Проблемы выбора методов лечения

DOI: https://doi.org/10.29296/25877305-2020-08-02
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Номер журнала: 
8
Год издания: 
2020

И.В. Самородская, доктор медицинских наук, профессор Национальный медицинский исследовательский
центр терапии и профилактической медицины, Москва E-mail: samor2000@yandex.ru

В дискуссионной статье представлены вопросы интуитивного, научно-обоснованного и доказательного применения методов лечения. Четких критериев между этими понятиями нет, также как и нет четких критериев доказательств эффективности лечения. Сегодня даже в лучших журналах существуют проблемы с надежностью и корректностью размещаемой информации. Интуитивные и теоретически обоснованные поиски лечения (рассмотрено на примере COVID-19) быстро трансформируются в мифы и дезинформацию, включая широкое применение препаратов «off-label» и неверное толкование результатов исследований о методах профилактики, диагностики и лечения.
Ключевые слова: 
доказательная медицина
выбор методов лечения
критерии эффективности
препараты «off-label»
COVID-19
Для цитирования
И.В. Самородская Проблемы выбора методов лечения . Врач, 2020; (8): 11-18 https://doi.org/10.29296/25877305-2020-08-02

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Список литературы: 
  1. «Solidarity» clinical trial for COVID-19 treatments. URL: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments [Available 22.06.2020].
  2. Schunemann H., Brozek J., Oxman A. GRADE handbook for grading quality of evidence and strength of recommendation. Ontario: The GRADE Working Group, 2013.
  3. Scottish Intercollegiate Guidelines Network (SIGN). URL: http://www.sign.ac.uk/ [Available 22.06.2020].
  4. Приказ №103 МЗ РФ от 28.02.2019 «Об утверждении порядка и сроков разработки клинических рекомендаций, их пересмотра, типовой формы клинических рекомендаций и требований к их структуре, составу и научной обоснованности включаемой в клинические рекомендации информации» [Prikaz №103 MZ RF ot 28.02.2019 «Ob utverzhdenii poryadka i srokov razrabotki klinicheskikh rekomendatsii, ikh peresmotra, tipovoi formy klinicheskikh rekomendatsii i trebovanii k ikh strukture, sostavu i nauchnoi obosnovannosti vklyuchaemoi v klinicheskie rekomendatsii informatsii» (in Russ.)].
  5. ESC. Clinical Practice Guidelines. URL: https://www.escardio.org/Guidelines/Clinical-Practice-Guidelines [Available 22.06.2020].
  6. 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults Report From the Panel Members Appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014; 311 (5): 507–20 DOI: 10.1001/jama.2013.284427
  7. Off-label use of medicines for COVID-19. Scientific brief. URL: https://www.who.int/news-room/commentaries/detail/off-label-use-of-medicines-for-covid-19 [Available 22.06.2020].
  8. Временные методические рекомендации «Профилактика диагностика и лечение новой коронавирусной инфекции COVID-19. Версия 7». Минздрав России [Vremennye metodicheskie rekomendatsii «Profilaktika diagnostika i lechenie novoi koronavirusnoi infektsii COVID-19. Versiya 7». Minzdrav Rossii (in Russ.)]. URL: https://static-0.rosminzdrav.ru/system/attachments/attaches/000/050/584/original/03062020_%D0%9CR_COVID-19_v7.pdf [Available 22.06.2020].
  9. Darrow J.J., Sarpatwari A., Avorn J. et al. Practical, legal, and ethical issues in expanded access to investigational drugs. N Engl J Med. 2015; 372 (3): 279–86. DOI: 10.1056/NEJMhle1409465
  10. Sullivan T. Understanding FDA Regulatory Terminology During COVID-19. URL: https://www.fda.gov/consumers/consumer-updates/understanding-regulatory-terminology-potential-preventions-and-treatments-covid-19 [Available 22.06.2020].
  11. International Union for Basic and Clinical Pharmacology (IUPHAR) Clinical Division considerations in the context of COVID-19 pandemics. URL: https://iuphar.org/wp-content/uploads/2020/05/IUPHAR-Clinical-Division-Considerations-in-the-Context-of-COVID-19-Pandemics.pdf [Available 22.06.2020].
