Новые возможности использования тиотропия бромида с помощью аэрозольного устройства доставки – ингалятора Респимат®
https://doi.org/10.18093/0869-0189-2013-0-5-70-80
Аннотация
Новые возможности использования тиотропия бромида с помощью аэрозольного устройства доставки – ингалятора Респимат®.
Об авторе
С. Н. Авдеев
ФГБУ "НИИ пульмонологии" ФМБА России
Россия
Россия
д. м. н., профессор, руководитель клинического отдела
105077, Россия, Москва, ул. 11-я Парковая, 32, корп. 4. Тел. / факс: (495) 465-52-64.
Список литературы
1. Global Initiative for Chronic Obstructive Lung Diseas (GOLD). Global strategy for diagnosis, management, and prevention of chronic obstructive pulmonary disease. NHLBI / WHO workshop report. The 2013 report is available on www.goldcopd.com
2. Celli B.R., MacNee W.; ATS / ERS Task Force. Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS / ERS position paper. Eur. Respir. J. 2004; 23: 932–946.
3. Buist A.S., McBurnie M.A., Vollmer W.M. et al. International variation in the prevalence of COPD (the BOLD Study): a population-based prevalence study. Lancet 2007; 370: 741–750.
4. Panning C.A., DeBisschop M. Tiotropium: an inhaled, long-acting anticholinergic drug for chronic obstructive pulmonary disease. Pharmacotherapy 2003; 23: 183–189.
5. Yohannes A.M., Connolly M., Hanania N.A. Ten years of tiotropium: clinical impact and patient perspectives. Int. J. Chron. Obstruct. Pulm. Dis. 2013; 8: 117–125.
6. Tashkin D.P. Long-acting anticholinergic use in chronic obstructive pulmonary disease: efficacy and safety. Curr. Opin. Pulm. Med. 2010; 16: 97–105.
7. Donohue J.F., van Noord J.A., Bateman E.D. et al. A 6-month, placebo-controlled study comparing lung function and health status changes in COPD patients treated with tiotropium or salmeterol. Chest 2002; 122: 47–55.
8. Vincken W., van Noord J.A., Greefhorst A.P.M. et al. Improved health outcomes in patients with COPD during 1 year's treatment with tiotopium. Eur. Respir. J. 2002; 19: 209–216.
9. Casaburi R., Mahler D.A., Jones P.W. et al. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. Eur. Respir. J. 2002; 1: 217–224.
10. Brusasco V., Hodder R., Miravitlles M. et al. Health outcomes following treatment for six months with once daily tiotropium compared with twice daily salmeterol in patients with COPD. Thorax 2003; 58: 399–404.
11. Celli B., Wallack R.Z., Wang S. et al. Improvement in resting inspiratory capacity and hyperinflation with tiotropium in COPD patients with increased static lung volumes. Chest 2003; 124: 1743–1748.
12. O'Donnell D.E., Fluge T., Gerken F. et al. Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD. Eur. Respir. J. 2004; 23: 832–848.
13. Tashkin D.P., Celli B., Senn S. et al. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N. Engl. J. Med. 2008; 359: 1543–1554.
14. Decramer M., Celli B., Kesten S. et al. Effect of tiotropium on outcomes in patients with moderate chronic obstructive pulmonary disease (UPLIFT): a prespecified subgroup analysis of a randomised controlled trial. Lancet 2009; 374: 1171–1178.
15. Troosters T., Celli B., Lystig T. et al. Tiotropium as a first maintenance drug in COPD: secondary analysis of the UPLIFT trial. Eur. Respir. J. 2010; 36: 65–73.
16. Morice A.H., Celli B., Kesten S. et al. COPD in young patients: A pre-specified analysis of the four-year trial of tiotropium (UPLIFT). Respir. Med. 2010; 104: 1659–1667.
17. Panos R.J. Efficacy and safety of eco-friendly inhalers: focus on combination ipratropium bromide and albuterol in chronic obstructive pulmonary disease. Intern. J. COPD 013; 8: 221–230.
18. Dalby R.N., Eicher J., Zierenberg B. Development of Respimat(®) Soft Mist™ Inhaler and its clinical utility in respiratory disorders. Med. Devices (Auckl.). 2011; 4: 145–155.
19. Dalby R., Spallek M., Voshaar T. A review of the development of Respimat Soft Mist Inhaler. Int. J. Pharm. 2004; 283: 1–9.
20. van Noord J.A., Smeets J.J., Creemers J.P. et al. A randomised, double-blind (within device), placebo-controlled, cross-over, dose-ranging study in asthmatic patients. Respiration 2000; 67: 672–678.
21. Longest P.W., Hindle M., Choudhuri S.D., Byron P.R. Numerical simulations of capillary aerosol generation: CFD model development and comparisons with experimental data. Aerosol. Sci. Technol. 2007; 41: 952–973.
