Рецепт. 2022; : 85-95
Фармакоэпидемиологическое исследование лечения хронической мигрени в практике невролога
https://doi.org/10.34883/PI.2022.25.1.002Аннотация
Цель. Провести фармакоэпидемиологический анализ лечения хронической мигрени (ХМ), оценить рациональность фармакотерапии, ее соответствие национальным и международным рекомендациям.
Материалы и методы. Дизайн исследования – открытое фармакоэпидемиологическое ретроспективное исследование. Была проанализирована терапия ХМ у 64 пациентов, проживающих в различных регионах Республики Беларусь, которые обращались в консультативно-поликлиническое отделение РНПЦ неврологии и нейрохирургии c 2019 по 2021 г.
Результаты и обсуждение. Фармакоэпидемиологический анализ установил, что только 15,6% пациентов использовали триптаны для купирования приступа головной боли, низкий процент назначения данной группы лекарственных средств был обусловлен гиподиагностикой мигрени на амбулаторном этапе. Частое назначение комбинированных анальгетиков приводило к сочетанию ХМ с лекарственно-индуцированной головной болью у 26 (49,1%) пациентов, что обуславливало трудности в коррекции лечения и вызывало необходимость госпитализации в неврологическое отделение для курса лечения. Данные ретроспективного фармакоэпидемиологического анализа свидетельствуют о низкой частоте применения профилактической терапии ХМ, которая на амбулаторном этапе до консультации специалиста РНПЦ неврологии и нейрохирургии была назначена только 43,7% пациентов с ХМ, и низкой комплаентности пациентов. Только 17,2% пациентов принимали назначенное лекарственное средство для профилактического лечения ХМ более 1 месяца.
Выводы. Полученные данные свидетельствуют о том, что необходимо повышение уровня знаний врачей по вопросам диагностики и установления диагноза ХМ согласно Международной классификации головной боли, рационального выбора фармакотерапии согласно национальным клиническим протоколам и в соответствии с международными рекомендациями.
Список литературы
1. Natoli J.L., Manack A., Dean B. (2010) Global Prevalence of Chronic Migraine: a Systematic Review. Cephalalgia, no 30 (5), pp. 599–609.
2. Disease and Injury Incidence and Prevalence Collaborators (2016) Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet, no 388 (10053), pp. 1545–1602.
3. Kolbin A.S., Naprienko M.V., Artemenko A.R. (2018) Sotsial’no-ekonomicheskoe bremya khronicheskoi migreni v Rossii [Socio-Economic Burden of Chronic Migraine in Russia]. Good clinical practice, no 3, pp. 26–41 (in Russian).
4. Sadokha K.A., Kisten’ O.V., Evstigneev V.V. (2017) Migren’: nekotorye vozrastnye, gendernye i patogeneticheskie aspekty, problema komorbidnosti (obzor literatury i klinicheskoe nablyudenie) [Migraine: Some Age, Gender and Pathogenetic Aspects, the Problem of Comorbidity (Literature Review and Clinical Experience)]. International neurological journal, no 3 (89), pp. 118–124 (in Russian).
5. Charnukha T.N., Likhachev S.A., Gavrilenko L.N. (2016) Sovremennye farmakoepidemiologicheskie issledovaniya v nevrologii [Current Pharmacoepidemiological Studies in Neurology]. Actual problems of neurology and neurosurgery, no 19, pp. 165–171 (in Russian).
6. Tatarinova K.V., Artemenko A.R. (2015) Vliyanie klinicheskikh proyavlenii migreni, depressii i narusheniya sna na kachestvo zhizni patsientov s khronicheskoi migren’yu [Influence of Clinical Manifestations of Migraine, Depression and Sleep Disturbance on the Life Quality of Patients with Chronic Migraine]. Neuromuscular diseases, no 3, pp. 31–36 (in Russian).
