沙利度胺联合低剂量地塞米松治疗多发性骨髓瘤的临床研究

Treatment with low-dose dexamethasone combined with thalidomide in multiple myeloma

目的探讨低剂量地塞米松联合沙利度胺治疗多发性骨髓瘤(Multiple Myeloma,MM)的临床疗效。方法选择临床治疗的MM患者56例,其中初发及难治MM患者36例、平台期患者20例(低剂量组),采用低剂量地塞米松联合沙利度胺治疗。另选匹配的非随机、历史对照患者23例(标准剂量组)采用标准剂量的地塞米松联合沙利度胺方案治疗。结果低剂量组36例初发及难治性患者中21例患者获得不同程度的缓解,总有效率为58.33%,其中完全缓解(CR)2例(5.56%),很好的部分缓解(VGPR)1例(2.78%),部分缓解(PR)18例(50.00%),1年无进展生存期(PFS)和总生存期(OS)分别为53.70%和43.50%。标准剂量组的23例患者中CR 2例(8.70%),VGPR 3例(13.04%),PR 9例(39.13%),总有效率为60.87%,两组疗效相当,差异无统计学意义(P>0.05)。低剂量组肺部感染等副作用明显低于标准剂量组,差异有统计学意义((P<0.05)。结论低剂量地塞米松联合沙利度胺可有效治疗初发及难治多发性骨髓瘤患者,并可用于MM平台期患者的维持治疗,临床疗效与标准剂量相当,但毒副作用更小。

Objective To evaluate the efficacy of low-dose dexamethasone combined with thalidomide as standardized treatment in multiple myeloma. Methods 56 patients were diagnosed with multiple myeloma. 36 patients among them were previously untreated or recurrently intractable, and the other 20 patients were in a stable condition. Low-dose dexamethasone and thalidomide was adopted as therapeutic schedule. 23 patients in non-randomized matched historical control group were treated with standard-dose dexamethasone and thalidomide. Results Among the 36 previously untreated and refractory patients, 21 case achieved varied degrees of remission. The total effective rate of this treatment was 65.63%, which includes 2 case of CR （6.25%）, 1 case of VGPR（13.1%） and 18 cases of PR（46.25%）. The PFS and OS in one-year follow up were 53.7% and 43.5%, respectively. The total effective rate of 23 patients in control group was 70.0%, which includes 2 cases of CR （10%）, 3 cases of VGPR （15%） and 9 cases of PR （45%）. The treatment efficiency in two groups were consistent, showing no significantly statistic difference （P〉0.05）. While the incidence rate of lung infection and other side effects in low-dose dexamethasone group was significantly lower than the standard-dose dexamethasone group, and the difference was statistically significant（P〉0. 05）. Conclusion The therapeutic schedule of low-dose dexamethasone combined with thalidomide is effective in treating incipient and refractory patients with multiple myeloma and can be used for maintenance therapy in patients with stable condition of multiple myeloma due to the relatively mild side effects.