硼替佐米为主方案与常规化疗方案治疗多发性骨髓瘤疗效比较

目的:评估以硼替佐米为主方案及常规化疗方案对初发多发性骨髓瘤（MM）患者的疗效，并分析其影响生存的预后因素。方法:72例MM患者分别采用5种化疗方案，硼替佐米联合地塞米松（BD方案），硼替佐米联合吡喃阿霉素和地塞米松（BTD方案），长春新碱联合吡喃阿霉素和地塞米松（VTD方案），马法兰、泼尼松(MP)方案，马法兰、泼尼松联合沙利度胺（MPT方案），BD及BTD方案疗程的第 1、4、8、11天给予硼替佐米 1.3mg／m2 静脉注射，患者均接受了4-6个疗程的治疗。结果:72例患者随访期为6-54个月，中位随访期为32个月；治疗后BD、BTD、VTD、MP、MPT组中位PFS分别为26.6、28.1、19.5、17.4、20.5个月；中位OS分别为44.1、48.2、24.3、22.7、27.6个月。使用BD+BTD方案患者总ORR为85.29%（29/34）；VTD方案ORR为 58.33％(7/12)；MP方案ORR为 41.67％(5/12)；MPT方案ORR为 50.00％(7/14)。单因素和多因素分析均显示，治疗后是否获得完全缓解或非常好的部分缓解是影响患者生存的因素，而M蛋白分型、年龄、Durie-salmon分期、高血清肌酐、低血红蛋白、低白蛋白、高β2-微球蛋白、高乳酸脱氢酶均与预后无关。治疗中主要不良反应有血小板减少、外周神经病变、中性粒细胞减少、贫血、腹泻、转氨酶升高等。结论:硼替佐米为主方案治疗初发MM较常规化疗方案疗效显著，患者的耐受好，可消除传统认为的不良预后因素对生存的影响，是一种值得推荐的治疗MM安全、有效及可靠的方法。

Comparison of efficacy and safety between Bortezomib based therapy and routine chem-otherapy regimen on patients with newly diagnosed multiple myeloma

Objective:To evaluate the curative effect of Bortezomib based therapy and routine chemotherapy in treatment of patients with newly diagnosed multiple myeloma，and explore the prognositic factors.Methods:Seventy-two patients with newly diagnosed multiple myeloma received Bortezomib based therapy（BD，BTD），and the routine chemotherapy drugs used in chemotherapy included vincristine+hydrochloride+dexamethasone（VTD），melphalan+prednisone（MP），melphalan+prednisone+thalidomide（MPT），intravenous injection of 1.3mg/m2 Bortezomib was performed on the 1st，4th，8th and 11th day of each course．Patients were managed with 4 to 6 courses.Results:The median duration of follow-up was 32 months.The median progression-free survival of BD，BTD，VTD，MP and MPT was 26.6，28.1，19.5，17.4 and 20.5 months respectively,and the median overall survival was 44.1，48.2，24.3，22.7，27.6 months respectively．The overall response rate（complete remission+very good partial remission+partial remission，ORR） of BD and BTD was 85.29%（29/34）.The ORR of VTD，MP，MPT was 58.33％(7/12），41.67％(5/12)，50.00％(7/14).Univariate analysis and multivariate analysis revealed that complete remission and very good partial remission after treatment were prognostic factors，while M protein typing，age，Durie-salmon staging，high serum creatinine，low hemoglobin，low albumin，high β2-microglobulin and high lactate dehydrogenase were not related to prognosis．The major adverse events during treatment were thrombocytopenic，peripheral neuropathy and fatigue，leukocytopenia，thrombocytopenia，diarrhea，high transaminase.Conclusion:Bortezomib based chemotherapy is well tolerated and effective in treatment of patients with newly diagnosed multiple myeloma，which overcomes the poor prognosis conferred by traditional prognosis factors，and is a safe effective reliable method.