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

Author(s): Zhou J, Meng R, Wang Y, Yang BF

Affiliation(s): First Clinical Medical College of Ha'rbin Medical University, Ha'rbin 150001, China.

Publication date & source: 2004-03-02, Zhonghua Yi Xue Za Zhi., 84(5):405-8.

Publication type: Clinical Trial; Randomized Controlled Trial

OBJECTIVE: To assess the effectiveness and security of two arsenic trioxide (As(2)O(3)) administration methods in treatment of acute promyelocytic leukemia (APL). METHODS: Forty-eight APL cases were treated with As(2)O(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(2)O(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(2)O(3) treatment, increases the CR rate in treatment of APL.

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