Tigecycline 주사제(품명: 타이가실주)
기준 내용
감염 전문가의 자문 하에 아래와 같은 기준으로 투여 시 요양급여를 인정함.
○ “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 사유
국내·외 허가사항, 교과서, 가이드라인, 임상논문 등을 참고하여 허가사항 초과 전액본인부담 항목을 삭제함
관련문헌 등 12줄
· 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.)
첨부파일
- 고시 제2018-28호 Tigecycline 주사제.hwp
첨부파일은 심평원 원문 화면에서 내려받습니다.
출처: 건강보험심사평가원 보험인정기준 고시 고시 제2018-28호(약제) · 심평원 원문 보기. 참고용 정보이며 청구·심사의 최종 판단은 고시 원문과 심평원 기준을 따릅니다.