PTD方案与TD方案治疗多发性骨髓瘤疗效的随机对照试验

Effects of PTD versus TD Regimens for Multiple Myeloma: A Randomized Controlled Trial

目的比较PTD(帕米膦酸二钠+沙利度胺+地塞米松)方案与TD(沙利度胺+地塞米松)方案治疗多发性骨髓瘤的临床疗效。方法在2004年1月～2008年12月间,将符合纳入标准的患者按就诊顺序随机分配到PTD方案组和TD方案组,治疗8周后观察其疗效和不良反应。统计分析使用SPSS13.0软件。结果共纳入25例患者,其中PTD方案组13例,TD方案组12例。结果显示,PTD方案与TD方案的总有效率分别为84.6%和83.3%,差异无统计学意义(P>0.05);在骨痛改善方面,PTD组显效率(5/13vs1/12)及短期起效率(4/13vs1/12)优于TD组,差异有统计学意义(P<0.05)。结论PTD方案较TD方案对骨痛的缓解程度更强、起效更快;在总有效率方面,尚需增大样本量进一步研究。

Objective To evaluate the effectiveness of PTD regimen （pamidronate disodium ＋ thalidomide ＋ dexamethasone） and TD regimen （thalidomide ＋ dexamethasone） in the treatment of multiple myeloma. Methods The patients meeting the inclusion criteria were randomly treated with PTD and TD regimens from January 2004 to December 2008. The effectiveness and safety of the two groups were observed after 8 weeks and the statistical analyses were performed using SPSS 13.0 software. Results A total of 25 patients were included, of which 13 were treated with PTD regimen and the other 12 were treated with TD regimen. The results showed overall response rates were 84.6% and 83.3% in the PTD and TD groups, respectively, with no significant difference （P〉0.05）. The complete response rate （5/13 vs. 1/12） and early response rate （within 2 weeks, 4/13 vs. 1/12） for bone pain in the PTD group were better than those of TD group （P〈0.05）. Conclusion Compared with TD regimen, PTD regimen has more dramatic and faster effects on bone pain relief for multiple myeloma, but for overall response rate, further larger sample size randomized controlled trials are needed.