Risk Analysis of Cardiotoxic Medication Use Due to Sodium Arsenite Chloride Injection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- adverse reaction
研究概览
简要总结
To study the current status of cardiotoxicity of arsenious acid by analyzing the literature, monitoring data, and real-world applications, and to discuss risk factors and preventive and control measures.
详细描述
Through the project study, the risk rate of cardiotoxicity caused by arsenious acid will be verified and evaluated, and a typical case analysis will be conducted to assess the risk and benefit ratio of clinical use of arsenious acid injection and to formulate preventive measures, so as to guide the holder of the marketing authorization to carry out in-depth safety studies and to ensure the public's safe use of the drug.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the period of consultation (for inpatients, according to the time of admission) is from January 1, 2012 to December 31, 2022
- •the patient used arsenite sodium chloride injection
排除标准
- •Patients with incomplete clinical information
结局指标
主要结局
adverse reaction
时间窗: through study completion, an average of 1 year
All cardiac-related adverse events in the course of the disease regimen
Echocardiogram LVEF
时间窗: through study completion, an average of 1 year
Echocardiogram LVEF values
arrhythmia
时间窗: through study completion, an average of 1 year
Electrocardiogram shows arrhythmia with marked QT prolongation
troponin
时间窗: through study completion, an average of 1 year
Troponin values
次要结局
未报告次要终点
研究者
Yi Han
Associate professor of pharmacy
Qianfoshan Hospital