改良硼替佐米联合地塞米松治疗初发多发性骨髓瘤的疗效及安全性

Efficacy and safety of modified bortezomib combined with dexamethasone in the treatment of primary multiple myeloma

目的探讨改良硼替佐米联合地塞米松(BD)治疗初发多发性骨髓瘤(MM)的临床疗效及安全性。方法选取2013年6月~2015年6月在我院血液科接受诊治的40例初发MM患者为研究对象,按照治疗方案分为两组,改良BD方案治疗组17例,VAD(长春瑞滨+吡柔比星+地塞米松)方案治疗组23例。疗效判定采用欧洲骨髓移植协作组(EBMT)制定的统一标准评价,并按照美国国立癌症研究所不良事件通用命名标准(NCICTCAE)观察毒副作用。比较两组患者化疗后临床疗效,观察两组患者化疗前后血红蛋白、M蛋白、β-2微球蛋白、血清肌酐的水平变化并比较两组患者化疗毒副反应情况。结果改良BD组总有效率为88.24%,VAD组总有效率为52.18%,两组比较差异有统计学意义(P<0.05)。化疗后,两组患者M蛋白、β-2微球蛋白、血清肌酐水平均低于化疗前(P<0.05),且与VAD组相比,改良BD组患者化疗后M蛋白、β-2微球蛋白、血清肌酐水平显著降低,差异有统计学意义(P<0.05)。改良BD组出现的毒副作用轻微,均为≤2级毒副作用,经积极症状治疗后均可缓解,未发生严重的不良事件。改良BD组中白细胞下降、血小板降低发生率低于VAD组,差异具有统计学意义(P<0.05)。改良BD组在消化道副作用、乏力、感染、周围神经毒性、心脏毒性等方面发生率均低于VAD组,但差异无统计学意义(P>0.05)。结论改良硼替佐米联合地塞米松方案治疗初发多发性骨髓瘤疗效与标准剂量硼替佐米联合地塞米松方案疗效相似,优于传统VAD化疗方案,并且毒副作用轻微,患者耐受性好,值得临床推广应用。

Objective To explore the efficacy and safety of modified bortezomib combined with dexamethasone(BD)in the treatment of newly diagnosed multiple myeloma(MM).Methods A total of 40 newly diagnosed MM patients treated in Hematology Department of our hospital from June 2013 to June 2015 were selected as the subjects of study.According to the treatment method,they were divided into modified BD group(17 cases)and VAD(Vinorelbine+pirarubicin+dexamethasone)group(23 cases).Efficacy was assessed using a standardized standard developed by the European Society for Bone Marrow Transplantation(EBMT)and the side effects were observed according to the National Cancer Institute Common Criteria for Adverse Events(NCICTCAE).The clinical efficacy of the two groups were compared after chemotherapy,the changes of hemoglobin,M protein,β-2 microglobulin and serum creatinine levels were observed before and after chemotherapy,and the toxicity and side effects of chemotherapy were compared between two groups.Results The total effective rate was 88.24%in the modified BD,and 52.18%in the VAD group,the difference was statistically significant(P<0.05).After chemotherapy,the levels of M protein,β-2 microglobulin and serum creatinine in the two groups were lower than those before chemotherapy(P<0.05).Compared with the VAD group,the M protein,β-2 microglobulin and serum creatinine levels in the modified BD group were significantly lower after chemotherapy(P<0.05).The BD group showed mild toxic side effects,all of which were≤grade 2,which were all relieved after treatment,and no serious adverse events occurred.The incidence of leukopenia and thrombocytopenia in the modified BD group was lower than that in the VAD group,and the difference was statistically significant(P<0.05).The incidence of digestive tract side effects,fatigue,infection,peripheral neurotoxicity and cardiotoxicity in the modified BD group was lower than that in the VAD group,but the difference was not statistically significant(P>0.05).Conclusion The efficacy of modified bortezomib combined with dexamethasone in the treatment of primary multiple myeloma is similar to that of standard dose of bortezomib combined with dexamethasone,and superior to traditional VAD chemotherapy,with mild side effects and good tolerance,thus is worthy of promotion.