不同剂量硼替佐米治疗多发性骨髓瘤的临床研究

Clinical study of different dose of bortezomib for the treatment of multiple myeloma

目的:观察1.6mg/m2和1.3mg/m2两种剂量硼替佐米联合沙利度胺、地塞米松治疗多发性骨髓瘤患者的疗效和毒副反应。方法:快速静脉给予1.6mg/m2或1.3mg/m2 2种不同剂量的硼替佐米,同期应用沙利度胺和地塞米松。采用2006年国际骨髓瘤工作组制定的标准判定疗效,并按NCI CTCAE标准判断不良反应。结果:①剂量为1.6mg/m2的9例患者中,3例达到完全缓解(CR),CR率为33%;1.3mg/m2组25例患者中,8例达到CR,CR率为32%,2组差异无统计学意义(P>0.05);②2个疗程后早期评价疗效,1.6mg/m2组的总有效率(ORR)为87.5%,1.3mg/m2组ORR为43.5%,两组差异具有统计学意义(P<0.05);③2组主要不良反应多为胃肠道症状、周围神经病变、血小板减少,1.6mg/m2组发生率依次为66.7%、55%和33%,1.3mg/m2组发生率依次64%、56%和28%,两组差异无统计学意义(P>0.05)。结论:硼替佐米联合沙利度胺、地塞米松治疗多发性骨髓瘤临床疗效明显,不良反应轻微,1.6mg/m2硼替佐米组患者的症状改善明显,且起效快于1.3mg/m2组,患者耐受性良好。

Objective：The objective of the study was to evaluate the curative and toxicity of different doses of bortezomib for the treatment of multiple myeloma.Method：Thirty-four patients received 1.6 mg/ m^2 or 1.3 mg/ m^2 bortezomib in combination with thalidomide and dexamethasone.It was according to criteria of the IMWG develop in 2006 to determine efficacy.Adverse events were graded according to the NCI CTCAE.Result：①3 patients were CR in group of 1.6mg/ m^2,the rate was 33%.8 patients were CR in group of 1.3mg/ m^2,the rate was 32%.②After the second courses the effect is remarkable,The ORR of 1.6mg/ m^2 group was 87.5%,while 1.3 mg/ m^2 team was 43.5%.There was a significant difference between two group（P〈0.05）.③The adverse events included gastrointestinal symptoms,peripheral neuropathy and thrombocytopenia.The incident rate in 1.6 mg/m^2 group was 66.7%,55% and 33% respectively,while it was 64%,56% and 28% in 1.3 mg/m^2 group,which was no significant difference（P〈0.05）.Conclusion：It was more effective of Bortezomib in combination with thalidomide and dexamethasone for the treatment of MM,meanwhile the toxicity was mild.The symptoms were significantly improved in 1.6mg/ m^2 group,had quickly effect with little adverse events than 1.3mg/ m^2 group.