  12. Gautret P., Lagier J.C., Parola P. et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial [published online ahead of print, 2020 Mar 20]. Int J Antimicrob Agents. 2020; 105949. DOI: 10.1016/j.ijantimicag.2020.105949
  13. Frequently Asked Questions on the Emergency Use Authorization (EUA) for Chloroquine Phosphate and Hydroxychloroquine Sulfate for Certain Hospitalized COVID-19 Patients. URL: https://www.fda.gov/media/136784/download [Available 22.06.2020].
  14. Official Statement from International Society of Antimicrobial Chemotherapy (ISAC) Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial (Gautret P et al. PMID 32205204) URL: https://www.isac.world/news-and-publications/official-isac-statement [Available 22.06.2020].
  15. Piszczatoski CR. Powell Emergency Approval of Chloroquine and Hydroxychloroquine for Treatment of COVID-19. Ann Pharmacother. 2020: 1060028020925558. DOI: 10.1177/1060028020925558
  16. Омельяновский В.В., Антонов А.А., Безденежных Т.П. и др. Систематический обзор актуальных научных сведений о применении лекарственных препаратов в терапии новой коронавирусной инфекции COVID-19. Медицинские технологии. Оценка и выбор. 2020; 1: 8–18 [Omelyanovskiy V.V., Antonov A.A., Bezdenezhnykh T.P. et al. Current Research Data on Drug Therapy for Novel Coronavirus Associated Disease (COVID-19): Systematic Review. Medical Technologies. Assessment and Choice. 2020; 1: 8–18 (in Russ.).]. DOI: 10.31556/2219-0678.2020.39.1.008-018
  17. Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis. Lancet. 2020: S0140-6736(20)31180-6. https://doi.org/10.1016/S0140-6736(20)31180-6 .
  18. James Watson on the behalf of 201 signatories (2020, May 28). An open letter to Mehra et al. and The Lancet (Version 4). Zenodo. http://doi.org/10.5281/zenodo.3871094
  19. The Lancet Editors. Expression of concern: Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis. Lancet. 2020; 395 (10240): e102. DOI: 10.1016/S0140-6736(20)31290-3
  20. Mehra M.R., Desai S.S., Ruschitzka F. et al. RETRACTED: Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis [published online ahead of print, 2020 May 22] [retracted in: Lancet. 2020 Jun 5;:null]. Lancet. 2020; S0140-6736(20)31180-6. DOI: 10.1016/S0140-6736(20)31180-6
  21. https://www.theglobeandmail.com/world/video-who-set-to-resume-hydroxychloroquine-trial/ [Available 22.06.2020].
  22. О применении препарата Гидроксихлорохин для лечения пациентов с коронавирусной инфекцией [O primenenii preparata Gidroksikhlorokhin dlya lecheniya patsientov s koronavirusnoi infektsiei (in Russ.)]. URL: https://www.rosminzdrav.ru/news/2020/05/28/14067-o-primenenii-preparata-gidroksihlorohin-dlya-lecheniya-patsientov-s-koronavirusnoy-infektsiey [Ссылка активна / Available: 22.06.2020].
  23. Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19. URL: https://www.fda.gov/media/138490/download [Available 22.06.2020].
  24. Statement from the Chief Investigators of the Randomised Evaluation of COVid-19 thERapY (RECOVERY) Trial on hydroxychloroquine, 5 June 2020. URL: https://www.recoverytrial.net/files/hcq-recovery-statement-050620-final-002.pdf [Available 22.06.2020].
  25. «Solidarity» clinical trial for COVID-19 treatments URL: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments [Available 22.06.2020].
  26. Hydroxychloroquine / COVID-19. URL: https://clinicaltrials.gov/ct2/results?cond=COVID-19&term=hydroxychloroquine&cntry=&state=&city=&dist= [Available 22.06.2020].
  27. NIH Clinical Trial Shows Remdesivir Accelerates Recovery from Advanced COVID-19. URL: https://www.niaid.nih.gov/news-events/nih-clinical-trial-shows-remdesivir-accelerates-recovery-advanced-covid-19 [Available 22.06.2020].
