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1 임상검사와정도관리 : 제 30 권제 1 호 2008 J Med Qual Assur 2008 ; 30: TDM 및약물남용검사신빙도조사결과보고 () 김정호 ( 집필대표 ) 1 김병광 1 이수연 2 전사일 3 권계철 4 윤여민 5 임종백 1 신동훈 6 송경은 7 송선미 8 서순팔 9 김진규 10 연세의대 1, 성균관의대 2, 울산의대 3, 충남의대 4, 제주의대 5, 한림의대 6, 경북의대 7, 서울의과학연구소 8, 전남의대 9, 서울의대 10 대한임상검사정도관리협회 TDM 분과위원회 Annual Report on External Quality Assessment in Therapeutic Drug Monitoring and Drug of Abuse in Korea () Jeong-Ho Kim, Byung Kwang Kim, Soo Youn Lee, Sail Chun, Gye Cheol Kwon, Yeomin Yoon, Jong-Baeck Lim, Dong Hoon Shin, Kyung Eun Song, Sean-Mi Song, Soon-Pal Suh, and Jin Q Kim Therapeutic Drug Monitoring Subcommittee, The Korean Association of Quality Assurance for Clinical oratory, Seoul, Korea Two s of external quality assessment for Therapeutic Drug Monitoring (TDM) subcommittee of Korean Association of Quality Assurance for Clinical oratory (KAQACL) were performed in. Number of participating laboratories were increased to 109, by 5.63% increase comparing with the previous year. Response rates reached 98.7% for both s slightly lower than that of the previous year. Two kinds of control materials were requested to be tested in each so that each institution could know the possible systematic error. In both s, 20 test items were responded at least from one laboratory. The average drug item was 6.3 per institution, which was decreased slightly from 6.8 in recent 5 years. The most common test items were valproic acid, digoxin, carbamazepine, theophylline, phenytoin, and phenobarbital which were peformed in more than 55% of the participating laboratories, followed by cyclosporine, vancomycin, lithium, tacrolimus, methotrexate, amikacin, gentamicin, salicylate, tobramycin, acetaminophen, primidone, free phenytoin, and amitryptyline. The inter-laboratory coefficients of variations showed simliar tendency comparing with those of the previous years. We started the proficiency test for drug of abuse from and got the response from 13 and 17 laboratories in the and, respectively. Average drug items were 3.4 for the. We found the relatively good performances as we got the correct answers from all laboratories except 4 for each one mistake. In conclusion, the TDM external quality assessment of showed grossly similar pattern comparing with those of previous year and drug of abuse proficiency testing showed a relatively good performance. Key Words:Quality assurance, External quality assessment, Therapeutic drug monitoring 서 론 교신저자 : 김정호우 ) 서울시강남구도곡동 영동세브란스병원진단검사의학과전화 :02) , FAX:02) jeongho@yuhs.ac 대한임상검사정도관리협회 TDM 분과위원회에서 1995 년도부터혈중약물농도검사에대한신빙도조사를시작하여첫보고 [1] 이후매년보고를하였고 [2-4], 이번이 13 회째가되었다. 년도부터는남용약물검사에대한신빙도조사가추가되었다.
