健康人对青蒿琥酯片的耐受性和不良反应

Tolerance and adverse effects of artesunate tablet in healthy volunteers

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。

Studies on phase I clinical trials of artesunate tablet were carried out with double blind method in 22 male healthy volunteers. The result showed that the maximum tolerance in healthy volunteers was 12 mg/kg as a single dose, or 4 mg/ (kg. d) for 5 d. The most sensitive indices of adverse-effect were decrease of reticu-locyte count and abnormal transaminase. It is suggested that the curative dosage of artesunate tablet should temporarily be limited to 2 mg/(kg.d), with initial dose doubled, 12 mg/kg as a total dose for 5d.