在美国的临床实践指南中对药物遗传测试的建议
Daniel L Hertz1, Chad A Bousman2, Howard L McLeod3
1Department of Clinical Pharmacy, University of Michigan College of Pharmacy, Ann Arbor, MI, USA.
概括
美国的临床实践指南显示药物遗传学测试的建议有限且不一致. 标准化临床效用评估可以提高指导方针的一致性,并增加药物遗传学测试用于个性化医学的使用.
科学领域:
- 药物基因组学 药物基因组学
- 临床实践指南 临床实践指南
- 个性化医疗是个性化的医疗.
背景情况:
- 药物遗传学测试确定了那些可能从个性化药物治疗中受益的患者.
- 尽管药物遗传检测具有潜力,但其临床采用仍然有限.
- 临床实践指南建议进行生物标志物测试,证明其临床效用,改善患者的治疗结果.
研究的目的:
- 审查美国临床实践指南中药物遗传学测试建议的现状.
- 评估这些建议在不同组织和指南中的一致性.
主要方法:
- 对临床实践指南进行了叙述性审查.
- 评估了指导方针,对21种基因药物对进行推,这些基因药物对具有已建立的关联,被CPIC认为具有临床可行性.
- 评估了组织内部和组织之间的建议一致性.
主要成果:
- 很少有临床实践指南包括药物遗传学测试建议.
- 对于HLA-B*57:01 (阿巴卡维尔) 和G6PD (拉斯布里卡斯) 发现了一致的建议.
- 观察到对CYP2C19-clopidogrel,CYP2D6-codeine/tramadol,CYP2B6-efavirenz,TPMT-thiopurines和NUDT15-thiopurines的不一致建议,无论是在组织内部还是组织之间.
结论:
- 美国临床实践指南中的药物遗传测试建议稀疏且不一致.
- 评估临床效益的标准化方法可以提高指南的包含性和一致性.
- 改善指南的一致性可能会增加药物遗传学测试的临床使用,使患者和社会受益.
相关概念视频
01:12Analysis of Population Pharmacokinetic Data
252
Analysis of population pharmacokinetic data involves studying the behavior of drugs within diverse populations to understand their pharmacokinetic parameters. Traditional pharmacokinetic methods typically involve collecting samples from a few individuals and estimating these parameters. While these methods are commonly used, they have limitations in capturing the variability in drug response among individuals or heterogeneous populations. Population pharmacokinetics is employed to address these...
252
01:11Clinical Trials: Overview
2.9K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
2.9K
01:28Human Genetics
564
Human genetics provides a profound framework for understanding the interplay between genetic predispositions and human psychology. At the heart of this discipline lies the study of how genes influence physical traits, behaviors, and susceptibility to diseases. Each person carries a unique genetic code that subtly or significantly shapes their psychological and behavioral landscape.
The complex relationship between genetics and psychology is observable through common biological components such...
The complex relationship between genetics and psychology is observable through common biological components such...
564
01:28Preclinical Development: Overview
4.4K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
4.4K
01:15Chronopharmacokinetics: Circadian Rhythms and Influence on Drug Response
59
Circadian rhythms are cyclic changes that are crucial in plasma drug concentrations. Various standard circadian parameters, including core body temperature, heart rate, and other cardiovascular factors, directly impact disease states and the therapeutic response to drug therapy.
The time of drug administration is an important factor to consider, as it can influence the toxic dose of a drug. For example, a study conducted by Prins et al. in 1997 examined the effects of the timing of...
The time of drug administration is an important factor to consider, as it can influence the toxic dose of a drug. For example, a study conducted by Prins et al. in 1997 examined the effects of the timing of...
59
01:23Nonlinear Pharmacokinetics: Dependence of Elimination Half-Life and Dose Clearance
131
The elimination half-life and drug clearance of drugs following nonlinear kinetics can vary with dosage. The Michaelis-Menten parameters and drug concentration influence these factors. As the dose increases, the elimination half-life tends to lengthen, resulting in a reduction in clearance and a disproportionately larger area under the curve. The total clearance can be derived from the Michaelis-Menten equation for drugs following a one-compartment model.
A study on guinea pigs examined the...
A study on guinea pigs examined the...
131