独立选择试验、提取资料和评估方法学质量后,采用RevMan5.3软件进行Meta分析,并使用GRADE系统评价证据质量。结果:本研究最终纳入5个RCT,共423例患儿。Meta分析结果显示,与常规化疗相比,黄芪注射液结合化疗可显著降低ALL患儿微小残留病(MRD)≥1×10^-4发生率(RR=0.53,95%CI 0.32~0.88,P<0.05)和感染发生率(RR=0.59,95%CI 0.46~0.76,P<0.01);提高粒细胞水平(MD=0.93,95%CI 0.55~1.31,P<0.01);两组完全缓解率比较差异无统计学意义(RR=1.16,95%CI 0.98~1.37,P>0.05)。基于GRADE标准的证据等级评价显示,完全缓解率和感染发生率的证据水平为中级,MRD≥1×10^-4发生率证据等级为低级,粒细胞水平证据等级为极低级。结论:黄芪注射液结合化疗治疗ALL可显著降低患儿微小残留病发生率和感染发生率,提高粒细胞水平,增强患儿抗感染能力,但在改善完全缓解率上无优势。由于纳入研究样本量小,结论还需要高质量、大样本的试验进一步验证。

Objective: To systematically evaluate the efficacy of astragalus injection combined with chemotherapy in the treatment of children with acute lymphoblastic leukemia( ALL),so as to provide evidence-based reference for clinical treatment. Methods:PubMed,EMBase,the Cochrane Library,CBM,CNKI,VIP and Wanfang database were retrieved to collect the randomized controlled trials( RCT) of astragalus injection combined with chemotherapy in the treatment of children with ALL. References included in the literature were tracked. The retrieval time was from the establishment of the database to Aug. 2018. Two reviewers independently selected the trials,extracted the data and evaluated the methodological quality,and Meta-analysis was performed with RevMan5. 3 software,and the quality of evidence was evaluated with the GRADE system. Results: A total of 5 RCT were collected,including 423 children. Metaanalysis showed that compared with conventional chemotherapy,astragalus injection combined with chemotherapy could significantly decrease the incidence of minimal residual disease( MRD) ≥1×10^-4 in children with ALL( RR = 0. 53,95%CI: from 0. 32 to 0. 88,P<0. 05) and the incidence of infection( RR = 0. 59,95%CI: from 0. 46 to 0. 76,P<0. 01) and increase the levels of granulocyte( MD= 0. 93,95%CI: from 0. 55 to 1. 31,P<0. 01). There was no significant difference in complete remission rate between two groups( RR= 1. 16,95%CI: from 0. 98 to 1. 37,P>0. 05). According to evaluation of the evidence level based on the GRADE,the evidence level of complete remission rate and incidence of infection was intermediate,the evidence level of incidence of MRD ≥1×10^-4 was low,and the evidence level of granulocyte was extremely low. Conclusion: Astragalus injection combined with chemotherapy in the treatment of children with ALL can significantly decrease the incidence of MRD and infection,increase the levels of granulocyte and enhance the ability of anti-infection,yet without advantages in improving the complete remission rate. Due to the small sample size of the included literature,the conclusion still needs to be further verified by high quality and large sample RCT.