Salmeterol xinafoate + Fluticasone propionate 흡입제(품명: 세레타이드 디스커스 등, 세레타이드 에보할러)

기준 내용

각 약제의 허가사항 범위 내에서 아래와 같은 기준으로 투여 시 요양급여를 인정하며, 동 인정기준 이외에는 약값 전액을 환자가 부담토록 함.

가. 부분조절 이상 단계의 천식 단, 3～6개월에 한번씩 평가를 실시하여 평가결과를 기재토록 함.

나. 만성폐쇄성폐질환(FEV1 값이 예상 정상치의 60% 미만)

* 시행일: 2015.4.1.

* 종전고시: 고시 제2014-46호(시행일 2014.4.1.)

* 변경사유:교과서 및 국내외 가이드라인 등을 참조하여 문구를 정리함.

* 관련근거:· Ferri's Clinical Advisor 2015. Chronic Obstructive Pulmonary Disease. Basic Information Definition

· Current diagnosis & treatment 34: Chronic Obstructive Pulmonary Disease

· Goodman & Gilman's The Pharmacological Basis of Therapeutics, 12e;Chapter 36. Pulmonary Pharmacology

· Pharmacotherapy: A Pathophysiologic Approach, 9e 2014 ; Chapter 16. Chronic Obstructive Pulmonary Disease Pharmacologic Therapy

· Global Initiative for Chronic Obstructive Lung Disease - Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease.(revised 2014).

· COPD 진료지침 2014 개정판, 대한결핵 및 호흡기학회 COPD 진료지침 개정위원회

· Chronic obstructive pulmonary disease Management of chronic obstructive pulmonary disease in adults in primary and secondary care: NICE clinical guidance 101 (Issue date: June 2010)

· American College of Physicians, American College of Chest Physicians, American Thoracic Society, European Respiratory Society. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011 Aug 2;155(3):179-191.

· Nannini LJ1, Poole P, Milan SJ, Kesterton A.Combined corticosteroid and long-acting beta(2) -agonist in one inhaler versus inhaled corticosteroids alone for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2013 Aug 30;8:CD006826.

· Nannini LJ1, Lasserson TJ, Poole P.Combined corticosteroid and long-acting beta(2)-agonist in one inhaler versus long-acting beta(2)-agonists for chronic obstructive pulmonary disease.Cochrane Database Syst Rev. 2012 Sep 12;9:CD006829.

· Fukuchi Y1, et al. Budesonide/formoterol via Turbuhaler® versus formoterol via Turbuhaler® in patients with moderate to severe chronic obstructive pulmonary disease: phase III multinational study results. Respirology. 2013 Jul;18(5):866-73.

· Jenkins CR1, et al. Efficacy of salmeterol/fluticasone propionate by GOLD stage of chronic obstructive pulmonary disease: analysis from the randomised, placebo-controlled TORCH study. Respir Res. 2009 Jun 30;10:59.

· LINDBERG A, SZALAI Z, PULLERITS T, RADECZKY E. Fast onset of effect of budesonide/formoterol versus salmeterol/fluticasone and salbutamol in patients with COPD and reversible airway obstruction Respirology 2007; 12: 732·-739

· Chong J1, Leung B, Poole P.Phosphodiesterase 4 inhibitors for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2013 Nov 4;11:CD002309.

· Hanania NA1, et al. Pooled subpopulation analyses of the effects of roflumilast on exacerbations and lung function in COPD. Respir Med. 2014 Feb;108(2):366-75. doi: 10.1016/j.rmed.2013.09.018. Epub 2013 Sep 30.

· Rabe KF1, et al. Roflumilast--an oral anti-inflammatory treatment for chronic obstructive pulmonary disease: a randomised controlled trial. Lancet. 2005 Aug 13-19;366(9485):563-71.