국내 임상검사실의 반코마이신과 아미노글리코사이드 항생제 약물농도 결과값 비교 평가
Vancomycin and Aminoglycoside Antibiotic Drug Concentration Measurement: Current Status in Clinical Laboratories in Korea
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배경: 반코마이신과 아미노글리코사이드 계열 항생제는 좁은 치료범위와 고농도에서의 신독성 부작용 때문에 약물농도 측정(therapeutic drug monitoring)이 추천된다. 이 연구는 주요 국내 임상검사실의 약물농도 측정 현황을 분석하기 위해 수행되었다. 방법: 총 10개 기관이 연구에 참여했다. 반코마이신, 아미카신, 겐타마이신, 토브라마이신에 대해 5-6개의 농도로, 각 농도당 3개씩의 검체를 제조하였다. 각 측정값을 이용하여 전체 기관의 평균, 표준편차를 구하고 개별기관의 정밀도를 평가하였으며, 다양한 방법으로 기관별 결과 차이를 분석하였다. 결과: 세 회사의 여섯 가지 장비가 약물농도 측정에 사용되었다. 대부분의 기관이 최저농도 검체의 값은 최소정량한계 미만으로 보고하였다. 검사실 내 변이계수는 반코마이신에서 1.05-10.89%, 아미카신에서 0.80-18.16%, 겐타마이신에서 1.19-7.80%, 토브라마이신에서 1.27-6.05%였다. 전체 참여기관 결과를 기준으로 할 때 한 기관의 반코마이신 검체에서만 3 SDI를 초과했고 그 외에는 2 SDI 미만이었다. CAP 기준은 모든 기관에서 통과하였지만, 반코마이신에서 한 기관, 겐타마이신에서 세 기관이 RCPA 허용기준을 충족시키지 못했다. 결론: 개별 기관의 항생제 검사의 정밀도는 우수하였음에도 불구하고 기관들끼리 측정값에 차이가 있었다. 결과의 불일치를 줄이기 위해 항생제 약물농도 측정의 일치화가 필요하다.
Abstract
Background: Therapeutic drug monitoring (TDM) is clinically recommended for vancomycin and aminoglycoside antibiotics owing to their narrow therapeutic range and nephrotoxicity at high concentrations in the blood. This study was conducted to investigate the current status of TDM of vancomycin and aminoglycosides in Korean clinical laboratories. Methods: Ten organizations participated in this survey. Vancomycin, amikacin, gentamicin, and tobramycin were prepared in three samples of five or six different concentrations. Data from each institution were calculated for the mean, standard deviation, within-day, between-day, and within-laboratory precision. The results from each institution were compared in various ways. Results: Six instruments from three manufacturers were used. Samples with the lowest drug concentration were reported as below the lower limit of quantitation in most laboratories. Coefficients of variation for within-laboratory values ranged from 1.1% to 10.9% for vancomycin, 0.8% to 18.2% for amikacin, 1.2% to 7.8% for gentamicin, and 1.3% to 6.1% for tobramycin. Based on the overall results of the participants, only one institution’s vancomycin samples standard deviation index exceeded 3, with all other values below 2. The College of American Pathologist criteria were met by all institutions; however, measurement of vancomycin in one laboratory and of gentamycin in three laboratories failed to meet the Royal College of Pathologists of Australasia acceptance criteria. Conclusions: Although the precision of the antibiotic test in individual institutions was excellent, there was a difference in the measured values between laboratories. Harmonization of antibiotic TDM is needed to reduce inconsistencies in results.
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