Earticle

초록

영어

Amphotericin B is a mainstay in the treatment of many systemic fungal infections due to its wide antifungal spectrum and low incidence of resistance. However, the use of amphotericin B is limited by its nephrotoxicity. Objectives: The objective of this study was to evaluate the incidence and risk factors of renal adverse drug reactions (ADRs) of conventional amphotericin B (Fungizone®). In addition, we compared the changes of serum creatinine (SCr) between patients who remained conventional amphotericin B and patients who were switched to liposomal amphotericin B after occurrence of renal adverse reactions. Methods: Adult hospitalized patients who reported renal adverse reactions caused by conventional amphotericin B from January 2011 to July 2012 at pharmacovigilance center in Yonsei University Healthcare System included in this study. ADRs scored as ‘doubtful’ in Naranjo probability ADR scale were excluded. We retrospectively analyzed patients’ basic clinical characteristics, concurrent diseases or nephrotoxic drugs in order to find variables that can correlate with occurrence of renal ADRs. Changes in SCr were compared between conventional amphotericin B group and liposomal amphotericin B group. Results: A total of 231 ADRs after administration of conventional amphotericin B in 75 patients were reported to pharmacovigilance center and assessed their severities as ‘possible’, ‘probable’, or ‘definite’. Renal adverse reaction was the most common ADR with incidence rate of 42% (96 of 231 ADRs). Mean change in SCr from baseline was 0.26 mg/dL (change % 37.8) and statistically significant (p=0.000). Simple correlations analysis revealed that the number of concurrent diseases and number of nephrotoxic drugs were positively correlated with changes in SCr, but these results were not statistically significant. Among 43 patients who remained amphotericin B after occurrence of renal ADRs, 27 patients was administered conventional amphotericin B and 16 patients changed to liposomal amphotericin B. Mean change in SCr in amphotericin B group was 0.23 mg/dL (32.75%), whereas mean change in SCr in liposomal amphotericin B group were -0.28 mg/dL (19.38%) and difference between two groups was statistically significant (p=0.003). The numbers of patient with SCr elevation more than 30% were 9 (33.3%) in amphotericin B group and 2 (12.5%) in liposomal amphotericin B group (Odd Ratio=3.50, 95% Confidence Interval 0.65-18.85; p=0.130). Conclusion: An analysis of ADRs due to amphotericin B administration revealed significant mean changes in SCr from baseline. Switching to liposomal amphotericin B showed significant decrease in SCr compared with conventional amphotericin B.

목차

Abstract
 연구 방법
  연구 대상
  평가 변수
  통계분석
 연구 결과
  대상 환자의 특성
  Amphotericin B 신장 유해반응분석
  Amphotericin B 신장 유해반응의 위험인자 분석
  Amphotericin B군과 Liposomal amphotericin B군의 신독성 비교
 고찰 및 결론
 참고문헌

키워드

저자

• 이송빈 [ Song Bin Lee | 연세대학교 세브란스 병원 약무국 ]
• 김태경 [ Tae Kyung Kim | 연세대학교 세브란스 병원 약무국 ]
• 고종희 [ Jong Hee Ko | 연세대학교 세브란스 병원 약무국 ]
• 안지현 [ Ji Hyune Ahn | 연세대학교 세브란스 병원 약무국 ]
• 김성은 [ Sung Eun Kim | 연세대학교 세브란스 병원 약무국 ]
• 석현주 [ Hyun Ju Seok | 연세대학교 세브란스 병원 약무국 ]
• 김현아 [ Hyunah Kim | 아주대학교 약학대학 ] Corresponding Author

참고문헌

발행기관

간행물

표지보기 관심저널 등록

• 간행물명

  한국임상약학회지 [Korean Journal of Clinical Pharmacy]

• 간기

  계간

• pISSN

  1226-6051

• 수록기간

  1991~2026

• 등재여부

  KCI 등재

• 십진분류

  KDC 518 DDC 615