复方黄黛片治疗急性早幼粒细胞白血病Meta分析

Meta-analysis of Compound Huangdai Tablets in the Treatment of Acute Promyelocytic Leukemia

目的:系统评价联合复方黄黛片的方案用于治疗急性早幼粒细胞白血病的疗效及安全性。方法:计算机检索Cochrane图书馆、EMBase、Medline、PubMed、中国生物医学文献数据库、维普、万方、中国知网数据库,查找与复方黄黛片治疗急性早幼粒细胞白血病相关的随机和半随机对照研究,检索时限为建库至2017年12月。根据纳入及排除标准对文献进行筛选,采用Cochrane Reviewer’s Handbook 5.0评价标准和工具对纳入的研究进行方法学质量评价,对纳入的文献进行数据提取,采用RevMan 5.2软件进行统计分析。共计纳入10个随机对照研究,共498例患者。结果:复方黄黛片治疗急性早幼粒细胞白血病与目前常用治疗方案比较,在完全缓解、达到完全缓解的时间、早期病死率等方面比较,差异无统计学意义(P>0.05),各指标的RR及其95%CI分别1.64(0.53,5.05)、2.91(-4.55,10.38)、0.98(0.39,2.44);同时也对药物安全性进行了对比,在肝功能异常、胃肠反应、皮疹方面比较,两组之间差异亦无统计学意义(P>0.05),各评价指标的RR及其95%CI分别为0.98(0.39,2.44)、1.08(0.74,1.57)、0.75(0.38,1.48);在凝血功能异常方面,其RR及95%CI分别为0.12(0.02,0.56),差异具有统计学意义(P<0.05)。结论:复方黄黛片治疗急性早幼粒细胞白血病并未提高治疗有效性或减少治疗相关肝功能异常、胃肠反应、皮疹的作用;但可降低患者治疗相关凝血功能异常发生率。

Objective:To systematically evaluate the efficacy and safety of the combined regimen of Compound Huangdai Tablets in the treatment of acute promyelocytic leukemia.Methods:The Cochrane Library,EMBase,Medline,Pubmed,China Biomedical Literature Database,Weipu,Wanfang and China HowNet were searched by computer for randomized and semi-randomized controlled studies related to compound Huangdai tablets in the treatment of acute promyelocytic leukemia.The searching time was from the establishment of the database to December 2017.According to the inclusion and exclusion criteria,the literature was screened,and the methodology quality of the included research was evaluated by Cochrane Reviewer′s Handbook 5.0 evaluation criteria and tools.The data of the included literature were extracted and analyzed by RevMan 5.2 software.A total of 498 patients were enrolled in 10 randomized controlled trials.Results:There was no significant difference in complete remission,time to complete remission and early mortality between Compound Huangdai Tablets and the current commonly used treatment regimens(P>0.05).RR(MD)and 95%CI of each index were1.64(0.53,5.05),2.91(-4.55,10.38)and 0.98(0.39,2.44),respectively.At the same time,the drug safety was compared.There was no significant difference between the two groups in terms of liver dysfunction,gastrointestinal reaction and skin rash(P>0.05).The RR and 95%CI of each evaluation index were 0.98(0.39,2.44),1.08(0.74,1.57),0.75(0.38,1.48).In terms of coagulation dysfunction,there was no significant difference between the two groups(P>0.05).RR and 95%CI were 0.12(0.02,0.56)respectively,with statistical significance(P<0.05).Conclusion:Compound Huangdai Tablet did not improve the efficacy of treatment or reduce the effect of treatment-related liver dysfunction,gastrointestinal reaction and rash in acute promyelocytic leukemia,but it could reduce the incidence of treatment-related coagulation dysfunction in patients with acute promyelocytic leukemia.