7. Sergeev A.V., Meshcherina M.I., Tabeeva G.R. (2011) Golovnaya bol’, svyazannaya s izbytochnym priemom anal’getikov: kliniko-psikhologicheskii i neirofiziologicheskii analiz, osobennosti perioda otmeny [Headache Associated with Analgesic Overuse: Clinical and Psychological and Neurophysiological Analysis; Peculiarities of the Withdrawal Period]. Epilepsy and paroxysmal conditions, no 3 (3), pp. 21–28 (in Russian).
8. Belousov D.Yu., Cheberda A.E. (2017) Farmakoepidemiologicheskie issledovaniya: metodologiya i regulirovanie [Pharmacoepidemiological Research: Methodology and Regulation]. Good clinical practice, no 1, pp. 34–41 (in Russian).
9. Rachina S.A., Kozlov R.S., Bel’kova Yu.A. (2014) Farmakoepidemiologiya: ot teoriticheskikh osnov k prakticheskomu primeneniyu [Pharmacoepidemiology: from Theoretical Foundations to Practical Application]. Pharmacoeconomics, no 1, pp. 32–38 (in Russian).
10. Headache Classification Committee of the International Headache Society (IHS) (2018) The International Classification of Headache Disorders, 3rd edition. Cephalalgia, no 38 (1), pp. 1–211.
11. Latysheva N.V., Filatova E.G., Tabeeva G.R. (2015) Prakticheskie voprosy vedeniya patsientov s khronicheskoi migren’yu. Rekomendatsii rossiiskikh ekspertov [Practical Issues in the Management of Patients with Chronic Migraine. Recommendations of Russian Experts]. Neuromuscular diseases, no 3, pp. 31–36 (in Russian).
12. Koreshkina M.I. (2013) Sovremennye aspekty diagnostiki i lecheniya migreni [Current Aspects of Migraine Diagnosis and Treatment]. Neurology, neuropsychiatry, psychosomatics, no 2 (in Russian).
13. Osipova V.V. (2015) Migren’: effektivnaya diagnostika i lechenie pristupov [Migraine: Effective Diagnosis and Treatment of Seizures]. Medical advice, no 5, pp. 19–22 (in Russian).
14. Kozhanova I.N. (2006) Osnovy farmakoepidemiologicheskogo i farmakoekonomicheskogo analiza ispol’zovaniya lekarstvennykh sredstv pri khronicheskikh zabolevaniyakh: ucheb.-metod.posobie [Fundamentals of Pharmacoepidemiological and Pharmacoeconomic Analysis of Drug Administration in Chronic Conditions: Guidance Manual]. BelMAPO, p. 40. (in Russian)
15. WHO Collaborating Centre for Drug Statistics Methodology (2013) Guidelines for ATS classification and DDD assignment [Electronic resource]
16. Sagar S. Bachhav, Nilima A. Kshirsagar (2015) Systematic Review of Drug Utilization Studies & the Use of the Drug Classification System in the WHO-SEARO Region. IndianJMedRes, no 142 (2), pp. 120–129.
17. Ziganshina L.E., Magsumova D.R., Kuchaeva A.V. (2004) ATC/DDD; klassifikatsionnaya sistema v farmakoepidemiologicheskikh issledovaniyakh [ATC/DDD; Classification System in Pharmacoepidemiological Research]. Good clinical practice, no 1, pp. 28–33 (in Russian).
18. Buse C., Greisman J.D., Baigi K., Lipton R.B. (2018) Migraine Progression: A Systematic Review Dawn. Headache, no 59 (3), pp. 306–338.
19. Natoli J.L., Manack A., Dean B. (2010) Global Prevalence of Chronic Migraine: A Systematic Review. Cephalalgia, no 30 (5), pp. 599–609.
20. Osipova V.V., Filatova E.G., Artemenko A.R. (2017) Diagnostika i lechenie migreni: rekomendatsii rossiiskikh ekspertov [Migraine Diagnosis and Treatment: Recommendations by Russian Experts]. Korsakov Journal of Neurology and Psychiatry, no 1, pp. 28–42 (in Russian).
