石榴汁不影响环孢素在健康泰国志愿者中的生物利用度。

IF 3.2 Q2 Pharmacology, Toxicology and Pharmaceutics Current clinical pharmacology Pub Date : 2020-01-01 DOI:10.2174/1574884715666200110153125
Wirin Anlamlert, Pakawadee Sermsappasuk
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引用次数: 2

摘要

背景:石榴是否会引起药物相互作用仍然存在争议。在体外和动物实验中,石榴汁已被证明能抑制CYP3A。石榴汁与环孢素(环孢素是一种狭窄的治疗药物,是CYP3A的底物)共同服用可能导致药物毒性。本研究的目的是探讨石榴汁对环孢素在健康泰国志愿者体内药代动力学的影响。方法:研究设计为开放标签、随机、单剂量、交叉研究,洗脱期为2周。每个禁食受试者服用2片环孢素微乳剂,每片100毫克,加500毫升石榴汁(试验)或500毫升水(对照)。给药后24小时,连续采集血液样本,用化学发光微粒免疫分析法分析血液样本的环孢素浓度。14名健康志愿者完成了这项研究。结果:浓度-时间曲线下面积(AUC)从时间0到最后一次测定浓度(AUC0-t)、AUC从时间0到无穷远(AUC0-∞)、最大浓度(Cmax)的90%置信区间分别为91.6 ~ 105.6、92.0 ~ 105.2和82.3 ~ 102.5。结果在窄治疗指标药物的公认生物等效性范围内(AUC为90-111%,Cmax为80-125%)。两组间不良事件发生率无差异。结论:单次给药石榴汁对环孢素口服生物利用度无显著影响。然而,需要进一步的工作来彻底评估石榴对狭窄治疗药物的影响。
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Pomegranate Juice does not Affect the Bioavailability of Cyclosporine in Healthy Thai Volunteers.

Background: It is still controversial whether pomegranate causes drug interactions. Pomegranate juice has been shown to inhibit CYP3A in-vitro and animal studies. The coadministration of pomegranate juice with cyclosporine, a narrow therapeutic drug that is the substrate of CYP3A, might lead to drug toxicity. The objective of this study is to investigate the effect of pomegranate juice on the pharmacokinetics of cyclosporine in healthy Thai volunteers.

Methods: The study design was an open-label, randomized, single dose, crossover study with a 2- week washout period. Each fasting subject received 2 microemulsion tablets of 100 mg of cyclosporine with 500 ml of pomegranate juice (test) or 500 ml of water (control). Serial blood samples were collected up to 24 h after dosing, and blood samples were analyzed for cyclosporine concentrations by using chemiluminescent microparticle immunoassay. Fourteen healthy volunteers completed the study.

Results: The 90% confidence intervals for the test/control ratio using logarithmically transformed data of area under the concentration-time curve (AUC) from time zero until the last measured concentration (AUC0-t), AUC from time zero to infinity (AUC0-∞), and maximum concentration (Cmax) were 91.6-105.6, 92.0-105.2 and 82.3-102.5, respectively. The results were within the accepted bioequivalence range for narrow therapeutic index drugs (90-111% for AUC and 80-125% for Cmax). There were no differences in adverse event between the groups.

Conclusion: Single dose administration of pomegranate juice with cyclosporine did not significantly affect the oral bioavailability of cyclosporine. However, further work is needed to thoroughly evaluate the effect of pomegranate on narrow therapeutic drugs.

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Current clinical pharmacology
Current clinical pharmacology PHARMACOLOGY & PHARMACY-
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期刊介绍: Current Clinical Pharmacology publishes frontier reviews on all the latest advances in clinical pharmacology. The journal"s aim is to publish the highest quality review articles in the field. Topics covered include: pharmacokinetics; therapeutic trials; adverse drug reactions; drug interactions; drug metabolism; pharmacoepidemiology; and drug development. The journal is essential reading for all researchers in clinical pharmacology.
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