혈관질환 환자의 예방치료에 있어 메소글리칸의 안전성 및 유효성에 관한 시판 후 조사에 대한 연구

Post-Marketing Surveillance Study of the Safety and Efficacy of Mesoglycan Prescribed in Primary and Secondary Care of Patients with Vascular Disease

  • 김윤희 (이화여자대학교 임상보건과학대학원) ;
  • 정영혜 (초당약품공업㈜) ;
  • 이화정 (이화여자대학교 임상보건과학대학원) ;
  • 곽혜선 (이화여자대학교 임상보건과학대학원)
  • Kim, Yoon-Hee (Graduate School of Clinical Health Sciences, Ewha Womans University) ;
  • Jung, Young-Hye (Cho Dang Pharm. Co., Ltd.) ;
  • Lee, Hwa-Jeong (Graduate School of Clinical Health Sciences, Ewha Womans University) ;
  • Gwak, Hye-Sun (Graduate School of Clinical Health Sciences, Ewha Womans University)
  • 발행 : 2005.12.30

초록

The aim of this study was to evaluate the safety and efficacy of treatment of mesoglycan. This study was conducted between September 2003 and May 2004. A total of 292 patients with vascular disorders including cerebral infarction were enrolled. The patients were administered with 50-100mg of mesoglycan by an oral route everyday for eight weeks. Subjective physicians' assessments of efficacy had ratings of 'improvement', 'invariability', 'exacerbation' and 'not being able to assess'. An improvement was observed in 241 patients out of 274; 18 patients were rules out. The efficacy rate was influenced statistically significantly by the duration of therapy (p=0.0392) and daily mean drug dose (p<0.0001). The adverse events were reported in 8 patients (9 cases) out of 292 patients: skin/appendages disorders (0.7%), liver/biliary system disorders (0.7%), cardiovascular system disorders (0.7%), neurologic disorders (0.3%). respiratory disorders (0.3%) and gastrointestinal system disorders (0.3%). There showed no serious adverse events. These results indicate that mesoglycan was well tolerated and effective for the prevention of vascular disorders.

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