21. (2020) Klinicheskie rekomendatsii Ministerstva zdravookhraneniya Rossiiskoi Federatsii. Migren’ [Clinical Recommendations of the Ministry of Health of the Russian Federation. Migraine] (in Russian).
22. Osipova V.V., Tabeeva G.R. (2014) Pervichnye golovnye boli: diagnostika, klinika, terapiya. Prakticheskoe rukovodstvo [Primary Headaches: Diagnosis, Clinic, and Therapy. A Practical Guide]. M.: Meditsinskoe informatsionnoe agentstvo, p. 336. (in Russian)
23. Amelin A.V., Ignatov Yu.D., Skoromets A.A. (2014) Migren’. Patogenez, klinika, farmakoterapiya: rukovodstvo dlya vrachei, 3-e izd. [Migraine. Pathogenesis, Clinic, and Pharmacotherapy: A Guide for Physicians, 3rd ed.]. M: MEDpress-inform, p. 256. (in Russian)
24. Ha H., Gonzalez A. (2019) Migraine Headache Prophylaxis. Am Fam Physician, no 99 (1), pp. 17–24.
25. Overeem L.H., Raffaelli B., Mecklenburg J. (2021) Indirect Comparison of Topiramate and Monoclonal Antibodies against CGRP or its Receptor for the Prophylaxis of Episodic Migraine: A Systematic Review with Meta-Analysis. CNS Drugs, no 35 (8), pp. 805–820.
26. Dodick D.W. (2018) A Phase-by-Phase Review of Migraine Pathophysiology. Headache, no 58, suppl. 1, pp. 4–16.
27. Jabbari B., Machado D. (2011) Treatment of Refractory Pain with Botulinum Toxins – An Evidence-Based Review. Pain Med, no 12 (11), pp. 1594– 1606.
28. Puledda F., Messina R., Goadsby P.J. (2017) An update on migraine: current understanding and future directions. J Neurol., no 264 (9), pp. 2031– 2039.
29. Deen M., Correnti E., Kamm K. (2017) Blocking CGRP in Migraine Patients – A Review of Pros and Cons. J Headache Pain, no 18 (1), p. 96.
Recipe. 2022; : 85-95
Pharmacoepidemiological Study of Chronic Migraine Treatment in the Practice of a Neurologist
https://doi.org/10.34883/PI.2022.25.1.002Abstract
Purpose. Conduct a pharmacoepidemiological analysis of the treatment of chronic migraine (CM); assess the rationality of pharmacotherapy and its compliance with national and international recommendations.
Materials and methods. The study design was an open-label pharmacoepidemiological retrospective study. The therapy of CM was analyzed in 64 patients residing in different regions of the Republic of Belarus, who applied to the consultative and polyclinic department of the Republican Scientific and Practical Center for Neurology and Neurosurgery from 2019 to 2021.
Results and discussion. Pharmacoepidemiological analysis revealed that only 15.6% of patients used triptans to relieve a headache attack; the low percentage of prescription of this group of drugs was due to underdiagnosis of migraine at the outpatient stage. A frequent prescription of combined analgesics led to a combination of CM with druginduced headache in 26 (49.1%) patients, which caused difficulties in correcting treatment and necessitated hospitalization in the neurological department for a course of treatment. The data of the retrospective pharmacoepidemiological analysis indicate a low frequency of preventive therapy with CM, which was prescribed to only 43.7% of patients with CM at the outpatient stage before consulting a specialist from the Republican Scientific Practical Center of Neurology and Neurosurgery, and a low patient compliance. Only 17.2% of patients took the prescribed drug for prophylactic treatment of CM for more than 1 month.
Conclusions. The data obtained indicate the necessity to increase physicians knowledge in diagnostics and CM diagnosis setting according to the International Classification of Headache, in rational choice of pharmacotherapy as per national clinical protocols and in accordance with international recommendations.
References
1. Natoli J.L., Manack A., Dean B. (2010) Global Prevalence of Chronic Migraine: a Systematic Review. Cephalalgia, no 30 (5), pp. 599–609.
