호중구 감소성 발열환자에게 경험적으로 투여한 Teicoplanin의 효과
Efficacies of Teicoplanin in Patients with Febrile Neutropenia
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목 적 : 호중구감소성 발열 환자에게 경험적으로 teicoplanin을 투여할 때의 효과를 알아보고자 전향적 연구를 시행하였다. 방 법 : 2003년 7월부터 12월까지 가톨릭조혈모세포이식센터에 입원하여 항암치료 혹은 조혈모세포이식을 시행하고 호중구감소성 발열이 있는 환자 중 초기 항균요법에 반응이 없어 경험적 teicoplanin 투여가 필요한 49명을 대상으로 A, B 제조회사에서 제공한 teicoplanin을 무작위로 어느 한 쪽 치료군에 배정하여 투여하였다. 용량은 첫날 400 mg 부하용량을 정맥내 bolus로 투여하고 매 24시간마다 200 mg 유지용량을 투여하였다. 결 과 : A군 27명, B군 22명이 연구에 참여하였고 대부분의 환자가 신독성이 있는 약제를 병용하고 있었다. A군 8명, B군 7명에서 그람양성균이 동정되었고 teicoplanin에 대한 내성률은 A군 22.2%, B군 28.6%로 유의한 차이는 없었다(P=1.00; 0.61<95%CI<1.95). 미생물학적 확인 감염이 있었던 환자 중 평균 53.3%에서 완치 혹은 개선의 반응이 있었고 양 군간 유의한 차이는 없었다(A군 4명 [50.0%], B군 4명 [57.1%], P=1.00; 0.29<95%CI< 2.60). 미생물학적 제거율은 평균 62.5% (A군 55.6%, B군71.4%)이었고 그 외 미생물학적 효과는 A군에서 제거 후 재발 2명(22.2%), 내성 2명(22.2%)이었고 B군에서 각각 0명(0.0%), 2명(28.6%)이었으며 양 군간 유의한 차이는 없었다(P=0.28). 발열기간(P=0.89), teicoplanin 사용기간(P= 0.47) 및 전체적인 사망률(P=1.00; 0.78<95%CI<1.24)도 양 군간 유의한 차이는 없었다. 이상반응 중 신독성은 16.3% (A군 18.5%, B군 13.6%)에서 나타났고 양 군에 차이는 없었으며(P=0.72; 0.39<95%CI<3.51), 신기능 이상과 관련있는 약제를 적어도 2개 이상 병용하고 있었다. 피부발진은 A군에서 1명, B군에서 3명 발생하였다(P= 0.31; 0.93<95%CI<1.34). 결 론:호중구감소성 발열환자에게 teicoplanin을 투여하였을 때 임상적 반응률은 평균 53.3% (A군 50.5%, B군 57.1%), 미생물학적 제거율은 평균 62.5% (A군 55.6%, B군 71.4%)이었고 두 제조회사간 차이가 없었고 이상반응도 양 군간 차이가 없었다. 앞으로 국내 호중구감소증 환자에서의 teicoplanin의 적정 용량, 용법 등을 알기 위한 집단 약동학 등의 연구를 시행할 예정이다.
Abstract
Background:This study was done to elucidate the efficacy of teicoplanin as the empirical treatment for febrile neutropenia. Methods:Patients were randomized to two groups according to pharmaceutical company (company A or B). Total of 49 patients (A, 27; B, 22) with neutropenic fever were studied prospectively for 6 months (Jul. 2003-Dec. 2003). Patients received 400 mg i.v. once, then 200 mg i.v. once daily. Results:Groups were matched for all demographic variables. Most of the patients were concurrently receiving nephrotoxic drugs. Gram positive microorganisms were isolated in 8 patients for A and 7 patients for B. Resistance rate against teicoplanin was 22.2% in A and 28.6% in B (P=1.0; 0.61 < 95% confidence interval [CI] < 1.95). Among the patients with microbiologically documented infection, clinical cure or improvement was seen in 4 (50%) of 8 patients for A and 4 (57.1%) of 7 patients for B (P=1.00; 0.29 <95%CI <2.60). Bacteriologic efficacy was assessed as follows; elimination in 5 (55.6%), elimination with relapse in 2 (22.2%), resistance in 2 (22.2%) out of 9 gram-positive bacteria for A and 5 (51.4%), 0 (0.0%), 2 (28.6%) out of 7 bacteria for B, respectively (P=0.28). There were no significant differences in duration of fever, duration of use of teicoplanin, and overall mortality. The incidence of nephrotoxicity and ototoxicity was not significant. Conclusion:For using teicoplanin as the empirical therapy for febrile neutropenia, the rate of clinical, microbiological response, and nephrotoxicity was 53.3%, 62.5%, and 16.3% respectively with no significant differences between the 2 preparations of teicoplanin. Supplementary evaluation on the adequate dose and duration of teicoplanin may be required.
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