2 134 김정호 김병광 이수연 전사일 권계철 윤여민외 1. 관리물질 재료및방법 제1회차에는 년 5월 29일에 TDM 검사용인혈청 ( 人血淸 ) 정도관리물질인 Lyphocheck R TDM Control (Bio-Rad oratories, Hercules, CA, USA) Level 2 (07-01) 및 Level 3 (07-02) 의두종류의물질을총 110 개참여기관에발송하였다. 같은날에전혈 ( 全血 ) 정도관리물질인 Lyphocheck R whole blood control (Bio-Rad oratories, Hercules, CA, USA) Level 2 (07-01WB) 및 Level 3 (07-02WB) 의두종류의물질을 cyclosporine 또는 tacrolimus 검사를시행하는총 47개기관을대상으로발송하였다. 제2회차에는 년 10월 24일에 TDM 검사정도관리물질 Lyphocheck R TDM Control (Bio-Rad oratories, Hercules, CA, USA) Level 1 (07-03) 및 Level 3 (07-04) 의두종류의물질을총 111 개참여기관을대상으로발송하였다. 같은날에 Lyphocheck R whole blood control (Bio-Rad oratories, Hercules, CA, USA) Level 1 (07-03WB) 및 Level 3 (07-04WB) 의두종류의물질을 cyclosporine 또는 tacrolimus 검사를시행하는총 54개기관을대상으로발송하였다. 남용약물을위해서는 Liquicheck Qualitative Urine Toxicology Control (Bio-Rad oratories, Hercules, CA, USA) 을사용하였다. 남용약물정도관리물질은 1회차에는 (urine) 및 07-02(urine) 을각 13개기관에, 2회차에는 07-03(urine) 및 07-04(urine) 을각 17개기관에송부하였다. 2. 조사종목및방법 년도에 TDM 분과에서실시한약물검사신빙도조사종목은 acetaminophen, amikacin, amitriptyline, carbamazepine, digoxin, ethosuximide, free phenytoin, gentamicin, lithium, methotrexate, phenobarbital, phenytoin, primidone, salicylate, theophylline, tobramycin, valproic acid, vancomycin, cyclosporine, tacrolimus (FK-506) 등 20항목이었다. 최근실적이없는 chloramphenicol, disopyramide, ethosuximide, lidocaine, N-acetyl-procainamide, procainamide, propranolol 등의약물은제외하였다. 제2 회차에도동일한약물을대상으로실시하였다. 정도관리물질로검사하기위해서 Lyphocheck R TDM control 은사용시검사당일에탈이온수를정확히 5.0 ml 을넣어용해시키며실온에 15분간세워둔후잘섞어사용하도록고지하였다. Lyphocheck R Whole blood control 은검사당일에탈이온수를정확히 2.0 ml 를넣어용 해시키며실온에 20 분간세워둔후잘섞어사용하도록고지하였다. 남용약물정도관리물질은 d-amphetamine, d-methamphetamine, 3,4-methylenedioxymetham-phetamine, secobarbital, nordiazepam, oxazepam, 9-COOH-11-nor- 9-THC, benzoylecgonine, ethanol, lysergic acid diethylamide (L), methadone, methaqualone, free morphine, phencyclidine (PCP), propoxyphene, nortriptyline 등이상 16 종을정성적으로검사할수있는것이었다. 3. 결과분석및통계 결과분석및통계처리는 Microsoft R Excel 2003, Microsoft R Access 2003 및 Analyse-it Software (Version 1.68, Leeds, England, United Kingdom) 을사용하였다. 단위및유효숫자를 TDM 분과위원회에서제시한것으로하지않고임의대로한기관에대해서는본위원회제시안대로일괄환산처리하였다. 또한검사장비코드를기록하지않은기관은전년도와동일코드로처리하였으며통계분석은각검사종목별로장비의차이를고려하지않은전체통계와각장비별 (peer group) 로평균치, 표준편차, standard deviation index (I) 값을내되, I 값이 +3 또는 -3을벗어나는기관의결과치는제외하고다시평균, 표준편차, 및 I 값을계산하였다. 단, 참여기관이 1 기관인경우에는통계에서제외되었다. 또한각군별로변이계수 (coefficient of variation), 최저값, 및최대값을산출하였다. 본분과위원회의 TDM 검사에서수탁기관으로서의불인정기준은다음과같이처리하였다. 해당연도에정도관리사업의참여가전혀없는경우는자동적으로불인정이수탁불인정기관이되지만, 그외에다음두경우에도수탁불인정으로처리하였다. (1) 어떤약물의두가지농도의정도관리검체에서연속하여장비별 (peer group) I 값이 +3 이상또는 -3 미만의성적을보인경우가 2종목이상이발견되는경우, 또는 (2) 어떤약물의두가지농도의정도관리검체에서연속하여장비별 (peer group) I 값이 +2 이상또는 -2 미만의성적을보인경우가 4종목이상이발견되는기관으로하였다. 결 1. 참여기관및검사실시종목 약물검사정도관리결과보고회신율은 1차에서대상기관 110 기관중 99.1% 였고, 2차에는대상기관 111 기관중 98.2% 였다. 이는작년에비해회신율은감소했으나참여기관수는증가한것이었고참여기관은꾸준히증가함을 과
3 TDM 및약물남용검사신빙도조사결과보고 () 135 알수있었다 (Table 1 및 Fig. 1). 또한각기관당검사종목수는평균 6.3 종목으로최근 5개년간 (2002 년 ~ 2006 년 ) 의평균종목수 6.8 종목에비해약간감소하였다 (Table 2). Table 1. Number of institutions who responded in TDM proficiency testing in Korean Association of Quality Assurance and Clinical oratories (KAQACL) in the year of comparing with those of the previous years Trial of institutions participated %increase of comparing with that of the previous of institutions responded (response rate%) Average response rate First of (100.0 %) Second of % 95 (100.0 %) First of % 98 (100.0 %) Second of % 104 (100.0 %) First of % 109 (99.1 %) Second of % 109 (98.2 %) % % 98.7 % of laboratories '96_01 '96_02 '97_01 '97_02 '98_01 '98_02 '99_01 '99_02 '00_01 '00_02 '01_01 '01_02 '02_01 '02_02 '03_01 '03_02 '04_01 '04_02 '05_01 '05_02 '06_01 '06_02 '07_01 '07_02 Year Fig. 1. Change of number of participating laboratories in TDM proficiency testing in KAQACL according to the s of each year.
