| 健康人对青蒿琥酯片的耐受性和不良反应 |
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| 引用本文： | 张俊才,郭兴伯,钱本顺,陈建国,侯绍芝,李国桥. 健康人对青蒿琥酯片的耐受性和不良反应[J]. 中国新药与临床杂志, 1992, 0(2) |
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| 作者姓名： | 张俊才 郭兴伯 钱本顺 陈建国 侯绍芝 李国桥 |
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| 作者单位： | 广州中医学院三亚热带医学研究所 三亚572021(张俊才，郭兴伯，钱本顺，陈建国，侯绍芝)，广州中医学院三亚热带医学研究所 三亚572021(李国桥) |
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| 摘 要： | 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。
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| 关 键 词： | 青蒿琥酯 药物耐受性 抗疟药 药物评价 |
Tolerance and adverse effects of artesunate tablet in healthy volunteers |
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| ZHANG Jun-Cai,GUO Xing-Bo,QIAN Ben-Shun,CHEN Jian-Guo,HOU Shao-Zhi,LI Guo-Qiao. Tolerance and adverse effects of artesunate tablet in healthy volunteers[J]. Chinese Journal of New Drugs and Clinical Remedies, 1992, 0(2) |
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| Authors: | ZHANG Jun-Cai GUO Xing-Bo QIAN Ben-Shun CHEN Jian-Guo HOU Shao-Zhi LI Guo-Qiao |
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| Abstract: | 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. |
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| Keywords: | artesunate drug tolerance antimalarials drug evaluation |
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