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Rifampicin 경구제(품명: 리팜핀정 등)
  • 분류고시
  • 관련근거고시 제2018-174호(약제)
  • 게시일2018-09-01
  • 조회수2227
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■ 고시 신설 전체내용

1. 허가사항 범위 내에서 투여 시 요양급여함을 원칙으로 함.



2. 허가사항 범위를 초과하여 아래와 같은 기준으로 투여 시에도 요양급여를 인정함.



- 아 래 -

가. 투여대상: 메티실린에 내성을 보이는 황색포도알균(MRSA) 또는 혈장응고효소 음성포도알균 (MRCNS)에 의한 골수염, 인공삽입물 관련 감염

- 다만, MRSA 또는 MRCNS 감염이 의심되나 배양으로 검출되지 않는 경우에는 감염 전문가 자문하에 투여시 인정



나. 투여방법

○ 적절한 타 항생제와 병용투여 시 인정함



다. 투여용량

○ 1일 최대 900mg까지 인정



■ 고시 신설 고시번호(시행일자)

고시 제2018-174호(2018.9.1.)



■ 고시 신설 사유

교과서, 가이드라인, 임상문헌, 학회의견 등을 참고하여 허가범위를 초과하여 메티실린 저항성 포도알균(MRSA 또는 MRCNS)에 의한 골수염, 인공삽입물 관련 감염(인공판막 심내막염 등)에 적절한 타 항생제와 병용시 급여 인정함.



■ 관련문헌 등

· Harrison's Principles of Internal Medicine, 19edition.

· Goldman-Cecil Medicine, 25th edition.

· Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases, Updated edition, 8th edition.

· 감염학(INFECTIOUS DISEASES), 대한감염학회, 2014

· Liu C, Bayer A, Cosgrove SE, et al.; Infectious Diseases Society of America. Clinical practice guidelines by the infectious diseases society of america for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children: Executive Summary. Clin Infect Dis 2011;52:e18-55.

· Brad Spellberg, 외. Systemic Antibiotic Therapy for Chronic Osteomyelitis in Adults. Clinical Infectious Diseases 2012;54(3):393?407.

· 관절감염 임상진료지침 제정위원회. 국내 골관절감염 항균요법 권고안(대한감염학회, 대한화학요법학회, 대한정형외과학회). 2014

· Douglas R. Osmon, Elie F. Berbari, Anthony R. Berendt, et al. Diagnosis and Management of Prosthetic Joint Infection: Clinical Practice Guidelines by the Infectious Diseases Society of America. CID 2013:56(1):e1-25.

· Recommendations for bone and joint prosthetic device infections in clinical practice (prosthesis, implants, osteosynthesis). Organized by the Societe de Pathologie Infectieuse de Langue Francaise (SPILF). Medecine et maladies infectieuses 40 (2010) 185?211.

· S. Esposito, S. Leone, M. Bassetti, et al. Italian Guidelines for the Diagnosis and Infectious Disease Management of Osteomyelitis and Prosthetic Joint Infections in Adults. Infection 2009; 37: 478?496.

· The Task Force for the Management of Infective Endocarditis of the European Society of Cardiology (ESC). 2015 ESC Guidelines for the management of infective endocarditis. European Heart Journal (2015) 36, 3075?3123.

· F. Kate Gould, David W. Denning, Tom S. J. Elliott, et al. Guidelines for the diagnosis and antibiotic treatment of endocarditis in adults: a report of the Working Party of the British Society for Antimicrobial Chemotherapy. J Antimicrob Chemother 2012; 67: 269?89.

· S. Harbarth, et al. Randomized non-inferiority trial to compare trimethoprim/sulfamethoxazole plus rifampicin versus linezolid for the treatment of MRSA infection. J Antimicrob Chemother(2014) doi:10.1093/jac/dku352.

· Andrew E. Simor, et al. Randomized Controlled Trial of Chlorhexidine Gluconate for Washing, Intranasal Mupirocin, and Rifampin and Doxycycline Versus No Treatment for the Eradication of Methicillin-Resistant Staphylococcus aureus Colonization. Clinical Infectious Diseases 2007; 44:178?85.

· Alina Tone, et al. Six-Week Versus Twelve-Week Antibiotic Therapy for Nonsurgically Treated Diabetic Foot Osteomyelitis: A Multicenter Open-Label Controlled Randomized Study. Diabetes Care 2015;38:302-307.

· G. Euba, et al. Long-Term Follow-Up Trial of Oral Rifampin-Cotrimoxazole Combination versus Intravenous Cloxacillin in Treatment of Chronic Staphylococcal Osteomyelitis. ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, June 2009, p. 2672?2676

· S. Nguyen, et al. Efficacy and tolerance of rifampicin?linezolid compared with rifampicin?cotrimoxazole combinations in prolonged oral therapy for bone and joint infections. Clin Microbiol Infect 2009; 15: 1163?1169.

· Naval G. Daver, et al. Oral step-down therapy is comparable to intravenous therapy for Staphylococcus aureus osteomyelitis. Journal of Infection (2007) 54, 539-544

· Zimmerli W, et al. Role of rifampin for treatment of orthopedic implant-related staphylococcal infections: a randomized controlled trial. Foreign-Body Infection (FBI) Study Group. JAMA. 1998 May 20;279(19):1537-41.
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