Lyons Michael A
Department of Microbiology, Immunology and Pathology, Colorado State University, Fort Collins, CO, USA,
J Pharmacokinet Pharmacodyn. 2014 Dec;41(6):613-23. doi: 10.1007/s10928-014-9380-2. Epub 2014 Aug 31.
Dose selection for rifampin in the treatment of active pulmonary tuberculosis (TB) illustrates some of the challenges for dose optimization within multidrug therapies. Rifampin-based anti-TB regimens are often combined with antiretroviral therapies to treat human immunodeficiency virus (HIV) coinfection. The potent cytochrome P450 (CYP) enzyme inducing properties of rifampin give rise to significant drug-drug interactions, the minimization of which by limiting the dose, conflicts with the maximization of bacterial killing by increasing the dose. Such multiple and conflicting objectives lead to a set of trade-off optimal solutions for dose optimization rather than a single best solution. Here, we combine pharmacokinetic/pharmacodynamic (PK/PD) modeling with multiobjective optimization to quantitatively explore trade-offs between therapeutic and adverse effects of optimal dosing for the example of rifampin in TB-infected mice. The PK/PD model describes rifampin concentrations in plasma and liver following oral administration together with hepatic CYP enzyme induction and bacterial killing kinetics. We include optimization objectives descriptive of antimicrobial efficacy, CYP-mediated drug-drug interactions, and drug exposure-dependent toxicity. Results show non-conventional dosing scenarios that allow for increased efficacy relative to uniform dosing without increasing drug-drug interactions. Additionally, we find currently employed dosages for rifampin to be nearly optimal with respect to trade-offs between efficacy and toxicity. While limited by the accuracy and applicability of the PK/PD model, these results provide an avenue for experimental investigation of complex dose optimization problems. This method can be extended to include additional drugs and optimization objectives, and may provide a useful tool for individualized medicine.
利福平治疗活动性肺结核时的剂量选择体现了多药疗法中剂量优化面临的一些挑战。基于利福平的抗结核方案常与抗逆转录病毒疗法联合使用,以治疗合并感染人类免疫缺陷病毒(HIV)的患者。利福平具有强大的细胞色素P450(CYP)酶诱导特性,会引发显著的药物相互作用,通过限制剂量来最小化这种相互作用,却与增加剂量以最大化细菌杀伤效果相冲突。这种多重且相互冲突的目标导致了一系列用于剂量优化的权衡最优解,而非单一的最佳解决方案。在此,我们将药代动力学/药效学(PK/PD)建模与多目标优化相结合,以定量探究在感染结核的小鼠中,利福平最佳给药的治疗效果与不良反应之间的权衡。PK/PD模型描述了口服给药后血浆和肝脏中利福平的浓度,以及肝脏CYP酶诱导和细菌杀伤动力学。我们纳入了描述抗菌疗效、CYP介导的药物相互作用以及药物暴露依赖性毒性的优化目标。结果显示了非常规的给药方案,相对于均匀给药,在不增加药物相互作用的情况下可提高疗效。此外,我们发现目前使用的利福平剂量在疗效和毒性之间的权衡方面几乎是最优的。尽管受PK/PD模型的准确性和适用性限制,但这些结果为复杂剂量优化问题的实验研究提供了一条途径。该方法可扩展至纳入更多药物和优化目标,可能为个体化医疗提供有用工具。