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目的:观察硼替佐米联合沙利度胺治疗复发、难治性多发性骨髓瘤的疗效与安全性。方法:收集我院2007年3月至2010年12月采用硼替佐米联合沙利度胺方案治疗复发、难治性多发性骨髓瘤患者的临床资料进行回顾性分析。治疗方法为硼替佐米1.3 mg/m2,于第1、4、8、11天静脉注射;沙利度胺100 mg/d,口服;21 d为1个疗程。依据欧洲血液及骨髓移植组标准判定疗效,按CTCAE Version 3.0标准评价不良反应。结果:共有66例复发、难治性多发性骨髓瘤患者接受硼替佐米联合沙利度胺治疗,除外因个人原因未完成治疗的7例患者,共有59例患者的资料纳入分析。59例中男37例,女22例,中位年龄51(30～64)岁。中位疗程数为6(2～8),中位观察期5(2～10)个月,59例患者中有6例获得完全缓解,12例获得部分缓解,20例获得轻微缓解,总有效率为64.4%。最常见不良反应为胃肠道症状(42例,其中出现不同程度恶心或呕吐36例次,腹泻29例次),其他不良反应为乏力(37例)、血小板减少(23例)、肢端麻木(18例)、发热(15例)、憋气、心慌(5例)、体位性低血压(4例),有1例患者出现视觉障碍。经减少用药剂量或停药及对症治疗后均获缓解。结论:硼替佐米联合沙利度胺是治疗复发、难治性多发性骨髓瘤的有效方法,同时具有较好的安全性。
Objective: To observe the efficacy and safety of bortezomib and thalidomide in the treatment of relapsed and refractory multiple myeloma. Methods: The clinical data of patients with recurrent and refractory multiple myeloma treated with bortezomib plus thalidomide in our hospital from March 2007 to December 2010 were retrospectively analyzed. The treatment was bortezomib 1.3 mg / m2 intravenously on the 1st, 4th, 8th and 11th day. Thalidomide 100 mg / d, orally; 21 days for a course of treatment. According to European standards of blood and bone marrow transplantation group to determine the efficacy, according to CTCAE Version 3.0 standard evaluation of adverse reactions. RESULTS: A total of 66 relapsed and refractory multiple myeloma patients received bortezomib plus thalidomide, with the exception of 7 patients who did not complete treatment due to personal reasons. A total of 59 patients were included in the analysis. Among 59 patients, 37 were males and 22 were females, with a median age of 51 (30-64) years. The median course of treatment was 6 (2-8). The median observation period was 5 (2-10) months. Six of the 59 patients achieved complete remission, 12 had partial remission, 20 had slight remission, Efficiency is 64.4%. The most common adverse reactions were gastrointestinal symptoms (n = 42, with varying degrees of nausea or vomiting 36 and diarrhea 29), other adverse reactions were fatigue (n = 37), thrombocytopenia (n = 23) (18 cases), fever (15 cases), suffocation, palpitation (5 cases) and orthostatic hypotension (4 cases). One patient had visual impairment. By reducing the dosage or withdrawal and symptomatic treatment were relieved. Conclusion: Bortezomib combined with thalidomide is an effective treatment for relapsed and refractory multiple myeloma with good safety.