Abstract
Objective: To observe and analyze the effect of diacetyl hexamethylene diamine (CAHB, a differentiation inducer of cancer cells) on electrocardiogram (ECG) changes in patients with myelodysplastic syndrome (MDS). Methods: In a phase I clinical trial, 48 patients with MDS received designed single or multiple doses of CAHB infusion. In a phase IIA trial, 10 MDS patients were treated with continuous intravenous infusion of CAHB for 2 courses. ECG was monitored before, during and after CAHB treatment. Results: All patients finished the phase I trial. After CAHB administration, abnormal ECG was observed in totally 9 patients: temporary ventricular premature beats in 1 patient; T wave change in 3 patients; ST-T change in 3 patients; left ventricular hyper-voltage in 2 patients. No QT interval or QTc prolongation were observed. In the phase IIA trial, 10 patients were totally treated for 18 courses. Changes in ventricle depolarization and repolarization were observed in 2 patients, including U wave occurrence, ST segment depression, and T wave flatness. No symptoms, signs, and any abnormality of laboratory examination were found. The ECG changes recovered after the drug discontinuation. Conclusion: The abnormal ECG changes are correlated to the clinical trial drug CAHB, and can recover after drug discontinuation. No significant changes were detected in any other indexes for heart safety.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1525-1528 |
| Number of pages | 4 |
| Journal | Chinese Journal of New Drugs |
| Volume | 17 |
| Issue number | 17 |
| State | Published - 2008 |
Keywords
- Clinical trial
- Diacetyl hexamethylene diamine (CAHB)
- Electrocardiogram (ECG)
- Myelodysplastic syndrome(MDS)
ASJC Scopus subject areas
- Pharmacology, Toxicology and Pharmaceutics(all)
- Pharmacology (medical)