4 136 김정호 김병광 이수연 전사일 권계철 윤여민외 Table 2. Number of test items of TDM proficiency testing of KAQACL comparing with those of recent five years Year Average of test items '02~'06 Average Total number of institutions Average test items of test items evaluated 약물검사의종목당실시기관수를살펴보면 Table 3과같았다. 대부분의종목들이작년과유사한응답율을보였고, 최근 3년 (2004 년 ~2006 년 ) 평균에비해 tacrolimus, vancomycin, cyclosporine 등이꾸준히증가추세였다. 2. 검사장비별이용현황 년도에도검사방법및장비코드는전년도와유사한 방법으로조사하였다. 검사종목별장비의이용현황을보면가장많이이용되는장비는 Abbott 사의 TDxFLx 가 38.9% 의가장많은비율로사용되고있었으나, 전년도비율 41.3% 에비해서는감소하였다. 다음에는 Abbott 사의 Abbott AxSym 의사용율이 25.6% 로증가하였고, 그다음이 Roche 사의 Cobas Integra 로 20.9% 였다 (Table 4). 그외에 Abbott 사의 IMx, Bayer 사의 Centaur 등의순이었다 (Table 4). Lithium 검사의경우에는검사방법이나장비의사용에있어
5 TDM 및약물남용검사신빙도조사결과보고 () 137 Table 3. Distribution of test items in TDM proficiency testing in KAQACL in recent three years Name of drug Year The response rate of * The response rate of '04~'06 Acetaminophen % Inc 5.5 % Amikacin % 13.7 % Amitriptyline % 2.8% Carbamazepine % 80.1 % Cyclosporine % Inc 39.5 % Digoxin % 85.5 % Ethosuximide % 0.7 % Free Phenytoin % 3.9 % Gentamicin % 7.6 % Lithium % 33.3 % Methotriexate % 19.9 % Phenobarbital % 65.8 % Phenytoin % 75.9 % Primidone % 5.3 % Salicylate % 5.7 % Tacrolimus (FK-506) % Inc 25.5 % Theophylline % 76.4 % Tobramycin % Inc 6.6 % Valproic acid % 85.1 % Vancomycin % Inc 26.8 % Total number of institution responded % 33.3% * 'Inc' means the increase of both the number and the response rate of comparing with those of recent three years (2004~2006). 서전체 lithium 검사기관의 93.8% 인 30기관에서 ISE (ion selective electrode) 법이이용되고있어작년과유사한비율이었다. Atomic absorption spectrophotometry (AAS) 법및 flame emission spectrophotometry (FES) 를이용한기관도작년과유사하였다 (Table 5).
