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Возможности контроля безопасности антиаритмической терапии: современное состояние проблемы (обзор литературы)
Возможности контроля безопасности антиаритмической терапии: современное состояние проблемы (обзор литературы)
Ененков Н.В., Селезнев С.В., Щулькин А.В., Филоненко С.П., Якушин С.С. Возможности контроля безопасности антиаритмической терапии: современное состояние проблемы (обзор литературы) // CardioСоматика. 2025. Т. 16, № 3. С. 230–239. DOI: 10.17816/CS645388 EDN: JXARCC
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Аннотация
Антиаритмическая терапия сопряжена с высоким риском развития побочных эффектов, среди которых выделяют экстракардиальные и кардиальные (в т.ч. проаритмические) осложнения, а также осложнения, связанные с межлекарственными взаимодействиями. В настоящее время для контроля безопасности при приёме антиаритмических препаратов (ААП) проводят мониторинг параметров электрокардиограммы, функций печени, почек, щитовидной железы и лёгких, а также выявление кардиологической патологии, в т.ч. скрытых нарушений проводящей системы сердца (например, синдром врождённого удлинения интервала Q–T). Однако данные подходы не всегда позволяют избежать нежелательных лекарственных реакций. Проводился отбор литературы по базам данных PubMed и eLibrary в период с января 2019 по декабрь 2024 года (в ряде случаев, в связи с ограниченным количеством источников, диапазон увеличивался). Глубина поиска источников — с 1979 по 2024. В настоящем обзоре представлены современные подходы к контролю безопасности наиболее часто назначаемых в клинической практике ААП IC класса (пропафенон, лаппаконитина гидробромид и диэтиламинопропионилэтоксикарбониламинофенотиазин), а также III класса (амиодарон и соталол). Описаны перспективы применения терапевтического лекарственного мониторинга ААП и оценки генных полиморфизмов.
Ключевые слова: побочные эффекты, безопасность, антиаритмические препараты, пропафенон, лаппаконитина гидробромид, амиодарон, соталол, терапевтический лекарственный мониторинг
Keywords: adverse effects, patient safety, anti-arrhythmia agents, propafenone, lappaconitine hydrobromide, amiodarone, sotalol, therapeutic drug monitoring
Ключевые слова: побочные эффекты, безопасность, антиаритмические препараты, пропафенон, лаппаконитина гидробромид, амиодарон, соталол, терапевтический лекарственный мониторинг
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Keywords: adverse effects, patient safety, anti-arrhythmia agents, propafenone, lappaconitine hydrobromide, amiodarone, sotalol, therapeutic drug monitoring
Полный текст
Список литературы
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2. Al-Gobari M, El Khatib C, Pillon F, et al. β-Blockers for the prevention of sudden cardiac death in heart failure patients: a meta-analysis of randomized controlled trials BMC. Cardiovasc Disord. 2013;13(13):52. doi: 10.1186/1471-2261-13-52 EDN: YDMJBZ
3. Markman TM, Geng Z, Epstein AE, et al. Trends in antiarrhythmic drug use among patients in the United States between 2004 and 2016. Circulation. 2020;141(11):937–939. doi: 10.1161/CIRCULATIONAHA.119.044109 EDN: VXWLNA
4. Poulsen CB, Damkjær M, Løfgren B, Schmidt M. Trends in antiarrhythmic drug use in Denmark over 19 years. Am J Cardiol. 2020;125(4):562–569. doi: 10.1016/j.amjcard.2019.11.009 EDN: WSBYUU
5. Tarasov AV. Safety issues of antiarrhythmic therapy. Consilium Medicum. 2014;16(10):44–49. EDN: SXCNNF
6. Dan GA, Martinez-Rubio A, ESC Scientific Document Group. Antiarrhythmic drugs-clinical use and clinical decision making: a consensus document from the European Heart Rhythm Association (EHRA) and European Society of Cardiology (ESC) Working Group on Cardiovascular Pharmacology, endorsed by the Heart Rhythm Society (HRS), Asia-Pacific Heart Rhythm Society (APHRS) and International Society of Cardiovascular Pharmacotherapy (ISCP). Europace. 2018;20(5):731–732. doi: 10.1093/europace/eux373 EDN: YHLLBJ
7. Yakushin SS, Nikulina NN, Filippov EV. Results of the pilot part of the cardiac drug overdoses hospital registry (STORM): focus on drug-induced bradycardia. I.P. Pavlov Russian medical biological herald. 2020;28(2):153–163. doi: 10.23888/PAVLOVJ2020282153-163 EDN: AODSPJ
