Применение трансмукозальных форм фентанила для лечения прорывной боли у онкологических пациентов

1. Stanley TH, Egan TD, van Aken H. A tribute to Dr. Paul A. J. Janssen: entrepreneur extraordinaire, innovative scientist, and significant contributor to anesthesiology. Anesth Analg 2008; 106 (2): 451–62. DOI: 10.1213/ane.0b013e3181605add
2. Stanley TH. The fentanyl story. J Pain 2014; 15 (12): 1215–26. DOI: 10.1016/j.jpain.2014.08.010
3. Lotsch J, Walter C, Parnham MJ et al. Pharmacokinetics of non-intravenous formulations of fentanyl. Clin Pharmacokinet 2013; 52 (1): 23–36. DOI: 10.1007/s40262- 012-0016-7
4. Deandrea S, Corli O, Consonni D et al. Prevalence of breakthrough cancer pain: a systematic review and a pooled analysis of published literature. J Pain Symptom Manage 2014; 47: 57–76.
5. Portenoy RK, Payne D, Jacobsen P. Breakthrough pain: characteristics and impact in patients with cancer pain. Pain 1999; 81: 129–3.
6. Davies AN, Dickman A, Reid C et al. The management of cancer-related breakthrough pain: recommendations of a task group of the Science Committee of the Association for Palliative Medicine of Great Britain and Ireland. Eur J Pain 2009; 13: 331–8.
7. Mercadante S, Portenoy RK. Breakthrough cancer pain: twenty-five years of study. Pain 2016; 157 (12): 2657–63.
8. Portenoy RK. Treatment of temporal variations in chronic cancer pain. Semin Oncol 1997; 24: S16.7–S16.12.
9. Zeppetella G et al. Prevalence and characteristics of breakthrough pain in cancer patients admitted to a hospice. J Pain Symptom Manage 2000; 20: 87–92.
10. Doulton B. Pharmacologic management of adult breakthrough cancer pain. Can Fam Physician 2014; 60: 1111–4, e585–9.
11. Хронический болевой синдром (ХБС) у взрослых пациентов, нуждающихся в паллиативной медицинской помощи. Клинические рекомендации. М.: Минздрав РФ, 2016. / Khronicheskii bolevoi sindrom (KhBS) u vzroslykh patsientov, nuzhdaiushchikhsia v palliativnoi meditsinskoi pomoshchi. Klinicheskie rekomendatsii. M.: Minzdrav RF, 2016. [in Russian]
12. Portenoy RK, Hagen NA. Breakthrough pain: definition, prevalence and characteristics. Pain 1990; 41: 273–81.
13. Jackson LD, Little J, Kung E et al. Safe medication swallowing in dysphagia: a collaborative improvement project. Healthc Q 2008; 11 (3 Spec. No.): 110–6.
14. Mystakidou K, Katsouda E, Parpa E et al. Oral transmucosal fentanyl citrate: overview of pharmacological and clinical characteristics. Drug Deliv 2006; 13: 269–76.
15. Darwish M, Tempero K, Kirby M, Thompson J. Relative bioavailability of the fentanyl effervescent buccal tablet (FEBT) 1,080 pg versus oral transmucosal fentanyl citrate 1,600 pg and dose proportionality of FEBT 270 to 1,300 microg: a singledose, randomized, open-label, three-period study in healthy adult volunteers. Clin Ther 2006; 28 (5): 715–24.
16. Lichtor JL, Sevarino FB, Joshi GP et al. The relative potency of oral transmucosal fentanyl citrate compared with intravenous morphine in the treatment of moderate to severe postoperative pain. Anesth Analg 1999; 89: 732–8.
17. Darwish M, Kirby M, Robertson P et al. Comparison of equivalent doses of fentanyl buccal tablets and arteriovenous differences in fentanyl pharmacokinetics. Clin Pharmacokinet 2006; 45 (8): 843–50.
18. Portenoy RK, Messina J, Xie F, Peppin J. Fentanyl buccal tablet (FBT) for relief of breakthrough pain in opioid-treated patients with chronic low back pain: a randomized, placebo-controlled study. Curr Med Res Opin 2007; 23: 223–33.
19. Rauck R, North J, Gever LN et al. Fentanyl buccal soluble film (FBSF) for breakthrough pain in patients with cancer: a randomized, double-blind, placebo-controlled study. Ann Oncol 2010; 21: 1308–14.
