康莱特联合吉西他滨治疗晚期非小细胞肺癌有效性和安全性的Meta分析

Ef ectiveness and Safety of Kanglaite Combined with Gemcitabine for Advanced Non-small Cell Lung Cancer: A Meta-Analysis

目的系统评价康莱特联合吉西他滨治疗晚期非小细胞肺癌(NSCLC)的有效性及安全性。方法计算机检索PubMed、EMbase、h e Cochrane Library(2013年第9期)、CBM、CNKI、VIP和WanFang Data,查找康莱特联合吉西他滨治疗晚期NSCLC患者的随机对照试验(RCT),检索时限均为从建库至2013年9月。由2位评价员按照纳入与排除标准独立筛选文献、提取资料和评价纳入研究的方法学质量后,采用RevMan 5.2软件进行Meta分析。结果最终纳入7个RCT,共计506例患者。Meta分析结果显示:①在有效性方面,康莱特注射液联合吉西他滨化疗方案能有效提高晚期NSCLC患者的近期治疗有效率[OR=1.85,95%CI(1.29,2.65),P=0.000 8]、改善患者的生活质量[OR=3.02,95%CI(1.90,4.78),P<0.000 1]及免疫功能[MD=0.64,95%CI(0.31,0.97),P=0.000 1];在安全性方面,康莱特注射液联合吉西他滨化疗方案能减少白细胞下降[OR=0.30,95%CI(0.19,0.47),P<0.000 01]、恶心呕吐[OR=0.49,95%CI(0.34,0.73),P=0.000 3]、骨髓抑制[OR=0.27,95%CI(0.16,0.45),P<0.000 01]及肝肾功能损害[OR=0.43,95%CI(0.28,0.68),P=0.000 3]的发生率,其差异均有统计学意义。②两组在改善晚期NSCLC患者血小板下降方面无明显差异[OR=0.67,95%CI(0.40,1.14),P=0.14]。结论应用康莱特联合吉西他滨治疗晚期NSCLC可提高患者近期治疗有效率,改善患者生活质量,降低化疗不良反应发生率,但在减少血小板下降方面无明显优势。受纳入研究数量和质量限制,上述结论尚有赖于开展更多大样本、多中心、高质量的RCT加以验证。

Objective To systematically review the effectiveness and safety of Kanglaite combined with gemcit- abine in treating patients with advanced non-small cell lung cancer （NSCLC）. Methods The randomized controlled trials （RCTs） about Kanglaite ombined with gemcitabine treating advanced NSCLC was retrieved in PubMed, EMbase, The Cochrane Library （Issue 9, 2013）, CBM, CNKI, VIP, and WanFang Data from the dates of their establishment to Sep- tember 2013. Literature screening according to the inclusion and exclusion criteria, data extraction and methodological quality assessment were completed by two reviewers independently. Meta-analysis was then conducted using RevMan 5.2 software. Results A total of seven RCTs involving 506 patients were finally included. The results of meta-analysis indicated that： a） Kanglaite injection combined with gemcitabine chemotherapy increased short-term effectiveness （OR=1.85, 95%CI 1.29 to 2.65, P=O.O00 8）, patients＇ quality of life （OR=3.02, 95%CI 1.90 to 4.78, P〈0.000 1）, and immune function （MD=0.64, 95%CI 0.31 to 0.97, P=O.O00 1）; and reduced the incidences of leukopenia decrease （OR=0.30, 95%CI 0.19 to 0.47, P〈O.O00 01）, nausea and vomiting （OR=0.49, 95%CI 0.34 to 0.73, P=0.000 3）, bone marrow suppression （OR=0.27, 95%C! 0.16 to 0.45, P〈0.000 01）, and liver and renal impairments （OR=0.43, 95%CI 0.28 to 0.68, P=0.000 3）, all with sig- nificant differences, b） Both groups were alike in reducing thrombocytopenia （OR=0.67, 95%CI 0.40 to 1.14, P=0.14） without significant differences. Conclusion Applying Kanglaite injection combined with gemcitabine in treating patients with advanced NSCLC could increase short-term effectiveness, improve patients＇ quality of life and immune function; and reduce the incidences of adverse reaction caused by chemotherapy. However, it has no obvious advantage in reducing thrombocytopenia. Due to the limited quantity and quality high quality RCT are needed to verify the above conclusion.