Современные подходы к лечению болевой формы диабетической полинейропатии
Зайчикова М.Ф., Комелягина Е.Ю., Анциферов М.Б. Современные подходы к лечению болевой формы диабетической полинейропатии. FOCUS Эндокринология. 2021; 4: 19–25. DOI: 10.47407/ef2021.2.4.0045
Zaychikova М.F., Komelyagina Е.Yu., Anciferov М.B. Contemporary approaches to treatment of painful diabetic polyneuropathy. FOCUS Endocrinology. 2021; 4: 19–25. DOI: 10.47407/ef2021.2.4.0045
Нейропатическая боль при сахарном диабете может быть очень сильной, снижать качество жизни пациента, ограничивать его мобильность, приводить к депрессии и социальной дисфункции. Для оценки выраженности болевого синдрома самым удобным и распространенным методом является визуально-аналоговая шкала (ВАШ). Целью лечения болевой формы диабетической полинейропатии является купирование боли и улучшение качества жизни пациента. К 1-й линии терапии нейропатической боли относятся антиконвульсанты и антидепрессанты – как трициклические, так и ингибиторы обратного захвата серотонина и норадреналина. Терапию этими препаратами начинают с минимальных дозировок с плавной титрацией до средних и максимальных с учетом переносимости для минимизации нежелательных явлений. Дополнительно используют препараты для местного лечения, витамины группы В, препараты α-липоевой кислоты. Хирургическая нейростимуляция – метод, который применяется при лечении болевой диабетической полинейропатии, не поддающейся традиционной фармакотерапии.
Ключевые слова: болевая форма диабетической нейропатии, дулоксетин, габапентин, прегабалин, α-липоевая кислота, нейростимуляция.
Ключевые слова: болевая форма диабетической нейропатии, дулоксетин, габапентин, прегабалин, α-липоевая кислота, нейростимуляция.
1. Дедов И.И., Шестакова М.В., Викулова О.К. и др. Эпидемиологические характеристики сахарного диабета в Российской Федерации: клинико-статистический анализ по данным Федерального регистра сахарного диабета на 01.01.2021. Сахарный диабет. 2021; 24 (3): 204–21. DOI: 10.14341/DM12759
[Dedov II, Shestakova MV, Vikulova OK et al. Epidemiological characteris-tics of diabetes mellitus in the Russian Federation: clinical and statistical analysis according to the Federal diabetes register data of 01.01.2021. Diabetes Mellitus. 2021; 24 (3): 204–21 (in Russian)]. DOI: 10.14341/DM12759
2. Pop-Busui R, Boulton AJM, Feldman EL et al. Diabetic neuropathy: A posi-tion statement by the American diabetes association. Diabetes Care 2017; 40 (1): 136–54. DOI: 10.2337/dc16-2042
3. Алгоритмы специализированной медицинской помощи больным сахарным диабетом. Под редакцией И.И. Дедова, М.В. Шестаковой, А.Ю. Майорова. 9-й выпуск (дополненный). Сахарный диабет. 2019; 22 (S1): 1–212. DOI: 10.14341/DM221S1
[Standards of specialized diabetes care. Edited by I.I. Dedov, M.V. Shestakova, A.Yu. Mayorov. 9th Edition (revised). Diabetes mellitus 2019; 22 (S1): 1–212. DOI: 10.14341/DM221S1 (in Russian)].
4. Bakris G, Blonde L, Boulton AJM et al. American Diabetes Association. Stan-dards of Medical Care in Diabetes 2020. Diabetes Care 2019; 43 (S1).
5. Анциферов М.Б., Комелягина Е.Ю. Синдром диабетической стопы: ди-агностика, лечение и профилактика. М.: Медицинское информацион-ное агентство, 2013. 82 с.
[Antsiferov M.B., Komelyagina E.Yu. Sindrom diabeticheskoi stopy: diagnos-tika, lechenie i profilaktika. Moscow: Meditsinskoe informatsionnoe agentstvo, 2013. 82 s. (in Russian)].
6. Boulton AJM, Gries F.A. Guidelines for the diagnosis and outpatient manage-ment of diabetic peripherial neuropathy. Textbook of Diabetic Neuropathy. Thieme, 2002. Р. 378–85.
