• 제목/요약/키워드: The medicine approval

검색결과 217건 처리시간 0.023초

말 태반 가수분해 추출물의 Sprague-Dawley Rat를 이용한 단회 경구투여 독성시험 (Study on a Single Oral Dose Toxicity Test of Horse Placenta Hydrolysate Extract in Sprague-Dawley Rats)

  • 여인호;김이화;이은용
    • Journal of Acupuncture Research
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    • 제31권1호
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    • pp.105-110
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    • 2014
  • Objectives : The objective of this study is to analyze the single-dose toxicity of horse placenta hydrolysate extracts. Methods : Sprague-Dawley rats were chosen for the study. Doses of horse placenta hydrolysate extracts, 2,000 mg/kg, 1,000 mg/kg and 500 mg/kg, were administered to the experimental group, and the same doses of normal saline solution were administered to the control group. This study was conducted under the approval of the Institutional Animal Ethics Committee. Results : In all 4 groups, no deaths occurred, and the horse placenta hydrolysate extracts administered by oral was over 2,000 mg/kg. No significant changes in the weight between the control group and the experimental group were observed. To check for abnormalities in organs and tissues, we used microscopy to examine representative histological sections of each specified organ, the results showed no significant differences in any organs or tissues. Conclusions : The above findings suggest that treatment with horse placenta hydrolysate extracts is relatively safe. Further studies on this subject should be conducted to yield more concrete evidence.

Sa-am Five-element Acupuncture and Hwangyeon-haedoktang Pharmacopuncture Treatment for an Essential Tremor: Three Case Reports

  • Jeong, Jong-Jin;Sun, Seung-Ho
    • 대한약침학회지
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    • 제16권4호
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    • pp.49-53
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    • 2013
  • The purpose of this study was to report the effect of a combination of Sa-am five-element acupuncture and eight-principle pharmacopuncture (EPP) for the treatment of an essential tremor (ET). This study reviewed the medical records treated at OO Korean medical hospital for ET by using diverse types of acupuncture without herbal medicine, other types of physical therapy, and western medication related ET or Parkinson's disease and was performed after the approval of the institutional review board (IRB). The three cases that were finally selected were then extracted and reviewed. The three cases that were finally selected involved three women in their 70s to 80s. The evaluation of the progress was made by using the numeric rating scale. A combined treatment, the method of liver excess (肝乘格), from among Sa-am five-element acupuncture, and Hwangyeonhaedoktang EPP at CV23 and CV17, was applied to all cases. In all three cases, the ET was improved, and recurred ETs improved with the same treatment. The results suggest that the combined treatment of Sa-am five-element acupuncture and Hwangyeon-haedoktang EPP may be effective for treating an ET, even though this conclusion is based on only three cases.

한약제제 허가기준 개선방안 연구(I) (A Study on Amendment of Approval Specifications for Traditional Korean Medicines)

  • 한병현;황귀서
    • 대한예방한의학회지
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    • 제5권1호
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    • pp.57-75
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    • 2001
  • This study was conducted to improve the current regulation guidelines for developing traditional Korean medicines with effectiveness and productivity, in order to cope with the upcoming ICH on specifications on oriental herbal drugs. Also, major purposes of this study are to motivate R&D and to pioneer foreign markets for domestic herbal drug companies. First, after examining concepts of traditional Korean medicines and comparing the numbers and differentiation of herbal drugs registered on Pharmacopeia among Korea, China, and Japan, the current new drug development requirements for traditional Korean medicines were reviewed in detail, followed by comparison of foreign regulation systems including USA, EU, China, and Japan. Second, empirical cases on failure of development for new traditional Korean medicines under the current regulation system in the domestic companies including Dong-A, Kwangdong, and Samchondang, were collected and analyzed. As a result, hanbangsaengyak, the new category for traditional Korean medicines was newly developed on the basis of scientification of data between saengyak and hanyak, from the perspectives of harmonization between oriental medicine and western medicine and of balance between food and drug, in terms of industrialization, publicity, modernization, and effectiveness of administration. In addition, the new regulation requirements for the new hanbangsaengyak preparations were discussed by establishing principles of reinforcing preclinical test and of simplifying clinical trials in Korea. Finally, the further researches to articulate the complete specifications for pre-clinical and clinical requirements for traditional Korean medicines were strongly suggested.

