비허증 gut hormone profiling 모델구축과 비허증 치료처방의 효능평가기술 개발 = The Modeling of Gut Hormone Profiling of Spleen Qi Deficiency Pattern and the Development of Efficacy Evaluation Technique of Related Herbal Medicine

국문 초록 (Abstract)

<연구목표>
- 비기허증(脾氣虛證, U680000)의 한의학적 임상지표를 설명할 수 있는 gut hormone profiling 모델을 구축하고, 비기허증 치료 처방의 효능평가 기술을 구축함.
<연구내용>
- 비기허증의 병증진단과 중증도진단을 할 수 있는 비기허증 진단평가도구를 개발함.
- 비기허증의 임상지표를 설명할 수 있는 gut hormone profiling 모델을 구축함.
- 비기허증 대표 치료처방인 향사육군자탕이 비기허증 환자의 임상지표와 gut hormone profiling에 미치는 영향을 탐색함.
- 비기허증 치료처방의 효능평가기술을 확립함.
<연구결과>
- 문헌분석 및 전문가합의를 통한 비기허증 주요증후를 추출하고 중요도를 도출하여, <비기허증 진단평가도구>를 제작함.
- <비기허증 진단평가도구> 개발을 위한 임상연구를 실시하여, 신뢰도 및 타당도를 검증하고, 비기허증 진단을 위한 cutoff value를 확보함.
- 비기허증 gut hormone profiling 모델구축을 위한 임상연구를 실시하여, 정상인군과 다른 비기허증군의 특징적인 gut hormone 패턴을 탐색함.
- 비기허증 환자에 대한 향사육군자탕 투여 무작위배정, 위약대조, 이중맹검, 평행군 임상시험를 실시하여, <비기허증 진단평가 도구>의 진단 및 치료평가도구로서의 타당성을 검증하고, 비기허증 치료처방의 효능과 관련된 특징적인 gut hormone의 변화인 식사 전후 PYY의 감소를 탐색함.
<활용계획>
- [비기허증 진단평가도구(SQDQ)]와 gut hormone 평가방법 등을 관련 한약제제 효능평가를 위한 임상시험에 적용하여 활용함.
- 관련한 연구방법론을 다른 한의병증에 적용하여, 진단평가를 위한 도구개발과 평가기술개발에 적용함.
- 임상현장에서 평가도구를 활용하여, 환자 진단 및 치료효과 평가를 용이하게 하는데 적용함.

다국어 초록 (Multilingual Abstract)

<purpose>
-To construct gut hormone profiling model which could explain clinical factors of spleen qi deficiency syndrome and to establish efficacy evaluation techniques for treatment of spleen qi deficiency syndrome.
<contents>
-Development of a standard instrument of diagnosis and assessment for spleen qi deficiency syndrome and its severity
-Construction of gut hormone profiling model which could explain clinical factors of spleen qi deficiency syndrome
-Exploration of the effect of Hyangsayukgunja-tang (representative prescription of spleen qi deficiency syndrome) on the clinical factors and gut hormone profiling of patients with spleen qi deficiency syndrome.
-Suggestion of efficacy evaluation techniques for treatment of spleen qi deficiency syndrome.
<results>
-Standard instrument of diagnosis and assessment of spleen qi deficiency was completed after assessment of references and reflection of opinions by expert committee to select major symptoms of spleen qi deficiency syndrome.
-Performed clinical study to develop standard instrument of diagnosis and assessment of spleen qi deficiency and verified its reliability and validity and ensured optimum cut-off value.
-Performed clinical study to construct gut hormone profiling model, and explored distinguished gut hormone pattern in spleen qi deficiency syndrome group compared to healthy group.
-Performed clinical trial of the effect of Hyangsayukgunja-tang on patients with spleen qi deficiency syndrome; randomization, placebo-controlled, double-blind, parallel trial. As a result, we verified the validity of standard instrument of diagnosis and assessment of spleen qi deficiency and explored the pre-post prandial reduction of plasma PYY which is related to efficacy of treatment of spleen qi deficiency syndrome.
<expected contribution="">
-Foundation of clinical research for application of SQDQ and evaluation methods of gut hormone to evaluate efficacy of traditional medicine.
-Application of methods of study on another traditional Korean medicine so contribute to develop diagnosis and treatment evaluation tool.
-Application of standard instrument of diagnosis and assessment of spleen qi deficiency in clinics so make it easy to diagnose and evaluate the treatment efficacy.</expected></results></contents></purpose>