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儿童、特别是婴幼儿,肝、肾功能及中枢神经系统,内分泌系统尚未发育完全,对同一药物毒性较其他任何人群更敏感,成人用药安全有效的剂量标准在儿童及婴幼儿人群中往往不易被评价。对胎儿和新生儿,则无一个可以对药物的毒性加以限制的安全范围。因缺乏试验提供准确的药物动力学数据,经常由成人药动学参数推荐儿童用药剂量,其安全性往往是不可信的。
Children, especially infants and young children, liver and kidney function and the central nervous system, endocrine system has not yet fully developed, more toxic to the same drug than any other population, safe and effective dose of adult medication often not easy to be in children and infants and young children Evaluation. For fetuses and newborns, there is no safe limit to limit the toxicity of the drug. Because of the lack of trials to provide accurate pharmacokinetic data, it is often unsure of the safety of children to recommend doses to children for pharmacokinetic parameters in adults.