目的:系统评价小牛脾提取物注射液辅助化疗治疗肿瘤的疗效与安全性,以为临床治疗提供循证参考。方法:计算机检索Cochrane 图书馆、PubMed、Medline、EMBase、中国期刊全文数据库、万方数据库和中文科技期刊数据库,收集小牛脾提取物注射液辅助化疗治疗肿瘤的随机对照试验(RCT),对符合纳入标准的临床研究进行资料提取,采用Cochrane系统评价员手册5.0版进行质量评价,采用Rev Man 5.0统计软件进行Meta分析。结果:共纳入23项RCT,合计1 682例患者。Meta分析结果显示,小牛脾提取物注射液辅助化疗治疗肿瘤能显著提高有效率[OR=2.17,95%CI(1.68,2.81),P<0.001]和生存质量改善率[OR=4.26,95%CI(2.47,7.32),P<0.001],同时还能降低白细胞、血小板减少率和恶心、呕吐等发生率,差异均有统计学意义。结论:小牛脾提取物注射液辅助化疗治疗肿瘤的疗效与安全性均较好。
Abstract
OBJECTIVE: To systematically review the efficacy and safety of Calf spleen extract injection combined with chemotherapy in the treatment of cancer, and provide evidence-based reference for clinical treatment. METHODS: Retrieved from Cochrane Library, PubMed, Medline, EMBase, CJFD, Wanfang and VIP Database, randomized controlled trials (RCT) of the efficacy and safety about Calf spleen extract injection combined with chemotherapy in the treatment of cancer were collected. Meta-analysis was performed by using Rev Man 5.0 software after data extract and quality evaluation by Cochrane 5.0. RESULTS: Totally 23 RCT were enrolled, including 1 682 patients. Results of Meta-analysis showed Calf spleen extract injection combined with chemotherapy in the treatment of cancer can significantly improve the effective rate [OR=2.17,95%CI(1.68,2.81),P<0.001] and improvement rate of life quality [OR=4.26,95% CI(2.47,7.32),P<0.001] and also reduce the degree rate of WBC and PLT,the incidence rate of nausea and emesis, the differences were statistically significant. CONCLUSIONS: Calf spleen extraction injection combined with chemotherapy has good efficacy and safety in the treatment of cancer.