Preliminary Determination of the Therapeutic Reference Range of Lurasidone in Chinese Patients and Analysis of the Factors Influencing Lurasidone Dose-Corrected Concentrations.

IF 2.8 4区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY
Ye Yang, Zhanzhang Wang, Tao Xiao, Xiaojia Ni, Emei Song, Lijing Dai, Yuqing Chen, Haoyang Lu, Dewei Shang, Yuguan Wen
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引用次数: 0

Abstract

Background: The aim of this study was to determine the therapeutic reference range of lurasidone, and to analyze the factors influencing the dose-corrected concentration of lurasidone in Chinese psychiatric patients, thereby providing a basis for the development of individualized dosing of lurasidone.

Methods: A retrospective analysis was conducted for hospitalized patients who had received lurasidone and undergone blood concentration monitoring from May 2022 to September 2023 at the Affiliated Brain Hospital of Guangzhou Medical University. Analyses were based on patient demographic data, treatment regimens, and administered drug concentrations.

Results: Data for a total of 123 lurasidone steady-state trough concentrations were collected from 120 hospitalized patients. It was found that 85.56% of lurasidone steady-state trough concentrations were below the lower limit of the lurasidone therapeutic reference range (15 ng·mL-1), and that the median steady-state trough concentration was 7.09 ng·mL-1 (IQ1-IQ3 = 4.12-11.82 ng·mL-1). Gender, age, and co-medication with valproic acid were found to be significant factors influencing lurasidone steady-state trough concentration/daily dose (C/D) values. C/D values for females were 14% higher than those obtained for males. Among patients who did not receive concomitant administration of valproic acid, the C/D values were 55% higher than those who had received co-administered valproic acid. Furthermore, C/D values obtained for elderly patients (≥60 years) were 140% higher than those recorded for adolescents (<18 years) and 157% higher than those in younger adults (18-60 years).

Conclusions: The findings of this study indicated that the guideline-recommended therapeutic reference range (15-40 ng·mL-1) for lurasidone may not be appropriate, at least for the Chinese population. More extensive therapeutic drug monitoring is recommended for elderly female patients and those receiving co-medication with lurasidone and valproic acid.

中国患者鲁拉西酮治疗参考范围的初步确定及影响鲁拉西酮剂量校正浓度的因素分析。
背景:本研究旨在确定鲁拉西酮的治疗参考范围,分析影响我国精神病患者鲁拉西酮剂量校正浓度的因素,为鲁拉西酮个体化给药提供依据。方法:回顾性分析广州医科大学附属脑科医院2022年5月至2023年9月期间接受鲁拉西酮治疗并进行血药浓度监测的住院患者。分析基于患者人口统计数据、治疗方案和给药浓度。结果:从120例住院患者中收集了123个鲁拉西酮稳态谷浓度数据。85.56%的鲁拉西酮稳态谷浓度低于鲁拉西酮治疗参考范围下限(15 ng·mL-1),中位稳态谷浓度为7.09 ng·mL-1 (IQ1-IQ3 = 4.12-11.82 ng·mL-1)。性别、年龄和与丙戊酸的联合用药是影响鲁拉西酮稳态谷浓度/日剂量(C/D)值的重要因素。女性的C/D值比男性高14%。在未同时服用丙戊酸的患者中,C/D值比同时服用丙戊酸的患者高55%。此外,老年患者(≥60岁)的C/D值比青少年患者高140%(结论:本研究结果表明,指南推荐的鲁拉西酮治疗参考范围(15-40 ng·mL-1)可能不合适,至少对中国人群不合适。建议对老年女性患者和与鲁拉西酮和丙戊酸联合用药的患者进行更广泛的治疗药物监测。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Therapeutic Drug Monitoring
Therapeutic Drug Monitoring 医学-毒理学
CiteScore
5.00
自引率
8.00%
发文量
213
审稿时长
4-8 weeks
期刊介绍: Therapeutic Drug Monitoring is a peer-reviewed, multidisciplinary journal directed to an audience of pharmacologists, clinical chemists, laboratorians, pharmacists, drug researchers and toxicologists. It fosters the exchange of knowledge among the various disciplines–clinical pharmacology, pathology, toxicology, analytical chemistry–that share a common interest in Therapeutic Drug Monitoring. The journal presents studies detailing the various factors that affect the rate and extent drugs are absorbed, metabolized, and excreted. Regular features include review articles on specific classes of drugs, original articles, case reports, technical notes, and continuing education articles.
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