8. Wang F, Zhou B, Sun H, Wu X. Proarrhythmia associated with antiarrhythmic drugs: a comprehensive disproportionality analysis of the FDA adverse event reporting system. Front Pharmacol. 2023;14:1170039. doi: 10.3389/fphar.2023.1170039 EDN: KVNSQG
9. Lin CY, Lin YJ, Lo LW, et al. Factors predisposing to ventricular proarrhythmia during antiarrhythmic drug therapy for atrial fibrillation in patients with structurally normal heart. Heart Rhythm. 2015;12(7):1490–1500. doi: 10.1016/j.hrthm.2015.04.018
10. Mansourati J, Khattar P. Benefit and concern about the "pill‑in‑the‑pocket". J Med Liban. 2013;61(2):101–104. doi: 10.12816/0000410
11. Tisdale JE, Chung MK, Campbell KB. Drug-Induced Arrhythmias: A Scientific Statement From the American Heart Association. Circulation. 2020;142(15):214–233. doi: 10.1161/CIR.0000000000000905 EDN: QPZRVI
12. Mrochek AG, Gubar EN. The effectiveness of allapinin in patients with coronary artery disease with various rhythm disturbances. Russian Journal of Cardiology. 2010;5(85):116–121. EDN: NYLQWN
13. Sokolov SF. Results of a clinical study of the drug allapinin and modern approaches to the treatment of patients with cardiac arrhythmias. Bulletin of Arrhythmology. 2011;64:60–70. EDN: OYEMQJ
14. Arakelyan MG, Bockeria LA, Vasilyeva EYu, et al. 2020 clinical guidelines for atrial fibrillation and atrial flutter. Russian Journal of Cardiology. 2021;26(7):4594. doi: 10.15829/1560-4071-2021-4594 EDN: FUZAAD
15. Syrov AV, Pavlova TV. Antiarrhythmic medication propafenone: place in clinical practice (review). Consilium Medicum. 2019;21(12):112–117. doi: 10.26442/20751753.2019.12.190724 EDN: RVRPJA
16. Martino E, Bartalena L, Bogazzi F, Braverman LE. The effects of amiodarone on the thyroid. Endocr Rev. 2001;22(2):240–254. doi: 10.1210/edrv.22.2.0427
17. Trohman RG, Sharma PS, McAninch EA, Bianco AC. Amiodarone and thyroid physiology, pathophysiology, diagnosis and management. Trends Cardiovasc Med. 2019;29(5):285–295. doi: 10.1016/j.tcm.2018.09.005 EDN: YMAIHB
18. Mediс F, Bakula M, Alfireviс M, et al. Amiodarone and thyroid dysfunction. Acta Clin Croat. 2022;61(2):327–341. doi: 10.20471/acc.2022.61.02.20 EDN: JUFRPO
19. Cheung AT, Weiss SJ, Savino JS, et al. Acute circulatory actions of intravenous amiodarone loading in cardiac surgical patients. Ann Thorac Surg. 2003;76(2):535–541. doi: 10.1016/s0003-4975(03)00509-5
20. Sinopalnikov AI, Tikhomirov ES, Smirnov IP, Duganov VK, Kharlanov VD. The case of “amiodarone lung”. Pulmonology. 1994;2:83–86. (In Russ.)
21. Ruzieh M, Moroi MK, Aboujamous NM, et al. Meta-analysis comparing the relative risk of adverse events for amiodarone versus placebo. Am J Cardiol. 2019;124(12):1889–1893. doi: 10.1016/j.amjcard.2019.09.008
22. Colby R, Geyer H. Amiodarone-induced pulmonary toxicity. JAAPA. 2017;30:23–26. doi: 10.1097/01.JAA.0000524713.17719.c8
23. Koenig RJ. Regulation of type 1 iodothyronine deiodinase in health and disease. Thyroid. 2005;15(8):835–840. doi: 10.1089/thy.2005.15.835
24. Harjai KJ, Licata AA. Effects of amiodarone on thyroid function. Ann Intern Med. 1997;126(1):63–73. doi: 10.7326/0003-4819-126-1-199701010-00009
25. Albert SG, Alves LE, Rose EP. Thyroid dysfunction during chronic amiodarone therapy. J Am Coll Cardiol. 1987;9(1):175–183. doi: 10.1016/s0735-1097(87)80098-0
26. Mohammadi K, Shafie D, Vakhshoori M, et al. Prevalence of amiodarone‑induced hypothyroidism; A systematic review and meta‑analysis. Trends Cardiovasc Med. 2023;33(4):252–262. doi: 10.1016/j.tcm.2022.01.001 EDN: DHXZOL
27. Biddle JR. Amiodarone and thyroid function. Ann Intern Med. 1997;127(8 Pt 1):653. doi: 10.7326/0003-4819-127-8_part_1-199710150-00020
28. Basaria S, Cooper DS. Amiodarone and the thyroid. Am J Med. 2005;118(7):706–714. doi: 10.1016/j.amjmed.2004.11.028
29. Vassallo P, Trohman RG. Prescribing amiodarone: an evidence‑based review of clinical indications. JAMA. 2007;298(11):1312–1322. doi: 10.1001/jama.298.11.1312
30. Jaworski K, Walecka I, Rudnicka L, et al. Cutaneous adverse reactions of amiodarone. Med Sci Monit. 2014;21(20):2369–2372. doi: 10.12659/MSM.890881
31. Johnson LN, Krohel GB, Thomas ER. The clinical spectrum of amiodarone‑associated optic neuropathy. J Natl Med Assoc. 2004;96(11):1477–1491.
