• 제목/요약/키워드: 한방제제

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감기 치료를 위한 한약제제 임상시험 가이드라인 개발 (Development of Clinical Trial Guidelines for Using Korean Herbal Medicine in Treatment of Common Cold)

  • 박지원;김관일
    • 대한예방한의학회지
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    • 제28권1호
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    • pp.131-157
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    • 2024
  • 목적 : 본 연구는 감기에 대한 한약제제 임상시험을 수행하고 평가하는 데 보편적인 원칙을 제공하는 가이드라인 개발과정 및 내용을 소개하여 가이드라인 활용성 및 접근성을 높이고자 한다. 방법 : 임상시험 가이드라인 개발을 위해 총 9인으로 이루어진 위원회를 구성하고, 전반적인 절차를 수립하였다. 먼저, 가이드라인 집필위원회에서 관련된 국내외 가이드라인을 고찰하고, 감기에 대한 최신 임상시험 논문을 분석하여 초안을 완성하였다. 이후 대한한방내과학회 소속 전문가 자문위원회 검토 및 8인의 전문가로 구성된 협의회 자문을 통해 최종 가이드라인을 도출하였다. 결과 : 본 가이드라인은 (1) 일반적 사항 (2) 유효성 평가 기준 (3) 유효성 평가 방법 (4) 시험 대상자 선정 (5) 임상시험 설계 (6) 안전성 평가 (7) 감기 치료에서의 병용요법 (8) 한의학적 고려 사항의 8가지 범주로 나뉘어진다. 최종 개발된 가이드라인은 한의약임상시험센터 협의회와 대한한방내과학회의 인증을 득하였다. 결론 : 본 가이드라인은 감기 치료를 위한 임상시험을 수행하고 평가하는 데 유용하게 사용될 것이며, 이를 통해 신뢰할 수 있는 결과를 이끌어내고 정확한 해석을 용이하게 할 수 있을 것이라 기대된다. 또한 추후 해당 가이드라인 개정 및 관련된 호흡기질환 가이드라인 개발 과정에 도움을 줄 수 있을 것으로 사료된다.

한방생약제품의 제제 유형에 따른 중금속 함량 연구(II)

  • 오성윤;안국원;부이티투하;박문기
    • 한국환경과학회:학술대회논문집
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    • 한국환경과학회 2007년도 춘계 학술발표회 발표논문집
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    • pp.577-579
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    • 2007
  • 탕액으로 제조된 생약제제 4개 제품의 중금속의 농도는 허용치보다 낮게 검출이 되었으며, 맥문동탕의 경우 As의 농도는 0.048ppm, Cd의 농도는 0.0001ppm, Pb의 농도는 0.002ppm, Hg의 농도는 0.003ppm으로 측정되었으며, 갈근탕의 경우 As의 농도는 0.05ppm, Cd의 농도는 0.0002ppm, Pb의 농도는 0.003ppm, Hg의 농도는 0.003ppm으로 측정되었고, 쌍화탕의 경우 As의 농도는 0.063ppm, Cd의 농도는 0.001ppm, Pb의 농도는 0.004ppm, Hg의 농도는 0.002ppm으로 측정되었으며 20전 대보탕의 경우 As의 농도는 0.049ppm, Cd의 농도는 0.001ppm, Pb의 농도는 0.0185ppm, Hg의 농도는 0.003ppm으로 측정되었다.

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합성의약품으로 호전되지 않은 소화기 증상 환자(KCD K-코드)에 대한 반하사심탕 제제 병용의 효과 : 후향적 차트 분석 (Effectiveness of Additional Administration of a Banha-sasim-tang Formulation to Patients with Gastrointestinal Symptoms (KCD K-code) Not Improved by Western Medicines: A Retrospective Chart Review)