20. Vasisht N, Gever LN, Tagarro I, Finn AL. Single-dose pharmacokinetics of fentanyl buccal soluble film. Pain Med 2010; 11 (7): 1017–23.
21. Christrup LL, Foster D, Popper LD et al. Pharmacokinetics, efficacy, and tolerability of fentanyl following intranasal versus intravenous administration in adults undergoing third-molar extraction: a randomized, double-blind, double-dummy, two-way, crossover study. Clin Ther 2008; 30: 469–81.
22. Zhang H, Zhang J, Streisand JB. Oral mucosal drug delivery: clinical pharmacokinetics and therapeutic applications. Clin Pharmacokinet 2002; 41 (9): 661–80. DOI: 10.2165/00003088-200241090-00003
23. Mystakidou K, Katsouda E, Parpa E et al. Oral transmucosal fentanyl citrate: overview of pharmacological and clinical characteristics. Drug Deliv 2006; 13 (4): 269–76. DOI: 10.1080/10717540500394 661
24. Coluzzi PH, Schwartzberg L, Conroy JD et al. Breakthrough cancer pain: a randomized trial comparing oral transmucosal fentanyl citrate (OTFC) and morphine sulfate immediate release (MSIR). Pain 2001; 91 (1–2): 123–30.
25. Mandel L, Carunchio MJ. Rampant caries from oral transmucosal fentanyl citrate lozenge abuse. J Am Dent Assoc 2011; 142 (4): 406–9.
26. Gordon D, Schroeder M. Oral transmucosal fentanyl citrate – OTFC (ACTIQ) #103. J Palliat Med 2008; 11 (4): 633–4.
27. Dale O, Hjortkjaer R, Kharasch ED. Nasal administration of opioids for pain management in adults. Acta Anaesthesiol Scand 2002; 46 (7): 759–70.
28. Illum L. Nanoparticulate systems for nasal delivery of drugs: a real improvement over simple systems? J Pharm Sci 2007; 96 (3): 473–83. DOI: 10.1002/jps.20718
29. Dhuria SV, Hanson LR, Frey WH. Intranasal delivery to the central nervous system: mechanisms and experimental considerations. J Pharm Sci 2010; 99 (4): 1654–73. DOI: 10.1002/jps. 21924
30. Illum L, Davis SS, Pawula M et al. Nasal administration of morphine-6-glucuronide in sheep – a pharmacokinetic study. Biopharm Drug Dispos 1996; 17 (8): 717–24.
31. Instanyl. Summary of product characteristics. http://www.instanyl. com/∼/media/Products/instanyl com/Protected/Files/Instanyl Sm PCBooklet WEB 250110.pdf
32. Paech MJ, Bloor M, Schug SA. New formulations of fentanyl for acute pain management. Drugs Today 2012; 48 (2): 119–32.
33. Portenoy RK, Burton AW, Gabrail N, Taylor D. Fentanyl Pectin Nasal Spray 043 Study G. A multicenter, placebo-controlled, double-blind, multiple-crossover study of fentanyl pectin nasal spray (FPNS) in the treatment of breakthrough cancer pain. Pain 2010; 151 (3): 617–24.
34. Mercadante S, Vellucci R, Cuomo A et al. Long-term efficacy and tolerability of intranasal fentanyl in the treatment of breakthrough cancer pain. Support Care Cancer 2015; 23 (5): 1349–54.
35. Mercadante S, Radbruch L, Davies A et al. A comparison of intranasal fentanyl spray with oral transmucosal fentanyl citrate for the treatment of breakthrough cancer pain: an open-label, randomised, crossover trial. Curr Med Res Opin 2009; 25 (11): 2805–15.
36. Kress HG. Intranasal fentanyl spray for breakthrough cancer pain: an innovative approach to the unmet needs. Eur J Pain 2010; Suppl. 4 (S3): 191–4.
37. Davies A, Sitte T, Elsner F et al. Consistency of efficacy, patient acceptability, and nasal tolerability of fentanyl pectin nasal spray compared with immediate-release morphine sulfate in breakthrough cancer pain. J Pain Symptom Manage 2011; 41 (2): 358–66.
38. Zeppetella G, Davies A, Eijgelshoven I et al. A network meta-analysis of the efficacy of opioid analgesics for the management of breakthrough cancer pain episodes. J Pain Symptom Manage 2014; 47 (4): 772–85.
39. Vissers D, Stam W, Nolte T et al. Efficacy of intranasal fentanyl spray versus other opioids for breakthrough pain in cancer. Curr Med Res Opin 2010; 26 (5): 1037–45.

