沙利度胺联合CAG方案治疗老年人急性髓系白血病效果观察

目的 评价沙利度胺联合CAG方案治疗老年急性髓系白血病（AML）患者的临床疗效及安全性.方法 对51例初治的老年AML患者进行前瞻性研究,采用简单随机分组法分为沙利度胺联合CAG方案治疗组26例、CAG方案单用对照组25例,评估临床疗效及患者不良反应.结果 诱导缓解治疗2个周期后,治疗组完全缓解（CR）率为61.5％（16/26）,对照组为48.0％（12/25）,两组差异无统计学意义（P=0.404）.治疗组1年CR率为53.8％（14/26）,对照组为24.0％（6/25）（P=0.045）;治疗组2年CR率为42.3％（11/26）,对照组为12.0％（3/25） （P=0.027）;治疗组1年及2年生存率分别为73.1％和46.1％,对照组分别为52.0％和24.0％;随访2年,治疗组中位生存时间为22个月,对照组为13个月,差异有统计学意义（P=0.018）.两组患者诱导死亡率及血液学不良反应发生率差异无统计学意义;但治疗组恶心、呕吐明显减轻,与对照组相比差异有统计学意义（P=0.025）.结论 沙利度胺联合CAG方案治疗老年AML患者,疗效理想,患者不良反应轻,值得进一步研究及临床应用.

Clinical observation of elderly patients with acute myelogenous leukemia treated with CAG regimen combined with thalidomide

Objective　To evaluate the clinical efficacy and safety for the CAG regimen combined with thalidomide in elderly patients with acute myelogenous leukemia (AML). Methods　51 untreated elderly cases with AML were randomly divided into treatment group (treated with CAG regimen combined with thalidomide, 26 cases) and control group (treated with CAG regimen alone, 25 cases), and the clinical efficacy and safety were observed. Results　After 2 cycles of treatment, the complete remission (CR) rates of treatment group and control group were 61.5 % (16/26) and 48.0 % (12/25) respectively, the difference was not significant (P = 0.404). With regard to prostecdtive efficacy, the difference was markedly significant, 1-year CR rates of treatment group and control group were 53.8 %(14/26) and 24.0 % (6/25) respectively (P = 0.045), and 2-year CR rates were 42.3 % (11/26) and 12.0 % (3/25) respectively (P = 0.027). During the follow-up of 2 years, overall 1- and 2-year overall survival rates were 73.1 % and 46.1 % in treatment group versus 52.0 % and 24.0 % in control group. During the follow-up of 2 years, the estimated mean overall survival time in treatment group was 22 months and it was 13 months in control group (P = 0.018). The induction mortality rates and myelosuppression showed no difference between the two groups. Compared with control group, the side effect rate of nausea and vomiting was significantly decreased in treatment group (P = 0.025). Conclusion　The CAG regimen combined with thalidomide is effective with little side effects for elderly AML, and is worthy of further study and clinic application.