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沙利度胺治疗多发性骨髓瘤的疗效:102例中国患者的临床分析

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

作者信息

Qi Pei-Jing, Wang Ya-Fei, Xu Yan, Li Ye-Nan, Zou De-Hui, Zhao Yao-Zhong, Xiao Zhi-Jian, Qiu Lu-Gui

机构信息

Institute of Hematology and Blood Diseases Hospital, CAMS and PUMC, Tianjin 300020, China.

出版信息

Zhonghua Xue Ye Xue Za Zhi. 2008 Apr;29(4):226-9.

Abstract

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 thalidomide at a median dosage of 200 mg/d. Thirteen cases were treated with Thal alone (group A), and 105 case with Thal 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 M, regimen (72 cases) and Thal + MP regimen (33 cases) was not statistically significant (62.5% versus 48.5%, P >0.05). 2) The median duration of response maintenance was 15.5 (1.0-58.0) months in 21 cases. 3) Among 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, hemoglobin > or = 100 g/L and bone marrow megakaryocytes > 20 per smear were associated with longer OS (P = 0.0014, 0.0101, 0.019, respectively). 4) Multivariate analysis suggested that the accumulative time for use of Thal and bone marrow megakaryocytes > 20 were independent good prognostic factors for OS (P = 0.006, 0.036, respectively). 5) The 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.

摘要

目的

分析沙利度胺(Thal)治疗多发性骨髓瘤(MM)患者的疗效和安全性。

方法

回顾性分析102例接受沙利度胺治疗的MM患者,中位剂量为200mg/d。其中13例单独使用沙利度胺治疗(A组),105例联合其他治疗药物使用沙利度胺治疗(B组)。

结果

1)52例患者诱导治疗的缓解率(RR)(完全缓解+部分缓解)为65.4%,66例患者挽救治疗的缓解率为45.5%。B组的RR高于A组(58.1%对23.1%,P=0.017),无反应/进展(NR)率较低(15.2%对46.2%,P=0.015)。在B组中,50例新诊断MM患者的NR率低于55例难治或复发MM患者(6.0%对23.6%,P=0.012)。在B组中,沙利度胺+VAD或M方案(72例)与沙利度胺+MP方案(33例)的RR无统计学差异(62.5%对48.5%,P>0.05)。2)21例患者反应维持的中位持续时间为15.5(1.0-58.0)个月。3)在97例有随访数据的患者中,中位随访20个月时,估计中位总生存期为44个月,沙利度胺的累计使用时间为8个月。单因素分析中,沙利度胺累计使用时间≥6个月、血红蛋白≥100g/L和骨髓涂片巨核细胞>20个与较长的总生存期相关(P分别为0.0014、0.0101、0.019)。4)多因素分析表明,沙利度胺的累计使用时间和骨髓涂片巨核细胞>20个是总生存期的独立良好预后因素(P分别为0.006、0.036)。5)沙利度胺的不良事件大多可耐受,血栓事件发生率低于文献报道。

结论

沙利度胺单独或联合化疗是治疗MM的有效方法。累计使用时间超过6个月可能改善生存。

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