Journal of Acupuncture Research

  • 제15권2호
  • /
  • Pages.183-198
  • /
  • 1998
  • /
  • 2586-288X(pISSN)
  • /
  • 2586-2898(eISSN)
대한침구의학회 (Korean Acupuncture & Moxibustion Medicine Society)
권호 표지

약침제제(藥鍼製劑)의 안전성(安全性)을 위한 임상시험방법(臨床試驗方法)에 대한 연구(硏究)

A Study of clinical trial method for safety of herb-acupuncture

  • 전금선 (경희대학교 한의과대학 침구학교실) ;
  • 남상수 (경희대학교 한의과대학 침구학교실) ;
  • 이재동 (경희대학교 한의과대학 침구학교실) ;
  • 최도영 (경희대학교 한의과대학 침구학교실) ;
  • 안병철 (경희대학교 한의과대학 침구학교실) ;
  • 박동석 (경희대학교 한의과대학 침구학교실) ;
  • 이윤호 (경희대학교 한의과대학 침구학교실) ;
  • 최용태 (경희대학교 한의과대학 침구학교실)
  • Jun Kum-Sun (Dept. of Acupuncture & Moxibustion Oriental Medical College, Kyung Hee University) ;
  • Nam Sang-Soo (Dept. of Acupuncture & Moxibustion Oriental Medical College, Kyung Hee University) ;
  • Lee Jae-Dong (Dept. of Acupuncture & Moxibustion Oriental Medical College, Kyung Hee University) ;
  • Choi Do-Young (Dept. of Acupuncture & Moxibustion Oriental Medical College, Kyung Hee University) ;
  • Ahn Byoung-Choul (Dept. of Acupuncture & Moxibustion Oriental Medical College, Kyung Hee University) ;
  • Park Dong-Seok (Dept. of Acupuncture & Moxibustion Oriental Medical College, Kyung Hee University) ;
  • Lee Yun-Ho (Dept. of Acupuncture & Moxibustion Oriental Medical College, Kyung Hee University) ;
  • Choi Yong-Tae (Dept. of Acupuncture & Moxibustion Oriental Medical College, Kyung Hee University)
  • 발행 : 1998.12.30
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초록

This study was done in order to present clinical trial method for safety of herb-acupuncture. The results were summerized as follow: In case of western medicine, clinical trial divides into four phase 1. Phase I: Investigate safety and drug movement for health people. 2. The first phase II: Investigate safety, effectiveness for the limited patient. The late phase II: Investigate propriety of an applicable disease, the way to use and dose. 3. Phase III: Through the comparative, public trial, investigate a final, applicable disease and side effect. 4. Phase IV: After NDA, investigate safety and effectiveness for the wide patients. In case of herb-acupuncture, we have to investigate the following for safety and effectiveness 1. Drug dose: Decide with 1/2 or 1/3 of oral dosage or a basis of animal's of maximum dosage or a ratio of man and animal. 2. Toxicity: Examine blood, urine, liver function, EKG, after herb-acupuncture during acertain period of time. 3. Regional response: Estimate response of swelling, redness, pruritus. etc 4. Treatment effectiveness: After exactly diagnosis, estimate effectiveness with a objective guide post.

키워드

참고문헌

  1. 신약평가를 위한 임상실험과 자료분석 고응린
  2. 대한의학협회지 v.37 no.2 신약개발과 임상약리학 장인진
  3. 대한의학협회지 v.37 no.2 임상약리학의 해외동향 노형근
  4. 대한화학요법학회지 v.12 no.1 신약 임상시험의 과정 및 관련지침 신상구
  5. 의약품임상시험관리기준(GCP) 보건복지부
  6. 국립보건안전연구원보 v.4 국내 임상시험을 위한 가이드라인에 관한 고찰 김성윤(외10인)
  7. 국내에서 승인된 임상시험계획서의 과학적 타당성에 관한 고찰 허순임
  8. 임상시험연구를 위한 통계적 방법 박미라;이재원
  9. 의약품 임상시험 관리기준 도입방법 연구 이의경
  10. 약침제제와 임상응용 대한약침학회
  11. 외국의 한약제형에 관한 조사 자료집 대한약침학회