6 138 김정호 김병광 이수연 전사일 권계철 윤여민외 Table 4. Usage of the instrument for TDM KAQACL proficiency testing in Name of instruments Rank of usage in Abbott TDx/TDxFLx 43.8 % 41.3 % 38.9 % 37.8 % 1 Abbott AxSym 21.3 % 24.3 % 25.6 % 26.4 % 2 Roche Cobas Integra 21.9 % 20.9 % 20.9 % 18.8 % 3 Abbott IMx 3.7 % 3.8 % 4.0 % 4.2 % 4 DPC Immulite 0.3% 1.3% 1.8% 2.1% 5 Bayer Centaur 1.3 % 2.5 % 2.5 % 1.8 % 6 Other method 1.7 % 0.1 % 1.2 % 1.8 % 6 Behring Dimension RXL 2.1 % 1.2 % 1.1 % 1.5 % 8 Roche Modular P 0.0 % 0.8 % 1.1 % 1.1 % 9 Syva (EMIT) 0.2 % 0.2 % 0.3 % 0.8 % 10 VIDAS 0.0 % 0.3 % 0.5 % 0.5 % 11 Roche Elecsys % 0.3 % 0.4 % 0.5 % 11 Microgenics CEDIA 0.0 % 0.6 % 0.0 % 0.5 % 11 HPLC 0.3 % 0.4 % 0.5 % 0.5 % 11 Roche Modular E % 0.8 % 0.3 % 0.4 % 15 RIA 0.5 % 0.6 % 0.3 % 0.4 % 15 Johnson & Johnson 0.0 % 0.0 % 0.1 % 0.3 % 17 Beckman Access 0.2 % 0.2 % 0.2 % 0.2 % 18 Bayer ACS % 0.1 % 0.0 % 0.2 % 18 LC/MS/MS 0.0 % 0.3 % 0.3 % 0.2 % 18 Dade Behring ACA 1.2% 0.0% 0.0% 0.0% - Dade Behring Opus 0.5 % 0.0 % 0.0 % 0.0 % - Sum % 100.0% % % Table 5. Distribution of the method of lithium determination in the year of in KAQACL proficiency testing Principle of determination % of ISE % AAS % FES % Sum % Abbreviations: ISE, ion selective electrode method; AAS, atomic absorption spectrophotometric method; FES, flame emission spectrophotometry.
7 TDM 및약물남용검사신빙도조사결과보고 () 방법별검사결과치및검사실간변이계수 2004 년도 TDM 분과에서실시한약물검사신빙도조사의항목별검사실간의변이계수 () 값을보면 Table 6, Table 7, 및 Table 8과같이각농도별로나누어볼때일부종목에서검사실간측정치의차이가커진경우도있었으나대부분의종목에서약간씩향상된것을볼수있었다. 각검사항목별신빙도조사결과를장비별평균, 표준편차, 변이계수, 참가기관검사결과의최저치, 최대치를 Table 9-28 에정리하였다. 삼성서울병원에서참고방법으로인정되는 LC-tandem mass 로 cyclosporine 및 tacrolimu 검사를시행한바, 기존 immunoassay 법이 참고방법보다약간씩높게측정되는것을발견할수있었다 (Table 13 및 Table 23). 년도에정도관리사업에성적으로말미암아수탁불인정이된기관은없었다. 올해처음시작된남용약물검사에참여한기관은 1회차에는 13기관이고 2회차에는 17기관이었고전문검사센터가각 4기관씩참여하여비교적높은참여율을보였고, 대학병원이 1회차에 6기관에서 2회차에 9기관으로참여기관이증가하였다 (Table 29). 신빙도조사대상남용약물의종류는 d-methamphetamine 등 12종이었고각양성및음성의 2가지종류의검체를보내어 1회차에는오답을낸기관이 4종의약물에서각 1기관씩있었는데 2회차에서는오답을낸기관은없었다 (Table 30). Table 6. Average between-laboratory of each item using low-level control materials in recent 5 years Item Trials 2005 () 2006 () 2006 () Average of recent 5 years () Number of institutions participated Acetaminophen Amikacin Amitriptyline Carbamazepine Cyclosporine Digoxin Free phenytoin Gentamicin Lithium Methotriexate Phenobarbital Phenytoin Primidone Salicylate Tacrolimus (FK506) Theophylline Tobramycin Valproic acid Vancomycin Total mean All numbers are between-laboratory coefficient of variation (, %) regardless of methods. Several results of some institution was deleted for the calculation of since they seemed to be random errors. Amitryptiline was according to high performance of liquid chromatography. *, not evaluated.
8 140 김정호 김병광 이수연 전사일 권계철 윤여민외 Table 7. Average between-laboratory of each item using medium-level control materials in recent 5 years Item Trials 2005 () 2005 () 2006 () Average of recent 5 years () Number of institution participated Acetaminophen Amikacin Amitriptyline Carbamazepine Cyclosporine Digoxin Free phenytoin Gentamicin Lithium Methotrexate Phenobarbital Phenytoin Primidone Salicylate Tacrolimus (FK506) Theophylline Tobramycin Valproic acid Vancomycin Total mean All numbers are between-laboratory coefficient of variation (, %) regardless of methods. Several results of some institution was deleted for the calculation of since they had random error. Amitryptiline was according to high performance of liquid chromatography. *, not evaluated.
