参一胶囊联合化疗治疗胃肠道恶性肿瘤的系统评价

摘要

目的：：系统评价参一胶囊联合化疗治疗胃肠道恶性肿瘤的安全性和有效性。方法：利用计算机和手工方式检索中国生物医学文献数据库(CBM)、中国期刊全文数据库(CNKI)、中文科技期刊数据库(VIP)、万方数据库、中国中医药数据库、Pubmed、Cochrane图书馆。检索参一胶囊联合化疗治疗胃肠道恶性肿瘤(包括食管)的随机对照临床研究。3位研究者对文献质量进行独立的评价,由Cochrane Collaboration's software Rev-Man5.2进行Meta分析。结果：本系统评价共纳入14项研究,纳入病例942例。 Meta分析结果显示参一胶囊联合化疗治疗胃肠道恶性肿瘤(包括食管)与单纯化疗相比,化疗缓解率显著增高( RR=1.47,95%CI 1.24-1.76,P<0.00001),显著改善患者KPS评分(RR=2.17,95%CI 1.51-3.10,P<0.0001),显著降低血清VEGF水平[SMD=0.49,95%CI (-0.71)-(-0.26),P<0.0001],且能够改善化疗的毒副反应。结论：参一胶囊联合化疗治疗胃肠道恶性肿瘤比单纯化疗有效,不增加化疗的毒副反应。由于纳入的文献质量不高且样本量小,这一证据需要更大规模的多中心随机临床对照研究进一步验证。%Objective:To evaluate the efficacy and safety of Shenyi capsule with chemotherapy in treatment of gas-trointestinal cancer. Methods:We searched the PubMed,Cochrane Library,CBM,CNKI,VIP,WanFang Data-base up to the year of 2014. Manual search and additional search were also conducted. Randomized controlled trials of Shenyi capsule with chemotherapy treated Gastrointestinal Cancer were included. Three reviewers independently extracted da-ta and evaluated the quality of eligible studies. Meta-analysis was performed for the results of homogeneous studies by the Cochrane Collaboration`s software RevMan 5. 21. Results:All 14 researches were included in the system review. Total 942 patients were involved. Meta-analyses showed that Shenyi capsule with chemotherapy compared with chemotherapy was more effective in response rate (RR=1. 47,95%CI 1. 24-1. 76,P<0. 00001),KPS scale im-proved rate(RR=2.17,95%CI 1.51-3.10,P<0. 0001),serum VEGF decreased (SMD=0. 49,95%CI (-0. 71)-(-0. 26),P<0. 0001),and improved the adverse reaction of chemotherapy. Conclusion:Shenyi capsule combined with chemotherapy has beneficial effects in treatment of gastrointestinal cancer. Due to the poor quality and small sample of the included trials,more large-scale multicenter randomized trials are needed.