Adverse Reaction, Cardiotoxicity, Evaluation Study
Conditions
Keywords
arsenious acid, arsenic trioxide, cardiotoxicity
Brief summary
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.
Detailed description
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.
Interventions
DRUGSodium arsenite chloride injection
Patient use of arsenite sodium chloride injection
Sponsors
Qianfoshan Hospital
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Patients with incomplete clinical information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Echocardiogram LVEF | through study completion, an average of 1 year | Echocardiogram LVEF values |
| adverse reaction | through study completion, an average of 1 year | All cardiac-related adverse events in the course of the disease regimen |
| troponin | through study completion, an average of 1 year | Troponin values |
| arrhythmia | through study completion, an average of 1 year | Electrocardiogram shows arrhythmia with marked QT prolongation |
Countries
China
Contacts
Primary ContactYi Han, doctorate
Outcome results
None listed