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首页> 外文期刊>Journal of clinical laboratory analysis. >Development and Validation of Liquid Chromatography/Tandem Mass Spectrometry Analysis for Therapeutic Drug Monitoring of Risperidone and 9‐Hydroxyrisperidone in Pediatric Patients with Autism Spectrum Disorders
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Development and Validation of Liquid Chromatography/Tandem Mass Spectrometry Analysis for Therapeutic Drug Monitoring of Risperidone and 9‐Hydroxyrisperidone in Pediatric Patients with Autism Spectrum Disorders

机译：液相色谱/串联质谱分析法在儿童自闭症谱系障碍患者中利培酮和9-羟基利培酮治疗药物监测的开发和验证

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BackgroundRisperidone (RIS) is a widely used atypical antipsychotic drug. We developed and validated a sensitive and accurate LC-MS/MS method, which requires a small-volume of plasma and small-volume injection for measurement of RIS levels in ASD pediatric patients. We also investigated the relationship between RIS levels and RIS dosages, including prolactin levels. MethodBlood samples were processed by protein precipitation extraction. Only 1 μl of sample was injected. Plasma samples were separated on a C18 column (4.6 cm × 50 mm; 1.8 μm particle size). Detection was by MS-MS with an analytical run time of 6 min. ResultsThe inter-day accuracy of RIS was 101.33–107.68% and 95.24–103.67% for 9-OH-RIS. The inter-day precision of RIS was ≤7.27% CV and ≤7.41% CV for 9-OH-RIS. The extraction recovery of RIS and 9-OH-RIS were 95.01 ± 7.31–112.62 ± 7.50% and 90.27 ± 11.15–114.00 ± 10.35%, respectively. This method was applied in the therapeutic drug monitoring of ASD pediatric patients. Higher RIS dosage has a tendency to produce higher RIS plasma levels. The high RIS plasma levels have a tendency to produce hyperprolactinemia. ConclusionThe determination of RIS in individual patients might be clinically useful for monitoring and prediction of treatment response.
机译：背景利培酮（RIS）是一种广泛使用的非典型抗精神病药。我们开发并验证了灵敏且准确的LC-MS / MS方法，该方法需要小剂量的血浆和小剂量的注射液来测量ASD小儿患者的RIS水平。我们还研究了RIS水平与RIS剂量（包括催乳激素水平）之间的关系。方法通过蛋白质沉淀提取法处理血液样品。仅注射了1μl样品。血浆样品在C18色谱柱上分离（4.6 cm×50 mm; 1.8μm粒径）。通过MS-MS检测，分析运行时间为6分钟。结果9-OH-RIS的RIS的日间准确性为101.33–107.68％和95.24–103.67％。对于9-OH-RIS，RIS的日间精度为≤7.27％CV和≤7.41％CV。 RIS和9-OH-RIS的提取回收率分别为95.01±7.31–112.62±7.50％和90.27±11.15–114.00±10.35％。该方法用于ASD儿科患者的治疗药物监测。较高的RIS剂量倾向于产生较高的RIS血浆水平。高RIS血浆水平有产生高泌乳素血症的趋势。结论确定个体患者的RIS在临床上可能对监测和预测治疗反应有用。

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