9 TDM 및약물남용검사신빙도조사결과보고 () 141 Table 8. Average between-laboratory of each item using high-level control materials in recent 5 years Item Trials 2005 () 2006 () Average of recent 5 years () () Number of institution participated Acetaminophen Amikacin Amitriptyline Carbamazepine Cyclosporine Digoxin Free phenytoin Gentamicin Lithium Methotriexate Phenobarbital Phenytoin Primidone Salicylate Tacrolimus (FK506) Theophylline Tobramycin Valproic acid Vancomycin Total mean All numbers are between-laboratory coefficient of variation (, %) regardless of methods. Several results of some institution was deleted for the calculation of since they had random error. Amitryptiline was according to high performance of liquid chromatography. *, not evaluated. Table 9. Acetaminophen proficiency testing results of KAQACL in the year of (unit, μg/ml) All methods Roche Integra Abbott TDx
10 142 김정호 김병광 이수연 전사일 권계철 윤여민외 Table 10. Amikacin proficiency testing results of KAQACL in the year of (unit, μg/ml) All methods Abbott (TDx) Cobas Integra Abbott AxSym Table 11. Amitriptyline proficiency testing results of KAQACL in the year of (unit, ng/ml) Abbott TDx HPLC * We did not calculate the statistics for "All methods" because Abbott TDx determines "Total TCA", and difficult to be compared with those by HPLC. Table 12. Carbamazepine proficiency testing results of KAQACL in the year of (unit, μg/ml) All methods Abbott TDx Abbott AxSym Cobas Integra Bayer Centaur DPC Immulite Modular P Dimension RXL Other method Bayer ACS: Syva(EMIT) Microgenics
11 TDM 및약물남용검사신빙도조사결과보고 () 143 Table 13. Cyclosporine proficiency testing results of KAQACL in the year of (unit, ng/ml) All methods Abbott TDx Abbott AxSym Cobas Integra RIA Other method Syva(EMIT) LC/MS/MS Microgenics Table 14. Digoxin proficiency testing results of KAQACL in the year of (unit, ng/ml) All methods Abbott TDx Abbott AxSym Cobas Integra Bayer Centaur VIDAS DPC Immulite Elecsys Modular E Dimension RXL Other method Beckman Access Modular P Microgenics Table 15. Free phenytoin proficiency testing results of KAQACL in the year of (unit, μg/ml) All methods Abbott TDx
12 144 김정호 김병광 이수연 전사일 권계철 윤여민외 Table 16. Gentamicin proficiency testing results of KAQACL in the year of (unit, μg/ml) All methods Abbott TDx Abbott AxSym Cobas Integra Table 17. Lithium proficiency testing results of KAQACL in the year of (unit, mmol/l) All methods NOVA CRT Vitros Cobas Integra AVL Scientific NOVA others Dimension RXL Other method AAS IL Vitros DT 60II AAS, atomic absorption spectrophotometry IL, Instrumentation oratory Table 18. Methotrexate proficiency testing results of KAQACL in the year of (unit, μmol/l) All methods Abbott TDx
13 TDM 및약물남용검사신빙도조사결과보고 () 145 Table 19. Phenobarbital proficiency testing results of KAQACL in the year of (unit, μg/ml) All methods Abbott TDx Abbott AxSym Cobas Integra Bayer Centaur Other method Dimension RXL Syva(EMIT) Microgenics Table 20. Phenytoin proficiency testing results of KAQACL in the year of (unit, μg/ml) All methods Abbott TDx Abbott AxSym Cobas Integra Dimension RXL Modular P Other method Bayer ACS: Bayer Centaur DPC Immulite Syva (EMIT) Microgenics Table 21. Primidone proficiency testing results of KAQACL in the year of (unit, μg/ml) All methods Cobas Integra HPLC
14 146 김정호 김병광 이수연 전사일 권계철 윤여민외 Table 22. Salicylate proficiency testing results of KAQACL in the year of (unit, mg/dl) All methods Cobas Integra Table 23. Tacrolimus (FK-506) proficiency testing results of KAQACL in the year of (unit, ng/ml) All methods Abbott IMx Abbott AxSym Abbott TDx LC/MS/MS Other method Syva (EMIT) Table 24. Theophylline proficiency testing results of KAQACL in the year of (unit, μg/ml) ( %) All methods Abbott TDx Abbott AxSym Cobas Integra DPC Immulite Bayer Centaur J & J Dimension RXL Modular P Vitros Other method Syva(EMIT) Microgenics , could not be calculated since number of institution responded was one or zero.
