摘要
目的:回顾分析沙利度胺(Thal)对多发性骨髓瘤(MM)患者的维持治疗效果。方法:45例初发MM患者采用VAD,DVD,MP等方案化疗,缓解者采用Thal维持治疗,评估疗效、生存期和不良反应。结果:45例MM患者经诱导化疗获得完全缓解(CR)11例,部分缓解(PR)19例,有效率66.6%,30例有效者Thal治疗平均生存期(OS)和平均无进展生存期(PFS)为38.7和15.6月;CR维持者OS和PFS分别为52.5和22.1月,均比PR维持者明显延长。Thal维持<65岁,前6月累积剂量≥30 g患者的OS、PFS和累积剂量显著增加,但平均最小维持剂量没有显著性差异。不良反应出现末梢神经炎28例(93.3%),便秘11例(36.7%),心动过缓8例(26.7%),疲乏6例(20%),双下肢水肿5例(16.7%),皮疹2例(6.7%)。结论:Thal单药维持可延长缓解后MM者的OS和PFS,对CR者效果较好,Thal不良反应较重。
OBJECTIVE: To retrospectively evaluate the curative efficacy of the maintenance therapy with thalidomide (Thal) for patients of multiple myeloma (MM). METHODS: 45 initial MM patients were assigned to receive chemical therapy including VAD, DVD, and MP etc, and the patients with good clinical outcome were treated with Thal for maintenance therapy. The curative efficacy, survival time and adverse effects were evaluated. RESULTS: Of the 45 MM cases, the inductive chemical therapy resulted in an overall response rate (CR + PR) of 66.6%, with complete response in 11 cases, and partial response in 19 cases. The median overall survival (OS) and progression- free survival (PFS) of 30 cases with successful outcome after treatment with Thai were 38.7 and 15.6 months, respectively. The OS and PFS for CR patients who received maintenance therapy with Thai were 52.5 and 22.1 months, respectively, which were significantly higher than in PR patients. For patients aged less than 65 years receiving Thal therapy and those whose accumulative dose of Thal ≥30 g in the initial 6 months had statistical increase with regard to OS, PFS and accumulative dose, but no statistically significant difference on mean minimum maintenance dose. Adverse effects included peripheral neuritis in 28 cases (93.3%), constipation in 11 (36.7%), bradycardia in 8 (26.7%), fatigue in 6 (20%), edema of both lower extremities in 5 (16.7 % ) and skin rash in 2 (6.7 % ). CONCLUSION: Maintenance therapy with Thai alone prolongs both OS and PFS for MM patients after showing successful outcome, especially for those with CR (complete response). However, the adverse effects induced by Thai are serious.
出处
《中国医院用药评价与分析》
2009年第10期768-770,共3页
Evaluation and Analysis of Drug-use in Hospitals of China