摘要
新生儿是特殊的儿童群体,其药代动力学和药效学与年长儿和成年人有显著差异,既往将年长儿或成年人用药经验用于新生儿群体疾病治疗,曾造成严重后果。由于新生儿药物临床试验存在费用高、风险大、伦理学问题及受试者招募困难等问题,新生儿临床用药研究仍亟待加强。目前各国已制定相应的法律、法规推动和规范儿童药物试验,新的研究技术和方法也不断应用于新生儿临床药物研究,新生儿科医师、临床药师及其他科研工作者有必要通力合作加大新生儿用药研究,确保新生儿用药的安全性和有效性。
Newborn infants are special groups of children. Their pharmacokinetics and pharmacodynamics are significantly different from those of children and adults. In the past, children and adults medication experiences were used on newborn infants and then caused severe consequence. Due to the high cost, high risk, ethical issues, difficulty of participant recruitment and other issues of neonatal clinical medication, neonatal clinical medication still needs to be strengthened and highlighted up to now. At present, as many countries have made laws and regulations to promote and regulate the children clinical medication, and new research techniques and methods have been applied to neonatal clinical medication, neonatal clinicians, clinical pharmacists and other researchers should work together to improve the progress of neonatal clinical medication and ensure the safety and effectiveness of neonatal clinical medication.
出处
《中华妇幼临床医学杂志（电子版）》
CAS
2015年第1期1-3,共3页
Chinese Journal of Obstetrics & Gynecology and Pediatrics(Electronic Edition)
基金
四川省科技厅科技支撑项目(2014SZ0149)~~
关键词
婴儿
新生
疾病
药物疗法
药物
临床试用
药物评价
临床前
伦理委员会
临床
药理
临床
Infant, newborn, diseases
Drug therapy
Drugs, investigational
Drug evaluation,preclinical
Ethics committees, clinical
Pharmacology, clinical