2. Disease and Injury Incidence and Prevalence Collaborators (2016) Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet, no 388 (10053), pp. 1545–1602.
3. Kolbin A.S., Naprienko M.V., Artemenko A.R. (2018) Sotsial’no-ekonomicheskoe bremya khronicheskoi migreni v Rossii [Socio-Economic Burden of Chronic Migraine in Russia]. Good clinical practice, no 3, pp. 26–41 (in Russian).
4. Sadokha K.A., Kisten’ O.V., Evstigneev V.V. (2017) Migren’: nekotorye vozrastnye, gendernye i patogeneticheskie aspekty, problema komorbidnosti (obzor literatury i klinicheskoe nablyudenie) [Migraine: Some Age, Gender and Pathogenetic Aspects, the Problem of Comorbidity (Literature Review and Clinical Experience)]. International neurological journal, no 3 (89), pp. 118–124 (in Russian).
5. Charnukha T.N., Likhachev S.A., Gavrilenko L.N. (2016) Sovremennye farmakoepidemiologicheskie issledovaniya v nevrologii [Current Pharmacoepidemiological Studies in Neurology]. Actual problems of neurology and neurosurgery, no 19, pp. 165–171 (in Russian).
6. Tatarinova K.V., Artemenko A.R. (2015) Vliyanie klinicheskikh proyavlenii migreni, depressii i narusheniya sna na kachestvo zhizni patsientov s khronicheskoi migren’yu [Influence of Clinical Manifestations of Migraine, Depression and Sleep Disturbance on the Life Quality of Patients with Chronic Migraine]. Neuromuscular diseases, no 3, pp. 31–36 (in Russian).
7. Sergeev A.V., Meshcherina M.I., Tabeeva G.R. (2011) Golovnaya bol’, svyazannaya s izbytochnym priemom anal’getikov: kliniko-psikhologicheskii i neirofiziologicheskii analiz, osobennosti perioda otmeny [Headache Associated with Analgesic Overuse: Clinical and Psychological and Neurophysiological Analysis; Peculiarities of the Withdrawal Period]. Epilepsy and paroxysmal conditions, no 3 (3), pp. 21–28 (in Russian).
8. Belousov D.Yu., Cheberda A.E. (2017) Farmakoepidemiologicheskie issledovaniya: metodologiya i regulirovanie [Pharmacoepidemiological Research: Methodology and Regulation]. Good clinical practice, no 1, pp. 34–41 (in Russian).
9. Rachina S.A., Kozlov R.S., Bel’kova Yu.A. (2014) Farmakoepidemiologiya: ot teoriticheskikh osnov k prakticheskomu primeneniyu [Pharmacoepidemiology: from Theoretical Foundations to Practical Application]. Pharmacoeconomics, no 1, pp. 32–38 (in Russian).
10. Headache Classification Committee of the International Headache Society (IHS) (2018) The International Classification of Headache Disorders, 3rd edition. Cephalalgia, no 38 (1), pp. 1–211.
11. Latysheva N.V., Filatova E.G., Tabeeva G.R. (2015) Prakticheskie voprosy vedeniya patsientov s khronicheskoi migren’yu. Rekomendatsii rossiiskikh ekspertov [Practical Issues in the Management of Patients with Chronic Migraine. Recommendations of Russian Experts]. Neuromuscular diseases, no 3, pp. 31–36 (in Russian).
12. Koreshkina M.I. (2013) Sovremennye aspekty diagnostiki i lecheniya migreni [Current Aspects of Migraine Diagnosis and Treatment]. Neurology, neuropsychiatry, psychosomatics, no 2 (in Russian).
13. Osipova V.V. (2015) Migren’: effektivnaya diagnostika i lechenie pristupov [Migraine: Effective Diagnosis and Treatment of Seizures]. Medical advice, no 5, pp. 19–22 (in Russian).