32. Passman RS, Bennett CL, Purpura JM, et al. Amiodarone-associated optic neuropathy: a critical review. Am J Med. 2012;125(5):447–553. doi: 10.1016/j.amjmed.2011.09.020
33. Su VY, Hu YW, Chou KT, et al. Amiodarone and the risk of cancer: a nationwide population-based study. Cancer. 2013;119(9):1699–1705. doi: 10.1002/cncr.27881
34. Lim YP, Lin CL, Lin YN, et al. Antiarrhythmic agents and the risk of malignant neoplasm of liver and intrahepatic bile ducts. PloS One. 2015;10(1):e0116960. doi: 10.1371/journal.pone.0116960
35. Chen YY, Chen CY, Leung KK. Acute pancreatitis and amiodarone: a case report. World J Gastroenterol. 2007;3(6):975–977. doi: 10.3748/wjg.v13.i6.975
36. Famularo G, Minisola G, Nicotra GC, et al. Acute pancreatitis caused by amiodarone. Eur J Emerg Med. 2004;11(5):305–306. doi: 10.1097/00063110-200410000-00015
37. Singh JP, Blomström-Lundqvist C, Turakhia MP, et al. Dronedarone versus sotalol in patients with atrial fibrillation: A systematic literature review and network meta-analysis. Clin Cardiol. 2023;46(6):589–597. doi: 10.1002/clc.24011 EDN: KRXHOR
38. Samanta R, Thiagalingam A, Turner C, et al. The Use of Intravenous Sotalol in Cardiac Arrhythmias. Heart Lung Circ. 2018;27(11):1318–1326. doi: 10.1016/j.hlc.2018.03.017 EDN: YHZOAX
39. Fetsch T, Bauer P, Engberding R, et al. Prevention of atrial fibrillation after cardioversion: results of the PAFAC trial. Eur Heart J. 2004;25:1385–1394. doi: 10.1016/j.ehj.2004.04.015
40. Lafuente-Lafuente C, Valembois L, Bergmann JF, Belmin J. Antiarrhythmics for maintaining sinus rhythm after cardioversion of atrial fibrillation. Cochrane Database Syst Rev. 2015;28(3):CD005049. doi: 10.1002/14651858.CD005049
41. Joglar JA, Chung MK, Armbruster AL, et al. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024;149(1):1–156. doi: 10.1161/CIR.0000000000001193 EDN: VPOKXQ
42. Rabatin A, Snider MJ, Boyd JM, et al. Safety of Twice Daily Sotalol in Patients with Renal Impairment: A Single Center, Retrospective Review. J Atr Fibrillation. 2018;11(3):2047. doi: 10.4022/jafib.2047
43. Ates HC, Roberts JA, Lipman J, et al. On-Site Therapeutic Drug Monitoring. Trends Biotechnol. 2020;38(11):1262–1277. doi: 10.1016/j.tibtech.2020.03.001 EDN: CSJMWR
44. Mylnikov PYu, Tranova Yu, Shchulkin AV, et al. Development and validation of hplc-ms/ms method for quantitative determination of metoprolol in blood plasma of patients. Eruditio Juvenium. 2022;10(4):361–372. doi: 10.23888/HMJ2022104361-372 EDN: VESREJ
45. Campbell TJ, Williams KM. Therapeutic drug monitoring: antiarrhythmic drugs. Br J Clin Pharmacol. 1998;46(4):307–319. doi: 10.1046/j.1365-2125.1998.t01-1-00768.x EDN: EUDQYP
46. Baer DM. Critical values for therapeutic drug levels. MLO: medical laboratory observer. 2012;36(13 Suppl):9.
47. Hiji JT, Duff JH, Burgess ED. Clinical pharmacokinetics of propafenone. Clin Pharmacokinet. 1991;21(1):1–10. doi: 10.2165/00003088-199121010-00001 EDN: OKDFJP
48. Gui Y, Lu Y, Li S, Zhang M, et al. Direct analysis in real time-mass spectrometry for rapid quantification of five anti-arrhythmic drugs in human serum: application to therapeutic drug monitoring. Sci Rep. 2020;10(1):15550. doi: 10.1038/s41598-020-72490-w EDN: LRCCUL
49. Jоrgensen AM, Hermann TS, Christensen HR, et al. Use of Therapeutic Drug Monitoring in Amiodarone Treatment: A Systematic Review of Recent Literature. Ther Drug Monit. 2023;45(4):487–493. doi: 10.1097/FTD.0000000000001079 EDN: XBYAUO
50. Hrudikova Vyskocilova E, Grundmann M, Duricova J, Kacirova I. Therapeutic monitoring of amiodarone: pharmacokinetics and evaluation of the relationship between effect and dose/concentration. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2017;161(2):134–143. doi: 10.5507/bp.2017.016
51. Stoschitzky K, Stoschitzky G, Lercher P, et al. Propafenone shows class Ic and class II antiarrhythmic effects. Europace. 2016;18(4):568–571. doi: 10.1093/europace/ euv195
52. Doki K, Shirayama Y, Sekiguchi Y, et al. Optimal sampling time and clinical implication of the SCN5A promoter haplotype in propafenone therapeutic drug monitoring. Eur J Clin Pharmacol. 2018;74(10):1273–1279. doi: 10.1007/s00228-018-2541-2
53. Sunthankar SD, Kannankeril PJ, Gaedigk A, et al. Influence of CYP2D6 genetic variation on adverse events with propafenone in the pediatric and young adult population. Clin Transl Sci. 2022;15(7):1787–1795. doi: 10.1111/cts.13296 EDN: HSOWHZ
54. Doki K, Shirayama Y, Sekiguchi Y, et al. Effect of CYP2D6 genetic polymorphism on peak propafenone concentration: no significant effect of CYP2D6*10. Pharmacogenomics. 2020;2:1279–1288. doi: 10.2217/pgs-2020-0105 EDN: AEYMKN
