沙利度胺治疗102例多发性骨髓瘤患者的临床研究  

The efficacy of thalidomide for multiple myeloma： a clinical analysis of 102 Chinese patients

作　　者：漆佩静 王亚非 李业楠 徐燕 邹德慧 赵耀中 肖志坚 邱录贵 

机构地区：[1]中国医学科学院血液学研究所、血液病医院实验血液学国家重点实验室,天津300020

出　　处：《中华血液学杂志》2008年第4期226-229,共4页Chinese Journal of Hematology

基　　金：天津市自然科学基金（06YFJMSC08500）;天津市科技发展计划项目（06YFSYSF01900）

摘　　要：目的探讨沙利度胺（thalidomide，Thai）治疗多发性骨髓瘤（MM）患者的疗效及安全性。方法回顾性分析Thal单药及联合其他化疗方案治疗102例MM患者的疗效及不良反应。结果①102例患者共接受Thal治疗139例次，中位用药剂量200mg／d。②52例次患者诱导治疗的有效[完全缓解（CR）＋部分缓解（PR）]率为65.4％，66例次患者挽救治疗有效率为45．5％。其中Thal单药治疗13例次，联合化疗105例次；联合组的有效率优于单药组（分别为58.1％和23.1％，P=0．017），无反应和疾病进展（NR）率低于单药组（分别为15.2％和46.2％，P=0.015）。联合组中，50例次初治患者NR率低于55例次复发和难治患者（分别为6.0％和23．6％，P=0．012）；72例次Thal联合VAD（长春新碱、多柔比星和地塞米松）或M2[长春新碱、苯丙氨酸氮芥（马法兰）、卡氮芥、环磷酰胺和泼尼松]等静脉用药方案的患者与33例次联合MP（苯丙氨酸氮芥和泼尼松）等非静脉用药方案的患者有效率分别为62．5％和48.5％，差异无统计学意义。⑧采用Thal维持治疗的患者用药至疾病进展的中位时间为15．5（1～58）个月。④在可随访的97例患者中，患者使用Thal的中位用药时间为8（1～46）个月。中位随访20（1～67）个月，预计中位总体生存（OS）期为44个月。单因素分析显示累计用药时间长于6个月（P=0．0014），治疗前骨髓涂片巨核细胞多于20个／片（P=0．0101），血红蛋白浓度大于100g／L（P=0．019）的患者OS期较长。⑤多因素分析显示累计用药时间长于6个月[P=0.006，相对危险度（RR）0.430]，骨髓涂片巨核细胞多于20个／片（P=0．036，RR0.502）是OS期的预后良好因素。⑥患者对Thal治疗的不良反应多可耐受，血栓性疾病发生率显著低于国外文献报道。结论Thal单药或联合化疗对MM患者有疗效。累计用药时间达6个月者可以显著提Objective To analyse the efficacy and safety of thalidomide（Thal） for patients with multiple myeloma（MM）. Methods Effectiveness and adverse events of 102 MM patients treated with thalido- mide at a median dosage of 200 mg/d. Thirteen cases were treated with Thal alone （group A） , and 105 case with Thai in combination with other therapeutic agents （group B） were retrospectively analyzed. Result ① The response rate （RR） （CR ＋ PR） was 65.4% for induction therapy in 52 cases and 45.5% for salvage therapy in 66 cases. RR in group B was higher than that in group A （58.1% versus 23.1/% , P = 0. 017） , and the non-response/progress（NR） rate was lower（ 15.2% versus 46.2% ,P =0. 015）. In group B, the NR rate was lower in 50 cases of newly diagnosed MM than in 55 cases of refractory or relapsed MM（6.0% versus 23.6% ,P =0. 012）. In group B, RR between Thal＋ VAD or M2 regimen （72 cases） and Thal＋ MP regimen（33 cases） was not statistically significant（62.5% versus 48.5% ,P 〉0.05）. ②The median duration of response maintenance was 15.5（ 1.0 -58.0） months in 21 cases. ③Among 97 patients with follow-up data, the estimated median duration of OS was 44 months in a median follow-up duration of 20 months and the accumulative time for use of Thal was 8 months. In univariate analysis, the accumulative duration for use of Thal 6 months, hemoglobins〉 100 g/L and bone marrow megakaryocytes 〉 20 per smear were associated with longer OS（ P = 0. 0014,0. 0101,0. 019, respectively）. ④Muhivariate analysis suggested that the accumulative time for use of Thai and bone marrow megakaryocytes 〉 20 were independent good prognostic factors for OS（P = 0. 006, 0. 036, respectively）. ⑤The adverse events of Thal were mostly endurable, the rate of thrombus events was lower than that reported in literature. Conclusion Thalidomide alone or combined with chemotherapy is an useful therapy for MM. The accumulative time for use longer than 6 months may improve survival.

关 键 词：多发性骨髓瘤 沙利度胺 治疗结果 不良反应 

分 类 号：R686[医药卫生—骨科学]