硼替佐米在多发性骨髓瘤维持治疗的疗效与安全性:一项随机对照研究  

The efficacy and safety of Bortezomib in maintenance therapy for multiple myeloma:a randomized controlled study

作　　者：张晨 范锦 许媛媛 Zhang Chen;Fan Jin;Xu Yuanyuan(Heze Municipal Hospital,Heze,Shandong 274000,China)

机构地区：[1]山东省菏泽市立医院,山东菏泽274000

出　　处：《首都食品与医药》2025年第10期77-80,共4页Capital Food Medicine

摘　　要：目的评估硼替佐米在多发性骨髓瘤(multiple myeloma,MM)患者维持治疗中的疗效和安全性。方法采用一项随机对照试验,将符合纳入标准的MM患者随机分为两组,一组接受硼替佐米维持治疗,另一组为不接受硼替佐米治疗的对照组。主要终点为无进展生存期(PFS)和总生存期(OS),次要结局包括不良事件的发生和严重程度。结果研究共纳入了129名患者,其中69名接受了硼替佐米维持治疗。结果显示,硼替佐米组的PFS(HR=0.65,95%CI=0.50-0.77,P<0.05)和OS(HR=0.70,95%CI=0.56-0.97,P<0.05)均显著优于对照组。然而,硼替佐米组的周围神经炎(RR=2.06,95%CI=1.33-2.53,P=0.001)、中性粒细胞减少症(RR=1.22,95%CI=1.06-1.89)和血小板减少(RR=1.90,95%CI=1.02-3.28,P=0.02)的风险显著增加。结论硼替佐米维持治疗能显著改善MM患者的PFS和OS,但应注意周围神经炎及血液系统不良事件发生风险的增加。本研究结果为临床医生在决定是否使用硼替佐米作为MM维持治疗方案时提供了重要的参考依据。Objective To evaluate the efficacy and safety of bortezomib in maintenance therapy for Multiple myeloma(MM)patients.Methods A randomized controlled trial,randomly dividing eligible MM patients into two groups:one group received bortezomib maintenance therapy,and the other group was the control group without bortezomib.The primary endpoints were progression-free survival(PFS)and overall survival(OS),and the secondary outcomes included the occurrence and severity of adverse events.Results A total of 129 patients were included in the study,among whom 69 received bortezomib maintenance therapy.The results showed that the PFS(HR=0.65,95%CI=0.50-0.77,P<0.05)and OS(HR=0.70,95%CI=0.56-0.97,P<0.05)of the bortezomib group were significantly better than those of the control group.However,the risk of peripheral neuropathy(RR=2.06,95%CI=1.33-2.53,P=0.001),neutropenia(RR=1.22,95%CI=1.06-1.89),and thrombocytopenia(RR=1.90,95%CI=1.02-3.28,P=0.02)was significantly increased in the bortezomib group.Conclusion Bortezomib maintenance therapy can significantly improve PFS and OS in MM patients,but the increased risk of peripheral neuropathy and hematological adverse events should be noted.The results of this study provide important reference for clinicians in deciding whether to use bortezomib as maintenance therapy for MM.

关 键 词：硼替佐米 多发性骨髓瘤 维持治疗 疗效 安全性 

分 类 号：R733.3[医药卫生—肿瘤]