55. Morike K, Kivistö KT, Schaeffeler K, et al. Propafenone for the prevention of atrial tachyarrhythmias after cardiac surgery: a randomized, double‑blind placebo‑controlled trial. Clin Pharmacol Ther. 2008;84:104–110. doi: 10.1038/sj.clpt.6100473
56. Siddoway LA, Thompson KA, McAllister CB, et al. Polymorphism of propafenone metabolism and disposition in man: clinical and pharmacokinetic consequences. Circulation. 1987;75:785–791. doi: 10.1161/01.cir.75.4.785
57. Neuvonen P, Elonen E, Tarssanen L. Sotalol intoxication, two patients with concentration-effect relationships. Acta Pharmacol Toxicol. 1979;45:52–57. doi: 10.1111/j.1600-0773.1979.tb02360.x
2. Al-Gobari M, El Khatib C, Pillon F, et al. β-Blockers for the prevention of sudden cardiac death in heart failure patients: a meta-analysis of randomized controlled trials BMC. Cardiovasc Disord. 2013;13(13):52. doi: 10.1186/1471-2261-13-52 EDN: YDMJBZ
3. Markman TM, Geng Z, Epstein AE, et al. Trends in antiarrhythmic drug use among patients in the United States between 2004 and 2016. Circulation. 2020;141(11):937–939. doi: 10.1161/CIRCULATIONAHA.119.044109 EDN: VXWLNA
4. Poulsen CB, Damkjær M, Løfgren B, Schmidt M. Trends in antiarrhythmic drug use in Denmark over 19 years. Am J Cardiol. 2020;125(4):562–569. doi: 10.1016/j.amjcard.2019.11.009 EDN: WSBYUU
5. Tarasov AV. Safety issues of antiarrhythmic therapy. Consilium Medicum. 2014;16(10):44–49. EDN: SXCNNF
6. Dan GA, Martinez-Rubio A, ESC Scientific Document Group. Antiarrhythmic drugs-clinical use and clinical decision making: a consensus document from the European Heart Rhythm Association (EHRA) and European Society of Cardiology (ESC) Working Group on Cardiovascular Pharmacology, endorsed by the Heart Rhythm Society (HRS), Asia-Pacific Heart Rhythm Society (APHRS) and International Society of Cardiovascular Pharmacotherapy (ISCP). Europace. 2018;20(5):731–732. doi: 10.1093/europace/eux373 EDN: YHLLBJ
7. Yakushin SS, Nikulina NN, Filippov EV. Results of the pilot part of the cardiac drug overdoses hospital registry (STORM): focus on drug-induced bradycardia. I.P. Pavlov Russian medical biological herald. 2020;28(2):153–163. doi: 10.23888/PAVLOVJ2020282153-163 EDN: AODSPJ
8. Wang F, Zhou B, Sun H, Wu X. Proarrhythmia associated with antiarrhythmic drugs: a comprehensive disproportionality analysis of the FDA adverse event reporting system. Front Pharmacol. 2023;14:1170039. doi: 10.3389/fphar.2023.1170039 EDN: KVNSQG
9. Lin CY, Lin YJ, Lo LW, et al. Factors predisposing to ventricular proarrhythmia during antiarrhythmic drug therapy for atrial fibrillation in patients with structurally normal heart. Heart Rhythm. 2015;12(7):1490–1500. doi: 10.1016/j.hrthm.2015.04.018
10. Mansourati J, Khattar P. Benefit and concern about the "pill‑in‑the‑pocket". J Med Liban. 2013;61(2):101–104. doi: 10.12816/0000410
11. Tisdale JE, Chung MK, Campbell KB. Drug-Induced Arrhythmias: A Scientific Statement From the American Heart Association. Circulation. 2020;142(15):214–233. doi: 10.1161/CIR.0000000000000905 EDN: QPZRVI
12. Mrochek AG, Gubar EN. The effectiveness of allapinin in patients with coronary artery disease with various rhythm disturbances. Russian Journal of Cardiology. 2010;5(85):116–121. EDN: NYLQWN
13. Sokolov SF. Results of a clinical study of the drug allapinin and modern approaches to the treatment of patients with cardiac arrhythmias. Bulletin of Arrhythmology. 2011;64:60–70. EDN: OYEMQJ
14. Arakelyan MG, Bockeria LA, Vasilyeva EYu, et al. 2020 clinical guidelines for atrial fibrillation and atrial flutter. Russian Journal of Cardiology. 2021;26(7):4594. doi: 10.15829/1560-4071-2021-4594 EDN: FUZAAD
15. Syrov AV, Pavlova TV. Antiarrhythmic medication propafenone: place in clinical practice (review). Consilium Medicum. 2019;21(12):112–117. doi: 10.26442/20751753.2019.12.190724 EDN: RVRPJA
16. Martino E, Bartalena L, Bogazzi F, Braverman LE. The effects of amiodarone on the thyroid. Endocr Rev. 2001;22(2):240–254. doi: 10.1210/edrv.22.2.0427
17. Trohman RG, Sharma PS, McAninch EA, Bianco AC. Amiodarone and thyroid physiology, pathophysiology, diagnosis and management. Trends Cardiovasc Med. 2019;29(5):285–295. doi: 10.1016/j.tcm.2018.09.005 EDN: YMAIHB
18. Mediс F, Bakula M, Alfireviс M, et al. Amiodarone and thyroid dysfunction. Acta Clin Croat. 2022;61(2):327–341. doi: 10.20471/acc.2022.61.02.20 EDN: JUFRPO
19. Cheung AT, Weiss SJ, Savino JS, et al. Acute circulatory actions of intravenous amiodarone loading in cardiac surgical patients. Ann Thorac Surg. 2003;76(2):535–541. doi: 10.1016/s0003-4975(03)00509-5
20. Sinopalnikov AI, Tikhomirov ES, Smirnov IP, Duganov VK, Kharlanov VD. The case of “amiodarone lung”. Pulmonology. 1994;2:83–86. (In Russ.)