  28. Wang Y., Zhang D., Du G. et al. Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial [published correction appears in Lancet. 2020 May 30; 395 (10238): 1694]. Lancet. 2020; 395 (10236): 1569–78. DOI: 10.1016/S0140-6736(20)31022-9
  29. FDA. URL: https://www.fda.gov/media/137564/download [Available 22.06.2020].
  30. Recommendations for Hospitalized Patients with Severe COVID-19. URL: https://www.covid19treatmentguidelines.nih.gov/antiviral-therapy/remdesivir/ [Available 22.06.2020].
  31. Suzuki H.G., Dewez J.E., Nijman R.G. et al. Clinical practice guidelines for acute otitis media in children: a systematic review and appraisal of European national guidelines. BMJ Open. 2020; 10 (5): e035343. DOI: 10.1136/bmjopen-2019-035343
  32. Dagens A., Sigfrid L., Cai E. et al. Scope, quality, and inclusivity of clinical guidelines produced early in the COVID-19 pandemic: rapid review. BMJ. 2020; 369: m1936. DOI: https://doi.org/10.1136/bmj.m1936. URL: https://www.bmj.com/content/369/bmj.m1936 [Available 22.06.2020].
  33. COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. Available at https://www.covid19treatmentguidelines.nih.gov/
  34. Smith G.C.S., Pell J.P. Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials. BMJ. 2003; 327: 1459. DOI: 10.1136/bmj.327.7429.1459
  35. Рotts M., Prata N., Walsh J.et al. Parachute approach to evidence based medicine. BMJ. 2006; 333: 701. DOI: 10.1136/bmj.333.7570.701. URL: https://www.bmj.com/content/333/7570/701?ijkey=6b4577e0734d5e2589fd478a63132206469106aa&keytype2=tf_ipsecsha [Available 22.06.2020].
  36. Perry Wilson F. COVID-19 Data, Fast and Furious: ‘We Need to Adapt’ URL: https://www.medscape.com/viewarticle/927616 [Available 22.06.2020].
  37. Mandrola J. Some Data May Be Worse Than No Data in the COVID Era. URL: https://www.medscape.com/viewarticle/930504 [Available 22.06.2020].
  38. Zagury-Orly I., Schwartzstein R.M. Covid-19 – A Reminder to Reason [published online ahead of print, 2020 Apr 28]. N Engl J Med. 2020. DOI: 10.1056/NEJMp2009405
  39. Farsalinos K., Barbouni A., Niaura R. Systematic review of the prevalence of current smoking among hospitalized COVID-19 patients in China: could nicotine be a therapeutic option? Intern Emerg Med. 2020; 1–8. DOI: 10.1007/s11739-020-02355-7
  40. France Bans the Online Sale of Nicotine Products. URL: https://tobaccoreporter.com/2020/04/24/france-bans-the-online-sale-of-nicotine-products/ [Available 22.06.2020]. Wang B., Kovalchuk A., Li D. et al. In Search of Preventative Strategies: Novel Anti-Inflammatory High-CBD Cannabis Sativa Extracts Modulate ACE2 Expression in COVID-19 Gateway Tissues. Preprints. 2020; 2020040315. DOI: 10.20944/preprints202004.0315.v1
  41. Yichang Yang. Use of herbal drugs to treat COVID-19 should be with caution. Lancet. 2020; 395 (10238): 1689–90. https://doi.org/10.1016/S0140-6736(20)31143-0
  42. COVID-19 и Coronavirus fuels a surge in fake medicines. URL: https://www.bbc.com/news/health-52201077 [Available 22.06.2020].
  43. US FDA also published a warning regarding the sale and use of chlorine dioxide products – which when mixed with other chemicals can become bleach – as a prevention or treatment for COVID-19. [Available 22.06.2020].
  44. Ratzan S., Gostin L., Meshkati N. et al. COVID-19: An Urgent Call for Coordinated, Trusted Sources to Tell Everyone What They Need to Know and Do. NAM Perspectives. Commentary, National Academy of Medicine, Washington, DC, 2020. DOI: 10.31478/202003a. URL: https://nam.edu/covid-19-an-urgent-call-for-coordinated-trusted-sources-to-tell-everyone-what-they-need-to-know-and-do/ [Available 22.06.2020].