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目的:评价包含吉西他滨的3代药物3药联合方案与常用两药标准方案治疗晚期非小细胞肺癌(NSCLC)的效果和毒性反应,以期为临床用药提供依据。方法:采用系统评价的方法,收集国内外所有上述3药联合和两药联合方案做比较的Ⅲ期和Ⅱ期临床试验文献,进行Meta分析。检索PubMed数据库、Wiley-Blackwel期刊数据库、BMJ电子资源数据库、EMBASE数据库、Karger数据库、中国生物医学文献数据库,按照纳入排除标准提取资料并进行核对。最后对所纳入的研究进行汇总分析。结果:检索出11篇临床研究2 615例患者符合标准,通过Meta分析,3药联合方案的有效率(RR=1.31,95%CI:1.06～1.63)和2年生存率(RR=1.22,95%CI:1.02～1.45)显著高于两药联合方案,1年生存率(RR=1.06,95%CI:0.96～1.16)方面两者差异无统计学意义,但是3药联合方案的血液毒性也高于两药联合方案。亚组分析发现与非铂类两药方案相比3药方案的有效率和血液毒性较高,而与含铂类两药方案相比较无差别。结论:目前的研究结果尚不能推荐3药联合作为NSCLC的首选治疗方案,需要进一步的评价研究。
OBJECTIVE: To evaluate the efficacy and toxicity of gemcitabine combined with 3rd-generation and 3rd-generation drugs and standard two-drug regimens in the treatment of advanced non-small cell lung cancer (NSCLC) in order to provide evidence for clinical use. Methods: A systematic review was carried out to collect all the literature of phase Ⅲ and phase Ⅱ clinical trials of all above-mentioned three drug combination and two drug combination programs at home and abroad for Meta-analysis. The PubMed database, Wiley-Blackwel journal database, BMJ electronic resource database, EMBASE database, Karger database and Chinese biomedical literature database were searched and the data were extracted and checked according to inclusion criteria. Finally, the included studies are summarized and analyzed. Results: A total of 615 clinical studies were performed in 11 clinical trials. Meta-analysis showed that the efficacy of the three-drug combination regimen (RR = 1.31, 95% CI: 1.06-1.63) and 2-year survival rate % CI: 1.02-1.45) was significantly higher than the two-drug combination program, the 1-year survival rate (RR = 1.06, 95% CI: 0.96 to 1.16), there was no statistically significant difference between the two, Higher than the two drugs joint program. Subgroup analysis found that compared with the non-platinum two-drug regimen, the efficacy of the three-drug regimen was higher and the blood toxicity was higher, but no difference compared with the platinum-containing two regimen. Conclusion: The current results can not recommend the combination of 3 drugs as the treatment of choice for NSCLC, the need for further evaluation study.