  • 김철현;김광호;이영웅;강선이;강건희
    • 대한한방내과학회지
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    • 제42권6호
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    • pp.1349-1355
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    • 2021
  • Objectives: The aim of this study was to evaluate the effectiveness of additional administration of Banha-sasim-tang formulation to patients with gastrointestinal symptoms that did not improve with Western medicines. Methods: The patients who met the inclusion and exclusion criteria were analyzed retrospectively. A paired t-test was performed on the Nepean Dyspepsia Index-Korean version (NDI-K) scores before and after administering the Banha-sasim-tang formulation. Results: A total of 27 subjects were included. The mean duration of taking the Banha-sasim-tang formulation was 15.6±3.1 days. The most commonly used Western medicine before taking the Banha-sasim-tang formulation was rebamipide. The means of the NDI-K score were 57.4±21.8 before administering Banha-sasim-tang formulation and 34.9±16.5 after administration, and the difference was statistically significant (p<0.0001). No serious side effects were encountered while taking the Banha-sasim-tang formulation. Conclusions: For patients whose gastrointestinal symptoms do not improve with Western medicines, additional administration of Banha-sasim-tang formulation may be an option. However, as this study is a retrospective chart review, prospective, large-scale, double-blind studies are needed in the future.

퇴행성 슬관절염의 한약제제 치료에 대한 체계적 문헌고찰 (A Systematic Review of Herbal Medicine Treatment for Knee Osteoarthritis)

  • 김지훈;윤영석;이원준;고홍제;김선종
    • 한방재활의학과학회지
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    • 제29권4호
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    • pp.47-60
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    • 2019
  • Objectives This study reviewed recent clinical research trends regarding the effectiveness of herbal medicine treatments for knee osteoarthritis. Methods We reviewed 4 different online databases (PubMed, China National Knowledge Infrastructure [CNKI], National Digital Science Library [NDSL], Oriental Medicine Advanced Searching Integrated System [OASIS]) from January 1, 2015 to August 31, 2019. Results Thirty-two randomized controlled trial papers were selected in this review. Most of them were conducted during 12 weeks, used Western Ontario and Mcmaster Universities Arthritis Index. In 22 of the papers, the effectiveness in the intervention groups was significantly higher than that in the control groups statistically (p<0.05). 5 studies reported intervention group was not inferior to the control group. Conclusions Most of studies showed herbal medicine treatments were statistically effective to knee osteoarthritis. More scientific and systematic clinical studies should be actively conducted in the future, and the results of this study could be used as basic data in the future clinical studies on herbal medicine treatment for knee osteoarthritis.

폐암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰 (Analysis of Existing Guidelines and Randomized, Controlled, Clinical Trials for Development of [Guideline of Clinical Trial with Herbal Medicinal Product for Lung Cancer])

  • 한가진;조민지;박은주;성신;김성수;김관일;정희재;이범준;임정태
    • 대한한의학회지
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    • 제40권1호
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    • pp.153-173
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    • 2019
  • Objectives: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer" by analyzing the existing guidelines and clinical trials. Methods: The committee searched guidelines and clinical trials about herbal medicine for lung cancer. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of our analysis with the guidelines to identify the issues we will have to consider when making the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer". Several guidelines for anti-tumor agents and clinical trials with herbal medicine were searched on the national institution homepage. The search terms were as follows: 'lung neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional' etc. Results: There was no guideline for clinical trial with herbal medicine for lung cancer. In addition, 7 articles were searched through database searching. All the participants had non-small cell lung cancer. The type of intervention was decoction. Comparators included conventional treatments such as chemotherapy. The outcome measurements used in the studies were quality of life, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events and blood test. Conclusions: Findings were made by reviewing existing guidelines and comparing them with clinical trials for lung cancer and herbal medicinal products. These results will be utilized in the development of "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer".

Saikosaponin 유도체의 합성

  • 성충기
    • 한국응용약물학회:학술대회논문집
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    • 한국응용약물학회 1993년도 제2회 신약개발 연구발표회 초록집
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    • pp.125-125
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    • 1993
  • Saikosaponin은 한방에서 중요하게 사용되고 있는 시호의 항염증작용 성분으로서 주로 염증의 후기 단계에 작용하고 있다. 그러나 현재 시호는 생약자체로만 사용되고 성분이 약물로서 개발되지 못하고 있다. 그것은 Saikosaponin의 용해성이 극히 저조하여 제제화하기 힘든 때문이다. 연자는 시호 Saponin의 용해성을 증가시킬 목적으로 시호 Saponin의 하나인 saikosaponin-a를 Pyridine 중에서 succinic anhydride와 반응시켜 6"-hemisuccinyl saikosaponin-a를 얻고 이를 THF에 용해한 후 KOH와 반응시킨 후 다량의 THF를 추가하여 hemisuccinyl esler의 potassium염을 합성하였다. 이 화합물의 용해도를 원래의 Saponin과 비교시험하였다.

