复方黄黛片治疗急性早幼粒细胞白血病的荟萃分析

Meta-analysis of realgar-indigo naturalis formula in the treatment of acute promyelocytic leukemia

目的对复方黄黛片治疗急性早幼粒细胞白血病的药物有效性和其安全性进行系统评价。方法在CNKI、CBM、万方、VIP和PubMed,Cochrane Library,EM base,Web of Science等主要中英文数据库进行检索。使用中文检索词“复方黄黛片”、“急性早幼粒细胞白血病”和英文检索词“compound realgar natural indigo tablet”or“Realgar-Indigo naturalis formula(RIF)”、“acute promyelocytic leukemia(APL)”为主题和关键词,收集有关复方黄黛片治疗急性早幼粒细胞白血病的临床随机对照试验(randomized controlled trial,RCT),检索的时间是从建立数据库开始到2021年8月。挑选出所有符合要求并纳入质量评价的文献,提取基线数据信息并对文献质量进行评估,对本文献研究结果相关数据的可靠性进行了统计学数据分析。结果总共有21篇纳入RCTS,总样本量1440例,试验组734例,对照组706例。Meta应用分析复方黄黛片治疗急性早幼粒细胞白血病在临床缓解率方面:RIF+西药治疗优于单用西药,RIF+全反式维甲酸优于全反式维甲酸+甲氨蝶呤+巯嘌呤;在缓解时间方面:RIF+全反式维甲酸优于全反式维甲酸+三氧化二砷,RIF+西药优于西药,RIF+模拟全反式维甲酸优于全反式维甲酸+模拟RIF,RIF+全反式维甲酸优于全反式维甲酸+甲氨蝶呤+巯嘌呤;在生存率方面:RIF+全反式维甲酸优于全反式维甲酸+甲氨蝶呤+巯嘌呤,RIF+化疗优于全反式维甲酸+化疗。结论RIF联合全反式维甲酸或者西药(化疗)治疗急性早幼粒细胞白血病能够提高临床缓解率和缓解时间,提高生存率;但受目前纳入临床研究的数量较少、纳入临床研究的结果质量不高等诸多因素制约,相关研究结果质量偏低。因此,目前还需要进一步的临床结果证明和分析才能加以证实。

Objective To systematically evaluate the efficacy and safety of Compound Huangdai Tablets in the treatment of acute promyelocytic leukemia.Methods Search in major Chinese and English databases such as CNKI,CBM,Wan fang,VIP and Pub Med,Cochrane Library,EM base,Web of Science.Use the Chinese search terms"compound realgar natural indigo tablet","acute promyelocytic leukemia"and the English search terms"compound realgar natural indigo tablet"or"Realgar-Indigo naturalis formula(RIF)","acute promyelocytic leukemia(APL)"as the theme and keywords.We collected the randomized controlled trial RCTs(randomized controlled trial RCT)of compound Huangdai tablets in the treatment of acute promyelocytic leukemia.The retrieval time was from the establishment of the database to August 2021.Select all relevant documents that meet the requirements and are included in the quality evaluation criteria,extract the relevant baseline data information and perform a final evaluation of the quality of the relevant literature,and perform a statistical data analysis on the reliability of the relevant data of the research results of this literature.Results A total of 21 RCTS were included,with a total sample size of 1440 cases,734 cases in the experimental group,and 706 cases in the control group.Meta application analysis of compound Huangdai tablets in the treatment of acute promyelocytic leukemia in terms of clinical remission rate:RIF+western medicine was better than western medicine alone,RIF+all-trans retinoic acid was better than all-trans retinoic acid+methotrexate+mercaptopurine;In terms of remission time:RIF+all-trans retinoic acid was better than all-trans retinoic acid+arsenic trioxide,RIF+Western medicine was better than western medicine,RIF+simulated all-trans retinoic acid was better than all-trans retinoic acid+simulated RIF,RIF+all-trans Retinoic acid was better than all-trans retinoic acid+methotrexate+mercaptopurine;in terms of survival rate:RIF+all-trans retinoic acid was better than all-trans retinoic acid+methotrexate+mercaptopurine,RIF+chemotherapy was better All-trans retinoic acid+chemotherapy.Conclusion RIF combined with all-trans retinoic acid or western medicine(chemotherapy)in the treatment of acute promyelocytic leukemia can improve the clinical remission rate and remission time,and improve the survival rate;however,due to the small number of clinical studies currently included and the results of clinical studies included the low quality and many other restricted factors have resulted in the low quality of the research results.Therefore,further clinical results and analysis are needed to confirm it.