21. Ruzieh M, Moroi MK, Aboujamous NM, et al. Meta-analysis comparing the relative risk of adverse events for amiodarone versus placebo. Am J Cardiol. 2019;124(12):1889–1893. doi: 10.1016/j.amjcard.2019.09.008
22. Colby R, Geyer H. Amiodarone-induced pulmonary toxicity. JAAPA. 2017;30:23–26. doi: 10.1097/01.JAA.0000524713.17719.c8
23. Koenig RJ. Regulation of type 1 iodothyronine deiodinase in health and disease. Thyroid. 2005;15(8):835–840. doi: 10.1089/thy.2005.15.835
24. Harjai KJ, Licata AA. Effects of amiodarone on thyroid function. Ann Intern Med. 1997;126(1):63–73. doi: 10.7326/0003-4819-126-1-199701010-00009
25. Albert SG, Alves LE, Rose EP. Thyroid dysfunction during chronic amiodarone therapy. J Am Coll Cardiol. 1987;9(1):175–183. doi: 10.1016/s0735-1097(87)80098-0
26. Mohammadi K, Shafie D, Vakhshoori M, et al. Prevalence of amiodarone‑induced hypothyroidism; A systematic review and meta‑analysis. Trends Cardiovasc Med. 2023;33(4):252–262. doi: 10.1016/j.tcm.2022.01.001 EDN: DHXZOL
27. Biddle JR. Amiodarone and thyroid function. Ann Intern Med. 1997;127(8 Pt 1):653. doi: 10.7326/0003-4819-127-8_part_1-199710150-00020
28. Basaria S, Cooper DS. Amiodarone and the thyroid. Am J Med. 2005;118(7):706–714. doi: 10.1016/j.amjmed.2004.11.028
29. Vassallo P, Trohman RG. Prescribing amiodarone: an evidence‑based review of clinical indications. JAMA. 2007;298(11):1312–1322. doi: 10.1001/jama.298.11.1312
30. Jaworski K, Walecka I, Rudnicka L, et al. Cutaneous adverse reactions of amiodarone. Med Sci Monit. 2014;21(20):2369–2372. doi: 10.12659/MSM.890881
31. Johnson LN, Krohel GB, Thomas ER. The clinical spectrum of amiodarone‑associated optic neuropathy. J Natl Med Assoc. 2004;96(11):1477–1491.
32. Passman RS, Bennett CL, Purpura JM, et al. Amiodarone-associated optic neuropathy: a critical review. Am J Med. 2012;125(5):447–553. doi: 10.1016/j.amjmed.2011.09.020
33. Su VY, Hu YW, Chou KT, et al. Amiodarone and the risk of cancer: a nationwide population-based study. Cancer. 2013;119(9):1699–1705. doi: 10.1002/cncr.27881
34. Lim YP, Lin CL, Lin YN, et al. Antiarrhythmic agents and the risk of malignant neoplasm of liver and intrahepatic bile ducts. PloS One. 2015;10(1):e0116960. doi: 10.1371/journal.pone.0116960
35. Chen YY, Chen CY, Leung KK. Acute pancreatitis and amiodarone: a case report. World J Gastroenterol. 2007;3(6):975–977. doi: 10.3748/wjg.v13.i6.975
36. Famularo G, Minisola G, Nicotra GC, et al. Acute pancreatitis caused by amiodarone. Eur J Emerg Med. 2004;11(5):305–306. doi: 10.1097/00063110-200410000-00015
37. Singh JP, Blomström-Lundqvist C, Turakhia MP, et al. Dronedarone versus sotalol in patients with atrial fibrillation: A systematic literature review and network meta-analysis. Clin Cardiol. 2023;46(6):589–597. doi: 10.1002/clc.24011 EDN: KRXHOR
38. Samanta R, Thiagalingam A, Turner C, et al. The Use of Intravenous Sotalol in Cardiac Arrhythmias. Heart Lung Circ. 2018;27(11):1318–1326. doi: 10.1016/j.hlc.2018.03.017 EDN: YHZOAX
39. Fetsch T, Bauer P, Engberding R, et al. Prevention of atrial fibrillation after cardioversion: results of the PAFAC trial. Eur Heart J. 2004;25:1385–1394. doi: 10.1016/j.ehj.2004.04.015
40. Lafuente-Lafuente C, Valembois L, Bergmann JF, Belmin J. Antiarrhythmics for maintaining sinus rhythm after cardioversion of atrial fibrillation. Cochrane Database Syst Rev. 2015;28(3):CD005049. doi: 10.1002/14651858.CD005049
41. Joglar JA, Chung MK, Armbruster AL, et al. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024;149(1):1–156. doi: 10.1161/CIR.0000000000001193 EDN: VPOKXQ
42. Rabatin A, Snider MJ, Boyd JM, et al. Safety of Twice Daily Sotalol in Patients with Renal Impairment: A Single Center, Retrospective Review. J Atr Fibrillation. 2018;11(3):2047. doi: 10.4022/jafib.2047
