三氧化二砷不同给药方法治疗急性粒细胞白血病的临床观察和随访

Clinical observation and following up of two administration methods of arsenic trioxide in treatment of acute promyelocytic leukemia

目的 评价三氧化二砷 (As2 O3 )的两种给药方法在治疗急性早幼粒细胞白血病 (APL)中的有效性及安全性。方法 观察并随访了分别应用As2 O3 两种给药方法治疗的APL 96例 ,试验组 4 8例 ,按 0 16mg/kg计算每例患者As2 O3 的日治疗总量 ,分 2次加 5 %的葡萄糖液 2 5 0ml稀释 ,缓慢静脉滴注 ,每分钟 8滴 ,2次给药间隔 2～ 3h ;对照组 4 8例 ,按常规给药 0 16mg/kg计算As2 O3日治疗总量 ,每日用药 1次 ,2h完成。分别测两组患者不同时间点的血砷浓度 ,并随访治疗后 6个月中的复发率和砷蓄积情况。结果 连续用药 2 8d ,试验组总有效率为 93 8% ,对照组为 83 3%。血砷促凋亡有效浓度在 0 2mg/L以上的持续时间分别为试验组 18 4h± 3 3h ,对照组 9 4h± 1 6h。患者达到完全缓解的时间分别为 2 6 4d± 2 0d和 35 7d± 4 8d。随访 6个月两组骨髓抑制和复发率均未发现有差异。结论 分次缓慢静脉给药不良反应轻 ,并可缩短APL的完全缓解的时间 ,提高缓解率。

Objective To assess the effectiveness and security of two arsenic trioxide(As 2O 3)administration methods in treatment of acute promyelocytic leukemia (APL). Methods Forty-eight APL cases were treated with As 2O 3 with the total daily dosage of 0.16 mg/kg that was divided into two equal doses diluted in 250 ml of 5% glucose given twice in the morning and evening respectively by intravenous infusion'at a speed of 8 drops/min with an interval of 2～3 hours. Forty-eight sex- and age-matched APL cases were treated with As 2O 3 with the same total daily dosage of 0.16 mg/kg given according to the routine method: infused intravenously once a day with a duration of at most 2 hours. Serum was collected at different time points to examine the arsenic concentration. The remission rate and side effects were observed. Results The remission rate was 93.8% in the patients treated by the new method, and was 83.3% in the patients treated by the routine method 28 days after the treatment. The lasting duration of effective arsenic level was at least 18.4±3.3 hours in the new method group, and was 9.4±1.6 hours in the routine method group. The average time from the initiation of treatment to complete remission (CR) in the new method group was 26.4±2.4 days, and was 35.7±4.8 days in the routine method group. No late liver functional lesion and bone marrow depression was found in the two groups during the 6 months followed up. Conclusion The 'multi-times and slowing intravenous infusion' method relieves the side effects of As 2O 3 treatment, increases the CR rate in treatment of APL.