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양식자라분말의 가공조건에 따른 화학적 성분조성

  • 김영명;김영동;김은미;조진호
    • 한국어업기술학회:학술대회논문집
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    • 한국어업기술학회 2001년도 춘계 수산관련학회 공동학술대회발표요지집
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    • pp.180-181
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    • 2001
  • 자라는 일본, 대만, 중국 및 한국 등 극동아시아지역에서 주로 건강식품 소재로 소비되고 있으며 최대 소비국인 일본의 경우 전통적인 특수 보양식의 소재로 널리 이용되거나 oil, 혈액, 엑기스, 분말, 혼합제제 등 다양한 형태의 건강식품으로 가공ㆍ이용되고 있어 그 양식량도 급격히 증가하고 있다. 우리 나라는 90년대 소규모의 자라양식의 성공으로 양식산 자라의 생산량이 급증하는 추세이나 고부가가치 이용기술의 부재(不在)로 대부분 민간 한방요법 소재로 소량 활용되고 있을 뿐 본격적인 가공이용 및 수출도 기대하기 어려운 실정이다. (중략)

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한약제제의 골성장 효과에 대한 국내외 실험 연구 고찰 (A Literature Review of Experimental Study about Herbal Medicine for Bone Growth)

  • 김태정;김동연;양희원;최동건;권나연;이동녕;성현경
    • 대한한방소아과학회지
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    • 제35권3호
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    • pp.1-27
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    • 2021
  • Objectives The purpose of this study is to investigate the effect of herbal medicine on bone growth and growth factors by collecting and analyzing domestic and foreign experimental research papers to establish a platform for future research. Methods Experimental studies published before March 2021 were searched using 7 Korean databases and 2 foreign databases. Among the numbers of studies searched, 48 experimental studies met the criteria and were selected. The results of those 48 studies upon herbal medicine administration were analyzed by bone growth, growth plate, weight. Results 23 studies mainly used monotherapy of either Astragali Radix and Cervi Parvum Cornu. 28 studies used combination of Poria Sclerotium, Dioscoreae Rhizoma, and Acanthopanacis Cortex. Among all studies selected, weight, bone growth, Insulin-like growth factor-1 (IGF-1) and Growth hormone (GH) were increased, but the increase was significant only in some of the studies. Conclusions The result of this study can be utilized as a background information for further studies and treatment in pediatric growth. Further randomized control studies are needed to underscore the finding.

부신피질호르몬제제 치료를 받지 않은 돌발성 난청 환자 한방치험 2례 (Two Cases of Korean Medical Treatments of Sudden Sensorineural Hearing Loss without Corticosteroid Treatments)

  • 손재웅;김민희;고성규;최인화
    • 한방안이비인후피부과학회지
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    • 제29권1호
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    • pp.157-167
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    • 2016
  • Objective : The purpose of this study is to know the effect of Korean medical treatments on sudden sensorineural hearing loss(SSNHL) without systemic or intratympanic steroid treatments.Method : We conducted retrospective review who was diagnosed as SSNHL and treated with Korean medicine in Dept. of Otolaryngology Kyung Hee University Hospital at Gangdong. There were two patients with SSNHL who refused to be treated with western medicine and were treated with Korean medicine including acupuncture, moxibustion, and herbal medicine.Result : One patient recovered completely after eight days of admission, and another patient partial recovered during 30 days through Korean medical treatments.Conclusion : Through these studies, SSNHL is expected to treated more effectively by conventional Korean medical treatments than corticosteroid treatments alone. But the additional study is needed to reveal the exact effects of Korean medical treatments.