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갱년기 여성의 안면홍조에 대한 침치료 다기관 임상시험 : 프로토콜 (The effect of acupuncture on hot flushes : A study protocol of multi-center randomized controlled clinical trial)

  • 박지은;오달석;강경원;김동일;최선미
    • Korean Journal of Acupuncture
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    • 제24권3호
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    • pp.33-45
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    • 2007
  • Background : Hot flushes are general postmenopausal symptoms which about 75% of climacteric women undergo. They affect hotness, perspirations, systemic weakness, panic disorders, insomnia. Acupuncture is effective in alleviating hot flushes in practice. Assessment effectiveness and safety of acupuncture in hot flushes would be needed through multi-center trial. Objectives : Purpose of this study is to develope the protocol of effects of acupuncture on hot flushes, a postmenopausal symptom in climacteric women. Methods & Results : It will be a multi-centered, randomized, sham controlled, comparative trial. It will be performed by Good Clinical Practice after approval of Institutional Review Board. Selection criteria will be set according those of FDA above moderate degree. There will be a notice on concomitant medication, other herbs, dietary supplements. Superficial needling on sham points will be used for control group. Treatment period will be 8 weeks with 12 weeks' follow up. Some questionnaire scale will be used as the primary and secondary outcome. Conclusions : The clinical trials based on this protocol will be performed.

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The Necessity of Education in Response to Technological Advancements and Future Environmental Changes: A Comparison of Korean Medicine Doctors and Students

  • Yu Seong Park;Kyeong Heon Lee;Hye In Jeong;Kyeong Han Kim
    • 대한한의학회지
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    • 제44권4호
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    • pp.72-86
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    • 2023
  • Objectives: The medical field is rapidly evolving with AI and digital technologies like AI-based X-ray analysis and digital therapeutics gaining approval. Telemedicine is becoming prominent, and medical schools are adapting by integrating AI education. Pusan National University leads a talent training project for AI in health. Korean Medicine is incorporating AI with diagnostic systems and chatbots. However, there's a lack of research on education awareness in Korean Medicine Colleges. The study aims to assess opinions on integrating AI, digital therapeutics, and DNA test into the Korean medicine college curriculum for improved education. Methods: We selected appropriate four specific areas: artificial intelligence in medicine, digital therapeutics, DNA test, and telemedicine. The questionnaire developed for this study underwent expert evaluation and was subsequently administered to registered KMDs of the Association of Korean Medicine, as well as students from 12 Korean Medicine universities. The survey was designed to analyze the awareness and perceived importance of the 4 areas. Results: Both KMDs and Korean medicine students exhibited comparable awareness levels across the four objectives. Notably, both groups identified a high educational necessity and importance of artificial intelligence in medicine for clinical settings. Statistically significant differences were observed between KMDs and students in their perspectives on the importance of telemedicine and DNA test in the Korean medicine field, the educational necessity of DNA test within Korean medicine universities, and the need for comprehension of regulations related to digital therapeutics. Conclusion: The survey of Korean medicine professionals and students underscores a strong understanding of key areas such as Telemedicine, medical AI, DNA test, and digital therapeutics. Medical AI is identified as crucial for future education. There's a consensus on the need for curriculum changes in Korean medicine schools, particularly in adapting to evolving healthcare trends. The focus should be on practical clinical application, with a call for additional research to better integrate student and practitioner perspectives in future curriculum reform discussions.

E10의 경항부 근육통 완화에 대한 효과; 전-후 비교, 예비 임상 연구 (Effect of E10 on Relief of Cervical Myalgia; One Group Pre-Post, Pilot Trial Study)

  • 정동훈;김혜정;김정섭;이귀선;박원형;차윤엽
    • 한방재활의학과학회지
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    • 제26권3호
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    • pp.119-128
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    • 2016
  • Objectives The purpose of this study is to investigate the efficacy of E10 on the relief of cervical myalgia. Methods This study is a one group pre-post, pilot trial test. After the approval of institutional review board (IRB), we have recruited 25 patients suffering from cervical myalgia. 23 patients (2 patients dropped out) was treated by using E10 on the cervical muscle and acupuncture points, three times a week for a total of two weeks from February 2016 to April 2016. Evaluations of VAS for bothersomeness of neck pain (VASB), VAS for pain intensity (VASP), NDI, SF-36, X-ray, thermography, etc. before and 1 week after treatment were carried out. The primary outcome measure was the VASB, measured 1 week after the end of the therapy. Results VASB scores was significantly decreased from $72.5{\pm}9.9$ to $50.4{\pm}9.9$. VASP scores was significantly decreased from $71.5{\pm}10.5$ to $48.5{\pm}18.3$. Results showed significant improvements in VASB, VASP, NDI, SF-36 from the baseline. However, in X-ray, thermography, there was no singnificant difference. Conclusions This study demonstrates the effectiveness of E10 treatment for relieving cervical myalgia.

