沙立度胺、三氧化二砷联合罗盖全治疗骨髓增生异常综合征临床分析

Combination of thalidomide,calcitriol and andarsenic trioxide in the treatment of myelodysplastic syndrome

目的探讨沙立度胺、三氧化二砷联合罗盖全治疗骨髓增生异常综合征的疗效和耐受性。方法设治疗组和对照组,治疗组22例:沙立度胺每晚睡前口服,初始剂量50mg/d,然后每周剂量递增50mg/d,达最大耐受量300mg/d改维持剂量75-200mg/d;罗盖全2μg/d,口服,服药3个月;三氧化二砷10mg/d,静脉滴注,每个月20次,间隔3周为1个疗程;对照组22例:予司坦唑醇、全反式维甲酸或小剂量化疗、干扰素等以及对症、支持治疗。临床疗效判断标准采用骨髓增生异常综合征国际工作组提出的新疗效标准。结果治疗组完全缓解(CR)5例(22.73%),部分缓解6例(27.27%),血液学改善(HI)8例(36.36%),无效3例,总有效率为86.36%,未发现严重不良反应,常见乏力、便秘、水肿、皮疹、肝肾轻度异常等,对症处理后好转。对照组无CR,PR2例(9.09%),HI7例(31.82%),无效13例,总有效率为40.90%,与治疗组比较差异有统计学意义(P<0.05)。结论沙立度胺、三氧化二砷联合罗盖全治疗骨髓增生异常综合征有效率高,不良反应轻微,耐受性好。

Objective To study the efficacy and tolerance of the combination of thalidomide, calcitriol and andarsenic trioxide in the treatment of myelodysplastic syndrome. Methods all patiens were randomly divided into two groups： treatment group and control group. 22 cases in treatment group： thalidomide orally every night before going to bed, the initial, The initial dose of thalidomide was 50 mg/d, then increased 50 mg/d every week until the patients reached maximal tolerance 300mg/d , the maintain dose was 100 -200 mg/d. Calcitriol was administered 2μg/d for 3 months. Arsenic trioxide was administered 10 mg/d, intravenous infusion, 20 times per month, 3 weeks interval for a course of treatment. 22 cases in control group were administered male hormone, interferon, all - trans retinoie acid or low - dose chemotherapy. Results In the treatment group, 19 （5 CR , 6 PR , 8 HI） of 22 patients had an objective response （ 86.36 % ）. The side - effect was gentle inclucling fatigue, constipation, edema, tetter and abnormality of liver function and kidney function. In the control group, 9 （2 PR, 7 HI） of 22 patients had an objective response （40.90%）. The response rate between two groups were significant different （P 〈 0.05）. Conchtsion The combination of thalidomide, calcitriol and andarsenie trioxide thalidomide was efficient and well tolerated in the treatment of patients with myelodysplastic syndrome.