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本试验是在17名健康志愿者中进行的,把17名志愿者随机分为对照组和注射组两个组。注射组又分为以五天总量7.2mg/kg、9.6mg/kg和12mgkg三个剂量组,注射组分别按剂量肌肉注射蒿甲醚注射液,对照组注射等量的溶剂油。以双盲法进行观察。结果表明发热反应和网织红细胞下降是蒿甲醚注射液引起人体反应的较敏感指标,并提示该药对健康人五天最大耐受剂量是12mg/kg,而安全剂量是9.6mg/kg。
The trial was conducted in 17 healthy volunteers. 17 volunteers were randomly divided into control group and injection group. The injection group was further divided into three dose groups of 7.2 mg/kg, 9.6 mg/kg and 12 mg kg for five days. The injection group was given an intramuscular injection of artemether injection and the control group was injected with the same amount of solvent oil. Double blinded observations. The results showed that febrile reactions and reticulocyte decline were more sensitive indicators of the human response caused by artemether injection, and suggested that the maximum tolerated dose of the drug to healthy people for five days was 12 mg/kg, while the safe dose was 9.6 mg/kg.