参芪扶正注射液联合放疗治疗非小细胞肺癌的Meta分析

Meta-analysis on Treatment of Non-small Cell Lung Cancer by Shenqi Fuzheng Injection in Combination with Radiotherapy

目的:系统评价参芪扶正注射液联合放疗方案治疗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2014年5月,查找参芪扶正注射液联合放疗与单纯使用放疗对比治疗非小细胞肺癌的随机对照试验,任何文种的文献都在检索范围之内,采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,采用Rev Man5.2软件进行Meta分析。结果:共纳入7个随机对照试验,合计517例患者。Meta分析结果显示:与单纯放疗相比,参芪扶正注射液联合放疗方案治疗非小细胞肺癌可显著提高有效率[OR=2.74,95%CI(1.85,4.05),P<0.000 01];提高患者的生活质量[OR=4.85,95%CI(2.65,8.89),P<0.000 01];改善临床症状[OR=4.23,95%CI(2.33,7.69),P<0.000 01];减少放疗引起的骨髓抑制[OR=0.28,95%CI(0.15,0.51),P<0.000 1],放射性肺炎[OR=0.34,95%CI(0.20,0.58),P<0.000 1]和放射性食管炎[OR=0.40,95%CI(0.27,0.61),P<0.000 1],其差异均有统计学意义。结论:参芪扶正注射液联合放疗方案治疗非小细胞肺癌可显著提高有效率,提高患者的生活质量,改善临床症状,减少放疗引起的严重不良反应。然而,现有小样本的随机对照试验(RCT)方法学和报告质量较低,这些结果还需要进一步大样本严格设计的临床试验证实。

Objective ： To study the efficacy and safety of Shenqi Fuzheng injection （SQFZI） combined with radiotherapy in treating non-small cell lung cancer （NSCLC）. Method： Systematic literature searches were performed in PubMed, CBM, CNKI, VIP and WanFang Data from database inception to May 2014. Randomized controlled trials （RCTs） of SQFZI combined with radiotherapy （versus radiotherapy alone） in any language were included. No language limitation was applied. Two reviewers separately assessed the quality of each included study and extracted the data. Meta-analysis was carried out according to the method provided by the Cochrane Collaboration with RevMan5.2 software. Result： A total of 7 RCTs were included. The Meta-analysis showed that the combination of SQFZI and radiotherapy couldimprove the curative effect [ OR = 2.74, 95% CI （1.85, 4, 05）, P 〈0. 000 01 ], improve the quality of life [ OR =4.85, 95% CI （2.65, 8.89）, P 〈0.000 01], improve clinical symptom [OR =4.23, 95% CI （2.33, 7.69）, P 〈0. 000 01 ], reduce myelosuppression [ OR =0.28, 95% CI（0. 15, 0.51）, P〈0.000 1], radiation pneumonitis [OR =0.34, 95%CI （0.20, 0.58）, P 〈0.000 1] and radiation esophagitis [ OR = 0.40, 95% CI （0.27, 0.61 ） , P 〈 0. 000 1 ] as compared with radiotherapy alone. Conclusion： The current results indicates that SQFZI can improve the curative effect on NSCLC patients, improve the quality of life, improve clinical symptom and reduce the adverse effect of radiotherapy. These findings require further confirmation with rigorously controlled trials.