罗特西普治疗骨髓增生异常综合征患者贫血的有效性与安全性的单组率Meta分析  

Efficacy and safety of luspatercept in the treatment of myelodysplastic syndrome anemia:a single-group rate meta-analysis

作　　者：李佳璟 王安安 郭元成 于晓达 郭建刚 刘蓓[2] LI Jiajing;WANG An’an;GUO Yuancheng;YU Xiaoda;GUO Jiangang;LIU Bei(The First Clinical Medical College,Lanzhou University,Lanzhou 730000,China;Dept.of Hematology,the First Hospital of Lanzhou University,Lanzhou 730000,China)

机构地区：[1]兰州大学第一临床医学院,兰州730000 [2]兰州大学第一医院血液内科,兰州730000

出　　处：《中国药房》2025年第9期1135-1140,共6页China Pharmacy

基　　金：甘肃省科技计划项目(No.24JRRA297)。

摘　　要：目的分析罗特西普治疗骨髓增生异常综合征(MDS)患者贫血的有效性与安全性,为临床用药提供参考。方法计算机检索数据库PubMed、Cochrane Library、Embase、Web of Science中有关罗特西普治疗MDS患者贫血的文献,检索时限均为建库起至2024年1月。根据纳入与排除标准筛选文献后对其进行质量评价,采用RevMan 5.4软件进行单组率Meta分析与敏感性分析,并进行亚组分析。结果本研究纳入9篇文献,共756例患者。Meta分析结果显示,使用罗特西普后,实现脱离红细胞输注≥8周的MDS患者比例为46%[95%CI(0.28,0.64),P<0.00001],实现血液学改善-红系的患者比例为59%[95%CI(0.43,0.74),P<0.00001]。其中5篇文献报道了发生3~4级不良事件的MDS患者比例为14%[95%CI(0.07,0.22),P=0.0002],一般情况不良、感染、血液及淋巴系统疾病是常见的不良事件。亚组分析结果显示,输血负担为实现脱离红细胞输注≥8周的患者比例的异质性来源,修订版国际预后评分系统(IPSS-R)分级、SF3B1基因突变和输血负担为实现血液学改善-红系的患者比例的异质性来源。敏感性分析结果显示,本研究结果稳定。结论罗特西普可显著改善MDS患者的输血依赖性,减轻输血负担,促进血液学改善;但应警惕其3~4级不良事件的发生,其中一般情况不良、感染、血液和淋巴系统疾病等较为常见。OBJECTIVE To analyze the efficacy and safety of luspatercept in the treatment of myelodysplastic syndromes(MDS)anemia,and provide reference for clinical medication.METHODS The literature related to luspatercept for MDS anemia in PubMed,Cochrane Library,Embase and Web of Science were searched by computer,and the search time was from the establishment of the database to January 2024.The quality of literature was evaluated after they were screened according to inclusion and exclusion criteria,the single-group rate meta-analysis and sensitivity analysis were performed by using RevMan 5.4 software,and the subgroup analysis was conducted.RESULTS A total of 756 patients in 9 articles were included in this study.The results of meta-analysis showed that the proportion of MDS patients who reached≥8 weeks of red blood cell transfusion independence(RBC-TI)was 46%after using luspatercept[95%CI(0.28,0.64),P<0.00001].The proportion of MDS patients whose hematological improvement in erythrocyte(HI-E)was 59%[95%CI(0.43,0.74),P<0.00001].Among them,5 articles reported that the proportion of MDS patients with grade 3-4 adverse reactions was 14%[95%CI(0.07,0.22),P=0.0002],and the poor general condition,infection,blood and lymphatic system disease were the common adverse reactions.Subgroup analysis showed that the source of heterogeneity was the blood transfusion burden in the proportion of MDS patients with RBC-TI≥8 weeks,and the source of heterogeneity was the revised international prognostic scoring system(IPSS-R)risk grade,SF3B1 mutation status and blood transfusion burden in the proportion of MDS patients with HI-E.Sensitivity analysis showed that the results of this study were stable.CONCLUSIONS Luspatercept can significantly improve blood transfusion dependence,reduce blood transfusion burden and promote hematology improvement in MDS patients.But attention should be paid to the occurrence of grade 3-4 adverse events;adverse events such as poor general condition,infection,blood and lymphatic system diseases are more common.

关 键 词：罗特西普 骨髓增生异常综合征 贫血 有效性 安全性 

分 类 号：R979.1[医药卫生—药品]