7. Галстян Г.Р., Старостина Е.Г., Яхно Н.Н. и др. Диагностика и рацио-нальная терапия болевой формы диабетической периферической нейропатии: междисциплинарный консенсус экспертов. Сахарный диабет. 2019; 22 (4): 305–27. DOI: 10.14341/DM9625
[Galstyan GR, Starostina EG, Yakhno NN et al. Diagnosis and rational treat-ment of painful diabetic peripheral neuropathy: an interdisciplinary expert consensus. Diabetes Mellitus 2019; 22 (4): 305–27 (in Russian)]. DOI: 10.14341/DM9625
8. Patel R, Dickenson AH. Mechanisms of the gabapentinoids and α 2 δ-1 cal-cium channel subunit in neuropathic pain. Pharmacol Res Perspect 2016; 4 (2): e00205.
9. Давыдов О.С., Яхно Н.Н., Кукушкин М.Л. и др. Невропатическая боль: клинические рекомендации по диагностике и лечению Российского об-щества по изучению боли. 2019. Российский журнал боли. 2018; 4. DOI: 10.25731/RASP.2018.04.025
[Davydov OS, Yakhno NN, Kukushkin ML. Neuropathic pain: clinical guide-lines on the diagnostics and treatment from the Russian Association for the Studying of Pain. Russian Journal of Pain 2018; 4 DOI: 10.25731/RASP.2018.04.025 (in Russian)].
10. Bockbrader HN, Wesche D, Miller R et al. A comparison of the pharmacoki-netics and pharmacodynamics of pregabalin and gabapentin. Clin Pharma-cokinet 2010; 49 (10): 661–9.
11. Freeman R, Durso-DeCruz E, Emir B. Efficacy, safety, and tolerability of pre-gabalin treatment for painful diabetic peripheral neuropathy: findings from seven randomized, controlled trials across a range of doses. Diabetes Care 2008; 31 (7): 1448–54. DOI: 10.2337/dc07-2105
12. Храмилин В.Н., Завьялов А.Н., Демидова И.Ю. Диагностика и лечение ран-них стадий диабетической полинейропатии. Медицинский совет. 2020; 7: 56–65.
[Hramilin V.N., Zavyalov A.N., Demidova I.Y. Diagnosis and treatment of the early stages of diabetic polyneuropathy. Meditsinskiy sovet = Medical Council. 2020; 7: 56–65. (in Russian)]. DOI: 10.21518/2079-701X-2020-7-56-65
13. Attal N, Cruccu G, Baron R et al. European Federation of Neurological Soci-eties. EFNS guidelines on the pharmacological treatment of neuropathic pain: 2010 revision. Eur J Neurol 2010; 17 (9): 1113–e88.
14. Obata H. Analgesic Mechanisms of Antidepressants for Neuropathic Pain. Int J Mol Sci 2017; 18 (11): 2483.
15. Hardy T, Sachson R, Shen S et al. Does treatment with duloxetine for neuro-pathic pain impact glycemic control? Diabetes Care 2007; 30: 21–6.
16. Tesfaye S, Wilhelm S, Lledo A et al. Duloxetine and pregabalin: High-dose monotherapy or their combination? The “COMBO-DN study” – a multina-tional, randomized, double-blind, parallel-group study in patients with dia-betic peripheral neuropathic pain. Pain 2013; 154 (12): 2616–25.
17. Holbech JV, Jung A, Jonsson T et al. Combination treatment of neuropathic pain: Danish expert recommendations based on a Delphi process. J Pain Res 2017; 10: 1467–75.
18. Finnerup NB, Attal N, Haroutounian S et al. Pharmacotherapy for neuro-pathic pain in adults: a systematic review and meta-analysis. Lancet Neurol 2015; 14 (2): 162–73.
19. Baron R. Mahn F. Types of topical treatment for peripheral neuropathic pain: mechanism of action and indications. Schmerz 2010; 24 (4): 317–25.
20. van Nooten F, Treur M, Pantiri K et al. Capsaicin 8% patch versus oral neu-ropathic pain medications for the treatment of painful diabetic periph-eral neuropathy: a systematic literature review and network meta-analy-sis. Clin Ther 2017; 39 (4): 787–803.e18. DOI: 10.1016/j.clinthera. 2017.02.010
21. Wolff R, Bala M, Westwood M et al. 5% lidocaine medicated plaster in painful diabetic peripheral neuropathy (DPN): a systematic review. Swiss Med Wkly 2010; 140 (21-22): 297–306. DOI: 10.4414/smw. 2010.12995
22. Mimenza AA, Aguilar NS. Clinical Trial Assessing the Efficacy of Gabapentin Plus B Complex (B1/B12) versus Pregabalin for Treating Painful Diabetic Neuropathy. J Diabetes Res 2016; 4078695.
