培门冬酶和左旋门冬酰胺酶在中国治疗儿童初发急性淋巴细胞白血病的荟萃分析

摘要

目的 进行培门冬酶(PEG-asp)和左旋门冬酰胺酶(L-asp)在中国治疗儿童初发急性淋巴细胞白血病的疗效、安全性及药物经济学方面的系统分析.方法 检索中国知网、万方数据库、维普科技期刊数据库、Pubmed数据库、OVID数据库,收集国内关于PEG-asp和L-asp治疗儿童初发急性淋巴细胞白血病的RCT,时间截止至2017年3月.采用RevMan5.3软件进行Meta分析.结果 最终纳入5篇RCT,共544例患者(PEG-asp组272例,L-asp组272例).①与L-asp组相比,PEG-asp组在诱导缓解治疗中的完全缓解率(OR=0.85,95％CI=0.55～1.34,P>0.05),总有效率(OR=1.35,95％CI=0.63～2.90,P>0.05);两组疗效相当.②PEG-asp组和L-asp组不良反应发生率差异无统计学意义.③PEG-asp组比L-asp组住院时间短(WMD=-6.60,95％CI=-7.99～-5.22).结论 PEG-asp与L-asp在儿童急 性 淋巴细胞白血病诱导治疗中的疗效和安全性相当,从药物经济学的角度来看, PEG-asp可能是更好的选择.%Objective To evaluate the efficacy,safety and pharmacoeconmics between pegaspargase(PEG-asp) and L-sparaginase (L-asp)in treatment of Chinese children with acute lymphoblasfic leukemia.Methods CNKI, Wanfang,VIP,PubMed and OVID databases were searched to collect RCTs which compared PEG-asp with L-asp in treatment of Chinese children with acute lymphoblasfic leukemia,and the retrieval time was until March,2017.Meta-analysis was conducted by Revman 5.3 software.Results Finally,five RCTs were included in this study.A total of 544 children with ALL were enrolled,including 272 patients in PEG-asp group and 272 patients in L-asp group.①The meta-analysis showed that the complete remission CR)rate and the total response (RR)rate between the two therapy groups were similar.Compared to L-asp group,the OR of the CR rate of PEG-asp group was 0.85 (95％ CI =0.55-1.34,P >0.05);and the RR of the CR rate was 1.35 (95％ CI =0.63-2.90,P >0.05).② All five articles reported the occurrence of adverse reaction.In each study,the occurrence rate of adverse reaction between the two therapy groups was no statistically significant difference.③ In three articles,the hospitalized days and the number of drugs between the two therapy groups were compared.The meta-analysis of the hospitalized days between the two therapy groups showed that the hospitalized days of PEG-asp group was significantly shorter than that in L-asp group (WMD:-6.60,95％ CI =-7.99 to -5.22).Conclusion The effectiveness of PEG-asp and L-asp in treatment of pediatric ALL is similar and has no difference in adverse effect.However,PEG-asp may be a better choice from the point of view of pharmacoeconmics.