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Ampicillin + Sulbactam 주사제(품명: 썰바신주 등)
  • 분류고시
  • 관련근거고시 제2026-24호(약제)
  • 게시일2026-02-01
  • 조회수1014
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■ 고시 신설 전체내용

1. 허가사항 범위 내에서 투여 시 요양급여 함을 원칙으로 함.



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



- 아 래 -



○카바페넴 내성 아시네토박터 바우마니균(Carbapenem-resistant Acinetobacter baumannii) 감염이 증명된 경우

가. 투여용량: 최대 27g/day

나. 투여기간: 14일 이내(단, 14일 초과 시 투여소견서를 참조하여 인정함.)





■ 고시 신설 고시번호(시행일자)

고시 제2026-24호(2026.2.1.)



■ 고시 신설 사유

○교과서, 가이드라인, 임상연구문헌, 학회(전문가) 의견 등을 참조하여 카바페넴 내성 아시네토박터 바우마니균 감염에 급여 확대



■ 관련문헌 등

· 감염학, 3판, 2024> 20. 아시네토박터균 감염

· Harrison's Principles of Internal Medicine, 22e, 2025> Chapter 167: Acinetobacter Infections

· Goldman-Cecil Medicine, 27e, 2024> Chapter 283. DISEASES CAUSED BY ACINETOBACTER AND STENOTROPHOMONAS SPECIES

· Tamma PD, et al. Infectious Diseases Society of America 2024 Guidance on the Treatment of Antimicrobial-Resistant Gram-Negative Infections. Clin Infect Dis. 2024 Aug 7:ciae403.

· Tamma PD, et al. Infectious Diseases Society of America 2023 Guidance on the Treatment of Antimicrobial Resistant Gram-Negative Infections. Clin Infect Dis. 2023 Jul 18:ciad428.

· Paul M, et al. European Society of Clinical Microbiology and Infectious Diseases (ESCMID) guidelines for the treatment of infections caused by multidrug-resistant Gram-negative bacilli (endorsed by European society of intensive care medicine). Clin Microbiol Infect. 2022 Apr;28(4):521-547.

· Pintado V, et al. Executive summary of the consensus document of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) on the diagnosis and antimicrobial treatment of infections due to carbapenem-resistant Gram-negative bacteria. Enferm Infecc Microbiol Clin (Engl Ed). 2023 Jun-Jul;41(6):360-370.

· Tiseo G, et al. Diagnosis and management of infections caused by multidrug-resistant bacteria: guideline endorsed by the Italian Society of Infection and Tropical Diseases (SIMIT), the Italian Society of Anti-Infective Therapy (SITA), the Italian Group for Antimicrobial Stewardship (GISA), the Italian Association of Clinical Microbiologists (AMCLI) and the Italian Society of Microbiology (SIM). Int J Antimicrob Agents. 2022 Aug;60(2):106611.

· Sy, C. L., et al. (2022). Recommendations and guidelines for the treatment of infections due to multidrug resistant organisms. Journal of Microbiology, Immunology and Infection, 55(3), 359-386.

· 질병관리청. 2025 요양병원 감염병 진단 및 항생제 사용 지침.

· Liu J, et al. Comparative efficacy and safety of combination therapy with high-dose sulbactam or colistin with additional antibacterial agents for multiple drug-resistant and extensively drug-resistant Acinetobacter baumannii infections: A systematic review and network meta-analysis. J Glob Antimicrob Resist. 2021 Mar;24:136-147.

· Jung SY, et al. Antimicrobials for the treatment of drug-resistant Acinetobacter baumannii pneumonia in critically ill patients: a systemic review and Bayesian network meta-analysis. Crit Care. 2017 Dec 20;21(1):319.

· Lee J, et al. Comparative effectiveness and safety of colistin-based versus high-dose ampicillin/sulbactam-based combination therapy for nosocomial pneumonia caused by carbapenem-resistant Acinetobacter baumannii. Antimicrob Agents Chemother. 2025 Jun 4;69(6):e0188024.

· Makris D, et al. Colistin versus Colistin Combined with Ampicillin-Sulbactam for Multiresistant Acinetobacter baumannii Ventilator-associated Pneumonia Treatment: An Open-label Prospective Study. Indian J Crit Care Med. 2018 Feb;22(2):67-77.

· Betrosian AP, et al. Efficacy and safety of high-dose ampicillin/sulbactam vs. colistin as monotherapy for the treatment of multidrug resistant Acinetobacter baumannii ventilator-associated pneumonia. J Infect. 2008 Jun;56(6):432-6.

· Betrosian AP, et al. High-dose ampicillin-sulbactam as an alternative treatment of late-onset VAP from multidrug-resistant Acinetobacter baumannii. Scand J Infect Dis. 2007;39(1):38-43.

· Ungthammakhun C, et al. Effect of colistin combined with sulbactam: 9 g versus 12 g per day on mortality in the treatment of carbapenems resistant Acinetobacter baumannii pneumonia: A randomized controlled trial. Int J Infect Dis. 2024 Dec;149:107267.

· Cheh-Oh N, et al. The Mortality of Colistin Monotherapy vs. Colistin-Sulbactam for Carbapenem-Resistant Acinetobacter baumannii Pneumonia: A Propensity Score Analysis. Infect Chemother. 2025 Mar;57(1):138-147.

· Jaruratanasirikul S, et al. Pharmacodynamics modeling to optimize dosage regimens of sulbactam. Antimicrob Agents Chemother. 2013 Jul;57(7):3441-4.

· 질병관리청. 2023 국가 항생제 내성균 조사 연보
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