43. Ates HC, Roberts JA, Lipman J, et al. On-Site Therapeutic Drug Monitoring. Trends Biotechnol. 2020;38(11):1262–1277. doi: 10.1016/j.tibtech.2020.03.001 EDN: CSJMWR
44. Mylnikov PYu, Tranova Yu, Shchulkin AV, et al. Development and validation of hplc-ms/ms method for quantitative determination of metoprolol in blood plasma of patients. Eruditio Juvenium. 2022;10(4):361–372. doi: 10.23888/HMJ2022104361-372 EDN: VESREJ
45. Campbell TJ, Williams KM. Therapeutic drug monitoring: antiarrhythmic drugs. Br J Clin Pharmacol. 1998;46(4):307–319. doi: 10.1046/j.1365-2125.1998.t01-1-00768.x EDN: EUDQYP
46. Baer DM. Critical values for therapeutic drug levels. MLO: medical laboratory observer. 2012;36(13 Suppl):9.
47. Hiji JT, Duff JH, Burgess ED. Clinical pharmacokinetics of propafenone. Clin Pharmacokinet. 1991;21(1):1–10. doi: 10.2165/00003088-199121010-00001 EDN: OKDFJP
48. Gui Y, Lu Y, Li S, Zhang M, et al. Direct analysis in real time-mass spectrometry for rapid quantification of five anti-arrhythmic drugs in human serum: application to therapeutic drug monitoring. Sci Rep. 2020;10(1):15550. doi: 10.1038/s41598-020-72490-w EDN: LRCCUL
49. Jоrgensen AM, Hermann TS, Christensen HR, et al. Use of Therapeutic Drug Monitoring in Amiodarone Treatment: A Systematic Review of Recent Literature. Ther Drug Monit. 2023;45(4):487–493. doi: 10.1097/FTD.0000000000001079 EDN: XBYAUO
50. Hrudikova Vyskocilova E, Grundmann M, Duricova J, Kacirova I. Therapeutic monitoring of amiodarone: pharmacokinetics and evaluation of the relationship between effect and dose/concentration. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2017;161(2):134–143. doi: 10.5507/bp.2017.016
51. Stoschitzky K, Stoschitzky G, Lercher P, et al. Propafenone shows class Ic and class II antiarrhythmic effects. Europace. 2016;18(4):568–571. doi: 10.1093/europace/ euv195
52. Doki K, Shirayama Y, Sekiguchi Y, et al. Optimal sampling time and clinical implication of the SCN5A promoter haplotype in propafenone therapeutic drug monitoring. Eur J Clin Pharmacol. 2018;74(10):1273–1279. doi: 10.1007/s00228-018-2541-2
53. Sunthankar SD, Kannankeril PJ, Gaedigk A, et al. Influence of CYP2D6 genetic variation on adverse events with propafenone in the pediatric and young adult population. Clin Transl Sci. 2022;15(7):1787–1795. doi: 10.1111/cts.13296 EDN: HSOWHZ
54. Doki K, Shirayama Y, Sekiguchi Y, et al. Effect of CYP2D6 genetic polymorphism on peak propafenone concentration: no significant effect of CYP2D6*10. Pharmacogenomics. 2020;2:1279–1288. doi: 10.2217/pgs-2020-0105 EDN: AEYMKN
55. Morike K, Kivistö KT, Schaeffeler K, et al. Propafenone for the prevention of atrial tachyarrhythmias after cardiac surgery: a randomized, double‑blind placebo‑controlled trial. Clin Pharmacol Ther. 2008;84:104–110. doi: 10.1038/sj.clpt.6100473
56. Siddoway LA, Thompson KA, McAllister CB, et al. Polymorphism of propafenone metabolism and disposition in man: clinical and pharmacokinetic consequences. Circulation. 1987;75:785–791. doi: 10.1161/01.cir.75.4.785
57. Neuvonen P, Elonen E, Tarssanen L. Sotalol intoxication, two patients with concentration-effect relationships. Acta Pharmacol Toxicol. 1979;45:52–57. doi: 10.1111/j.1600-0773.1979.tb02360.x
________________________________________________
2. Al-Gobari M, El Khatib C, Pillon F, et al. β-Blockers for the prevention of sudden cardiac death in heart failure patients: a meta-analysis of randomized controlled trials BMC. Cardiovasc Disord. 2013;13(13):52. doi: 10.1186/1471-2261-13-52 EDN: YDMJBZ
