参附注射液联合含铂一线化疗方案治疗非小细胞肺癌的Meta分析

Meta-analysis on Treatment of Non-small Cell Lung Cancer with Shenfu Injection in Combination with Platinum-contained First-line Chemotherapy

目的:系统评价参附注射液联合含铂一线化疗方案治疗非小细胞肺癌(Non-small cell lung carcinoma,NSCLC)的有效性及安全性。方法:计算机检索Cochrane Library,PubMed,CBM,CNKI,VIP,万方数据库,中国中医药数据库等数据库,检索时限为各库建库时间至2012年9月,搜索参附注射液联合化疗对比单纯化疗治疗非小细胞肺癌的临床随机对照试验,试验中所采用的化疗都是含铂类药物的一线化疗方案,任何文种的文献都在检索范围之内,由两名评价者独立评价并交叉核对纳入研究质量后,采用RevMan5.1软件进行Meta分析。结果:共纳入19篇RCTs,Meta分析结果显示:与单纯化疗相比,参附注射液联合含铂类药物的一线化疗方案治疗非小细胞肺癌不能提高近期疗效[OR=1.41,95%CI(0.98,2.02),P=0.06],但能改善患者的生活质量[OR=2.72,95%CI(1.48,5.00),P=0.001];提高CD3+[SMD=0.41,95%CI(0.10,0.71),P=0.008],CD4+[SMD=7.58,95%CI(4.32,10.84),P<0.000 01]和CD4+/CD8+[SMD=9.89,95%CI(4.76,15.02),P=0.000 2]水平,减少白细胞下降[RR=0.35,95%CI(0.23,0.54),P<0.000 01]、血红蛋白下降[RR=0.41,95%CI:0.20～0.83,P=0.01]和血小板下降[RR=0.34,95%CI(0.18,0.65),P=0.001],降低呕吐反应[RR=0.24,95%CI(0.13,0.45),P<0.000 01)]。结论:参附注射液联合含铂一线化疗方案治疗NSCLC不能增加化疗的近期疗效,但是能够改善患者的生活质量,增强患者的免疫力,并降低严重的化疗毒副反应。这些结果需要大样本的随机对照试验来进一步证明。

Objective： To study the efficacy and safety of Shenfu injection（SFI） in combination with platinum-contained first-line chemotherapy in treating non-small cell lung cancer（NSCLC）.Method： Cochrane library,PubMed,CBM,CNKI,VIP,WANFANG DATA and Traditional Chinese Medicine Database System were searched through computers.The search was finished in September,2012.Randomized controlled trials（RCTs） of SFI in combination with platinum-contained first-line chemotherapy（versus chemotherapy alone） in any language were included.Two researchers extracted data and assess literature quality separately,and made a metaanalyses by RevMan 5.1 software.Result： A Total of 19 RCTs was included.The Meta-analysis showed that compared with the pure application of platinum-contained first-line chemotherapy,the combination of SFI and chemotherapy can not enhance the near-term curative effect [OR = 1.41,95% CI（0.98,2.02）,P = 0.06],but may improve the quality of life [OR = 2.72,95% CI（1.48,5.00）,P = 0.001],enhance CD3＋[SMD = 0.41,95% CI（0.10,0.71）,P = 0.008 ],CD4＋ [SMD = 7.58,95% CI（4.32,10.84）,P 0.000 01]and CD4＋ / CD8＋ [SMD = 9.89,95% CI（4.76,15.02）,P = 0.000 2] and reduced WBC toxicity [RR = 0.35,95% CI（0.23,0.54）,P 0.000 01 ],Hemoglobin toxicity（RR = 0.41,95% CI： 0.20 ～ 0.83,P = 0.01）,Platelet toxicity [RR = 0.34,95% CI（0.18,0.65）,P = 0.001 ],the gastrointestinal reactions [RR = 0.24,95% CI（0.13,0.45）,P 0.000 01） ].Conclusion： The current evidence indicates that SFI can not enhance the chemotherapeutic effect on NSCLC patients,but may improve the quality of life and reduce adverse effect of contained therapy of platinum and chemotherapeutics.These results require confirmation with rigorously controlled trials.