________________________________________________

1. Stanley TH, Egan TD, van Aken H. A tribute to Dr. Paul A. J. Janssen: entrepreneur extraordinaire, innovative scientist, and significant contributor to anesthesiology. Anesth Analg 2008; 106 (2): 451–62. DOI: 10.1213/ane.0b013e3181605add
2. Stanley TH. The fentanyl story. J Pain 2014; 15 (12): 1215–26. DOI: 10.1016/j.jpain.2014.08.010
3. Lotsch J, Walter C, Parnham MJ et al. Pharmacokinetics of non-intravenous formulations of fentanyl. Clin Pharmacokinet 2013; 52 (1): 23–36. DOI: 10.1007/s40262- 012-0016-7
4. Deandrea S, Corli O, Consonni D et al. Prevalence of breakthrough cancer pain: a systematic review and a pooled analysis of published literature. J Pain Symptom Manage 2014; 47: 57–76.
5. Portenoy RK, Payne D, Jacobsen P. Breakthrough pain: characteristics and impact in patients with cancer pain. Pain 1999; 81: 129–3.
6. Davies AN, Dickman A, Reid C et al. The management of cancer-related breakthrough pain: recommendations of a task group of the Science Committee of the Association for Palliative Medicine of Great Britain and Ireland. Eur J Pain 2009; 13: 331–8.
7. Mercadante S, Portenoy RK. Breakthrough cancer pain: twenty-five years of study. Pain 2016; 157 (12): 2657–63.
8. Portenoy RK. Treatment of temporal variations in chronic cancer pain. Semin Oncol 1997; 24: S16.7–S16.12.
9. Zeppetella G et al. Prevalence and characteristics of breakthrough pain in cancer patients admitted to a hospice. J Pain Symptom Manage 2000; 20: 87–92.
10. Doulton B. Pharmacologic management of adult breakthrough cancer pain. Can Fam Physician 2014; 60: 1111–4, e585–9.
11. Khronicheskii bolevoi sindrom (KhBS) u vzroslykh patsientov, nuzhdaiushchikhsia v palliativnoi meditsinskoi pomoshchi. Klinicheskie rekomendatsii. M.: Minzdrav RF, 2016. [in Russian]
12. Portenoy RK, Hagen NA. Breakthrough pain: definition, prevalence and characteristics. Pain 1990; 41: 273–81.
13. Jackson LD, Little J, Kung E et al. Safe medication swallowing in dysphagia: a collaborative improvement project. Healthc Q 2008; 11 (3 Spec. No.): 110–6.
14. Mystakidou K, Katsouda E, Parpa E et al. Oral transmucosal fentanyl citrate: overview of pharmacological and clinical characteristics. Drug Deliv 2006; 13: 269–76.
15. Darwish M, Tempero K, Kirby M, Thompson J. Relative bioavailability of the fentanyl effervescent buccal tablet (FEBT) 1,080 pg versus oral transmucosal fentanyl citrate 1,600 pg and dose proportionality of FEBT 270 to 1,300 microg: a singledose, randomized, open-label, three-period study in healthy adult volunteers. Clin Ther 2006; 28 (5): 715–24.
16. Lichtor JL, Sevarino FB, Joshi GP et al. The relative potency of oral transmucosal fentanyl citrate compared with intravenous morphine in the treatment of moderate to severe postoperative pain. Anesth Analg 1999; 89: 732–8.
17. Darwish M, Kirby M, Robertson P et al. Comparison of equivalent doses of fentanyl buccal tablets and arteriovenous differences in fentanyl pharmacokinetics. Clin Pharmacokinet 2006; 45 (8): 843–50.
18. Portenoy RK, Messina J, Xie F, Peppin J. Fentanyl buccal tablet (FBT) for relief of breakthrough pain in opioid-treated patients with chronic low back pain: a randomized, placebo-controlled study. Curr Med Res Opin 2007; 23: 223–33.
19. Rauck R, North J, Gever LN et al. Fentanyl buccal soluble film (FBSF) for breakthrough pain in patients with cancer: a randomized, double-blind, placebo-controlled study. Ann Oncol 2010; 21: 1308–14.
20. Vasisht N, Gever LN, Tagarro I, Finn AL. Single-dose pharmacokinetics of fentanyl buccal soluble film. Pain Med 2010; 11 (7): 1017–23.
21. Christrup LL, Foster D, Popper LD et al. Pharmacokinetics, efficacy, and tolerability of fentanyl following intranasal versus intravenous administration in adults undergoing third-molar extraction: a randomized, double-blind, double-dummy, two-way, crossover study. Clin Ther 2008; 30: 469–81.
22. Zhang H, Zhang J, Streisand JB. Oral mucosal drug delivery: clinical pharmacokinetics and therapeutic applications. Clin Pharmacokinet 2002; 41 (9): 661–80. DOI: 10.2165/00003088-200241090-00003
23. Mystakidou K, Katsouda E, Parpa E et al. Oral transmucosal fentanyl citrate: overview of pharmacological and clinical characteristics. Drug Deliv 2006; 13 (4): 269–76. DOI: 10.1080/10717540500394 661
24. Coluzzi PH, Schwartzberg L, Conroy JD et al. Breakthrough cancer pain: a randomized trial comparing oral transmucosal fentanyl citrate (OTFC) and morphine sulfate immediate release (MSIR). Pain 2001; 91 (1–2): 123–30.
25. Mandel L, Carunchio MJ. Rampant caries from oral transmucosal fentanyl citrate lozenge abuse. J Am Dent Assoc 2011; 142 (4): 406–9.
26. Gordon D, Schroeder M. Oral transmucosal fentanyl citrate – OTFC (ACTIQ) #103. J Palliat Med 2008; 11 (4): 633–4.
27. Dale O, Hjortkjaer R, Kharasch ED. Nasal administration of opioids for pain management in adults. Acta Anaesthesiol Scand 2002; 46 (7): 759–70.
28. Illum L. Nanoparticulate systems for nasal delivery of drugs: a real improvement over simple systems? J Pharm Sci 2007; 96 (3): 473–83. DOI: 10.1002/jps.20718
29. Dhuria SV, Hanson LR, Frey WH. Intranasal delivery to the central nervous system: mechanisms and experimental considerations. J Pharm Sci 2010; 99 (4): 1654–73. DOI: 10.1002/jps. 21924
30. Illum L, Davis SS, Pawula M et al. Nasal administration of morphine-6-glucuronide in sheep – a pharmacokinetic study. Biopharm Drug Dispos 1996; 17 (8): 717–24.
31. Instanyl. Summary of product characteristics. http://www.instanyl. com/∼/media/Products/instanyl com/Protected/Files/Instanyl Sm PCBooklet WEB 250110.pdf
32. Paech MJ, Bloor M, Schug SA. New formulations of fentanyl for acute pain management. Drugs Today 2012; 48 (2): 119–32.
33. Portenoy RK, Burton AW, Gabrail N, Taylor D. Fentanyl Pectin Nasal Spray 043 Study G. A multicenter, placebo-controlled, double-blind, multiple-crossover study of fentanyl pectin nasal spray (FPNS) in the treatment of breakthrough cancer pain. Pain 2010; 151 (3): 617–24.
34. Mercadante S, Vellucci R, Cuomo A et al. Long-term efficacy and tolerability of intranasal fentanyl in the treatment of breakthrough cancer pain. Support Care Cancer 2015; 23 (5): 1349–54.
35. Mercadante S, Radbruch L, Davies A et al. A comparison of intranasal fentanyl spray with oral transmucosal fentanyl citrate for the treatment of breakthrough cancer pain: an open-label, randomised, crossover trial. Curr Med Res Opin 2009; 25 (11): 2805–15.
36. Kress HG. Intranasal fentanyl spray for breakthrough cancer pain: an innovative approach to the unmet needs. Eur J Pain 2010; Suppl. 4 (S3): 191–4.
37. Davies A, Sitte T, Elsner F et al. Consistency of efficacy, patient acceptability, and nasal tolerability of fentanyl pectin nasal spray compared with immediate-release morphine sulfate in breakthrough cancer pain. J Pain Symptom Manage 2011; 41 (2): 358–66.
38. Zeppetella G, Davies A, Eijgelshoven I et al. A network meta-analysis of the efficacy of opioid analgesics for the management of breakthrough cancer pain episodes. J Pain Symptom Manage 2014; 47 (4): 772–85.
39. Vissers D, Stam W, Nolte T et al. Efficacy of intranasal fentanyl spray versus other opioids for breakthrough pain in cancer. Curr Med Res Opin 2010; 26 (5): 1037–45.

