성인의 복잡성 복강내 감염증의 치료에서 Ertapenem 단독투여와 Ceftriaxone과Metronidazole 병용투여의 안전성과 유효성 평가를위한 다기관, 공개, 무작위, 비교 임상연구
A Randomized, Controlled, Open, Multi-Center Clinical Trial Comparing Ertapenem versus Ceftriaxone plus Metronidazole for the Treatment of Complicated Intra-abdominal Infections in Adults
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목 적:경증 및 중등도의 복잡성 복강내 감염 환자에서 ertapenem 단독투여와 ceftriaxone 과 metronidazole 병용투여의 안전성 및 유효성을 비교 평가하고자 하였다. 재료 및 방법:지역사회획득 복잡성 복강내 감염 성인 환자를 대상으로 다기관, 무작위, 공개, 비교연구를 시행하였다. 대상 환자를 ertapenem 1 g 단독투여군과 ceftriaxone 2 g 및 metronidazole 1.5 g 병합투여군으로 질병의 중증도에 따라 층화 무작위 배정하여 실험군과 대조군간의 임상적 효능과 안전성을 비교하였다. 결 과:5개 연구기관이 참여하여, 총 163명의 환자 중 80명이 ertapenem 단독투여군에 83명이 ceftriaxone과 metronidazole 병용투여군으로 배정되었다. 이중에 134명이 임상적으로 분석 가능하였다. 두 치료군 간의 성별, 연령, APACHE II score와 질병의 특성은 유의한 차이가 없었으며 가장 흔한 감염부위는 충수였다. 임상적 호전을 보인 환자의 비율은 ertapenem 단독투여군 98.6% (71/72)와 ceftriaxone과 metronidazole 병용투여군 91.3% (73/ 80)였다. 임상적 이상반응은 ertapenem단독투여군 16.3%와 ceftriaxone과 metronidazole 병용투여군에서 14.5%로 통계적인 차이는 없었다. 결 론:지역사회 획득 복잡성 복강내 감염 환자의 경험적 항생제로서 ertapenem 단독요법은 ceftriaxone과 metronidazole 병합요법과 대등하게 효과적이고 안전하였다.
Abstract
Background : Ertapenem, a novel β-lactam agent with a wide range of activity, has a pharmacokinetic profile and antimicrobial spectrum that support its potential use as a once-a-day agent for the treatment of common mixed aerobic and anaerobic pathogens encountered in intraabdominal infections. Materials and Methods : The prospective, randomized, controlled, open, and multicenter trial was conducted to compare the clinical efficacy and safety of ertapenem with ceftriaxone plus metronidazole as therapy before or following adequate surgical management of complicated intraabdominal infections. Results : One hundred sixty-three patients were included in the modified intent-to-treat population, of which 134 were clinically evaluable. Patients with a wide range of infections were enrolled; perforated appendicitis or periappendiceal abscess were most common. As for the modified intent- to-treat groups, 71 of 72 (98.6%) patients treated with ertapenem and 73 of 80 (91.3%) treated with ceftriaxone/metronidazole showed favorable clinical response. Conclusion : In this study, the efficacy of ertapenem was equivalent to ceftriaxone plus metronidazole in the treatment of complicated intraabdominal infections. Ertapenem was generally well tolerated and had a similar safety and tolerability profile compared to ceftriaxone plus metronidazole. The results of this trial suggest that ertapenem could be considered as a useful option that could eliminate the need for combination and/or multi-dosed antibiotic regimens for the empiric treatment of complicated intraabdominal infections.
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