Efficiency and safety of using the modified protocol for the administration of the domestic class III antiarrhythmic drug for the relief of paroxysmal atrial fibrillation

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Abstract

Aim. Evaluation of the efficacy and safety of the modified refralon administration protocol for the relief of paroxysmal atrial fibrillation (AF).

Materials and methods. The study included 39 patients (19 men, mean age 63±12.8 years). All patients, after excluding contraindications in the intensive care unit, were injected intravenously with refralon at an initial dose of 5 mg/kg. If AF was preserved and there were no contraindications, after 15 min, repeated administration was performed at a dose of 5 mg/kg (total dose of 10 mg/kg). After another 15 min, while maintaining AF and the absence of contraindications, the third injection of the drug was performed at a dose of 10 mg/kg (total dose of 20 mg/kg). In the absence of relief and the absence of contraindications, another injection of refralon at a dose of 10 mg/kg was performed after another 15 min (in this case, the maximum total dose of 30 mg/kg was reached). After each injected bolus and before the introduction of the next one, the ECG parameters and the general condition of the patient were assessed. The patient was monitored for 24 hours to exclude the arrhythmogenic effect and other possible adverse events.

Results. Restoration of sinus rhythm (SR) was noted in 37 patients out of 39 (95%). Of these, 19 people (48.7%) had SR recovery after the administration of a minimum dose of refralone of 5 mg/kg. The effectiveness of the total dose of 10 mg/kg was 76.9%, the dose of 20 mg/kg was 89.7%, and the dose of 30 mg/kg was 95%. Only two patients did not recover HR after administration of the maximum dose of refralon 30 mg/kg. Pathological prolongation of the QTc interval (>500 ms) was recorded in 5% of patients. Not a single case of ventricular arrhythmogenic action (induction of Torsade de pointes) has been reported. Bradyarrhythmias (pauses, bradycardia) were registered in 13% of cases, were of a transient nature.

Conclusion. Refralon has a high efficiency of relief (95%) of paroxysmal AF, while in almost half of cases (48.7%), SR recovery is achieved using the minimum dose of refralon – 5 mg/kg. Despite the prolongation of the QTc>500 ms recorded in 5% of cases, none of the patients developed Torsade de pointes after administration of the drug.

About the authors

Khava M. Dzaurova

Myasnikov Institute of Clinical Cardiology, National Medical Research Center of Cardiology

Author for correspondence.
Email: dr_dzaurova@mail.ru
ORCID iD: 0000-0003-4291-1040

аспирант отд. клинической электрофизиологии и рентгенохирургических методов лечения нарушений ритма сердца

Russian Federation, Moscow

Nikolay Yu. Mironov

Myasnikov Institute of Clinical Cardiology, National Medical Research Center of Cardiology

Email: dr_dzaurova@mail.ru
ORCID iD: 0000-0002-6086-6784

канд. мед. наук, ст. науч. сотр. лаб. интервенционных методов диагностики и лечения нарушений ритма, проводимости сердца и синкопальных состояний

Russian Federation, Moscow

Yuliia A. Yuricheva

Myasnikov Institute of Clinical Cardiology, National Medical Research Center of Cardiology

Email: dr_dzaurova@mail.ru
ORCID iD: 0000-0002-5532-6345

канд. мед. наук, науч. сотр. отд. клинической электрофизиологии и рентгенохирургических методов лечения нарушений ритма сердца

Russian Federation, Moscow

Vladislav V. Vlodzyanovsky

Myasnikov Institute of Clinical Cardiology, National Medical Research Center of Cardiology

Email: dr_dzaurova@mail.ru
ORCID iD: 0000-0002-8976-8539

врач – анестезиолог- реаниматолог отд. клинической электрофизиологии и рентгенохирургических методов лечения нарушений ритма сердца

Russian Federation, Moscow

Nataliia A. Mironova

Myasnikov Institute of Clinical Cardiology, National Medical Research Center of Cardiology

Email: dr_dzaurova@mail.ru
ORCID iD: 0000-0002-2374-3718

канд. мед. наук, ст. науч. сотр. отд. клинической электрофизиологии и рентгенохирургических методов лечения нарушений ритма сердца

Russian Federation, Moscow

Lada Yu. Laiovich

Myasnikov Institute of Clinical Cardiology, National Medical Research Center of Cardiology

Email: dr_dzaurova@mail.ru

канд. мед. наук, науч. сотр. отд. клинической электрофизиологии и рентгенохирургических методов лечения нарушений ритма сердца

Russian Federation, Moscow

Tatiana A. Malkina

Myasnikov Institute of Clinical Cardiology, National Medical Research Center of Cardiology

Email: dr_dzaurova@mail.ru
ORCID iD: 0000-0003-4773-8080

канд. мед. наук, науч. сотр. отд. клинической электрофизиологии и рентгенохирургических методов лечения нарушений ритма сердца

Russian Federation, Moscow

Liudmila V. Zinchenko

Myasnikov Institute of Clinical Cardiology, National Medical Research Center of Cardiology

Email: dr_dzaurova@mail.ru
ORCID iD: 0000-0002-7859-1686

лаборант-исследователь отд. клинической электрофизиологии и рентгенохирургических методов лечения нарушений ритма сердца

Russian Federation, Moscow

Sergei F. Sokolov

Myasnikov Institute of Clinical Cardiology, National Medical Research Center of Cardiology

Email: dr_dzaurova@mail.ru
ORCID iD: 0000-0001-5418-7796

канд. мед. наук, внештат. науч. сотр. отд. клинической электрофизиологии и рентгенохирургических методов лечения нарушений ритма сердца

Russian Federation, Moscow

Sergey P. Golitsyn

Myasnikov Institute of Clinical Cardiology, National Medical Research Center of Cardiology

Email: dr_dzaurova@mail.ru
ORCID iD: 0000-0001-9913-9974

д-р мед. наук, проф., рук. отд. клинической электрофизиологии и рентгенохирургических методов лечения нарушений ритма сердца

Russian Federation, Moscow

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Supplementary files

Supplementary Files
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2. Fig. 1. Results of using the 4-stage scheme of Refralon for the relief of paroxysmal atrial fibrillation.

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3. Fig. 2. The accumulated effectiveness of Refralon when using a 4-stage scheme with increasing the drug dose.

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