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在常规临床实践中评估RISPERIDONE ISM®的现实世界药理动力学
Francisco José Toja-Camba1,2, María Vidal-Millares3, María José Duran-Maseda3
1Pharmacy Department, University Clinical Hospital of Santiago de Compostela (SERGAS), 15706 Santiago de Compostela, Spain.
里斯佩里每月注射的ISM®可以实现治疗精神分裂症的快速和持续的血水平. 然而,药物水平的显著个体间变异性需要进一步调查,以获得最佳的患者结果.
科学领域:
- 药理学 药理学是指药理学的学科.
- 精神病学是一个精神病学.
- 药物输送系统 药物输送系统
背景情况:
- 里斯佩里ISM®是一种治疗精神分裂症的每月长效注射剂 (LAI) 配方.
- 它利用现场微植入技术进行双相药物释放.
- 这种配方旨在达到立即和持续的治疗性血度,而不需要口服补充剂或加载剂量.
研究的目的:
- 评估里斯佩里ISM®的现实世界药理动力学特征.
- 为了评估活性部分 (Risperidone + 9-OH-Risperidone) 的血度.
- 分析按剂量和注射部位分层的药理学参数.
主要方法:
- 观察性研究设计.观察性研究设计.
- 在接受75毫克或100毫克Risperidone ISM®的患者中测量的血度.
- 在多个时间点进行采样:注射前,注射后2小时,24小时,14日,21日,25日.
- 药物动力学参数 (Cmax,Cmin,Tmax,AUC) 的计算.
主要成果:
- 治疗性血水平在几个小时内达到,持续28天.
- 平均Cmin值:34.4 ng/mL (75毫克) 和36.1 ng/mL (100毫克).
- 24小时的Tmax中位数;平均Cmax:55.7 ng/mL (75毫克) 和59 ng/mL (100毫克).
- 与deltoid管理观察到更高的全身暴露.
- 观察到显著的个体间变化;45.4%的患者的低谷水平超出治疗范围.
结论:
- 利斯佩里ISM®有效地实现了快速和持续的治疗性血水平,用于治疗精神分裂症.
- 观察到的高个体间变异性需要进一步研究.
- 识别导致变化的因素对于优化治疗有效性和安全性至关重要.
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