OBJECTIVE: From the perspective of evidence-based medicine, to systematically review the efficacy and safety of Kang'ai injection combined with chemotherapy in treatment of gastric cancer, so as to provide references for clinical medication. METHODS: Randomized controlled trials (the observation group was given Kang'ai injection combined with systematic chemotherapy, the control group was given systematic chemotherapy alone) on Kang'ai injection combined with chemotherapy in treatment of gastric cancer during 2005-2015 were retrieved from CNKI, PubMed and Wanfang, data were submitted and Meta-analysis was conducted according to the Cochrane evaluation manual. RESULTS: A total of 16 studies were involved, results of Meta-analysis indicated that the effects of Kang'ai injection combined with chemotherapy in improving living quality (P＜0.000 01), increasing the effective rate of chemotherapy (P＜0.000 01), reducing incidence of white blood cell count reduction (P＜0.000 01), reducing incidences of gastrointestinal reaction (P＜0.000 01) and liver injury (P=0.002) were significantly better than those of chemotherapy alone; there was no statistical significance in difference in reducing the incidence of renal injury between two therapeutic regimens (P=0.15). CONCLUSIONS: Based on present clinical evidence, Kang'ai injection combined with chemotherapy in treatment of gastric cancer can improve the effective rate of chemotherapy and quality of life, reduce part of adverse drug reactions; however, due to the small number of involved studies, the above conclusions should to be treated with caution, which need further verification by high quality, long-term and large-sample trials.%目的:从循证医学的角度, 系统评价康艾注射液联合化疗治疗胃癌的疗效与安全性, 为临床用药提供依据.方法:计算机检索2005—2015年中国期刊全文数据库、PubMed及万方数据库等中英文数据库中关于康艾注射液联合全身化疗方案治疗胃癌的临床随机对照试验 (观察组患者给予康艾注射液联合全身化疗方案, 对照组患者单纯给予全身化疗方案), 依据Cochrane评价手册评价文献质量, 提交数据并进行文献荟萃分析 (Meta分析).结果:共纳入16篇文献, Meta分析结果显示, 康艾注射液联合化疗在改善胃癌患者生活质量 (P＜0.000 01) 、提高化疗有效率 (P＜0.000 01) 和降低白细胞计数降低发生率 (P＜0.000 01) 、肠胃道反应发生率 (P＜0.000 01) 及肝损伤发生率 (P=0.002) 等方面的作用明显优于单纯化疗;两种方案降低肾损伤发生率作用的差异无统计学意义 (P=0.15).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化疗有效率, 改善患者生活质量, 减轻化疗的部分不良反应;但由于纳入研究数量较少, 上述结论需谨慎对待, 期待高质量、长期和大样本的试验进一步验证.
展开▼
