紫杉醇脂质体与紫杉醇治疗乳腺癌有效性和安全性的Meta分析

Efficacy and Safety of Paclitaxel Liposomes and Paclitaxel in the Treatment of Breast Cancer: A Meta-analysis

目的:采用Meta分析方法评价紫杉醇脂质体注射剂和紫杉醇注射液治疗乳腺癌的临床有效性与安全性。方法:计算机检索CNKI、WanFang Data、VIP、SinoMed、PubMed、Embase、The Cochrane Library数据库,搜集有关紫杉醇脂质体注射剂和紫杉醇注射液治疗乳腺癌的随机对照试验(RCT),检索时限均从建库至2018年6月,语言限于中文和英文。由两名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5. 3软件进行Meta分析。结果:共纳入16个RCTs,共1 340例患者。Meta分析结果显示:紫杉醇脂质体注射剂与紫杉醇注射液治疗乳腺癌总有效率相当[OR=1. 17,95%CI (0. 92,1. 49),P=0. 19];紫杉醇脂质体注射剂治疗乳腺癌患者导致血液系统毒性(白细胞减少、血小板减少)和神经系统毒性(周围神经炎)的发生率低于紫杉醇注射液,差异有统计学意义(P <0. 05),紫杉醇脂质体注射剂与紫杉醇注射液导致关节肌肉痛、胃肠道反应(恶心呕吐)和过敏反应(皮疹、皮肤潮红、呼吸困难)发生率的差异有统计学意义(P <0. 01),导致血红蛋白降低、脱发和肝功能异常发生率的差异无统计学意义(P> 0. 05)。结论:紫杉醇脂质体注射剂与紫杉醇注射液治疗乳腺癌有效性相当,紫杉醇脂质体注射剂安全性明显优于紫杉醇注射液。

Objective:To explore the efficacy and safety of paclitaxel liposomes and paclitaxel in the treatment of breast cancer.Methods:CNKI,WanFang Data,VIP,SinoMed,PubMed,Embase and Cochrane Library were searched to collect the relative randomized controlled trials(RCTs)of paclitaxel liposomes and paclitaxel in the treatment of breast cancer from the inception to June 2018 in Chinese and English.Two reviewers screened the literatures,extracted the data and assessed the bias risk of the included studies independently.Meta-analysis was performed using RevMan 5.3 software.Results:Totally 16 RCTs involving 1 340 patients were included.The results of meta-analysis suggested the following aspects:no statistical difference was found in the efficacy between paclitaxel liposomes and paclitaxel against breast cancer[OR=1.17,95%CI(0.92,1.49),P=0.19],while statistical differences were found in leukopenia,thrombocytopenia and peripheral neuritis(P<0.05);Significantly statistical differences were found in aches of joint and muscle,nausea and vomiting and anaphylaxis(rush,flushing and dyspnea)(P<0.01).No statistical differences were found in hemoglobin reduction,alopecia and abnormity of liver function(P>0.05).Conclusion:The efficacy of paclitaxel liposomes and paclitaxel against breast cancer is equal,and the safety of paclitaxel liposomes is much better.