15 TDM 및약물남용검사신빙도조사결과보고 () 147 Table 25. Tobramycin proficiency testing results of KAQACL in the year of (unit, μg/ml) All methods Abbott TDx Abbott AxSym Cobas Integra Table 26. Valproic acid proficiency testing results of KAQACL in the year of (unit, μg/ml) All methods Abbott TDx Abbott AxSym Cobas Integra Bayer Centaur DPC Immulite Dimensin RXL Other method Bayer ACS: Modular P Syva(EMIT) Microgenics Table 27. Vancomycin proficiency testing results of KAQACL in the year of (unit, μg/ml) All methods Abbott TDx Cobas Integra Abbott AxSym Other method
16 148 김정호 김병광 이수연 전사일 권계철 윤여민외 Table 28. Ethosuximide proficiency testing results of KAQACL in the year of (unit, μg/ml) All methods HPLC , could not be calculated since number of institution responded was one or zero. Table 29. The participating laboratories for drug of abuse in the proficiency testing of KAQACL in the year of The kinds of laboratories of of University hospital laboratories 6 9 Commercial laboratories 4 4 Community hospital laboratories 3 4 Total * Average numbers of drug of abuse items were 3.8 for and 3.4 for. Table 30. The items of drug of abuse and the number of participating laboratories with the percent of correct answer in the proficiency testing of KAQACL in the year of Name of drug of abuse (percent of correct answer) of the participating laboratories in 1 d-methamphetamine 9 (94.4 %) 13 (100 %) 2 d-amphetamine 8 (93.8 %) 8 (100 %) 3 9-COOH-11-nor- 9-THC 6 (100 %) 7 (100 %) 4 Morphine, free 6 (91.7 %) 7 (100 %) 5 Benzoylecgonine 5 (100 %) 6 (100 %) 6 Phencyclidine (PCP) 4 (100 %) 4 (100 %) 7 Oxazepam 3 (100 %) 3 (100 %) 8 3,4-Methylenedioxymethamphetamine 2 (75 %) 3 (100 %) 9 Nordiazepam 2 (100 %) 2 (100 %) 10 Secobarbital 2 (100 %) 2 (100 %) 11 Ethanol 1 (100 %) 1 (100 %) 12 Nortriptyline 1 (100 %) 1 (100 %) Total 49 57
17 TDM 및약물남용검사신빙도조사결과보고 () 149 고 대한임상정도관리협회 TDM 분과위원회의 년도신빙도조사사업은예년과같이 2 회실시하였으며, 참가기관이 109 기관으로전년도에비해 5.7% 증가하였고, 꾸준히참여기관이늘고있음을알수있었다 (Table 1, Fig. 1) [1]. 회신율은평균 98.7% 로서전년도의 100% 에미치지는못하였으나높은수준을유지하였다 (Table 1). 가장많은기관에서회신한약물농도검사종목은 valproic acid, digoxin, carbamazepine, theophylline, phenytoin, phenobarbital 등의 6 종목으로서 55% 이상의기관에서응답하였다 (Table 3). 