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以双盲法对22名健康男性志愿者进行青蒿琥酯片口服的耐受性和不良反应研究。结果:最大耐受量,单次给药为12mg/kg,5d连续给药为4mg/(kg·d);不良反应,最敏感的指标是网织红细胞下降,其次是转氨酶升高.建议青蒿琥酯片口服治疗量暂定为2mg/(kg·d),首剂加倍,5d疗程总量12mg/kg。
Twenty-two healthy male volunteers were treated with artesunate tablets orally in a double-blind fashion for their tolerability and adverse reactions. Results: The maximum tolerated dose was 12mg / kg for single administration and 4mg / (kg · d) for continuous administration for 5 days. The most sensitive indicators were the decrease of reticulocyte and the increase of transaminase. Artesunate tablets oral treatment is tentatively scheduled for 2mg / (kg · d), the first dose doubled, 5d total dose of 12mg / kg.