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Tigecycline 주사제(품명: 타이가실주)
  • 분류고시
  • 관련근거고시 제2018-28호(약제)
  • 게시일2018-03-01
  • 조회수1265
  • 자료가 다운되지 않을 경우 담당부서로 연락주시기 바랍니다.
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■ 고시 개정 전체내용

감염 전문가의 자문 하에 아래와 같은 기준으로 투여 시 요양급여를 인정함.

- 아 래 -

○ “복합성 중증 연조직 감염(Complicated severe soft tissue infections) 및 복합성 복부 내 감염(Complicated intra-abdominal infections)”에 적절한 항생제 치료에 내성이 있거나 실패한 경우



■ 고시 개정 고시번호(시행일자)

고시 제2018-28호(2018.3.1.)



■ 고시 개정 사유

국내·외 허가사항, 교과서, 가이드라인, 임상논문 등을 참고하여 허가사항 초과 전액본인부담 항목을 삭제함



■ 관련문헌 등

· Harrison's Principles of Internal Medicine, 19e 2015 - Chapter 186: Diseases Caused by Gram-Negative Enteric Bacilli, 187: Acinetobacter Infections,

· Goldman-Cecil Medicine Twenty-Fifth Edition(2016) - Diseases Caused by Acinetobacter and Stenotrophomonas Species - Acinetobacter Species

· Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases, Eighth Edition(2015)

· Goodman & Gilman's: The Pharmacological Basis of Therapeutics, Thirteenth Edition(2018) - Chapter 59: Protein Synthesis Inhibitors and Miscellaneous Antibacterial Agents

· 2017년도 카바페넴내성장내세균속균종(CRE) 관리지침 - 보건복지부 질병관리본부

· Yahav D et al. Efficacy and safety of tigecycline: a systematic review and meta-analysis. J Antimicrob Chemother. 2011 Sep;66(9):1963-71

· Efthimia Tasina et al. Efficacy and safety of tigecycline for the treatment of infectious diseases: a meta-analysis. Lancet Infect Dis. 2011 Nov;11(11):834-44.

· Paritosh prasad et al. Excess Deaths Associated With Tigecycline After Approval Based on Noninferiority Trials. Clinical Infectious Diseases, June 2012, Pages 1699?1709.

· Shen F et al. Efficacy and safety of tigecycline for the treatment of severe infectious diseases: an updated meta-analysis of RCTs. Int J Infect Dis. 2015 Oct;39:25-33

· Arthur LE et al. Antibiotics for ventilator-associated pneumonia. Cochrane Database Syst Rev. 2016 Oct 20;10:CD004267.

· Oren Zusman et al. Polymyxin monotherapy or in combination against carbapenem-resistant bacteria: systematic review and meta-analysis. J Antimicrob Chemother 2017; 72: 29?39

· Matthew E. Falagas et al. Antibiotic Treatment of Infections Due to Carbapenem-Resistant Enterobacteriaceae: Systematic Evaluation of the Available Evidence. Antimicrobial Agents and Chemotherapy. February 2014;654?663



■ 변경 전 고시번호(시행일자)

고시 제2013-127호 (2013.9.1.)
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