Tuberculosis and Respiratory Diseases

The Korean Academy of Tuberculosis and Respiratory Diseases (대한결핵및호흡기학회)
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Effect of Beraprost Sodium in Patients with Chronic Obstructive Pulmonary Disease

만성폐쇄성폐질환 환자에서 Beraprost sodium의 효과에 대한 연구: 이중 맹검 무작위 임상시험

  • Lee, Sang-Do (Division of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Seo, Kwang Won (Division of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Lee, Jung Yeon (Division of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Huh, Jin Won (Division of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Choi, Ik Su (Division of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Park, Jae Sun (Division of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Shim, Tae Sun (Division of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Oh, Yeon-Mok (Division of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Park, In Won (Division of Pulmonology and Allergy, Department of Internal Medicine, Chung Ang University, College of Medicine, Yongsan Hospital) ;
  • Ryu, Wang-Seong (Division of Cardiology, Department of Internal Medicine, Chung Ang University, College of Medicine, Yongsan Hospital) ;
  • Choi, Byoung Whui (Division of Pulmonology and Allergy, Department of Internal Medicine, Chung Ang University, College of Medicine, Yongsan Hospital)
  • 이상도 (울산대학교 의과대학 내과학 교실) ;
  • 서광원 (울산대학교 의과대학 내과학 교실) ;
  • 이정연 (울산대학교 의과대학 내과학 교실) ;
  • 허진원 (울산대학교 의과대학 내과학 교실) ;
  • 최익수 (울산대학교 의과대학 내과학 교실) ;
  • 박재선 (울산대학교 의과대학 내과학 교실) ;
  • 심태선 (울산대학교 의과대학 내과학 교실) ;
  • 오연목 (울산대학교 의과대학 내과학 교실) ;
  • 박인원 (중앙대학교 의과대학 내과학교실) ;
  • 류왕성 (중앙대학교 의과대학 내과학교실) ;
  • 최병휘 (중앙대학교 의과대학 내과학교실)
  • Received : 2004.08.05
  • Accepted : 2004.09.21
  • Published : 2004.10.30
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Abstract

Background : Pulmonary vascular changes which occur early in the course of chronic obstructive pulmonary disease (COPD) are prevalent manifestation and later cause pulmonary hypertension, which is a bad prognostic factor in COPD. Beraprost sodium (BPS), an orally active prostacyclin analogue, has been shown to improve survival in patients with primary pulmonary hypertension. This study investigated the effect of BPS in the patients with COPD. Methods : This is a double-blind randomized placebo-controlled, two center clinical trial. Twenty one consecutive patients with COPD were enrolled from June 2003 to June 2004 (patients treated with BPS for 3 months, BPS group, n=11; those with placebo, placebo group, n=10). The baseline demographic, pulmonary function and hemodynamic data were not significantly different between two groups. Results : On echocardiographic examination, trans tricuspid valve pressure gradient has decreased significantly after 3 months with beraprost in the BPS group [17.7(${\pm}11.4$) to 8.2(${\pm}8.9$) mm Hg, p-value<0.05], while there was no significant change in the control group. Six-minute walking distance has decreased in the control group and increased in the BPS group, but there was no statistical significance. Conclusion : In patients with COPD oral administration of BPS reduced the pulmonary arterial pressure. The clinical significance of this finding, that is improving symptoms and natural course of the disease, needs further study.

연구배경 : 만성폐쇄성폐질환의 경과 중 조기에 나타나는 폐혈관의 변화는 이후 만성폐쇄성폐질환의 불량한 예후 인자인 폐고혈압증의 원인이 된다. Beraprost sodium (BPS)은 경구투여가 가능한 prostacyclin 유사 약제이며, 원발성폐고혈압 환자에서 생존율을 향상시킨다고 알려져 있다. 본 연구는 만성폐쇄성폐질환 환자에 대한 BPS의 효과에 대해 알아보고자 하였다. 연구방법 : 본 연구는 이중맹검, 무작위, 무효약대조, 2기관 임상시험이다. 2003년 6월부터 2004년 6월까지 만성폐쇄성폐질환 환자 21명이 선정되었다(이중 BPS를 3개월간 복용한 BPS군은 11명, 무효약을 복용한 무효약군은 10명). 기초평가, 폐기능검사, 혈역학적 지표에서 두 군간 통계적 차이는 없었다. 연구결과 : 심장초음파검사에서 Trans Tricuspid valve Pressure Gradient(TTPG) 측정값이 BPS군에서 BPS 복용 전보다 복용 3개월 후 현저한 감소를 보였다[17.7(${\pm}11.4$)에서 8.2(${\pm}8.9$) mm Hg, p-value<0.05]. 한편 무효약군 에서는 통계학적 차이가 없었다. 6분 도보거리는 무효약군에서는 감소를 보였고 BPS군에서는 증가된 결과를 보였으나 통계적 유의성은 없었다. 결 론 : 만성폐쇄성폐질환 환자에서 BPS의 경구복용은 폐동맥압을 감소하게 하였다. 이런 결과의 임상적 중요 성인 증상 및 질병의 자연경과의 개선을 조사하기 위한 추가연구가 필요할 것으로 사료된다.

Keywords

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