22. Longest P.W., Hindle M., Choudhuri S.D., Xi J. Comparison of ambient and spray aerosol deposition in a standard induction port and more realistic mouth-throat geometry. J. Aerosol. Sci. 2008; 39: 572–591.
23. Newman S.P., Pavia D., Moren F. et al. Deposition of pressurised aerosols in the human respiratory tract. Thorax 1981; 36: 52–55.
24. Newman S.P. Aerosol deposition considerations in inhalation therapy. Chest 1985; 88 (Suppl. 2): 152S–160S.
25. Stein S.W., Gabrio B.J. Understanding throat deposition during cascade impactor testing. In: Dalby R.N., Byron P.R., Farr S.J., Peart J., eds. Respiratory drug delivery VII. Serentec, Raleigh, NC; 2000. 573–576.
26. Longest P.W., Hindle M. Quantitative analysis and design of a spray aerosol inhaler. Part 1: effects of dilution air inlets and flow paths. J. Aerosol. Med. Pulm. Drug Deliv. 2009; 22: 271–283.
27. Hochrainer D., Holz H., Kreher C. et al. Comparison of the aerosol velocity and spray duration of Respimat Soft Mist inhaler and pressurized metered dose inhalers. J. Aerosol. Med. 2005; 18: 273–282.
28. Khachikian D.; VA Pharmacy Benefits Management Services, Medical Advisory Panel, VISN Pharmacist Executives. Ipratropium / Albuterol (Combivent® Respimat®) Abbreviated Review. 2012. Available from: http://www.pbm.va.gov/ClinicalGuidance/Abbreviated Reviews/Ipratropium&albuterol (CombiventRespimat). doc. Accessed February 12, 2013.
29. Newman S.P., Steed K.P., Reader S.J. et al. Efficient delivery to the lungs of flunisolide aerosol from a new portable hand-held multidose nebulizer. J. Pharm. Sci. 1996; 85: 960–964.
30. Newman S.P., Brown J., Steed K.P. et al. Lung deposition of fenoterol and flunisolide delivered using a novel device for inhaled medicines: comparison of RESPIMAT with conventional metered-dose inhalers with and without spacer devices. Chest 1998; 113: 957–963
31. Pitcairn G., Reader S., Pavia D., Newman S. Deposition of corticosteroid aerosol in the human lung by Respimat Soft Mist inhaler compared to deposition by metered dose inhaler or by Turbuhaler dry powder inhaler. J. Aerosol. Med. 2005; 18: 264–272.
32. Caillaud D., Le Merre C., Martinat Y. et al. A dose-ranging study of tiotropium delivered via Respimat® Soft MistTM Inhaler or HandiHaler® in COPD patients. Int. J. Chron. Obstruct. Pulmon. Dis. 2007; 2: 559–565.
33. Ichinose M., Fujimoto T., Fukuchi Y. Tiotropium 5 mg via Respimat and 18 mg via HandiHaler; efficacy and safety in Japanese COPD patients. Respir. Med. 2010; 104: 228–236.
34. Hodder R., Price D. Patient preferences for inhaler devices in chronic obstructive pulmonary disease: experience with Respimat® Soft Mist™ Inhaler. Int. J. Chron. Obstruct. Pulmon. Dis. 2009; 4: 381–390.
35. Schurmann W., Schmidtmann S., Moroni P. et al. Respimat® Soft Mist Inhaler versus hydrofluoroalkane metered dose inhaler: Patient preference and satisfaction. Treat. Respir. Med. 2005; 4: 53–61.
36. Brand P., Hederer B., Austen G. et al. Higher lung deposition with Respimat Soft Mist inhaler than HFA-MDI in COPD patients with poor technique. Int. J. Chron. Obstruct. Pulmon. Dis. 2008; 3: 763–770.
37. Anderson P. Patient preference for and satisfaction with inhaler devices. Eur. Respir. Rev. 2005; 14: 109–116.
38. Kozma C.M., Slaton T.L., Monz B.U. et al. Development and validation of a patient satisfaction and preference questionnaire for inhalation devices. Treat. Respir. Med. 2005; 4: 41–52.
39. Hodder R., Reese P.R., Slaton T. Asthma patients prefer Respimat® Soft Mist™ Inhaler to Turbuhaler®. Int. J. Chron. Obstruct. Pulm. Dis. 2009; 4: 225–232.
40. Freytag F., Rau&Berger H., Glaab T. et al. Respimat® Soft Mist™ Inhaler preferred to Diskus by patients with COPD and / or asthma. Am. J. Respir. Crit. Care Med. 2007; 175: A639.
41. Rau&Berger H., Mitfessel H., Glaab T. Tiotropium Respimat® improves physical functioning in chronic obstructive pulmonary disease. Int. J. Chron. Obstruct. Pulm. Dis. 2010; 5: 367–373.