23. Ang CD, Alviar MJ, Dans AL et al. Vitamin B for treating peripheral neu-ropathy. Cochrane Database Syst Rev 2008; 4 (3): CD004573.
24. Karalis DT, Karalis T, Karalis S et al. The Effect of Alpha-Lipoic Acid on Diabetic Peripheral Neuropathy and the Upcoming Depressive Disorders of Type II Di-abetics. Cureus 2021; 13 (1): e12773. DOI: 10.7759/cureus.12773
25. Agathos E, Tentolouris A, Eleftheriadou I et al. Effect of α-lipoic acid on symptoms and quality of life in patients with painful diabetic neuropathy. J Int Med Res 2018; 46 (5): 1779–90.
26. Geneen LJ, Moore RA, Clarke C et al. Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. Cochrane Database Syst Rev 2017; 4: CD011279.
27. Gibson W, Wand BM, O'Connell NE. Transcutaneous electrical nerve stim-ulation (TENS) for neuropathic pain in adults. Cochrane Database Syst Rev 2017; 9: CD011976.
28. Turk DC, Audette J, Levy RM et al. Assessment and treatment of psychoso-cial comorbidities in patients with neuropathic pain. Mayo Clin Proc 2010; 85 (3 Suppl): S42–50.
29. Eccleston C, Hearn L, Williams AC. Psychological therapies for the man-agement of chronic neuropathic pain in adults. Cochrane Database Syst Rev 2015; 10: CD011259.
30. Парфенов В.А., Головачева В.А. Хроническая боль и ее лечение в нев-рологии. М.: ГЭОТАР-Медиа, 2018. 288 с.
[Parfenov V.A., Golovacheva V.A. Hronicheskaja bol' i ee lechenie v nevrologii. Moscow: GЕOTAR-Media, 2018. 288 s. (in Russian)].
31. Hansson PT, Attal N, Baron R, Cruccu G. Toward a definition of pharma-coresistant neuropathic pain. Eur J Pain 2009; 13 (5): 439–40. DOI: 10.1016/j.ejpain.2009.02.008
32. Dworkin RH, O’Connor AB, Kent J et al. Interventional management of neuropathic pain: NeuPSIG recommendations. Pain 2013; 154 (11): 2249–61. DOI: 10.1016/j.pain.2013.06.004
33. Slangen R, Schaper NC, Faber CG et al. Spinal cord stimulation and pain relief in painful diabetic peripheral neuropathy: A prospective two-center randomized controlled trial. Diabetes Care. 2014; 37 (11): 3016–24. DOI: 10.2337/dc14-0684
34. Raghu ALB, Parker T, Aziz TZ et al. Invasive Electrical Neuromodulation for the Treatment of Painful Diabetic Neuropathy: Systematic Review and Meta-Analysis. Neuromodulation Technol Neural Interface 2021; 24 (1): 13–21. DOI: doi/10.1111/ner.13216
35. Albers JW, Herman WH, Pop-Busui R et al. Effect of prior intensive insulin treatment during the Diabetes Control and Complications Trial (DCCT) on peripheral neuropathy in type 1 diabetes during the Epidemiology of Dia-betes Interventions and Complications (EDIC) study. Diabetes Care 2010; 33 (5): 1090–6.
[Dedov II, Shestakova MV, Vikulova OK et al. Epidemiological characteris-tics of diabetes mellitus in the Russian Federation: clinical and statistical analysis according to the Federal diabetes register data of 01.01.2021. Diabetes Mellitus. 2021; 24 (3): 204–21 (in Russian)]. DOI: 10.14341/DM12759
2. Pop-Busui R, Boulton AJM, Feldman EL et al. Diabetic neuropathy: A posi-tion statement by the American diabetes association. Diabetes Care 2017; 40 (1): 136–54. DOI: 10.2337/dc16-2042
3. Алгоритмы специализированной медицинской помощи больным сахарным диабетом. Под редакцией И.И. Дедова, М.В. Шестаковой, А.Ю. Майорова. 9-й выпуск (дополненный). Сахарный диабет. 2019; 22 (S1): 1–212. DOI: 10.14341/DM221S1
[Standards of specialized diabetes care. Edited by I.I. Dedov, M.V. Shestakova, A.Yu. Mayorov. 9th Edition (revised). Diabetes mellitus 2019; 22 (S1): 1–212. DOI: 10.14341/DM221S1 (in Russian)].
