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目的分析硼替佐米联合化疗治疗初治及复发难治性多发性骨髓瘤(MM)的疗效及安全性。方法 43例MM患者采用硼替佐米联合地塞米松(PD)或硼替佐米联合地塞米松及阿霉素(PAD)方案化疗,其中12例患者经硼替佐米联合化疗后接受自体造血干细胞移植术。依据国际2006疗效反应标准评价疗效,毒性分级按美国国立癌症研究院不良事件通用名(NCI CTCAE)v 3.0判断。结果接受2~6个疗程硼替佐米联合化疗后,35例初治患者总反应率为88.6%,8例复发难治患者总反应率为75%。PD方案组(27例患者)总反应率为81.5%,PAD方案组(16例患者)总反应率为93.8%。所有患者获得疗效平均需1.2个疗程(1~3个疗程),中位无疾病进展时间为12个月(1~37个月),1年总生存率为81%,2年总生存率为62.6%。12例接受自体造血干细胞移植的患者,1年总生存率高于单纯接受化疗的患者,但差异无统计学意义(P>0.05)。不良反应主要为乏力、腹泻、便秘、周围神经病变、感染及血液学毒性,经对症治疗后好转。结论硼替佐米联合化疗可有效治疗初治或复发难治性MM患者,常见不良反应经对症治疗可缓解。
Objective To analyze the efficacy and safety of bortezomib combined with chemotherapy in the treatment of relapsed and refractory multiple myeloma (MM). Methods 43 patients with MM were treated with bortezomib combined with dexamethasone (PD) or bortezomib plus dexamethasone and doxorubicin (PAD). 12 patients received autologous hematopoietic stem cell transplantation after bortezomib combined with chemotherapy Surgery. The curative effect was evaluated according to the international 2006 efficacy response standard. Toxicity was graded according to the NCI CTCAE v 3.0. Results After receiving 2 to 6 courses of bortezomib in combination with chemotherapy, the overall response rate was 88.6% in 35 newly treated patients and 75% in 8 refractory patients. The overall response rate was 81.5% in the PD regimen (27 patients) and 93.8% in the PAD regimen (16 patients). All patients received an average of 1.2 courses of treatment (1-3 courses), median progression-free disease was 12 months (1-37 months), 1-year overall survival rate was 81%, 2-year overall survival rate was 62.6%. Among the 12 patients who received autologous stem cell transplantation, the one-year overall survival rate was higher than that of patients receiving chemotherapy alone, but the difference was not statistically significant (P> 0.05). Adverse reactions mainly fatigue, diarrhea, constipation, peripheral neuropathy, infection and hematological toxicity, after symptomatic treatment improved. Conclusion Bortezomib combined with chemotherapy can effectively treat patients with refractory or relapsed MM, the common adverse reactions can be alleviated by symptomatic treatment.