达沙替尼治疗慢性髓系白血病有效性及安全性的Meta分析  

Efficacy and Safety of Dasatinib in the Treatment of Chronic Myeloid Leukemia:A Meta-Analysis

作　　者：冯洁 季春梅 郭玉娇 闫雨婷 王紫怡 何伟 孙鲁宁 王永庆 FENG Jie;JI Chunmei;GUO Yujiao;YAN Yuting;WANG Ziyi;HE Wei;SUN Luning;WANG Yongqing(Department of Pharmacy,the First Affiliated Hospital of Nanjing Medical University,Nanjing 210029,China;Department of Clinical Pharmacy,Nanjing Meishan Hospital,Nanjing 210039,China)

机构地区：[1]南京医科大学第一附属医院药学部,南京210029 [2]南京梅山医院临床药学室,南京210039

出　　处：《药学与临床研究》2024年第5期421-426,共6页Pharmaceutical and Clinical Research

摘　　要：目的:系统性评价达沙替尼在治疗慢性髓系白血病(CML)中的有效性及安全性。方法:检索PubMed、Web of Science、Embase、Cochrane Library、中国知网、万方数据知识平台,从建库到2023年8月所有接受达沙替尼治疗CML的随机对照试验。对符合纳入标准的研究进行资料提取并评价偏倚风险,采用Rev Man 5.3软件对结果进行Meta分析。结果:共纳入9篇RCT文章,涉及1071例患者,对照组均采用伊马替尼治疗。治疗效果方面,达沙替尼组具有更高的主要分子生物学反应(MMR)[OR=1.93,95%CI(1.62,2.32)]和早期分子生物学反应[OR=2.31,95%CI(1.64,3.23)],累计1年的完全细胞遗传学反应(CCyR)也明显优于伊马替尼组[OR=2.08,95%CI(1.42,3.03)];不良反应方面,达沙替尼组发生3~4级严重药物不良反应(ADR)的几率更高[OR=1.56,95%CI(1.26,1.92)],尤其是血小板减少、贫血和胸腔积液更为显著,随访5年时达沙替尼组的ADR相关停药率也明显高于伊马替尼组[OR=2.39,95%CI(1.39,4.13)];但从随访结果来看,两治疗组患者的总体生存期和无进展生存期差异无统计学意义(P>0.05)。结论:达沙替尼在治疗CML时,可产生更高更快速的分子生物学反应,但也更容易发生血液毒性、液体潴留等3~4级严重ADR。Objective:To systematically evaluate the efficacy and safety of dasatinib in the treatment of chronic myeloid leukemia(CML).Methods:We searched PubMed,Web of Science,Embase,Cochrane Library,CNKI.cn and Wanfang data knowledge platforms to collect all randomized controlled trials(RCTs)of dasatinib treatment for CML from the establishment of the database to August 2023.Data were extracted from the studies that met the inclusion criteria and the risk of bias was assessed.The results were analyzed using RevMan5.3 software.Results:A total of 9 RCT articles were included,involving 1071 patients.Observation sieve selection results showed that the control groups were treated with imatinib.The results of meta-analysis showed that in terms of treatment effects,the dasatinib group had higher major molecular reactions(MMR)[OR=1.93,95%CI(1.62,2.32)]and early molecular reactions(EMR)[OR=2.31,95%CI(1.64,3.23)].The cumulative complete cytogenetic response(CCyR)for one year was also significantly better than that of the imatinib group[OR=2.08,95%CI(1.42,3.03)].In terms of adverse reactions,the dasatinib group had a higher incidence in serious adverse reactions(ADR)of grade 3-4[OR=1.56,95%CI(1.26,1.92)],especially in thrombocytopenia,anemia and pleural effusion.The ADR-related discontinuation rate in the dasatinib group was also significantly higher than that in the imatinib group[OR=2.39,95%CI(1.39,4.13)]after 5 years follow-up.However,from the short-term and long-term follow-up results,the overall survival(OS)and progression-free survival(PFS)in the two treatment groups were similar,with no statistically significant difference(P>0.05).Conclusion:Dasatinib can produce higher and faster molecular biological response in the treatment of CML,but it is also more prone to grade 3 to 4 severe ADR such as blood toxicity and fluid retention.

关 键 词：达沙替尼 慢性髓系白血病 有效性 安全性 META分析 

分 类 号：R733.72[医药卫生—肿瘤]