阵发性心房颤动患者服用氢溴酸拉帕康尼汀缓释剂和普罗帕酮的比较研究

Vrach Pub Date : 2024-01-31 DOI:10.29296/25877305-2024-01-04
А. Revishvili, S. Golitsyn, S. Aksentiev, А. Amiraslanov, А. Artyukhina, D. Duplyakov, Е. Zubov, Е. Isaeva, А. Loginova, Т. Malkina, G. Miloserdov, А. Rivin, S. Teplykh, I. Tsygankova, Yu. Shvarts, Y. Yuricheva, S. Kanorsky, S. Sokolov
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引用次数: 0

摘要

一种氢溴酸拉帕康尼汀的新剂型--长效药物Allaforte®已经问世,与传统剂型(Allapinin®)相比,它的副作用更少。评估Allaforte®与Rytmonorm®相比对阵发性心房颤动(房颤)患者治疗的有效性、安全性和耐受性。符合纳入标准的患者和不符合非纳入标准的患者被随机分为两组:第一组(n=50)--患者接受Allaforte®治疗,每天3次,每次25毫克,如果发现房颤发作,剂量增加到每天2次,每次50毫克;第二组(n=50)--患者接受Rytmonorm®治疗,每天3次,每次150毫克,如果发现房颤发作,剂量增加到每天2次,每次300毫克。第一组(Allaforte®)从首次服药到房颤发作的平均时间为(98.877±6.022)天,第二组(Rytmonorm®)为(98.808±5.876)天,从首次服药到研究结束的平均时间分别为(105.740±5.032)天和(103.732±5.353)天。药物 Allaforte® 和 Rytmonorm® 同样改善了患者的生活质量。根据不良反应的严重程度及其与药物的因果关系进行的分组比较分析未显示出显著差异。研究药物在预防房颤发作方面的疗效相当,安全性和耐受性相似。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A comparative study of lappaconitine hydrobromide extended release and propafenone in patients with paroxysmal atrial fibrillation
A new dosage form of lappaconitine hydrobromide has been created – the long-acting drug Allaforte®, which has fewer side effects compared to the traditional dosage form (Allapinin®). Objective. To evaluate the effectiveness, safety and tolerability of Allaforte® therapy in comparison with the drug Rytmonorm® in patients with paroxysmal atrial fibrillation (AF). Material and methods. Patients who met the inclusion criteria and those who did not meet the non-inclusion criteria were randomized into 2 groups: 1st (n=50) – patients received Allaforte® 25 mg 3 times a day with an increase in dose to 50 mg 2 times a day when detected attack of AF; 2nd (n=50) – patients received Rytmonorm® 150 mg 3 times a day with an increase in dose to 300 mg 2 times a day if an attack of AF was detected. Results. The average time from the first dose of the drug to the development of AF paroxysm in the 1st group (Allaforte®) was 98.877±6.022 days, in the 2nd group (Rytmonorm®) – 98.808±5.876 days, the average time from the first dose of the drug to the completion of the study – 105.740±5.032 and 103.732±5.353 days, respectively. The drugs Allaforte® and Rytmonorm® equally improved the quality of life of patients. A comparative analysis in groups according to the severity of adverse events and their cause-and-effect relationship with the drug did not show significant differences. Conclusion. The study drugs showed comparable effectiveness in preventing attacks of AF with similar safety and tolerability.
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