摘要
Abstract
OBJECTIVE:To systematically review the efficacy and safety of ixazomib in the treatment of relapsed or refractory multiple myeloma(RRMM).METHODS:Major Chinese and English databases were searched for randomized controlled trials of ixazomib in the treatment of RRMM(the study group received combination therapy containing isazzomib,while the control group was given combination therapy without isazzomib)from the establishment of database to Apr.10th,2023.Two researchers independently screened literature,extracted basic data and evaluated the risk bias.Meta-analysis was performed by Stata 13.0 software.RESULTS:A total of 5 randomized controlled trials with 1 071 patients were included.(1)Efficacy results of Meta-analysis showed that,compared with the control group,the treatment regimen in the study group could improve overall response rate(ORR,RR=1.12,95%CI=1.03-1.22,P=0.009)and≥very good partial response(≥VGPR)rate(RR=1.22,95%CI=1.04-1.43,P=0.016),with statistically significant differences.However,the treatment regimen in study group could not prolong the median overall survival(OS)or progression-free survival(PFS),the differences in median OS(HR=0.97,95%CI=0.62-1.53,P=0.91)and median PFS(HR=0.84,95%CI=0.62-1.14,P=0.26)in both groups were not statistically significant.Subgroup analysis showed that compared with the control group,isazzomib + lenalidomide + dexame-thasone(IRD)regimen could significantly prolong the median PFS,with statistical significances(HR=0.71,95%CI= 0.58-0.88,P=0.001).(2)In terms of safety,there were no significant differences between the study group and control group in grade 3 or higher adverse events(AE),dose reduction and treatment termination caused by AE(P>0.05).CONCLUSIONS:The current evidence shows that isazzomib has higher safety in the treatment of RRMM,with significant efficacy in improving ORR and≥VGPR rate.IRD may be related to prolonged PFS,yet ixazomib can't improve OS.关键词
伊沙佐米/多发性骨髓瘤/有效性/安全性/系统评价Key words
Ixazomib/Multiple myeloma/Efficacy/Safety/Meta-analysis分类
药学
