Journal of Korean Society for Clinical Pharmacology and Therapeutics (임상약리학회지)

Korean Society for Clinical Pharmacology and Therapeutics (대한임상약리학회)
권호 표지

The Effect of Rofecoxib in the Treatment of Postorthopedic Surgical Pain over 5-day Period -Active-Comparative, Randomized, Open, Multicenter Study-

정형외과 수술 후 5일간 투여 된 로페콕시브 50mg의 진통효과 -치료약 대조, 무작위배정, 다기관, 공개 임상시험-

  • Kim, Jung-Man (Department of Orthopedic Surgery, Catholic University) ;
  • Kim, Hee-Joong (Department of Orthopedic Surgery, Seoul National University College of Medicine) ;
  • Bae, Dae-Kyung (Department of Orthopedic Surgery, Kyung Hee University Hospital) ;
  • Seo, Jai-Gon (Department of Orthopedic Surgery, Samsung Medical Center Sungkyunkwan University School of Medicine) ;
  • Sun, Doo-Hoon (Department of Orthopedic Surgery, Catholic University) ;
  • Seong, Sang-Cheol (Department of Orthopedic Surgery, Seoul National University College of Medicine) ;
  • Lee, Myung-Chul (Department of Orthopedic Surgery, Seoul National University College of Medicine) ;
  • Lee, Soo-Ho (Department of Orthopedic Surgery, Ulsan University Asan Medical Center) ;
  • Cho, Woo-Shin (Department of Orthopedic Surgery, Ulsan University Asan Medical Center) ;
  • Cho, Yoon-Je (Department of Orthopedic Surgery, Kyung Hee University Hospital) ;
  • Han, Chang-Dong (Department of Orthopedic Surgery, Yonsei University College of Medicine) ;
  • Lee, Woo-Suk (Department of Orthopedic Surgery, Yonsei University College of Medicine) ;
  • Kim, Kang-Il (Department of Orthopedic Surgery, Kyung Hee University Hospital) ;
  • Ahn, Jin-Hwan (Department of Orthopedic Surgery, Samsung Medical Center Sungkyunkwan University School of Medicine) ;
  • Lee, Seok-Hyun (Department of Orthopedic Surgery, Korea University Guro Hospital) ;
  • Park, Youn-Soo (Department of Orthopedic Surgery, Samsung Medical Center Sungkyunkwan University School of Medicine)
  • 김정만 (가툴릭대학교 강남성모병원 정형외과) ;
  • 김희중 (서울대학교 의과대학 정형외과) ;
  • 배대경 (경희대학교 의과대학 정형외과) ;
  • 서재곤 (성균관의대 삼성서울병원 정형외과) ;
  • 선두훈 (가툴릭대학교 강남성모병원 정형외과) ;
  • 성상철 (서울대학교 의과대학 정형외과) ;
  • 이명철 (서울대학교 의과대학 정형외과) ;
  • 이수호 (울산 의과대학 서울중앙병원 정형외과) ;
  • 조우신 (울산 의과대학 서울중앙병원 정형외과) ;
  • 조윤제 (경희대학교 의과대학 정형외과) ;
  • 한창동 (연세대학교 의과대학 세브란스병원 정형외과) ;
  • 이우석 (연세대학교 의과대학 세브란스병원 정형외과) ;
  • 김강일 (경희대학교 의과대학 정형외과) ;
  • 안진환 (성균관의대 삼성서울병원 정형외과) ;
  • 이석현 (고려대학교 구로병원 정형외과) ;
  • 박윤수 (성균관의대 삼성서울병원 정형외과)
  • Published : 2000.12.30

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Abstract

Background: Nonsteroidal anti-inflammatory drugs(NSAIDs) inhibit both cyclooxygenase-1(COX1) and cyclooxygenase-2(COX-2). There have been several trials showing that a specific inhibitor of COX-2 provide efficacy in surgical pain comparable with NSAIDs. In this study, the efficacy and safety of the rofecoxib which specifically inhibits COX-2 were compared with aceclofenac, an NSAID, in patients with pain after orthopedic surgery. Method : A randomized, open, active comparator-controlled trial of 229 adults with orthopedic surgical pain was conducted. Patients were randomized to one of two treatment groups ; 50mg of rofecoxib once daily or 100mg of aceclofenac twice daily. Clinical efficacy and safety were evaluated over 5-day treatment period. Result : Rofecoxib at dosage of 50mg demonstrated efficacy that was clinically comparable to that of aceclofenac as assessed by primary endpoint(TOPAR8) according to predefined comparability criteria. Results from secondary endpoints(SPID8, patient global assessment of response to therapy) were consistent with those of the primary endpoint. All treatments were generally well tolerated. Conclusion : Rofecoxib was well tolerated and provided efficacy that was clinically comparable, according to predefined equivalence margin, to that of 100mg of aceclofenac twice daily in this 5-day study.

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