42. Asakura Y., Nishimura N., Maezawaet K. et al. Effect of Switching Tiotropium HandiHaler to Respimat Soft Mist Inhaler in patients with COPD: The difference of adverse events and usability between Inhaler devices. J. Aerosol. Med. Pulm. Drug Deliv. 2013; 26: 41–45.
43. ClinicalTrials.gov. 12 week comparison of 5 Mcg and 10 Mcg of Tiotropium / Respimat®, placebo and Ipratropium MDI in COPD. NCT00239473. 2010. http://clinicaltrials.gov/ct2/show/NCT00239473.
44. ClinicalTrials.gov. 12 week comparison of 5 Mcg and 10 Mcg of Tiotropium / Respimat®, placebo and Ipratropium MDI in COPD. NCT00240435. 2010. http://clinicaltrials.gov/ct2/show/NCT00240435.
45. ClinicalTrials.gov. Tiotropium/Respimat® one-year study. NCT 00168844. 2010. http://clinicaltrials.gov/ct2/show/NCT00168844.
46. ClinicalTrials.gov. Tiotropium / Respimat® one-year study. NCT 00168831. 2010. http://clinicaltrials.gov/ct2/show/NCT00168831.
47. ClinicalTrials.gov. Tiotropium / Respimat® one-year study in COPD. NCT00387088. 2010. http://clinicaltrials.gov/ct2/show/NCT00387088.
48. Bateman E., Singh D., Smith D. et al. Efficacy and safety of tiotropium Respimat® SMI in COPD in two 1-year randomized studies. Int. J. Chron. Obstruct. Pulm. Dis. 2010; 5: 197–208.
49. Bateman E.D., Tashkin D., Siafakas N. et al. A one-year trial of tiotropium Respimat® plus usual therapy in COPD patients. Respir. Med. 2010; 104: 1460–1472.
50. Feifel U., Wallenstein G., Rominger K.&L. et al. Pharmacokinetics and tolerability (Study 1) with particular reference to ocular safety (Study 2) of tiotropium Respimat® Soft Mist™ Inhaler: findings from two dose-ranging studies in healthy men. Int. J. Chron. Obstruct. Pulm. Dis. 2008; 3: 397–403.
51. Hodder R., Pavia D., Lee A., Bateman E. Lack of paradoxical bronchoconstriction after administration of tiotropium via Respimat® Soft Mist™ Inhaler in COPD. Int. J. Chron. Obstruct. Pulmon. Dis. 2011; 6: 245–251.
52. Beasley R. Tiotropium Respimat increases the risk of mortality: pro. Eur. Respir. J. 2013; 42: 584–589.
53. Bateman E.D. Tiotropium Respimat increases the risk of mortality: con. Eur. Respir. J. 2013; 42: 590–593.
54. Jenkins C.R., Beasley R. Tiotropium Respimat increases risk of mortality. Thorax 2013; 68: 5–7.
55. Singh S., Loke Y.K., Enrigh P.L., Furberg C.D. Mortality associated with tiotropium mist inhaler in patients with chronic obstructive pulmonary disease: systematic review and metaanalysis of randomised controlled trials. Br. Med. J. 2011; 342: d3215.
56. Lipworth B.J., Short P.M. Explaining differential effects of tiotropium on mortality in COPD. Thorax 2013; 68: 589–590.
57. Sharma A., Hohlfeld J., Cornelissen P. et al. Comparison of the pharmacokinetics and pharmacodynamics of once daily tiotropium Respimat® and tiotropium HandiHaler® in COPD patients. In: Proceeding of ERS congress. 2013: 981s (4631).
58. Wise R.A., Anzueto A., Cotton D. et al. Tiotropium Respimat Inhaler and the risk of death in COPD. N. Engl. J. Med. 2013; 369: 1491–1501.
59. Peters S.P., Kunselman S.J., Icitovic N. et al. Tiotropium bromide step-up therapy for adults with uncontrolled asthma. N. Engl. J. Med 2010; 363: 1715–1726.
60. Kerstjens H.A.M., Engel M., Dahl R. et al. Tiotropium in asthma poorly controlled with standard combination therapy. N. Engl. J. Med. 2012; 367: 1198–1207.
Рецензия
Для цитирования:
Авдеев С.Н. Новые возможности использования тиотропия бромида с помощью аэрозольного устройства доставки – ингалятора Респимат®. Пульмонология. 2013;(5):70-80. https://doi.org/10.18093/0869-0189-2013-0-5-70-80
For citation:
Avdeev S.N. New abilities of administration of tiotropium bromide using the aerosol delivery device Respimat®. PULMONOLOGIYA. 2013;(5):70-80. (In Russ.) https://doi.org/10.18093/0869-0189-2013-0-5-70-80
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