최근 10년간 교통사고 환자의 추나치료에 대한 국내 연구 동향 (Trends of Chuna Manual Therapy on Traffic Accident in Korea from 2005 to 2014)

  • 전용태;박상훈;한국인;이정한;고연석
    • 한방재활의학과학회지
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    • 제25권2호
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    • pp.89-96
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    • 2015
  • Objectives This study is to investigate domestic trends of chuna manual therapy on traffic accident for recent 10 years. Methods We searched the studies on chuna manual therapy for traffic accident in 6 Korean web databases. Consequently, 17 research papers were founded. We analyzed these papers according to their published year, the titles of journal, the type of study, the number of cases, the sites of injury, assessment scales of study, and ethics of research. Results 17 papers were published since 2005. The studies on chuna manual therapy about traffic accident were mainly published in the journal of korean society of chuna manual medicine for spine & nerves and the journal of korean medicine rehabilitation. All papers were clinical research include 2 case series, 2 non randomized controlled trials (NRCTs), 13 randomized controlled trials (RCTs). The most frequently occured symptom was neck pain. In assessment scales, visual analog scale (VAS) was mainly used. All clinical studies were not mentioned about approval of institutional review board (IRB). Conclusions In this study, we analyzed the trends of chuna manual therapy on traffic accident in Korea from 2005 to 2014. In reviewing published papers, we found several weak points in methods of research and quality of study protocol. It is needed to adjust these problems for development of future researches.

응급처치 교육 강사 자격요건에 대한 학교보건법 개정 방향에 관한 연구 (A study on revised direction of the school health act for first aid instructor qualification)

  • 김지원;강민성
    • 한국응급구조학회지
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    • 제24권2호
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    • pp.155-162
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    • 2020
  • Purpose: The aim of this study was to suggest the qualification criteria for the instructors of first aid education for teachers in the School Health Act. Methods: We compared and analyzed the approval provisions for qualifying as first aid educators under the School Health Act, the Emergency Medical Services Act, and prior studies of first aid education. Results: The comparison of the studies demonstrated some key points. First, the first aid education of teachers could be improved through the knowledge of professional instructors. Second, the doctors, emergency nurse practitioners, and emergency medical technicians (EMT) were suitable as specialized first aid instructors. Third, for qualifying as first aid instructor, only the EMTs required more than five years of career. Conclusion: We suggest that all emergency medical service providers qualify to become first aid educators. Additionally, the requirement of EMTs to have more than 5 years of career to qualify as an instructor should be eliminated.

Single-dose Intramuscular Toxicity of Neutral Natured Blood Stasis Pharmacopuncture in Sprague-Dawley Rats

  • Yeo, In Ho;Lee, Eun Yong
    • 대한약침학회지
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    • 제17권2호
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    • pp.41-45
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    • 2014
  • Objectives: This study was performed to analyze the single-dose toxicity of neutral natured blood stasis pharmacopuncture extracts. Methods: All experiments were conducted at Biotoxtech, an institution authorized to perform non-clinical studies, under the regulations of Good Laboratory Practice (GLP). Sprague-Dawley rats were chosen for the pilot study. Doses of neutral natured blood stasis pharmacopuncture extracts, 0.1, 0.5 and 1.0 mL, were administered to the experimental group, and the same doses of normal saline solution were administered to the control group. This study was conducted under the approval of the Institutional Animal Ethics Committee. Results: In all 4 groups, no deaths occurred, and the neutral natured blood stasis pharmacopuncture extracts administered by intramuscular (IM) injection was over 1.0 mL/animal. No significant changes in the body weights between the control group and the experimental group were observed. To check for abnormalities in organs and tissues, we used microscopy to examine representative histological sections of each specified organ; the results showed no significant differences in any organs or tissues. Conclusion: The above findings suggest that treatment with neutral natured blood stasis pharmacopuncture extracts is relatively safe. Further studies on this subject should be conducted to yield more concrete evidence.

Current development of therapeutic vaccines for the treatment of chronic infectious diseases

  • Pil-Gu Park;Munazza Fatima;Timothy An;Ye-Eun Moon;Seungkyun Woo;Hyewon Youn;Kee-Jong Hong
    • Clinical and Experimental Vaccine Research
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    • 제13권1호
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    • pp.21-27
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    • 2024
  • Chronic infectious diseases refer to diseases that require a long period of time from onset to cure or death, the use of therapeutic vaccines has recently emerged to eradicate diseases. Currently, clinical research is underway to develop therapeutic vaccines for chronic infectious diseases based on various vaccine formulations, and the recent success of the messenger RNA vaccine platform and efforts to apply it to therapeutic vaccines are having a positive impact on conquering chronic infectious diseases. However, since research on the development of therapeutic vaccines is still relatively lacking compared to prophylactic vaccines, there is a need to focus more on the development of therapeutic vaccines to overcome threats to human health caused by chronic infectious diseases. In order to accelerate the development of therapeutic vaccines for chronic infectious diseases in the future, it is necessary to establish a clear concept of therapeutic vaccines suitable for the characteristics of each chronic infectious disease, as well as standardize vaccine effectiveness evaluation methods, secure standards/reference materials, and simplify the vaccine approval procedure.