国产硼替佐米治疗多发性骨髓瘤的临床分析  

Clinical analysis of domestic bortezomib in treatment of multiple myeloma

作　　者：康娅 韦素华[2] 李淼静 张欣欣[1] 王梦昌[2] Kang Ya;Wei Suhua;Li Miaojing;Zhang Xinxin;Wang Mengchang(Department of Health Information Services,First Affiliated Hospital of Xi′an Jiaotong University,Xi′an 710061,Shaanxi Province,China;Department of Hematology,First Affiliated Hospital of Xi′an Jiaotong University,Xi′an 710061,Shaanxi Province,China)

机构地区：[1]西安交通大学第一附属医院医疗信息管理办公室,710061 [2]西安交通大学第一附属医院血液内科,710061

出　　处：《国际输血及血液学杂志》2020年第2期142-147,共6页International Journal of Blood Transfusion and Hematology

基　　金：陕西省重点研发计划项目(2019SF-025)。

摘　　要：目的探讨国产硼替佐米治疗多发性骨髓瘤(MM)患者的有效性及安全性。方法选择2018年1月至12月于西安交通大学第一附属医院血液内科接受国产硼替佐米治疗的28例MM患者的临床病例资料为研究对象。其中,男性患者为14例,女性为14例,平均年龄为60岁(46~75岁)。对MM患者采取PCD(硼替佐米+环磷酰胺+地塞米松)或者PAD(硼替佐米+多柔比星+地塞米松)方案治疗,28 d为1个疗程,治疗2~8个疗程。其中,硼替佐米均为国产硼替佐米。回顾性分析MM患者的临床特征、疗效及不良反应。本研究遵循的程序符合2013年修订的《世界医学协会赫尔辛基宣言》要求。结果①本研究28例MM患者接受治疗后,16例获得不同程度的缓解,10例疾病稳定(SD),2例疾病进展(PD),客观缓解率(ORR)为57.1%(16/28),有效率为92.8%(26/28)。28例MM患者的完全缓解(CR)率21.4%(6/28),非常好的部分缓解(VGPR)率为14.3%(4/28),部分缓解(PR)率为21.4%(6/28)。②MM患者接受国产硼替佐米治疗后,常见的治疗相关不良反应为四肢末梢感觉异常,发生率为35.7%(10/28),白细胞计数减少、血小板计数减少、乏力、便秘、腹泻发生率均为14.3%(4/28),肺部感染、带状疱疹病毒感染、头晕、肾功能异常、皮疹发生率均为7.1%(2/28),经对症处理后获得缓解。1例(3.5%)患者因出现反复心悸而终止治疗。除2例患者发生3~4级白细胞计数减少外,其他治疗相关不良反应为1~2级。结论国产硼替佐米治疗MM有效性及安全性评价结果良好。但是本研究为回顾性研究,有一定局限性。Objective To investigate the efficacy and safety of domestic bortezomib in treatment of patients with multiple myeloma(MM).Methods From January to December 2018,clinical case data of 28 MM patients who were treated with domestic bortezomib in Department of Hematology,First Affiliated Hospital of Xi′an Jiaotong University were enrolled in the study.Fourteen patients were male and 14 were female.Mean age was 60 years old(46-75 years old).Patients were treated with PCD(bortezomib+cyclophosphamide+dexamethasone)or PAD(bortezomib+doxorubicin+dexamethasone)regimens in 28 d as a course.Patients had received 2-8 courses.The bortezomib used in this study was domestic bortezomib.The clinical features,efficacy and adverse events of MM patients were analyzed retrospectively.This study met the requirements of World Medical Association Declaration of Helsinki revised in 2013.Results①After treatment,among 28 MM patients,16 cases had different degrees of remission,10 cases were stable disease(SD),2 cases were progressive disease(PD),objective response rate(ORR)was 57.1%(16/28)and effective rate was 92.8%(26/28).Complete remission(CR)rate of 28 MM patients was 21.4%(6/28),very good partial remission(VGPR)rate was 14.3%(4/28),and partial remission(PR)rate was 21.4%(6/28).②After treatment of domestic bortezomib,main adverse events were paresthesia in the extremities and incidence rate was 35.7%(10/28).Incidence rates of leukopenia,thrombocytopenia,weak,constipation and diarrheal were 14.3%(4/28).Incidence rates of pulmonary infection,herpes zoster virus infection,dizziness,renal dysfunction and rash were 7.1%(2/28),and these symptoms were relieved after symptomatic treatment.One patient(3.5%)developed recurrent palpitations and discontinued treatment.Adverse events wereⅠ-Ⅱstage,except 2 patients hadⅢ-Ⅳstage leukopenia.Conclusions Domestic bortezomib is effective and safe in the treatment of MM patients through preliminary evaluation.However,this study is a retrospective study with certain limitations.

关 键 词：多发性骨髓瘤 硼替佐米 药物 仿制 药物疗法 治疗结果 

分 类 号：R733[医药卫生—肿瘤]