3. Markman TM, Geng Z, Epstein AE, et al. Trends in antiarrhythmic drug use among patients in the United States between 2004 and 2016. Circulation. 2020;141(11):937–939. doi: 10.1161/CIRCULATIONAHA.119.044109 EDN: VXWLNA
4. Poulsen CB, Damkjær M, Løfgren B, Schmidt M. Trends in antiarrhythmic drug use in Denmark over 19 years. Am J Cardiol. 2020;125(4):562–569. doi: 10.1016/j.amjcard.2019.11.009 EDN: WSBYUU
5. Tarasov AV. Safety issues of antiarrhythmic therapy. Consilium Medicum. 2014;16(10):44–49. EDN: SXCNNF
6. Dan GA, Martinez-Rubio A, ESC Scientific Document Group. Antiarrhythmic drugs-clinical use and clinical decision making: a consensus document from the European Heart Rhythm Association (EHRA) and European Society of Cardiology (ESC) Working Group on Cardiovascular Pharmacology, endorsed by the Heart Rhythm Society (HRS), Asia-Pacific Heart Rhythm Society (APHRS) and International Society of Cardiovascular Pharmacotherapy (ISCP). Europace. 2018;20(5):731–732. doi: 10.1093/europace/eux373 EDN: YHLLBJ
7. Yakushin SS, Nikulina NN, Filippov EV. Results of the pilot part of the cardiac drug overdoses hospital registry (STORM): focus on drug-induced bradycardia. I.P. Pavlov Russian medical biological herald. 2020;28(2):153–163. doi: 10.23888/PAVLOVJ2020282153-163 EDN: AODSPJ
8. Wang F, Zhou B, Sun H, Wu X. Proarrhythmia associated with antiarrhythmic drugs: a comprehensive disproportionality analysis of the FDA adverse event reporting system. Front Pharmacol. 2023;14:1170039. doi: 10.3389/fphar.2023.1170039 EDN: KVNSQG
9. Lin CY, Lin YJ, Lo LW, et al. Factors predisposing to ventricular proarrhythmia during antiarrhythmic drug therapy for atrial fibrillation in patients with structurally normal heart. Heart Rhythm. 2015;12(7):1490–1500. doi: 10.1016/j.hrthm.2015.04.018
10. Mansourati J, Khattar P. Benefit and concern about the "pill‑in‑the‑pocket". J Med Liban. 2013;61(2):101–104. doi: 10.12816/0000410
11. Tisdale JE, Chung MK, Campbell KB. Drug-Induced Arrhythmias: A Scientific Statement From the American Heart Association. Circulation. 2020;142(15):214–233. doi: 10.1161/CIR.0000000000000905 EDN: QPZRVI
12. Mrochek AG, Gubar EN. The effectiveness of allapinin in patients with coronary artery disease with various rhythm disturbances. Russian Journal of Cardiology. 2010;5(85):116–121. EDN: NYLQWN
13. Sokolov SF. Results of a clinical study of the drug allapinin and modern approaches to the treatment of patients with cardiac arrhythmias. Bulletin of Arrhythmology. 2011;64:60–70. EDN: OYEMQJ
14. Arakelyan MG, Bockeria LA, Vasilyeva EYu, et al. 2020 clinical guidelines for atrial fibrillation and atrial flutter. Russian Journal of Cardiology. 2021;26(7):4594. doi: 10.15829/1560-4071-2021-4594 EDN: FUZAAD
15. Syrov AV, Pavlova TV. Antiarrhythmic medication propafenone: place in clinical practice (review). Consilium Medicum. 2019;21(12):112–117. doi: 10.26442/20751753.2019.12.190724 EDN: RVRPJA
16. Martino E, Bartalena L, Bogazzi F, Braverman LE. The effects of amiodarone on the thyroid. Endocr Rev. 2001;22(2):240–254. doi: 10.1210/edrv.22.2.0427
17. Trohman RG, Sharma PS, McAninch EA, Bianco AC. Amiodarone and thyroid physiology, pathophysiology, diagnosis and management. Trends Cardiovasc Med. 2019;29(5):285–295. doi: 10.1016/j.tcm.2018.09.005 EDN: YMAIHB
18. Mediс F, Bakula M, Alfireviс M, et al. Amiodarone and thyroid dysfunction. Acta Clin Croat. 2022;61(2):327–341. doi: 10.20471/acc.2022.61.02.20 EDN: JUFRPO
19. Cheung AT, Weiss SJ, Savino JS, et al. Acute circulatory actions of intravenous amiodarone loading in cardiac surgical patients. Ann Thorac Surg. 2003;76(2):535–541. doi: 10.1016/s0003-4975(03)00509-5
20. Sinopalnikov AI, Tikhomirov ES, Smirnov IP, Duganov VK, Kharlanov VD. The case of “amiodarone lung”. Pulmonology. 1994;2:83–86. (In Russ.)
