대한소화기학회지 (The Korean Journal of Gastroenterology)

  • 제72권4호
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  • Pages.170-178
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  • 2018
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  • 1598-9992(pISSN)
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  • 2233-6869(eISSN)
대한소화기학회 (The Korean Society of Gastroenterology)
권호 표지
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DOI QR Code

기능성 소화불량증 치료제의 임상시험 평가 가이드라인 권고안

Guideline Recommendation for Endpoints Used in Clinical Trials for Functional Dyspepsia

  • 이한희 (가톨릭대학교 의과대학 소화기내과학교실) ;
  • 정혜경 (이화여자대학교 의과대학 소화기내과학교실) ;
  • 최명규 (가톨릭대학교 의과대학 소화기내과학교실)
  • Lee, Han Hee (Division of Gastroenterology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea) ;
  • Jung, Hye-Kyung (Division of Gastroenterology, Department of Internal Medicine, Ewha Womans University School of Medicine) ;
  • Choi, Myung-Gyu (Division of Gastroenterology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea)
  • 투고 : 2018.09.03
  • 심사 : 2018.10.16
  • 발행 : 2018.10.31
⟨ 이전 논문 다음 논문 ⟩

초록

Functional dyspepsia is a disease, in which there is no organic lesion but chronic and repetitive postprandial fullness, early satiation, epigastric pain, and epigastric burning. Functional dyspepsia is not life-threatening but its symptoms are relapsing and remitting and persist over a lifetime, limiting the social life and reducing the quality of life. Therefore, the treatment for acute relapsing period may help improve the short-term symptoms. Continuous medication may be needed to improve the long-term symptoms. Research designs to demonstrate the short-term efficacy of therapeutic agents may differ from clinical trials to demonstrate long-term efficacy. There are many difficulties in clinical trial design, implementation, and screening because there are no international standards of clinical trials for functional dyspepsia. The purpose of this guideline recommendation is to develop a standard for clinical trials, such as clinical trial subjects and evaluation methods, in the development of therapeutic agents for functional dyspepsia. The ultimate aim is to enhance the safety and efficacy of therapeutic agents for functional dyspepsia and promote the development of new therapeutic agents.

키워드

참고문헌

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피인용 문헌

  1. Functional Dyspepsia vol.73, pp.2, 2018, https://doi.org/10.4166/kjg.2019.73.2.77
  2. The Efficacy and Safety of GCWB104 ( Flos Lonicera Extract) in Functional Dyspepsia: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study vol.14, pp.1, 2018, https://doi.org/10.5009/gnl19283