Therapeutic Drug Monitoring of Anxiolytics in Children
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Plasma drug concentration
研究概览
简要总结
In this study, the therapeutic drug monitoring of anxiolytics is carried out among children to obtain the drug concentration, clinical efficacy and safety data of children patients in different gender and age groups. Then the investigators analyze the relationship between blood drug concentration and efficacy and safety, and provide recommendations for the treatment window of anxiolytics in Chinese children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 29 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Anxiolytics was used for therapeutic purposes;
- •Age:≤18 years;
- •Patients with therapeutic concentration monitoring of anxiolytics.
排除标准
- •Patients without therapeutic concentration monitoring of anxiolytics;
- •The blood concentrations of the patient was not approved by the quality control center
- •Use foods or products that inhibit or induce CYP 3A activity.
研究组 & 干预措施
Anxiolytics
Pediatric patients treated with sedation using anxiolytics
干预措施: Midazolam/diazepam/propofol (Drug)
结局指标
主要结局
Plasma drug concentration
时间窗: Through study completion, an average of 14 days
To detect the plasma concentrations of teicoplanin at therapeutic drug monitoring (TDM).
次要结局
未报告次要终点
研究者
Wei Zhao
Professor; Head of department of clinical pharmacy and pharmacology
Shandong University