国产硼替佐米治疗多发性骨髓瘤的临床效果及安全性  

Clinical efficacy and safety of domestic bortezomib in treatment of patients with multiple myeloma

作　　者：李芳芳[1] 李颢[1] 桑玉旗[2] 刘南[2] 卞倩玉 冉学红[3] 于文征[4] 孟昭升 王鲁群[1] Li Fangfang;Li Hao;Sang Yuqi;Liu Nan;Bian Qianyu;Ran Xuehong;Yu Wenzheng;Meng Zhaosheng;Wang Luqun(Department of Hematology,Qilu Hospital of Shandong University,Jinan 250012,China;Department of Hematology,Heze Municipal Hospital in Shandong Province,Heze 274031,China;Department of Hematology,Weifang People's Hospital in Shandong Province,Weifang 261000,China;Department of Hematology,Binzhou Medical University Hospital in Shandong Province,Binzhou 256603,China;Department of Hematology,Zibo Central Hospital in Shandong Province,Zibo 255036,China)

机构地区：[1]山东大学齐鲁医院血液科,济南250012 [2]山东省菏泽市立医院血液科,274031 [3]山东省潍坊市人民医院血液科,261000 [4]山东省滨州医学院附属医院血液科,256603 [5]山东省淄博市中心医院血液科,255036

出　　处：《白血病．淋巴瘤》2020年第9期535-539,共5页Journal of Leukemia & Lymphoma

基　　金：山东省科技攻关计划(GG201703130159、2016GSF201038);吴阶平医学基金(320.6750.19088-84)。

摘　　要：目的:探讨国产硼替佐米治疗多发性骨髓瘤(MM)的临床效果及安全性。方法:回顾性分析2018年1月至2019年6月山东大学齐鲁医院、山东省菏泽市立医院、山东省潍坊市人民医院、山东省滨州医学院附属医院、山东省淄博市中心医院5家医疗中心采用国产硼替佐米为基础化疗方案治疗的60例MM患者资料,其中52例为初治患者,8例为复发难治患者。患者接受至少2个疗程以国产硼替佐米为基础的联合化疗方案,每2个疗程进行疗效评估。结果:随访至2019年6月30日,部分患者未能返院规律治疗。全部患者均完成了至少2个疗程的治疗,总有效率(ORR)为76.7%(46/60);42例患者完成了4个疗程的治疗,ORR为78.6%(33/42);30例患者完成了6个疗程的治疗,ORR为86.7%(26/30);2、4、6个疗程的ORR差异无统计学意义(P>0.05)。2、4、6个疗程的完全缓解+非常好的部分缓解率分别为16.7%(10/60)、47.6%(20/42)和66.7%(20/30),差异有统计学意义(P<0.01)。治疗过程出现的不良事件主要包括感染、周围神经病变、疱疹、消化道症状、血液学毒性等,多为轻度、中度,大多可逆转。2、4、6个疗程总的不良事件发生率分别为91.7%(55/60)、66.7%(28/42)和36.7%(11/30)。结论:以国产硼替佐米为基础的化疗方案治疗MM效果较好,不良事件发生率与原研药类似,患者可耐受。Objective To investigate the clinical efficacy and safety of domestic bortezomib in the treatment of patients with multiple myeloma(MM).Methods The data of 60 MM patients treated with domestic bortezomib as the basic chemotherapy regimen in 5 medical centers of Qilu Hospital of Shandong University,Heze Municipal Hospital,Weifang People's Hospital,Binzhou Medical University Hospital,Zibo Central Hospital in Shandong Province from January 2018 to June 2019 were retrospectively analyzed,52 of which were newly treated patients and 8 were relapsed and refractory patients.The patients received at least 2 courses of combined chemotherapy based on domestic bortezomib,and the efficacy was assessed and evaluated every 2 courses.Results Follow-up until June 30,2019 showed that some patients were unable to return to the hospital for regular treatment.All patients completed at least 2 courses of treatment,with an overall effective rate(ORR)of 76.7%(46/60);42 patients completed 4 courses of treatment,with an ORR of 78.6%(33/42);30 patients completed 6 courses of treatment,with an ORR of 86.7%(26/30);there was no significant difference in ORR of 2,4 and 6 courses(P>0.05).The complete remission+very good partial remission rates of 2,4 and 6 courses were 16.7%(10/60),47.6%(20/42)and 66.7%(20/30),respectively,and the difference was statistically significant(P<0.01).During the treatment,the adverse events mainly included infection,peripheral neuropathy,herpes,digestive tract symptoms,hematologic toxicities and so on,which were light and moderate mostly,and most of them can be reversed.The total incidence of adverse events in patients who completed 2,4 and 6 courses of treatment were 91.7%(55/60),66.7%(28/42)and 36.7%(11/30),respectively.Conclusions The domestic bortezomib-based chemotherapy regimens have good efficacy in the treatment of MM.The incidence of adverse events is similar to that of the original drug,and patients can tolerate the adverse events.

关 键 词：多发性骨髓瘤 硼替佐米 治疗结果 不良事件 

分 类 号：R733.3[医药卫生—肿瘤]