摘要
目的:系统评价伊沙佐米治疗复发/难治性多发性骨髓瘤(RRMM)的有效性和安全性。方法:检索主要的中英文数据库,检索时间为建库至2023年4月10日,选取关于伊沙佐米治疗RRMM的临床随机对照试验(研究组患者采用含有伊沙佐米的联合治疗方案,对照组患者采用不含伊沙佐米的联合治疗方案)。由2名研究者独立筛选文献,提取资料和评价文献质量,采用Stata 13.0软件进行Meta分析。结果:共纳入5项随机对照试验,涉及1 071例患者。(1)有效性的Meta分析结果显示,与对照组比较,研究组方案可显著提高总体缓解率(ORR,RR=1.12,95%CI=1.03~1.22,P=0.009)和≥非常好的部分缓解(≥VGPR)率(RR=1.22,95%CI=1.04~1.43,P=0.016),上述差异均有统计学意义;然而,研究组方案不能延长中位总生存期(OS)和中位无进展生存期(PFS),两组患者中位OS(HR=0.97,95%CI=0.62~1.53,P=0.91)和中位PFS(HR=0.84,95%CI=0.62~1.14,P=0.26)的差异均无统计学意义。亚组分析结果显示,与对照组比较,伊沙佐米+来那度胺+地塞米松(IRD)方案可显著延长中位PFS,差异有统计学意义(HR=0.71,95%CI=0.58~0.88,P=0.001)。(2)安全性方面,研究组与对照组患者≥3级不良事件(AE)、AE导致剂量减少和终止治疗的发生率比较,差异均无统计学意义(P>0.05)。结论:现有研究显示,伊沙佐米治疗RRMM患者的安全性良好,在提高ORR和≥VGPR率方面疗效显著,其中IRD方案可能与PFS延长有关,但伊沙佐米不能延长OS。
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 1071 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.
作者
李芸
李兵胜
李义秀
袁珍
LI Yun;LI Bingsheng;LI Yixiu;YUAN Zhen(Dept.of Pharmacy,the Second Affiliated Hospital of Nanchang University,Nanchang 330006,China;Dept.of Food and Drug,Nanchang Academy of Health Sciences,Nanchang 330004,China;Dept.of Health Care,the Second Affiliated Hospital of Nanchang University,Nanchang 330006,China)
出处
《中国医院用药评价与分析》
2024年第4期473-477,共5页
Evaluation and Analysis of Drug-use in Hospitals of China