4. Bakris G, Blonde L, Boulton AJM et al. American Diabetes Association. Stan-dards of Medical Care in Diabetes 2020. Diabetes Care 2019; 43 (S1).
5. Анциферов М.Б., Комелягина Е.Ю. Синдром диабетической стопы: ди-агностика, лечение и профилактика. М.: Медицинское информацион-ное агентство, 2013. 82 с.
[Antsiferov M.B., Komelyagina E.Yu. Sindrom diabeticheskoi stopy: diagnos-tika, lechenie i profilaktika. Moscow: Meditsinskoe informatsionnoe agentstvo, 2013. 82 s. (in Russian)].
6. Boulton AJM, Gries F.A. Guidelines for the diagnosis and outpatient manage-ment of diabetic peripherial neuropathy. Textbook of Diabetic Neuropathy. Thieme, 2002. Р. 378–85.
7. Галстян Г.Р., Старостина Е.Г., Яхно Н.Н. и др. Диагностика и рацио-нальная терапия болевой формы диабетической периферической нейропатии: междисциплинарный консенсус экспертов. Сахарный диабет. 2019; 22 (4): 305–27. DOI: 10.14341/DM9625
[Galstyan GR, Starostina EG, Yakhno NN et al. Diagnosis and rational treat-ment of painful diabetic peripheral neuropathy: an interdisciplinary expert consensus. Diabetes Mellitus 2019; 22 (4): 305–27 (in Russian)]. DOI: 10.14341/DM9625
8. Patel R, Dickenson AH. Mechanisms of the gabapentinoids and α 2 δ-1 cal-cium channel subunit in neuropathic pain. Pharmacol Res Perspect 2016; 4 (2): e00205.
9. Давыдов О.С., Яхно Н.Н., Кукушкин М.Л. и др. Невропатическая боль: клинические рекомендации по диагностике и лечению Российского об-щества по изучению боли. 2019. Российский журнал боли. 2018; 4. DOI: 10.25731/RASP.2018.04.025
[Davydov OS, Yakhno NN, Kukushkin ML. Neuropathic pain: clinical guide-lines on the diagnostics and treatment from the Russian Association for the Studying of Pain. Russian Journal of Pain 2018; 4 DOI: 10.25731/RASP.2018.04.025 (in Russian)].
10. Bockbrader HN, Wesche D, Miller R et al. A comparison of the pharmacoki-netics and pharmacodynamics of pregabalin and gabapentin. Clin Pharma-cokinet 2010; 49 (10): 661–9.
11. Freeman R, Durso-DeCruz E, Emir B. Efficacy, safety, and tolerability of pre-gabalin treatment for painful diabetic peripheral neuropathy: findings from seven randomized, controlled trials across a range of doses. Diabetes Care 2008; 31 (7): 1448–54. DOI: 10.2337/dc07-2105
12. Храмилин В.Н., Завьялов А.Н., Демидова И.Ю. Диагностика и лечение ран-них стадий диабетической полинейропатии. Медицинский совет. 2020; 7: 56–65.
[Hramilin V.N., Zavyalov A.N., Demidova I.Y. Diagnosis and treatment of the early stages of diabetic polyneuropathy. Meditsinskiy sovet = Medical Council. 2020; 7: 56–65. (in Russian)]. DOI: 10.21518/2079-701X-2020-7-56-65
13. Attal N, Cruccu G, Baron R et al. European Federation of Neurological Soci-eties. EFNS guidelines on the pharmacological treatment of neuropathic pain: 2010 revision. Eur J Neurol 2010; 17 (9): 1113–e88.
14. Obata H. Analgesic Mechanisms of Antidepressants for Neuropathic Pain. Int J Mol Sci 2017; 18 (11): 2483.
15. Hardy T, Sachson R, Shen S et al. Does treatment with duloxetine for neuro-pathic pain impact glycemic control? Diabetes Care 2007; 30: 21–6.
16. Tesfaye S, Wilhelm S, Lledo A et al. Duloxetine and pregabalin: High-dose monotherapy or their combination? The “COMBO-DN study” – a multina-tional, randomized, double-blind, parallel-group study in patients with dia-betic peripheral neuropathic pain. Pain 2013; 154 (12): 2616–25.
17. Holbech JV, Jung A, Jonsson T et al. Combination treatment of neuropathic pain: Danish expert recommendations based on a Delphi process. J Pain Res 2017; 10: 1467–75.
