去甲氧柔红霉素或柔红霉素联合阿糖胞苷治疗急性髓系白血病患者的安全性分析  

Safety analysis of idarubicin or daunorubicin combined with cytarabine in the treatment of patients with acute myeloid leukemia

作　　者：陈春红 徐鲁杰 刘璐 任美娟 张潇丹 闫美兴 CHEN Chun-hong;XU Lu-jie;LIU Lu;REN Mei-juan;ZHANG Xiao-dan;YAN Mei-xing(School of Medicine,Ocean University of China,Qingdao 266003,Shandong Province,China;Deparment of Pharmary,Qingdao Women and Children's Hospital,Qingdao 266034,Shandong Province,China)

机构地区：[1]中国海洋大学医药学院,山东青岛266003 [2]青岛市妇女儿童医院药学部,山东青岛266034

出　　处：《中国临床药理学杂志》2024年第15期2265-2268,共4页The Chinese Journal of Clinical Pharmacology

基　　金：山东省第二批药品临床综合评价基金资助项目(2022YZ021)。

摘　　要：目的分析去甲氧柔红霉素或柔红霉素联合阿糖胞苷治疗急性髓系白血病患者的安全性。方法检索中国生物医学数据库、中国期刊全文数据库、中文科技期刊全文数据库、万方数据库、Embase、PubMed、Cochrane Library,收集去甲氧柔红霉素联合阿糖胞苷(试验组)和柔红霉素联合阿糖胞苷(对照组)的随机对照试验(RCT),检索时间为2014-01-01—2024-02-23。用RevMan 5.4软件对所纳入文献的药物不良反应进行Meta分析、敏感性分析和发表偏倚分析。结果Meta分析总共纳入11篇RCT,共计1818例患者,其中,试验组912例、对照组906例。Meta分析结果显示,试验组和对照组的总药物不良反应发生率分别为22.9%(56例/245例)和42.9%(105例/245例),在统计学上差异有统计学意义[相对危险度(RR)=0.53,95%置信区间(CI)=0.41~0.69,P<0.001];在具体药物不良反应中,2组患者的血液学毒性、消化系统毒性、心脏毒性、肝肾毒性、感染、出血等发生率比较,在统计学上差异均无统计学意义(均P>0.05)。敏感性分析结果显示,所得分析结果稳定可靠;发表偏倚分析结果显示,本研究存在发表偏倚的可能性较小。结论去甲氧柔红霉素联合阿糖胞苷在治疗急性髓系白血病患者的总药物不良反应发生率显著低于柔红霉素联合阿糖胞苷,故前者的安全性较好。Objective To analyze the safety of idarubicin or daunorubicin combined with cytarabine in the treatment of patients with acute myeloid leukemia.Methods The Chinese Biomedical Database,Chinese Journal Full-text Database,Chinese Science and Technology Journal Full-text Database,Wanfang Database,Embase,PubMed,Cochrane Library were searched.The randomized controlled trials(RCTs)of idarubicin combined with cytarabine(treatment group)and daunorubicin combined with cytarabine(control group)were collected.The search time was from 2014-01-01 to 2024-02-23.RevMan 5.4 software was used to perform meta-analysis,sensitivity analysis and publication bias analysis on adverse drug reactions of the included studies.Results A total of 11 RCTs involving 1818 patients were included in the Meta-analysis.The treatment and control groups were enrolled 912 and 906 cases,respectively.The results of meta-analysis showed that the total incidence of adverse drug reactions in the treatment group and the control group was 22.9%(56 cases/245 cases)and 42.9%(105 cases/245 cases),respectively,and the difference was statistically significant[relative risk(RR)=0.53,95% confidence interval(CI)=0.41-0.69,P<0.001].In the specific adverse drug reactions,there were no statistically significant differences in the incidence of hematological toxicity,digestive system toxicity,cardiac toxicity,liver and kidney toxicity,infection,bleeding between the two groups(allP>0.05).Sensitivity analysis showed that the results were stable and reliable.The results of publication bias analysis showed that this study was less likely to have publication bias.Conclusion The incidence of adverse drug reactions of idarubicin combined with cytarabine in the treatment of patients with acute myeloid leukemia is significantly lower than that of daunorubicin combined with cytarabine,so the former has better safety.

关 键 词：去甲氧柔红霉素 柔红霉素 阿糖胞苷 急性髓系白血病 安全性 

分 类 号：R979.1[医药卫生—药品]