Ward Robert M, Sherwin Catherine M T
Division of Neonatology, Department of Pediatrics, University of Utah, 295 Chipeta Way, Salt Lake City, UT, 84108, USA,
Paediatr Drugs. 2015 Feb;17(1):37-42. doi: 10.1007/s40272-014-0099-8.
Drug studies in developing pediatric patients, especially newborns, create many ethical challenges that can be analyzed in terms of respect for persons, justice, and beneficence/maleficence as outlined in the Belmont Report. This report describes some of the ethical challenges in conducting drug studies in pediatric patients that must be considered when planning studies and offers some solutions to meet those challenges. Methods of optimal study design should be utilized to limit the number of patients and the number of blood samples. Parental permission should be obtained with equipoise, although the parents of a sick newborn may feel an internal pressure for their child to participate in a study of a new and potentially superior therapy. If appropriate to the study, consent before labor and delivery when parents are less stressed is optimal. It may be difficult or impossible to know all the risks and benefits accompanying studies in newborns due to the limited number of randomized controlled studies in this population. Many more carefully designed, randomized controlled studies of drugs are needed to address the therapeutic needs of the developing pediatric population. For sick newborns cared for in the neonatal intensive care unit (NICU), those studies should be better focused on the drugs used daily in their cares.
针对发育中的儿科患者，尤其是新生儿开展药物研究，会带来诸多伦理挑战，这些挑战可依据《贝尔蒙报告》中所概述的尊重个人、公正以及 beneficence/maleficence（此处 beneficence 意为有益、行善，maleficence 意为有害、作恶）进行分析。本报告描述了在儿科患者中开展药物研究时的一些伦理挑战，在规划研究时必须予以考虑，并提供了应对这些挑战的一些解决方案。应采用最佳研究设计方法来限制患者数量和血样数量。应在权衡利弊的情况下获得家长许可，尽管患病新生儿的父母可能会因内心压力而希望孩子参与新的、可能更优疗法的研究。若研究合适，在分娩前且父母压力较小的时候获得同意是最佳选择。由于该人群中随机对照研究数量有限，可能难以或无法知晓新生儿研究伴随的所有风险和益处。需要开展更多精心设计的药物随机对照研究，以满足发育中的儿科人群的治疗需求。对于在新生儿重症监护病房（NICU）接受护理的患病新生儿，这些研究应更聚焦于他们日常护理中使用的药物。