Д.В.Невзорова*1, Т.А.Куняева2, А.Н.Ибрагимов1,3

1 Филиал «Первый Московский хоспис им. В.В.Миллионщиковой» ГБУЗ «Московский многопрофильный центр паллиативной помощи» Департамента здравоохранения г. Москвы. 119048, Россия, Москва, ул. Доватора, д. 10;
2 ФГБОУ ВО «Национальный исследовательский Мордовский государственный университет им. Н.П.Огарева». 430005, Россия, Саранск, ул. Большевистская, д. 68
3 ФГАОУ ВО «Российский университет дружбы народов». 117198, Россия, Москва, ул. Миклухо-Маклая, д. 6
*gyn_nevzorova@mail.ru

________________________________________________

D.V.Nevzorova*1, T.A.Kunyaeva2, A.N.Ibragimov1,3

1 Branch "V.V.Millionshikova First Moscow Hospice" of the Multi-Center Palliative Care of the Department of Health of Moscow. 119048, Russian Rederation, Moscow, ul. Dovatora, d. 10;
2 N.P.Ogarev National Research Mordovia State University. 430005, Russian Federation, Saransk, ul. Bol'shevistskaia, d. 68
3 People’s Friendship University of Russia. 117198, Russian Federation, Moscow, ul. Miklukho-Maklaia, d. 6
*gyn_nevzorova@mail.ru