가) 환자상태를 고려하여 Streptomycin sulfate 또는 Amikacin sulfate를 추가할 수 있음.
나) Rifampicin을 투여할 수 없거나 임상적으로 악화된 경우 등에는 Rifabutin으로 변경할 수 있음.
2) Macrolide계(Clarithromycin, Azithromycin)에 내성이 있거나 Macrolide계(Clarithromycin, Azithromycin) 또는 Ethambutol을 투여할 수 없는 경우, 임상적으로 악화된 경우 등에는 Fluoroquinolone계 또는 Linezolid※로 변경하거나 추가할 수 있음.
(Clarithromycin, Azithromycin) 중 1종, Rifampicin, Ethambutol을 병용투여함.
- Rifampicin을 투여할 수 없거나 임상적으로 악화된 경우 등에는 Rifabutin으로 변경할 수 있음.
2) Rifampicin 또는 Rifabutin에 내성이 있거나 투여할 수 없는 경우, 임상적으로 악화된 경우 등에는 Fluoroquinolone계, Streptomycin sulfate, Amikacin sulfate, Trimethoprim/ Sulfamethoxazole, Linezolid※로 변경하거나 추가할 수 있음.
라. 원인균이 상기 가, 나, 다 이외의 비결핵항산균(NTM)인 경우에는 관련문헌 등을 참조하여 사례별로 인정함.
※ 관련 전문가(호흡기내과, 결핵과, 감염내과, 소아청소년과 전문의)에 의하여 투여하며, Linezolid는 경구제 투여를 원칙으로 함.
마. CD4 수가 50cells/㎣이하인 HIV 환자의 미코박테륨아비움복합체(MAC; Mycobacterium Avium Complex) 감염예방에 Clarithromycin 경구제 또는 Azithromycin 경구제를 CD4 수가 100cells/㎣ 이상으로 3개월 정도 유지될 때까지 투여 시
■ 고시 개정 고시번호(시행일자)
고시 제2019-38호(2019.3.1.)
■ 고시 개정 사유
국내외 허가사항, 교과서, 관련 학회의견, 임상진료지침, 임상연구 논문 등을 참조하여
① 학명 등 용어를 정비하고, 원인균종에 따른 치료를 위한 항생제별로 급여를 확대하고
② 허가범위를 초과하여 HIV 환자의 미코박테륨아비움복합체(MAC) 감염에 Azithromycin 경구제,
Clarithromycin 경구제를 예방적 투여가 필요함을 고려하여 급여를 인정함.
■ 관련문헌 등
· Harrison's Principles of Internal Medicine, 20e (2018)
· Goldman-cecil medicine 25th edition(2016)
· Mandell, Douglas and Bennett 8th (2015)
· Murray&Nadel’s textbook of respiratory medicine 6th ed (2016)
· Fishman's Pulmonary Diseases and Disorders, 5e (2014)
· An Official ATS/IDSA Statement: Diagnosis, Treatment, and Prevention of Nontuberculous Mycobacterial Diseases, Am J Respir Crit Care Med Vol 175. pp 367？416, 2007
· 결핵 진료지침(3판) 2017, 대한결핵 및 호흡기학회 결핵 진료지침 개정위원회
· British Thoracic Society (BTS) guidelines for themanagement of non-tuberculous mycobacterial pulmonary disease (NTM-PD), Thorax 2017;72:iii1？ii64
· R. J. WALLACE, Activities of Linezolid against Rapidly Growing Mycobacteria, ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, Mar. 2001, p. 764？767
· J.C. Rodriguez Diaz, In vitro activity of new fluoroquinolones and linezolid against nontuberculous mycobacteria, International Journal of Antimicrobial Agents 21 (2003) 585/588
· Zhijian Zhang, In vitro activity between linezolid and other antimicrobial agents against Mycobacterium abscessus complex, Diagnostic Microbiology and Infectious Disease 90 (2018) 31？34
· Shannon A. Novosad, Treatment of Mycobacterium abscessus Infection, Emerging Infectious Diseases Vol. 22, No. 3, March 2016
· Mario Nosotti et al, Infections after lung transplantation, J Thorac Dis 2018;10(6):3849-3868
· Koh W.J. et al, Mycobacterial Characteristics and Treatment Outcomes in Mycobacterium abscessus Lung Disease, Clinical Infectious Diseases 2017;64(3):309？16
· Park.J.et al, Progression and Treatment Outcomes of Lung Disease Caused by Mycobacterium abscessus and Mycobacterium massiliense, Clinical Infectious Diseases 2017;64(3):301？8
· Lyu J. et al, A shorter treatment duration may be sufficient for patients with Mycobacterium massiliense lung disease than with Mycobacterium abscessus lung disease, Respiratory Medicine (2014) 108, 1706-1712
？ Dennis L, Kasper, et al. Harrison's Principles of Internal Medicine, 20th edition, 2018
？ Mandell, Douglas, and Bennett's Principles and Practice pf Infectious Diseases, 8th ed, 2015
？ Murray and Nadel's Textbook of Respiratory Medicine, 6th edition, 2016
？ Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents. (Recommendations of the National Institutes of Health(NIH), theCenters for Disease Control and Prevention(CDC), and the HIV Medicine Association of the Infectious Diseases Society of America(HIVMA/IDSA) (Last Updated: May 7, 2013; Last Revised: June 14, 2017)
？ Uthman MM et, al. Interventions for the prevention of mycobacterium avium complex in adults and children with HIV. Cochrane Database Syst Rev. 2013 Apr 30;(4):CD007191.
？ El-Sadr WM et, al. Discontinuation of prophylaxis against Mycobacterium avium complex disease in HIV-infected patients who have a response to antiretroviral therapy. Terry Beirn Community Programs for Clinical Research on AIDS. N Engl J Med. 2000 Apr 13;342(15):1085-92.
？ Pierce, M, Crampton S et al. A randomized trial of clarithromycin as prophylaxis against disseminated Mycobacterium avium complex infection in patients with advanced acquired immunodeficiency syndrome. N Engl J Med, 1996 Aug 8;335(6):384-91
？ Benson CA et al. Clarithromycin or rifabutin alone or in combination for primary prophylaxis of Mycobacterium avium complex disease in patients with AIDS: A randomized, double-blind, placebo-controlled trial. The AIDS Clinical Trials Group 196/Terry Beirn Community Programs for Clinical Research on AIDS 009 Protocol Team. J Infect Dis. 2000 Apr;181(4):1289-97. Epub 2000 Apr 13.
？ Havlir DV et al. Prophylaxis against disseminated Mycobacterium avium complex with weekly azithromycin, daily rifabutin, or both. California Collaborative Treatment Group. N Engl J Med. 1996 Aug 8;335(6):392-8.
？ Currier JS et al. Discontinuation of Mycobacterium avium complex prophylaxis in patients with antiretroviral therapy-induced increases in CD4+ cell count. A randomized, double-blind, placebo-controlled trial. AIDS Clinical Trials Group 362 Study Team. Ann Intern Med. 2000 Oct 3;133(7):493-503.
？ Aberg JA et, al. Presence of macrolide resistance in respiratory flora of HIV-Infected patients receiving either clarithromycin or azithromycin for Mycobacterium avium complex prophylaxis. HIV Clin Trials. 2001 Nov-Dec;2(6):453-9.