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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 evaluate the efficacy and safety of astragalus injection combined with platinum-containing chemotherapy in the treatment of advanced non-small cell lung cancer. Methods The computer was searched by Pubmed, CNKI, VIP, Wan Fang Data, CBM (Chinese Biomedical Literature Database) Search time for each library construction time to October 2015, find Astragalus injection combined with platinum-containing chemotherapy and platinum-containing chemotherapy alone compared to the treatment of advanced non-small cell lung cancer randomized controlled trials, the literature of any kind of literature are in the search range , Using the Cochrane systematic review method for evaluation. The two reviewers independently assessed and cross-checked the quality of the included studies and performed Meta-analysis using RevMan 5.3 software. Results Eight RCTs were enrolled in a total of 536 patients. Meta-analysis showed that astragalus injection and platinum-containing chemotherapy regimen improved the quality of life of patients with advanced non-small cell lung cancer (OR = 3.15, 95% CI 1.79, 5.53, P <0.0001 (RR = 0.51, 95% CI (0.39, 0.66), P <0.00001]. The recent clinical trials (OR = 3.57,95% CII, 1.89,6.77, P <0.0001) There was no significant difference in efficacy between the two groups (OR = 1.39, 95% CI 0.96, 2.02, P 0.05). There was no significant difference in renal dysfunction between chemotherapy and chemotherapy alone (RR 0.50, 95% CI 0.22 , 1.13), P> 0.05]. Conclusion Astragalus injection combined with platinum-containing chemotherapy regimen in the treatment of advanced non-small cell lung cancer has no advantage in short term efficacy; it can significantly improve the quality of life of patients, improve clinical symptoms and reduce chemotherapy-induced bone marrow suppression. However, the small sample randomized controlled trials (RCTs) have poor methodological and reporting quality and the results need to be further substantiated by carefully designed clinical trials.