Ventricular premature beats caused by anthracyclines
Conditions
Interventions
Test group:For patients who develop ventricular premature beats during anthracycline-based chemotherapy, Zhengxintai Granules should be taken orally starting from Day 0 with boiling water, 5g for each
Control Group:During anthracycline-induced ventricular premature beats, the placebo (5g/sachet) will be orally administered from Day 0 with boiling water, 5g for each time, 3 times a day. Take contin
Sponsors
The first affiliated hospital of Dalian medical university
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients selected for anthracycline drug therapy, with an expected cumulative dose of anthracycline drugs =200 mg/m²; 2. Ventricular premature beats occurring at least 1 cycle after anthracycline drug therapy, meeting the clinical diagnostic criteria for ventricular premature beats,LOWN grading level 2 or above;meeting the TCM diagnostic criteria (Qi-Yin deficiency type of palpitations); 3. Age between 18 and 80 years (inclusive); 4. Life expectancy >6 months; 5. Subjects voluntarily participate and sign the informed consent form; 6. Not concurrently participating in any interventional study. Note: Anthracycline drugs include doxorubicin, epirubicin, pirarubicin, etc. The cumulative dose mentioned in this inclusion criterion refers to the dose of doxorubicin, and other anthracycline drugs require equivalent conversion.
Exclusion criteria
Exclusion criteria: 1. The patient had ventricular premature beats at grade 2 or above according to the LOWN classification before the administration of anthracycline agents. 2. The patient had used any antiarrhythmic drugs within five half-lives prior to randomization for other treatments, or had received antiarrhythmic therapy before randomization. 3. Patients with hyperthyroidism, liver dysfunction (ALT or AST > 3 times the upper limit of normal), or renal dysfunction (chronic kidney disease with eGFR < 30 mL/min/1.73m²). 4. Uncontrolled hypertension (systolic blood pressure = 180 mmHg and/or diastolic blood pressure = 110 mmHg). 5. Patients who are unable to take medication or follow-up within the specified time, with poor compliance. 6. Patients allergic to any herbal components in this study (Astragalus, Pueraria, Taxillus, Salvia, Crataegus, Ligusticum), or those in pregnancy or lactation. 7. Any other conditions deemed unsuitable for inclusion in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in ventricular premature beats burden =50%.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare the effect of two groups on liver function.;The proportion of patients requiring salvage therapy.;Comparison of the effects of two groups on cardiac function;Comparison of the Effect of Two Groups on Cardiac Injury;Compare the two groups in terms of readmission rate, all-cause mortality rate, and other adverse event incidence rates.; | — |
Countries
China
Contacts
Public ContactYunLong Xia
The first affiliated hospital of Dalian medical university
Outcome results
None listed