小剂量沙利度胺联合地塞米松治疗初诊多发性骨髓瘤的临床研究

Clinical research on low-dose thalidomide combined with dexamethasone for primarily diagnosed multiple myeloma

目的:比较小剂量沙利度胺(thalidomide)联合地塞米松(dexamethasone)简称TD方案,与采用VBMCP(M2)方案(长春新碱+卡氮芥+美法仑+环磷酰胺+泼尼松)在治疗初诊多发性骨髓瘤(multiple myeloma,MM)中的临床疗效和不良反应。方法:小剂量TD方案治疗30例初诊MM(TD组),沙利度胺100～300mg/d,连续口服,地塞米松40mg/d在每个疗程的第1～4天口服;以30例接受VBMCP(M2)方案治疗的临床资料匹配的初诊MM作为历史匹配对照(M2组),比较2组的疗效、生存情况和不良反应。匹配标准包括年龄、临床分期和β2-微球蛋白水平。结果:TD组的总有效率为66.7%,M2组为60.0%,2组相比差异无统计学意义(P>0.05)。TD组中位无疾病进展生存时间(progression free survival,PFS)为13个月,M2组的中位PFS为10个月,2组相比差异无统计学意义(P>0.05)。与TD组相比,M2组3级以上的中性粒细胞减少、血小板降低及周围神经病变等不良反应明显增多(P<0.05)。结论:对于初诊MM的一线治疗,小剂量TD方案被认为是患者能耐受的有效的口服替代方法,值得临床研究和推广应用。

Objective：To compare the efficacy and adverse reaction between low-dose thalidomide combined with dexamethasone （TD） and VBMCP（M2） rigimen in therapy for primarily diagnosed multiple myeloma（MM）. Methods： Thirty patients with primarily diagnosed MM received oral administration of thalidomide at a dose of 100-300 mg/d continuously and dexamethasone at a dose of 40 mg/d on clays 1-4 in every course （TD group）. Thirty MM patients who received VBMCP regimen were regarded as a historical matched case-control （M2 group）. The efficacy, survival time and adverse events were compared between two groups. Matching criteria included age, clinical stage and serum [32 microglobulin level. Rusults ：The overall response rates were 66.7% in TD group and 60.0% in M2 group. The difference was not significant （P 〉 0.05）. The median progression-free survival was 13 months in TD group and 10 months in M2 group. There was no significant difference between the two groups （P 〉 0.05 ）. In advanced grade 3-4 adverse events, included neu- tropenia,thrombocytopenia and peripheral neuropathy were observed in M2 group as compared with those in TD group （ P 〈 0.05 ）. Conclusion ：The combination of low-dose thalidomide and dexamethasone may be considered as an effective, relatively well-tolerated and oral alternative to the more complex VBMCP regimen as first-fine therapy for primarily diagnosed MM. It is worthy of clinical investigation and further application.