参芪扶正注射液联合化疗治疗结直肠癌的Meta分析

Meta-analysis of Shenqi Fuzheng Injection Combined with Chemotherapy for Colorectal Cancer

目的:系统评价参芪扶正注射液联合化疗治疗结直肠癌的疗效和安全性。方法:计算机检索Pub Med、EMBase、Clinical Trials、Cochrane图书馆、中国期刊全文数据库(CJFD)、中国生物医学文献数据库(CBM)、万方数据库、中文科技期刊数据库(VIP),纳入参芪扶正注射液联合化疗(试验组)对比单纯化疗(对照组)治疗结直肠癌的随机对照试验(RCT),提取资料并按照Cochrane系统评价员手册5.3评价质量后,采用Rev Man 5.3统计软件对数据进行Meta分析。结果:共纳入25篇RCT文献,合计1 987例患者。Meta分析结果显示,试验组患者客观缓解率显著高于对照组[RR=1.19,95%CI(1.02,1.39),P=0.02],生存质量改善情况显著优于对照组[RR=1.72,95%CI(1.49,1.99),P<0.001],CD4+/CD8+显著高于对照组[MD=0.40,95%CI(0.29,0.50),P<0.001],胃肠道反应发生率显著低于对照组[RR=0.59,95%CI(0.52,0.68),P<0.001],肝肾功能损害发生率显著低于对照组[RR=0.52,95%CI(0.41,0.67),P<0.001],差异均有统计学意义。结论:参芪扶正注射液联合化疗可提高结直肠癌患者的客观缓解率,改善其生存质量和免疫功能,减少毒副反应的发生。

OBJECTIVE： To evaluate the clinical efficacy and safety of Shenqi fuzheng injection combined with chemotherapy in the treatment of colorectal cancer. METHODS： Retrieved from PubMed, EMBase, Clinical Trials, Cochrane Library, CJFD, CBM, Wanfang database and VIP, RCTs about Shenqi fuzheng injection combined with chemotherapy （trial group） vs. chemotherapy alone （control group） in the treatment of colorectal cancer were included. Meta-analysis was performed by Rev Man 5.3 statistical software after data extraction and quality evaluation with Cochrane system evaluator manual. RESULTS ： A total of 25 RCTs were included, involving 1 987 patients. Results of Meta-analysis showed that objective remission rate of trial group was significantly higher than control group [RR=I.19, 95% CI （1.02, 1.39）, P----0.02]; the improvement of survival quality was significantly better than control group [RR= 1.72,95%CI（1.49, 1.99）,P〈0.001]; CD4＋/CD8~ was significantly higher than control group [MD=0.40,95%CI（0.29, 0.50）, P〈0.001]; the incidence of gastrointestinal reaction was significantly higher than control group [RR= 0.59,95 % CI （0.52, 0.68）, P〈 0.001]; the incidence of liver and renal injury was significantly lower than control group [RR = 0.52,95 % CI （0.41,0.67）, P〈 0.001] , with statistical significance. CONCLUSIONS： Shenqi fuzheng injection combined with chemotherapy can improve objective remission rate of colorectal cancer patients, survival quality and immune function, and reduce the occurrence of toxic reation.