参芪扶正注射液联合 FolFox4 方案与 FolFox4 方案对晚期胃癌患者疗效影响分 析简

目的系统评价参芪扶正注射液联合FolFox4方案与单用FolFox4方案在晚期胃癌治疗中的效果。方法根据Cochrane系统评价方法，对Cochranelibrary、Pubmed、中文科技期刊全文数据库、中国生物医学文献数据库等数据库进行检索，检索时间截至2012年12月。根据特定纳入／排除标准选择研究对象为晚期或进展期胃癌患者，实验组为参芪扶正注射液联合FolFox4方案，对照组为单独使用FolFox4方案，比较两组治疗效果的随机对照试验。使用Jadadscale评分对纳入研究进行质量评价，使用Revman5软件进行数据分析。结果根据纳入标准，共纳入6个临床研究，包含498例晚期或进展期胃癌患者。其中4个研究的Jadadscale评分为4分，其余2个研究的评分则较低。Meta分析结果表明，联合组在有效率方面OR=1．71，95％CI（1．04，2．80）]、不良反应方面血液学毒性，P〈0．01，OR=0．45，95％CI（0．27，0．75）；恶心呕吐，P〈0．01。OR=0．66，95％CI（0．39，1．13）]与单独化疗组相比，差异有统计学意义。采用漏斗图对纳入文献进行对称性分析发现可能存在发表偏倚。结论本次分析表明参芪扶正注射液联合FolFox4方案与FolFox4方案化疗相比，前者可提高晚期胃癌患者治疗效果及生活质量，降低不良反应的发生。

Analysis on the effect of Shenqi Fuzheng Injection combined with FolFox4 regimen versus FolFox4 regimen alone in patients with advanced gastric cancer

Objective To systematically review clinical effect of Shenqi Fuzheng Injection associated with FolFox4 reg- imen and FolFox 4 regimen alone for advanced gastric cancer. Methods Electronical databases of Cochrane library, Pubmed, Embase, Chinese science and technology journal full text database and Chinese biomedical literature database were explored in English and Chinese based on the method guidelines for systematic reviews of Cochrane, until Decem- ber 2012. The randomized controlled clinical studies were chosen according to criteria, in which Shenqi Fuzheng Injec- tion combined with FolFox4 regimen treatment group was compared with FolFox4 regimen control group for patients with advanced gastric cancer. Jadad scale was applied in the process of estimating the quality of included trials and Revman 5 software was used for data analysis. Results Six studies including 498 cases of advanced gastric cancer were included based on the inclusion criteria. According to the Jadad scale, four of them were scored as four and the rest re- searches scored a lower level. Compared with control group, there was a significant higher objective response OR = 1.71, 95%CI （1.04, 2.80）], but lower hematological toxicity （P 〈 0.01） OR = 0.45, 95%C! （0.27, 0.75）] and nausea and vomit- ing （P 〈 0.01） OR = 0.66, 95%CI （0.39, 1.13）] in the combination group. Funnel plot analysis revealed there may be a publication bias in some extent. Conclusion The analysis shows that the Shenqi Fuzheng Injection combined with chemotherapy FolFox4 scheme, compared to the control group, can improve treatment efficacy of the patients with ad- vanced gastric cancer and quality of life and reduce the occurrence of adverse reactions.