黄芪注射液联合含铂化疗方案治疗晚期非小细胞肺癌的Meta分析

Meta-analysis of Astragalus Injection in Combination with Platinum-based Chemotherapy for Treatment of Advanced Non-small Cell Lung Cancer

目的系统评价黄芪注射液联合含铂化疗方案治疗晚期非小细胞肺癌的有效性及安全性。方法计算机检索美国国立医学图书馆(Pubmed),中国期刊全文数据库(CNKI),维普中文科技期刊数据库(VIP),万方数字化期刊全文数据库(Wan Fang Data),中国生物医学文献数据库(CBM),检索时限为各库建库时间至2015年10月,查找黄芪注射液联合含铂化疗方案与单纯含铂化疗对比治疗晚期非小细胞肺癌的随机对照试验,任何文种的文献都在搜索范围之内,使用Cochrane系统评价方法进行评价,由两位评价者独立评价并交叉核对纳入研究的质量,应用Rev Man 5.3软件进行Meta分析。结果纳入8个随机对照试验,共536例患者。Meta分析结果显示,与单纯含铂化疗比较,黄芪注射液联合含铂化疗方案治疗晚期非小细胞肺癌可显著提高患者的生活质量[OR=3.15,95%CI(1.79,5.53),P<0.0001];改善临床症状[OR=3.57,95%CII(1.89,6.77),P<0.0001];减少化疗引起的骨髓抑制[RR=0.51,95%CI(0.39,0.66),P<0.00001];近期疗效比较差异无统计学意义[OR=1.39,95%CI(0.96,2.02),P>0.05];在肾功能损害方面与单纯化疗比较差异无统计学意义[RR=0.50,95%CI(0.22,1.13),P>0.05]。结论黄芪注射液联合含铂化疗方案治疗晚期非小细胞肺癌在近期疗效上无优势;可显著提高患者的生活质量,改善临床症状,减少化疗引起的骨髓抑制。但现有小样本的随机对照试验(RCT)方法学和报告质量较低,其结果还需要严格设计的临床试验进一步证实。

Objective To study the efficacy and safety of Astragalus injection combined with platinum- based chemotherapy in treating advanced non- small cell lung cancer（NSCLC）. Methods Systematic literature searches were performed in Pub Med, CNKI, VIP, Wan Fang Data and CBM from database establishment to September of 2015.Randomized controlled trials（RCTs） for Astragalus injection combined with platinum- based chemotherapy（versus platinum- based first- line chemotherapy alone） in any language were included. Two reviewers assessed the quality of each included study and extracted the data separately. Meta- analysis was carried out according to the method provided by the Cochrane Collaboration with Rev Man5.3 software. Results Eight RCTs involving 536 patients met the inclusion criteria.The Meta- analysis showed that compared with single application of platinum- based chemotherapy, the combination of Astragalus injection and platinum- based chemotherapy could significantly improve the quality of life[OR=3.15,95 % CI（1.79,5.53）,P0.0001] and clinical symptoms [OR=3.57,95 % CI（1.89,6.77）,P0.0001],and decrease the incidence of bone marrow suppression [RR=0.51, 95 % CI（0.39, 0.66）, P〈0.00001]. But the influence of the combined use on short- term effect [OR=1.39,95 % CI（0.96,2.02）,P0.05] and on the injury of renal function [RR=0.50, 95 % CI（0.22, 1.13）, P〈0.05] showed no significant differences as compared with the single application group. Conclusion Astragalus injection combined with platinum- based chemotherapy has no advantages in short- term effect,but could significantly improve the quality of life and clinical symptoms,and reduce bone marrow suppression. However,for the quality of the present RCTs is low,more high- quality clinical trials will be needed for study.