国产与进口紫杉醇抗肿瘤疗效和安全性的系统评价

Systematic Review on Efficacy and Safety of Domestic and Imported Paclitaxe in Anti-Tumor

目的:系统评价国产与进口紫杉醇抗肿瘤的疗效和安全性。方法:检索Pubmed、Cochrane Library、Embase、中国生物医学文献数据库、万方数据库、中国期刊全文数据库及中文科技期刊全文数据库等数据库,筛选所有国产与进口紫杉醇在不同肿瘤治疗中的临床疗效和安全性的随机对照试验,检索年限均为建库至2016年12月,根据纳入与排除标准,由2名研究者独立对符合要求的文献进行数据提取和方法学质量评价,采用Rev Man 5.2软件进行文献荟萃(Meta)分析。结果:纳入11篇文献,共665例患者。Meta分析结果显示,国产与进口紫杉醇抗肿瘤总有效率的差异无统计学意义(RR=1,95%CI=0.9~1.10,P=0.96);两者在血液系统反应、消化道反应及过敏反应等安全性指标方面的差异也无统计学意义。结论:现有证据表明,国产与进口紫杉醇抗肿瘤的临床疗效和安全性相近。

OBJECTIVE： To systematically review the efficacy and safety of domestic and imported paclitaxe in anti-tumor. METHODS： Randomized controlled trials on the clinical efficacy and safety of domestic and imported paclitaxe in different oncotherapies from base-building to Dec. 2016 were retrieved from Pub Med,Cochrane Library,Embase,CBM,Wanfang,CNKI and VIP. According to the including and excluding criteria,data extracting and methodological quality evaluation were conducted on the satisfactory studies by 2 independent researchers,and Rev Man5. 2 was adopted to carry out Meta analysis. RESULTS： 11 studies including 665 patients were involved. Results of Meta analysis indicated there was no statistical significance in the difference of total effective rate between domestic and imported paclitaxe in anti-tumor（ RR = 1,95% CI = 0. 9-1. 10,P = 0. 96）; and no statistical significances were found in safety indices of hematological system reaction,digestive tract reaction and anaphylactic reaction. CONCLUSIONS：Present evidence indicates domestic paclitaxe has similar efficacy and safety in anti-tumor with imported paclitaxe.