급성 단순성 방광염의 경험적 치료로써 Cefcapene Pivoxil의 유효성
Efficacy of Cefcapene Pivoxil for Empirical Therapy of Acute Uncomplicated Cystitis
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목 적 : 급성 단순성 방광염은 일반적으로 원인균에 대한 그 지역의 항생제 내성조사가 이루어지고 그 결과에 따라 항생제가 경험적으로 처방된다. 하지만 최근 우리나라에서 fluoroquinolone계 항생제에 대한 요로감염 원인균의 내성증가가 보고되고 있어 그 동안 경험적 1차치료제로 선택되었던 fluoroquinolone계 항생제의 역할에 한계가 보이고 있는 실정이다. 이에 저자들은 급성 단순성 방광염 환자에서 cefcapene pivoxil의 미생물학적, 임상적 유효성 및 안전성을 알아보고자 하였다. 재료 및 방법 : 시험은 전향적, 비맹검, 공개, 비비교 임상시험으로 시행되었고 서울지역 2개 종합병원을 방문한 92명의 급성 단순성 방광염 환자에게 cefcapene pivoxil 100 mg을 1일 3회, 5일간 경구 투여하여 1-3일과 2주 후에 추적 관찰하였다. 결 과 : 평가가 가능하였던 77명의 환자 중 75명의 환자에서 치료완료 2주 후에 원인균이 제거되어 97.4%의 미생물학적 유효성을 보였으며, 74명의 환자에서 치료 후 증상이 소실되었거나 호전되어 96.1%의 임상적 유효성을 보였다. 약물 관련 이상반응은 8명의 환자에서 나타났으나 이로 인한 치료 중단 사례는 없었으며, 심각한 생화학적 또는 혈액학적 이상반응은 나타나지 않았다. 결 론 : Cefcapene 100 mg 1일 3회 5일요법은 미생물학적, 임상적 유효성이 뛰어나며 안전한 치료요법으로 급성 단순성 방광염의 경험적 항생제 치료에 적합할 것으로 생각된다.
Abstract
Background : A high prevalence of fluoroquinolone resistance among uropathogens has been observed in Korea. Since empirical antimicrobial therapy should be guided by the proportion of pathogens resistant to the chosen antibiotic, the limitation of fluoroquinolones as the first empirical choice for acute cystitis is noticed in the clinical setting. The present study was undertaken to determine the susceptibility profiles of urinary isolates to cefcapene pivoxil and assess the clinical efficacy in patients with acute uncomplicated cystitis. Materials and Methods : The study was a prospective, open label, non-comparative, non-blinded trial. Ninety-two patients with acute, uncomplicated symptomatic cystitis from two hospitals were treated with cefcapene pivoxil 100 mg tid for 5 days and followed up for 2 weeks. Results : Seventy-seven of the 92 patients were evaluated. Bacteriological eradication of initial pathogens was achieved in 97.4% by 2 weeks after therapy termination. Seventy-four of 77 (96.1 %) patients were symptomatically cured or improved after completion of therapy. Drug related adverse experiences were seen in 8 patients. None necessitated cessation of therapy. No significant biochemical or hematological abnormalities occurred. Conclusion : These results demonstrate the clinical efficacy and safety of empirical 5-day cefcapene pivoxil for acute uncomplicated cystitis.
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