14. Kozhanova I.N. (2006) Osnovy farmakoepidemiologicheskogo i farmakoekonomicheskogo analiza ispol’zovaniya lekarstvennykh sredstv pri khronicheskikh zabolevaniyakh: ucheb.-metod.posobie [Fundamentals of Pharmacoepidemiological and Pharmacoeconomic Analysis of Drug Administration in Chronic Conditions: Guidance Manual]. BelMAPO, p. 40. (in Russian)
15. WHO Collaborating Centre for Drug Statistics Methodology (2013) Guidelines for ATS classification and DDD assignment [Electronic resource]
16. Sagar S. Bachhav, Nilima A. Kshirsagar (2015) Systematic Review of Drug Utilization Studies & the Use of the Drug Classification System in the WHO-SEARO Region. IndianJMedRes, no 142 (2), pp. 120–129.
17. Ziganshina L.E., Magsumova D.R., Kuchaeva A.V. (2004) ATC/DDD; klassifikatsionnaya sistema v farmakoepidemiologicheskikh issledovaniyakh [ATC/DDD; Classification System in Pharmacoepidemiological Research]. Good clinical practice, no 1, pp. 28–33 (in Russian).
18. Buse C., Greisman J.D., Baigi K., Lipton R.B. (2018) Migraine Progression: A Systematic Review Dawn. Headache, no 59 (3), pp. 306–338.
19. Natoli J.L., Manack A., Dean B. (2010) Global Prevalence of Chronic Migraine: A Systematic Review. Cephalalgia, no 30 (5), pp. 599–609.
20. Osipova V.V., Filatova E.G., Artemenko A.R. (2017) Diagnostika i lechenie migreni: rekomendatsii rossiiskikh ekspertov [Migraine Diagnosis and Treatment: Recommendations by Russian Experts]. Korsakov Journal of Neurology and Psychiatry, no 1, pp. 28–42 (in Russian).
21. (2020) Klinicheskie rekomendatsii Ministerstva zdravookhraneniya Rossiiskoi Federatsii. Migren’ [Clinical Recommendations of the Ministry of Health of the Russian Federation. Migraine] (in Russian).
22. Osipova V.V., Tabeeva G.R. (2014) Pervichnye golovnye boli: diagnostika, klinika, terapiya. Prakticheskoe rukovodstvo [Primary Headaches: Diagnosis, Clinic, and Therapy. A Practical Guide]. M.: Meditsinskoe informatsionnoe agentstvo, p. 336. (in Russian)
23. Amelin A.V., Ignatov Yu.D., Skoromets A.A. (2014) Migren’. Patogenez, klinika, farmakoterapiya: rukovodstvo dlya vrachei, 3-e izd. [Migraine. Pathogenesis, Clinic, and Pharmacotherapy: A Guide for Physicians, 3rd ed.]. M: MEDpress-inform, p. 256. (in Russian)
24. Ha H., Gonzalez A. (2019) Migraine Headache Prophylaxis. Am Fam Physician, no 99 (1), pp. 17–24.
25. Overeem L.H., Raffaelli B., Mecklenburg J. (2021) Indirect Comparison of Topiramate and Monoclonal Antibodies against CGRP or its Receptor for the Prophylaxis of Episodic Migraine: A Systematic Review with Meta-Analysis. CNS Drugs, no 35 (8), pp. 805–820.
26. Dodick D.W. (2018) A Phase-by-Phase Review of Migraine Pathophysiology. Headache, no 58, suppl. 1, pp. 4–16.
27. Jabbari B., Machado D. (2011) Treatment of Refractory Pain with Botulinum Toxins – An Evidence-Based Review. Pain Med, no 12 (11), pp. 1594– 1606.
28. Puledda F., Messina R., Goadsby P.J. (2017) An update on migraine: current understanding and future directions. J Neurol., no 264 (9), pp. 2031– 2039.
29. Deen M., Correnti E., Kamm K. (2017) Blocking CGRP in Migraine Patients – A Review of Pros and Cons. J Headache Pain, no 18 (1), p. 96.