18. Finnerup NB, Attal N, Haroutounian S et al. Pharmacotherapy for neuro-pathic pain in adults: a systematic review and meta-analysis. Lancet Neurol 2015; 14 (2): 162–73.
19. Baron R. Mahn F. Types of topical treatment for peripheral neuropathic pain: mechanism of action and indications. Schmerz 2010; 24 (4): 317–25.
20. van Nooten F, Treur M, Pantiri K et al. Capsaicin 8% patch versus oral neu-ropathic pain medications for the treatment of painful diabetic periph-eral neuropathy: a systematic literature review and network meta-analy-sis. Clin Ther 2017; 39 (4): 787–803.e18. DOI: 10.1016/j.clinthera. 2017.02.010
21. Wolff R, Bala M, Westwood M et al. 5% lidocaine medicated plaster in painful diabetic peripheral neuropathy (DPN): a systematic review. Swiss Med Wkly 2010; 140 (21-22): 297–306. DOI: 10.4414/smw. 2010.12995
22. Mimenza AA, Aguilar NS. Clinical Trial Assessing the Efficacy of Gabapentin Plus B Complex (B1/B12) versus Pregabalin for Treating Painful Diabetic Neuropathy. J Diabetes Res 2016; 4078695.
23. Ang CD, Alviar MJ, Dans AL et al. Vitamin B for treating peripheral neu-ropathy. Cochrane Database Syst Rev 2008; 4 (3): CD004573.
24. Karalis DT, Karalis T, Karalis S et al. The Effect of Alpha-Lipoic Acid on Diabetic Peripheral Neuropathy and the Upcoming Depressive Disorders of Type II Di-abetics. Cureus 2021; 13 (1): e12773. DOI: 10.7759/cureus.12773
25. Agathos E, Tentolouris A, Eleftheriadou I et al. Effect of α-lipoic acid on symptoms and quality of life in patients with painful diabetic neuropathy. J Int Med Res 2018; 46 (5): 1779–90.
26. Geneen LJ, Moore RA, Clarke C et al. Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. Cochrane Database Syst Rev 2017; 4: CD011279.
27. Gibson W, Wand BM, O'Connell NE. Transcutaneous electrical nerve stim-ulation (TENS) for neuropathic pain in adults. Cochrane Database Syst Rev 2017; 9: CD011976.
28. Turk DC, Audette J, Levy RM et al. Assessment and treatment of psychoso-cial comorbidities in patients with neuropathic pain. Mayo Clin Proc 2010; 85 (3 Suppl): S42–50.
29. Eccleston C, Hearn L, Williams AC. Psychological therapies for the man-agement of chronic neuropathic pain in adults. Cochrane Database Syst Rev 2015; 10: CD011259.
30. Парфенов В.А., Головачева В.А. Хроническая боль и ее лечение в нев-рологии. М.: ГЭОТАР-Медиа, 2018. 288 с.
[Parfenov V.A., Golovacheva V.A. Hronicheskaja bol' i ee lechenie v nevrologii. Moscow: GЕOTAR-Media, 2018. 288 s. (in Russian)].
31. Hansson PT, Attal N, Baron R, Cruccu G. Toward a definition of pharma-coresistant neuropathic pain. Eur J Pain 2009; 13 (5): 439–40. DOI: 10.1016/j.ejpain.2009.02.008
32. Dworkin RH, O’Connor AB, Kent J et al. Interventional management of neuropathic pain: NeuPSIG recommendations. Pain 2013; 154 (11): 2249–61. DOI: 10.1016/j.pain.2013.06.004
33. Slangen R, Schaper NC, Faber CG et al. Spinal cord stimulation and pain relief in painful diabetic peripheral neuropathy: A prospective two-center randomized controlled trial. Diabetes Care. 2014; 37 (11): 3016–24. DOI: 10.2337/dc14-0684
34. Raghu ALB, Parker T, Aziz TZ et al. Invasive Electrical Neuromodulation for the Treatment of Painful Diabetic Neuropathy: Systematic Review and Meta-Analysis. Neuromodulation Technol Neural Interface 2021; 24 (1): 13–21. DOI: doi/10.1111/ner.13216
35. Albers JW, Herman WH, Pop-Busui R et al. Effect of prior intensive insulin treatment during the Diabetes Control and Complications Trial (DCCT) on peripheral neuropathy in type 1 diabetes during the Epidemiology of Dia-betes Interventions and Complications (EDIC) study. Diabetes Care 2010; 33 (5): 1090–6.