摘要
目的系统评价卡非佐米在真实世界中治疗复发/难治性多发性骨髓瘤(RRMM)的疗效和安全性。方法检索国内外相关数据库(截至2023年4月),收集卡非佐米治疗RRMM的真实世界研究文献。采用非随机研究方法学指标(MINORS)量表对文献质量进行评价。提取卡非佐米治疗RRMM的有效性和安全性数据。有效性指标包括总体缓解率(ORR)、中位无进展生存期(PFS)和中位总生存期(OS),安全性指标包括不良事件(AE)发生率、因AE终止治疗率等。采用Stata 13.0软件进行单组率meta分析,对主要AE的发生情况进行描述性统计分析。结果共纳入12项研究,包括2615例患者。12项研究质量评价结果均为高质量。单组率meta分析结果显示,卡非佐米治疗RRMM的ORR为75%[95%置信区间(CI):68%~82%],≥3级AE发生率为46%(95%CI:44%~49%),因AE终止治疗率为14%(95%CI:10%~19%),主要AE(发生率>5%)包括血小板减少、贫血、中性粒细胞减少、感染、高血压、肝损伤和肾损伤等。结论真实世界中卡非佐米治疗RRMM的疗效低于临床试验。治疗期间需关注感染、血液系统、心血管系统、肝脏和肾脏毒性的发生。
Objective To systematically evaluate the efficacy and safety of carfilzomib in treating relapsed and/or refractory multiple myeloma(RRMM)in the real world.Methods Relevant databases at home and abroad were searched(up to April 2023),and the literature on real⁃world studies of carfilzomib in the treatment of RRMM was collected.The quality of the literature was evaluated with the methodological index for non⁃randomized studies(MINORS)scale.Research data on the effectiveness and safety in RRMM patients treated with carfilzomib were extracted.The effectiveness indicators included the overall response rate(ORR),median progression⁃free survival(PFS),and overall survival(OS).The safety indicators included the incidence of adverse events(AEs)and the rate of treatment termination due to AEs,etc.Stata 13.0 soft⁃ware was used for meta⁃analysis of single proportions,and the occurrence of major adverse events was analyzed by descriptive statistics.Results A total of 12 studies were entered,including 2615 patients.The quality evaluation results showed that all of the 12 studies were with high quality.The meta⁃analysis of single proportions showed that ORR of carfilzomib in the treatment of RRMM was 75%[95%confidence interval(CI):68%⁃82%],the incidence of≥grade 3 AEs was 46%(95%CI:44%⁃49%),and the incidence of treatment termination due to AEs was 14%(95%CI:10%⁃19%).AEs with an incidence of>5%included thrombocytopenia,anemia,neutropenia,infection,hypertension,liverinjury,andkidneyinjury.Conclusions In the real world,the efficacy of carfilzomib in the treatment of RRMM is lower than that in clinical trials.The occurrence of infection during carfilzomib treatment and drug toxicity to the hematological system,cardiovascular system,liver,and kidney need to be paid attention to.
作者
李芸
李兵胜
李义秀
袁珍
熊爱珍
Li Yun;Li Bingsheng;Li Yixiu;Yuan Zhen;Xiong Aizhen(Department of Pharmacy,the Second Affiliated Hospital to Nanchang University,Nanchang 330006,China;Department of Food and Drug,Nanchang Academy of Health Sciences,Nanchang 330004,China;Depart-ment of Health Care,the Second Affiliated Hospital to Nanchang University,Nanchang 330006,China)
出处
《药物不良反应杂志》
CSCD
2024年第3期162-169,共8页
Adverse Drug Reactions Journal
基金
江西省自然科学基金(20212BAB206054)
江西省卫生健康委员会基金(202210638)。
