Thomson Alison H, Elliott Henry L
Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, UK.
Paediatr Anaesth. 2011 Mar;21(3):190-6. doi: 10.1111/j.1460-9592.2010.03436.x. Epub 2010 Oct 29.
Conducting clinical pharmacology research studies in pediatric patients is challenging because of ethical and practical constraints but necessary to ensure that drugs are used safely and effectively in this population. Developments in laboratory analytical techniques, such as improved assay sensitivity and the use of alternative sample matrices, can reduce blood loss and offer less invasive blood sampling, causing less trauma to the patient and fewer ethical concerns. Recent advances in data analysis techniques, which aim to extract the maximum amount of useful information from small sample numbers, should be considered when planning a clinical trial and incorporated into the study design. Using 'population' methodology allows a more flexible sampling strategy that enables valuable data to be collected in the course of routine clinical practice, rather than in a rigid, and potentially artificial, setting. Integration of pharmacokinetics and pharmacodynamics and the application of physiological approaches and simulation techniques to the analysis and interpretation of drug concentration and effect data offer new opportunities that have particular relevance to pharmacological research in the field of pediatric anesthetics.
由于伦理和实际限制，在儿科患者中开展临床药理学研究具有挑战性，但对于确保药物在该人群中的安全有效使用是必要的。实验室分析技术的发展，如提高检测灵敏度和使用替代样本基质，可以减少失血并提供侵入性较小的采血方式，对患者造成的创伤更小，伦理问题也更少。数据分析技术的最新进展旨在从小样本数量中提取最大量的有用信息，在规划临床试验时应予以考虑并纳入研究设计。使用“群体”方法允许采用更灵活的抽样策略，从而能够在常规临床实践过程中收集有价值的数据，而不是在严格且可能人为的环境中。药代动力学和药效学的整合以及生理方法和模拟技术在药物浓度和效应数据分析与解释中的应用提供了新的机会，这些机会与儿科麻醉领域的药理学研究特别相关。
