参芪扶正注射液联合NP化疗方案治疗晚期非小细胞肺癌的Meta分析

Meta-analysis of Non-small Cell Lung Cancer with Shenqi Fuzheng Injection in Combination with NP Chemotherapy

目的:系统评价参芪扶正注射液联合长春瑞滨加顺铂(navelbline and cisplatin,NP)化疗方案治疗晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)的临床效果以及安全性。方法:计算机检索Cochrane Library,Pubmed,Embase,中国期刊全文数据库(CNKI),中国生物医学文献数据库(CBM),中国科技期刊全文数据库(VIP)和万方数据库等,检索时间限定为建库至2015年6月,检索所有参芪扶正注射液联合NP化疗方案治疗晚期非小细胞肺癌的随机对照试验(randomized controll trials,RCTs),并追索纳入研究的参考文献。由两位评价者独立对纳入研究的质量进行严格评价和资料提取后,采用Rev Man5.3软件进行Meta分析。结果:最终纳入10个研究,共688例患者。Meta分析结果显示:与单纯使用NP化疗方案相比,参芪扶正注射液联合NP化疗方案可显著提高患者生存质量[OR=3.23,95%CI(2.09,5.00),P<0.000 01],但两组在近期疗效方面无显著性差异[OR=1.38,95%CI(0.99,1.92),P=0.06]。不良反应方面,参芪扶正注射液联合NP化疗方案能减少NP化疗引起的骨髓抑制{白细胞下降[OR=0.33,95%CI(0.23,0.48),P<0.000 01],血红蛋白下降[OR=0.46,95%CI(0.30,0.70),P=0.000 3],血小板下降[OR=0.45,95%CI(0.31,0.67),P<0.000 01]},但在消化道不良反应[OR=0.60,95%CI(0.26,1.40),P=0.24],静脉炎[OR=0.98,95%CI(0.57,1.71),P=0.95],神经毒性[OR=0.78,95%CI(0.25,2.47),P=0.67],肝功能损害[OR=0.73,95%CI(0.30,1.81),P=0.50],肾功能损害[OR=1.48,95%CI(0.28,7.71),P=0.64]方面均无显著性差异。结论:参芪扶正注射液联合NP化疗方案治疗晚期非小细胞肺癌能有效提高患者生存质量,减少化疗引起的严重骨髓抑制,但在近期疗效和消化道不良反应、静脉炎、神经毒性、肝肾功能损害方面和单纯使用NP化疗方案相比无显著性差异。故参芪扶正注射液联合NP化疗方案治疗晚期非小细胞肺癌的疗效以及安全性仍需要严格的、大样本的随机双盲试验加以验证。

Objective： To study the safety and efficacy of Shenqi Fuzheng injection（ SFI） combined with navelbline and cisplatin（ NP） chemotherapy in treating non-small cell lung cancer（ NSCLC）. Method： We searched Cochrane Library,Pubmed,Embase,CNKI,CBM,VIP and Wanfang Data through computer for data as at June 2015. All of randomized controlled trials（ RCTs） of SFI combine with NP chmemotherapy were searched,and research literatures included in the RCTs were also traced. Two researchers independently conducted the strict quality evaluation and data extraction for the included studies and made a Meta-analysis by using Rev Man 5. 3software. Result： Totally 10 RCTs involving 688 patients were included into the study. The Meta-analysis results showed that compared with the pure application of NP chemotherapy regimens,Shenqi Fuzheng injection combined with NP chemotherapy can significantly improve the patients quality of life [OR = 3. 23,95% CI（ 2. 09,2. 09）,P 〈 0. 000 01],but with no significant difference between the two groups in the short-term efficacy [OR = 1. 38,95% CI（ 0. 99,0. 99）,P = 0. 06） ]. In terms of adverse reactions,Shenqi Fuzheng injection combined with NP chemotherapy can reduce bone marrow suppression caused by NP chemotherapy { white blood cells decline [OR =0. 33,95% CI（ 0. 23,0. 23）,P 〈 0. 000 01],hemoglobin decline [OR = 0. 46,95% CI（ 0. 30,0. 30）,P =0. 000 3],platelet decline [OR = 0. 45,95% CI（ 0. 31,0. 31）,P 〈 0. 000 01 ]},but with no significant differences in the digestive tract reactions [OR = 0. 60,95% CI（ 0. 26,0. 26）,P = 0. 24],and phlebitis [OR =0. 98,95% CI（ 0. 57,0. 57）,P = 0. 95 ],neurotoxic [OR = 0. 78,95% CI（ 0. 25,0. 25）,P = 0. 67 ],liver function damage [OR = 0. 73,95% CI（ 0. 30,0. 30）,P = 0. 50] and renal impairment [OR = 1. 48,95% CI（ 0. 28,0. 28）,P = 0. 64） ]. Conclusion： Shenqi Fuzheng injection combined with NP chemotherapy in treating non-small cell lung cancer can effectively improve the quality of life,reduce severe bone marrow suppression caused by chemotherapy,but with no significant difference in the short-term efficacy,gastrointestinal adverse reactions,phlebitis, nerve toxicity, liver and kidney function damage from the simple NP chemotherapy.Therefore,more strict randomized,double-blind trials with a large sample size are required to further verify the efficacy and safety of Shenqi Fuzheng injection combined with NP chemotherapy in treating non-small cell lung cancer.