目的:运用精准医学/药学理念,对癫痫自我管理工具进行探索,构建基于治疗药物监测(therapeutic drug monitoring,TDM)数据的癫痫自我管理移动应用程序(application,APP)。方法:通过问卷调查、文献查阅和功能调研,结合药学服务中的实际问...目的:运用精准医学/药学理念,对癫痫自我管理工具进行探索,构建基于治疗药物监测(therapeutic drug monitoring,TDM)数据的癫痫自我管理移动应用程序(application,APP)。方法:通过问卷调查、文献查阅和功能调研,结合药学服务中的实际问题,完成系统架构和交互设计,并应用APP开发工具进行系统集成和数据交换,实现对APP的开发。结果:癫痫自我管理APP的应用,可基本满足目标群体使用需求,癫痫患者可在线管理诊疗记录,设置服药提醒,建立癫痫日记,还可在线查看TDM报告单,向医生、药师免费咨询,功能全面,实用性强。医生和药师可在线管理病人群,对特殊患者进行长期追踪和随访,促进了医药患三方的良性互动。结论:癫痫自我管理移动APP为患者提供了一站式的健康管理平台,同时也为临床医师和药师参与患者管理、进行疗效评估与不良反应监护提供了切实可靠的路径,具备一定的应用推广价值。展开更多
Lamotrigine (LTG) is a widely used antiepileptic drug (AED) for the treatment of new-onset, as well as refractory epilepsy. Due to the narrow treatment window and large individual variability in the pharmacokinetics a...Lamotrigine (LTG) is a widely used antiepileptic drug (AED) for the treatment of new-onset, as well as refractory epilepsy. Due to the narrow treatment window and large individual variability in the pharmacokinetics and pharmacodynamics of LTG, therapeutic drug monitoring (TDM) is necessary in clinical practice to guide dose adjustments. Individual differences and drug combinations can also affect protein binding rate, which further affects the unbound concentration of LTG. The unbound fraction is more closely related to adverse reactions and therapeutic efficacy than total concentration. Therefore, it may be more meaningful to determine the unbound LTG concentration in plasma than the total concentration.Unbound LTG in plasma was extracted by ultrafiltration. High-performance liquid chromatography (HPLC) was used to measure unbound LTG concentration. This method was validated by studies of its selectivity, linearity, lower limit of quantification (LLOQ), accuracy, precision, recovery, and stability.The method was validated over a linear range of 0.2 to 10.0 μg·mL–1, and its LLOQ was 0.2 μg·mL–1. The method’s relative standard deviations (RSDs) for intra-day and inter-day precision were less than 15%, and its accuracy (RE) was ±4.69%. The recoveries of unbound LTG at three different concentrations satisfied the requirements for the analysis of biological samples, and no significant degradation of LTG was observed under different storage conditions.A simple HPLC method showed good performance when used to measure unbound LTG concentration. This method might be used to study the relationship between unboundLTG concentrations and its effectiveness according to TDM.展开更多
文摘目的:运用精准医学/药学理念,对癫痫自我管理工具进行探索,构建基于治疗药物监测(therapeutic drug monitoring,TDM)数据的癫痫自我管理移动应用程序(application,APP)。方法:通过问卷调查、文献查阅和功能调研,结合药学服务中的实际问题,完成系统架构和交互设计,并应用APP开发工具进行系统集成和数据交换,实现对APP的开发。结果:癫痫自我管理APP的应用,可基本满足目标群体使用需求,癫痫患者可在线管理诊疗记录,设置服药提醒,建立癫痫日记,还可在线查看TDM报告单,向医生、药师免费咨询,功能全面,实用性强。医生和药师可在线管理病人群,对特殊患者进行长期追踪和随访,促进了医药患三方的良性互动。结论:癫痫自我管理移动APP为患者提供了一站式的健康管理平台,同时也为临床医师和药师参与患者管理、进行疗效评估与不良反应监护提供了切实可靠的路径,具备一定的应用推广价值。
基金Liaoning Province Natural Science Foundation of China(Grant No.2013021079)
文摘Lamotrigine (LTG) is a widely used antiepileptic drug (AED) for the treatment of new-onset, as well as refractory epilepsy. Due to the narrow treatment window and large individual variability in the pharmacokinetics and pharmacodynamics of LTG, therapeutic drug monitoring (TDM) is necessary in clinical practice to guide dose adjustments. Individual differences and drug combinations can also affect protein binding rate, which further affects the unbound concentration of LTG. The unbound fraction is more closely related to adverse reactions and therapeutic efficacy than total concentration. Therefore, it may be more meaningful to determine the unbound LTG concentration in plasma than the total concentration.Unbound LTG in plasma was extracted by ultrafiltration. High-performance liquid chromatography (HPLC) was used to measure unbound LTG concentration. This method was validated by studies of its selectivity, linearity, lower limit of quantification (LLOQ), accuracy, precision, recovery, and stability.The method was validated over a linear range of 0.2 to 10.0 μg·mL–1, and its LLOQ was 0.2 μg·mL–1. The method’s relative standard deviations (RSDs) for intra-day and inter-day precision were less than 15%, and its accuracy (RE) was ±4.69%. The recoveries of unbound LTG at three different concentrations satisfied the requirements for the analysis of biological samples, and no significant degradation of LTG was observed under different storage conditions.A simple HPLC method showed good performance when used to measure unbound LTG concentration. This method might be used to study the relationship between unboundLTG concentrations and its effectiveness according to TDM.
