目的： 探讨康艾注射液联合化疗治疗胃癌在临床疗效方面是否优于单独化疗方案。 方法： 全面收集2005－2012年PubMed、中国期刊全文数据库、中文科技期刊全文数据库、中国生物医学文献光盘数据库发表的康艾注射液联合化疗治疗胃癌的临床随机对照试验（randomized controlled trial，RCT），采用Stata软件进行数据处理和Meta分析。 结果： 共有14项RCT纳入Meta分析，与单用化疗相比，康艾注射液联合化疗在改善胃癌患者生活质量（P=0.000）、白细胞降低 （P=0000）、肠胃反应（P=0.000）、肝功损害（P=0.047）、周围神经系统损伤（P=0.000）、体质量降低（P=0.002）及疼痛（P=0017）方面作用明显，而在临床有效率（P=0.093）及其他不良反应方面的差异无统计学意义。 结论： 基于现有临床证据，康艾注射液联合化疗治疗胃癌可提高患者生活质量、减轻化疗的部分不良反应。

Objective: To investigate whether Kang’ai injection combined with chemotherapy can improve the clinical efficiency of patients with gastric cancer treated with chemotherapy alone. Methods: Relevant randomized controlled trials (RCTs) of Kang’ai injection combined with chemotherapy on gastric cancer patients were searched in the PubMed, CJFD database, VIP database and CBMdisc database published in 2005-2012. Stata software was used for data processing and Meta analysis. Results: Fourteen RCTs were included in the Meta analysis. Meta analysis results suggested that compared with chemotherapy alone, the combination therapy containing Kang’ai injection significantly improved the quality of life (QOL) (P=0.000), white blood cell (WBC) reduction (P=0.000), gastrointestinal reaction (P=0.000), liver injury (P=0.047), peripheral neuritis (P=0.000), weight lose (P=0.002) and pain (P=0.017) of patients with gastric cancer. However, the Kang’ai injection combined with chemotherapy showed no significant difference on clinical efficiency (P=0.093) and other side effects compared with chemotherapy alone. Conclusion: From the existing clinical evidence, Kang’ai injection combined with chemotherapy can improve the life quality of patients with gastric cancer and alleviate some common side effects of chemotherapy.

山东省自然科学基金资助项目（No. ZR2010HM059）