초록 ▼

○ 총 1105명을 대상으로 갑상선 기능저하 평가 설문지, 갑상선 내분비 검사 및 한방검사 등을 통해 134명의 불현성 갑상선 기능저하증 환자를 1차 선별하고, 연구참여에 동의한 최종 60명을 블록 무작위배정법에 의해 보중익기탕군에 30명, 위약 대조군에 30명을 배정하여 1일 3회 8주간 임상시험약을 복용하면서 효능평가 및 안전성 평가를 시행함.
○ 보중익기탕이 임상증상 개선에 미치는 영향을 분석한 결과 보중익기탕 투여는 식욕저하 항목에서 대조군에 비해 유의한 개선 효과를 나타내었으며, 사상체질별 보중익기탕의 임상적 유효성

○ 총 1105명을 대상으로 갑상선 기능저하 평가 설문지, 갑상선 내분비 검사 및 한방검사 등을 통해 134명의 불현성 갑상선 기능저하증 환자를 1차 선별하고, 연구참여에 동의한 최종 60명을 블록 무작위배정법에 의해 보중익기탕군에 30명, 위약 대조군에 30명을 배정하여 1일 3회 8주간 임상시험약을 복용하면서 효능평가 및 안전성 평가를 시행함.
○ 보중익기탕이 임상증상 개선에 미치는 영향을 분석한 결과 보중익기탕 투여는 식욕저하 항목에서 대조군에 비해 유의한 개선 효과를 나타내었으며, 사상체질별 보중익기탕의 임상적 유효성 평가에서 사상체질중 소양인에서 TSH 수치의 유의한 개선효과를 보였으며, 임상증상 평가에서는 한불내성 항목에서 유의한 개선효과를 보였음.
○ 따라서 보중익기탕은 불현선 갑상선 기능저하증 환자의 임상증상 개선에 효과적이었으며, 특히 소양인에서는 임상증상 개선 뿐만 아니라 불현성 갑상선 기능저하증의 치료효능 판정에 가장 민감한 검사항목인 TSH에서의 개선효과를 나타내어 한의학적 체질감별을 바탕으로 보중익기탕을 투여하는 것이 임상증상과 갑상선 호르몬 개선에 모두 효과적임을 밝혀냄.

Abstract ▼

I. Purpose and necessity
○ Subclinical hypothyroidism is defined as serum TSH level above the upper limit of normal despite normal levels of FT4. General clinical course of Subclinical hypothyroidism is that 2% to 5% per year will progress to overt hypothyroidism, therefore it has been recognized

I. Purpose and necessity
○ Subclinical hypothyroidism is defined as serum TSH level above the upper limit of normal despite normal levels of FT4. General clinical course of Subclinical hypothyroidism is that 2% to 5% per year will progress to overt hypothyroidism, therefore it has been recognized as pre-stage of overt hypothyroidism. Howerer, there has been no therapy and guideline for subclinical hypothyroidism, because subclinical hypothyroidism patients complain less symptoms than overt hypothyroidism patients.
○ BojungIkqitang has been applied to treat fatigue such as chronic fatigue syndrome, and hypothyroidisim. Therefore, we hypothesize that BojungIkqitang could improve a fatigue caused by subclinical hypothyroidism, and we performed the randomized placebo controlled clinical trial to evaulate the clinical efficacy and safety of BojungIkqitang on subclinical hypothyroidism patients.
II. Content and scope of developmental research
○ Study Design of this clinical trial is a Double-blind, Placebo-controlled, Randomized controlled trial, and a total of 1105 subjects were screened at Kyung Hee University Medical Center. Subclinical hypothyroidism was defined as >4.5 uU/ml TSH levels with normal T3 (80-200 ng/dl) and FT4 (0.77-1.94 ng/dl).
○ Ultimately, 60 participants among 134 subclinical hypothyroidism patients were enrolled and completed physical examinations, blood sample measurements, Determination of Sasang constitution and Ryodoraku testing. Total 60 participants were rendomized to BojungIkqitang group (n=30) and placebo control group (n=30), and taken BojungIkqitang or placebo for 8 weeks.
III. Results
○ In order to confirm the quality of study drug, we analyzed the ginsenoside Rb1, Rg1 in Ginseng Radix, and Hesperidin in Aurantii Nobilis Pericarpium as the index components using high performance liquid chromatography (HPLC) method.
○ First, we analyzed the clinical characteristics between subclinical hypothyroidism patients and ormal healthy controls. The Incident rate of subclinical hypothyroidismis 12.12 % and it was 2.54 fold higher in women.
○ The mean levels of free thyroxine (FT4), glucose, red blood cells (RBC), and hematocrit in the subclinical hypothyroidism group were significantly lower than those in the healthy controls. The mean FT4 level of subclinical hypothyroidism patients was significantly lower than in Soeum-in controls (p=0.0423). The total RS was significantly higher in Taeum-in subclinical hypothyroidism and lower in Soeum-in subclinical hypothyroidism compared to controls.
○ In the thyroidal function test, TSH and Thyroid autoantibody was decreased by BojungIkqitang, and in the clinical symptom measured by VAS scale, indigestion was improved, although there were no significance.
○ We also analyzed the efficacy of Bojungikki-tang according to sasang constitution. The TSH levels of Taeumin (greater yin) in BojungIkqitang group was different from placebo control group, and the TSH levels of Soyangin (smaller yang) and indigestion were significantly improved by BojungIkqitang.
○ Finally, we access the clinical safety of BojungIkqitang. In the Liver function test (LFT), and Renal function test, there were no significant change in both group. And, subjects complained the mild adverse events such as eyeball pain, and Hot flush, but there were no severe events in both groups.
IV. Application
○ This clinical trial is a first study with herbal medicine in the subclinical hypothyroidism patients, and we confirmed that BojungIkqitang have the potential to serve as alternative and complementary therapeutic method for subclinical hypothyroidism, which could suggest new therapy for subclinical hypothyroidism and would be enhance Korean traditional medicine's competitiveness.
○ The study drug, BojungIkqitang, is a current sale drug and an one of most frequent prescribed herbal medicine, therefore it immediately could be applied to clinical treatment.

목차 Contents

• 1. 겉표지 (앞면) ... 1
• 1. 겉표지 (측면, 뒷면) ... 2
• 2. 제출문 ... 3
• 3. 보고서 요약서 ... 4
• 4. 요약문 (한글) ... 5
• 5. 요약문 (영문) ... 7
• 6. 연구 성과 실적 및 향후 계획 ... 9
• 7. 참여연구원 현황표 ... 15
• Ⅱ.총괄연구과제 연구결과 ... 16
• 1. 연구개발과제의 배경 및 필요성 ... 17
• 2. 국내외 기술개발 현황 ... 18
• 3. 연구개발과제의 추진체계 ... 21
• 4. 연구개발수행 내용 및 결과 ... 23
• 5. 목표달성도 및 관련분야 기여도 ... 40
• 6. 향후 연구성과 추진 계획(※해당되는 경우만 작성) ... 41
• 7. 연구개발결과의 파급효과 ... 41
• 8. 연구개발결과의 활용계획 ... 43
• 9. 연구개발과정에서 수집한 해외과학기술정보 ... 43
• 10. 참고문헌 ... 44
• Ⅲ. 첨부서류 ... 46
• 1. 자체평가의견서 ... 48
• 2. 실적 증빙자료 ... 51