다음으로 cyclosporine, vancomycin, lithium, tacrolimus, methotrexate, amikacin 등의순이었고, 10% 미만의회신을보인종목은 tobramycin, gentamicin, acetaminophen, salicylate, free phenytoin, primidone, amitryptyline, ethosuximide 등의순으로예년과유사한수준이었는데 vancomycin, cyclosporine, 및 tacrolimus 의응답율이증가하였다 (Table 3). Procainamide 및 quinidine 에대해서는회신기관이없었다. 또한각기관당검사종목수는평균 6.3 종목으로최근 5 개년간 (2002 년 ~2006 년 ) 의평균종목수 6.8 종목에비해 0.5 종목감소하였는데이는몇종류의약물만검사하는신규참여기관이증가한때문이라생각되었다 (Table 2). 사용기종중그비율이가장많은 Abbott 사의 TDx/TDxFLx 가약간줄고대신 Abbott 사의 AxSym 이꾸준한증가추세였고, Roche 사의 Cobas Integra 는조금씩사용빈도가주는추세였다 (Table 4). 각기관별평가를위해서검사기종의차이를고려하지않은종목별 I 값과검사기종별 I 값을별도로보고하였다 [2]. 연도별검사기관간변이계수를정도관리물질농도별로비교하여보았을때, 예년보다조금씩향상된종목이많았다 (Table 6, 7, 8). 약물별신빙도조사결과는대체로예년과유사하였다 (Table 9~28). 년도부터는남용약물에대한신빙도조사를시작하였는데, 첫번째회차에는 6 개의대학병원과 4 개의검사전문기관등총 13 개기관이참여하였고, 두번째회차에는 9 개의대학병원과 4 개의검사전문기관등총 17 개의기관이참여하였다 (Table 29). 각회차마다남용약물총 16 종을조사할수있는물질을송부하였으며이중에 d-methamphetamine, d-amphetamine, 9-COOH-11-nor- 9-THC, free morphine, benzoylecgonine 등 12 종의약물에대해회신이왔다. 회신된약물종류수는 1 회차에는평균 3.8 종, 2 회차에는평균 3.4 종이었다. 조사약물중에서 4 종의약물에대하여각 1 기관의오답을제외하고는모두정답을회신하여서비록농도가높거나전혀검출되지않는정도관리물질로서판별이어렵지않았지만좋은결과를보였다 (Table 30). 앞으로농도가높지않고실제환자와유사한정도관리물질을사용할것을고려해보아야할것이다. 찰 결론적으로 도 TDM 신빙도조사결과는참여기관이꾸준히늘고있다는것외에는예년과유사하였으며남용약물검사를시작하여 17 기관이신빙도조사에회신하였다. 요 1. 약물검사를실시하는기관은전년도에비해 5.7% 증가한 109 기관으로증가하였다. 2. 제 1 회차및제 2 회차모두에서두가지농도의정도관리물질을동시에평가하여연총 4 가지정도관리물질을평가하였고, 약물검사신빙도조사에대한참여기관의회신율은 1 회차및 2 회차모두에서각각 99.1% 및 98.2% 의회신율을보였다. 3. 가장많은기관에서검사를하고있는약물검사로는 valproic acid, digoxin, carbamazepine, theophylline, phenytoin, phenobarbital 등 6 종으로서전체참여기관 89 기관중 55% 이상에서응답하였다. 그다음으로 cyclosporine, vancomycin, lithium, tacrolimus, methotrexate, amikacin, tobramycin, gentamicin, acetaminophen, salicylate, free phenytoin, primidone, amitryptyline, 및 ethosuximide 순이었다. 4. 기관별약물농도검사종목수는평균 6.5 종목으로최근 5 개년간의평균종목수 6.8 종목에비해 0.5 종목증가하여약물농도를검사하는기관에서참여종목수를조금씩늘고있는것을알수있었다 5. 연도별검사기관간변이계수를정도관리물질농도별로비교하여보았을때, 예년과유사한수준이었고일부종목에서조금씩향상이관찰되었다. 6. 남용약물신빙도조사를처음시작하여 1 회차에 13 개기관이 2 회차에 17 개기관이참여하였고, 각기관별로는평균 3.4 종의약물에대한회신이왔다. 4 종의약물에대하여각 1 기관의오답을제외하고는모두정답을회신하여좋은결과를보였다. 약 참고문헌 1. 김진규, 권오헌, 권희정, 김영기, 김종원, 김태진등. TDM 검사신빙도조사결과보고 (1995). 임상병리와정도관리 1996;18: 김정호, 여운영, 정영순, 정영순, 이수연, 전사일등. TDM 검사신빙도조사결과보고 (2001). 임상병리와정도관리 2002;24: 김정호, 김병광, 이수연, 전사일, 권계철, 윤여민등. TDM 검사신빙도조사결과보고 (2004). 임상검사와정도관리 2005;27: 김정호, 김병광, 이수연, 전사일, 권계철, 윤여민등. TDM 검사신빙도조사결과보고 (2006). 임상검사와정도관리 ;29:
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