亚砷酸联合维生素C治疗复发难治性多发性骨髓瘤的疗效观察

The curative effect with the combination therapy of Arsenic Trioxide and Ascorbic Acid in relapsed and refractory multiple myeloma

目的探讨亚砷酸联合维生素C对复发难治性多发性骨髓瘤的疗效,并与单用亚砷酸治疗进行比较。方法将2008至2011年收治的42例复发难治性多发性骨髓瘤患者随机分为两组：单用亚砷酸组（对照组）、亚砷酸联合维生素C组（联合组）,每组患者21例。对照组予亚砷酸10 mg/d静脉滴注,6周一个疗程,其中前4周用药,间歇2周,共5个疗程;联合组在亚砷酸应用过程中加用维生素C 1.0 g/d静脉滴注,余同对照组。所有患者于疗程间歇期口服沙利度胺100 mg/d。结果 （1）联合组患者总有效率63%,明显高于对照组（29%）（P=0.043）。（2）联合组患者中位无进展生存期（PFS）为9.0个月（6.2~11.8个月）,Kaplan-Meier法分析联合组PFS长于对照组（P=0.043）;联合组中位总生存期（OS）为14.0个月（11.4~16.6个月）,Kaplan-Meier法分析联合组OS长于对照组（P=0.038）。（3）联合组各种不良反应与对照组比较均无显著差异（P〉0.05）。结论亚砷酸联合维生素C治疗复发难治性多发性骨髓瘤的疗效优于单用亚砷酸。

Objective To investigate the curative effect with the combination therapy of Arsenic Trioxide and Ascorbic Acid in relapsed and refractory multiple myeloma. Methods 42 patients of relapsed and refractory multiple myeloma hospitalized during 2008 and 2011 were enrolled, and randomly divided into two groups： arsenic trioxide intervention group（control group）and arsenic trioxide combine with ascorbic acid intervention group（combination group）, with each group 21 patients. The control group were given arsenic trioxide 10 mg/d intrave-nously daily. Each cycle was 6 weeks in duration, comprising 4 weeks of therapy followed by 2 weeks of intermission; while the combination group received ascorbic acid 1.0 g/d intravenously daily during the treatment time of arsenic trioxide in addition to the treatment of the control group. All patients received thalidomide 100 mg/d orally during the treatment intermission. Results（1） The combination group＇s overall response was 63%, which was much higher than the control group（29%）（P=0.043）.（2） Kaplan-Meier statistical analysis showed that the median progression-free survival of the combination group was 9.0 months（range 6.2-11.8 months）, which was longer than the control group（P=0.043）. The median overall survival of the combination group was 14.0 months（range 11.4-16.6 months）, which was also longer than the control group（P=0.038）.（3） No significant difference was found between the two groups when referred to the adverse events（P〉0.05）. Conclusion Compared with the control group, the combination therapy of arsenic Trioxide and ascorbic acid acquired better curative effect in relapsed and refractory multiple myeloma patients.