21. Ruzieh M, Moroi MK, Aboujamous NM, et al. Meta-analysis comparing the relative risk of adverse events for amiodarone versus placebo. Am J Cardiol. 2019;124(12):1889–1893. doi: 10.1016/j.amjcard.2019.09.008
22. Colby R, Geyer H. Amiodarone-induced pulmonary toxicity. JAAPA. 2017;30:23–26. doi: 10.1097/01.JAA.0000524713.17719.c8
23. Koenig RJ. Regulation of type 1 iodothyronine deiodinase in health and disease. Thyroid. 2005;15(8):835–840. doi: 10.1089/thy.2005.15.835
24. Harjai KJ, Licata AA. Effects of amiodarone on thyroid function. Ann Intern Med. 1997;126(1):63–73. doi: 10.7326/0003-4819-126-1-199701010-00009
25. Albert SG, Alves LE, Rose EP. Thyroid dysfunction during chronic amiodarone therapy. J Am Coll Cardiol. 1987;9(1):175–183. doi: 10.1016/s0735-1097(87)80098-0
26. Mohammadi K, Shafie D, Vakhshoori M, et al. Prevalence of amiodarone‑induced hypothyroidism; A systematic review and meta‑analysis. Trends Cardiovasc Med. 2023;33(4):252–262. doi: 10.1016/j.tcm.2022.01.001 EDN: DHXZOL
27. Biddle JR. Amiodarone and thyroid function. Ann Intern Med. 1997;127(8 Pt 1):653. doi: 10.7326/0003-4819-127-8_part_1-199710150-00020
28. Basaria S, Cooper DS. Amiodarone and the thyroid. Am J Med. 2005;118(7):706–714. doi: 10.1016/j.amjmed.2004.11.028
29. Vassallo P, Trohman RG. Prescribing amiodarone: an evidence‑based review of clinical indications. JAMA. 2007;298(11):1312–1322. doi: 10.1001/jama.298.11.1312
30. Jaworski K, Walecka I, Rudnicka L, et al. Cutaneous adverse reactions of amiodarone. Med Sci Monit. 2014;21(20):2369–2372. doi: 10.12659/MSM.890881
31. Johnson LN, Krohel GB, Thomas ER. The clinical spectrum of amiodarone‑associated optic neuropathy. J Natl Med Assoc. 2004;96(11):1477–1491.
32. Passman RS, Bennett CL, Purpura JM, et al. Amiodarone-associated optic neuropathy: a critical review. Am J Med. 2012;125(5):447–553. doi: 10.1016/j.amjmed.2011.09.020
33. Su VY, Hu YW, Chou KT, et al. Amiodarone and the risk of cancer: a nationwide population-based study. Cancer. 2013;119(9):1699–1705. doi: 10.1002/cncr.27881
34. Lim YP, Lin CL, Lin YN, et al. Antiarrhythmic agents and the risk of malignant neoplasm of liver and intrahepatic bile ducts. PloS One. 2015;10(1):e0116960. doi: 10.1371/journal.pone.0116960
35. Chen YY, Chen CY, Leung KK. Acute pancreatitis and amiodarone: a case report. World J Gastroenterol. 2007;3(6):975–977. doi: 10.3748/wjg.v13.i6.975
36. Famularo G, Minisola G, Nicotra GC, et al. Acute pancreatitis caused by amiodarone. Eur J Emerg Med. 2004;11(5):305–306. doi: 10.1097/00063110-200410000-00015
37. Singh JP, Blomström-Lundqvist C, Turakhia MP, et al. Dronedarone versus sotalol in patients with atrial fibrillation: A systematic literature review and network meta-analysis. Clin Cardiol. 2023;46(6):589–597. doi: 10.1002/clc.24011 EDN: KRXHOR
38. Samanta R, Thiagalingam A, Turner C, et al. The Use of Intravenous Sotalol in Cardiac Arrhythmias. Heart Lung Circ. 2018;27(11):1318–1326. doi: 10.1016/j.hlc.2018.03.017 EDN: YHZOAX
39. Fetsch T, Bauer P, Engberding R, et al. Prevention of atrial fibrillation after cardioversion: results of the PAFAC trial. Eur Heart J. 2004;25:1385–1394. doi: 10.1016/j.ehj.2004.04.015
40. Lafuente-Lafuente C, Valembois L, Bergmann JF, Belmin J. Antiarrhythmics for maintaining sinus rhythm after cardioversion of atrial fibrillation. Cochrane Database Syst Rev. 2015;28(3):CD005049. doi: 10.1002/14651858.CD005049
41. Joglar JA, Chung MK, Armbruster AL, et al. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024;149(1):1–156. doi: 10.1161/CIR.0000000000001193 EDN: VPOKXQ
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Авторы
Н.В. Ененков*, С.В. Селезнев, А.В. Щулькин, С.П. Филоненко, С.С. Якушин
Рязанский государственный медицинский университет им. академика И.П. Павлова, Рязань, Россия
*enenckow2013@yandex.ru
Ryazan State Medical University named after Academician I.P. Pavlov, Ryazan, Russia
*enenckow2013@yandex.ru
Рязанский государственный медицинский университет им. академика И.П. Павлова, Рязань, Россия
*enenckow2013@yandex.ru
________________________________________________
Ryazan State Medical University named after Academician I.P. Pavlov, Ryazan, Russia
*enenckow2013@yandex.ru
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