儿科临床研究风险的特殊考量

发布时间：2018-03-16 09:38

本文选题：儿童药品　切入点：最小风险　出处：《临床儿科杂志》2017年08期 　论文类型：期刊论文

【摘要】：正儿科临床研究是获得儿童用药安全资料的最有效途径~([1,2])。因机体代谢在不同年龄段儿童中具有多态性,与成人相比,将同一治疗方法用于不同年龄段的儿童时,疼痛、不适等不良反应发生的概率与强度亦会有所不同,且大多明显大于成人~([3])。因此,儿科临床研究更应重视研究的风险和受益的平衡。近年来,国家不断提高对儿科临床研究的重视和支持,优先支持研发儿童药品,修订儿童用药说明书~([3,4])。而这意味
[Abstract]:The clinical study of Zhengpaediatrics is the most effective way to obtain the safety information of drug use in children ([1] / 2] .Because the metabolism of the body is polymorphic in children of different ages, compared with adults, the same treatment method has pain in children of different ages. The probability and intensity of adverse reactions such as discomfort are also different, and most of them are significantly larger than those of adults ([3]). Therefore, pediatric clinical research should pay more attention to the balance of risk and benefit in recent years. The state has continuously increased its attention and support for clinical research in pediatrics, giving priority to the development of children's medicines and revising the instructions for children's drug use ([3n4] / [3n4] /).
【作者单位】：浙江大学医学院附属儿童医院;温州医科大学;
【基金】：国家自然科学基金项目(No.81573516,81273607) 国家科技重大专项项目(No.2013ZX09303003)
【分类号】：R72

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