• 대한한의학회지
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• 제26권2호
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• pp.95-104
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• 2005

Objectives: This was a double blinded, randomized, placebo-controlled clinical study for evaluation of safety and effective dose finding of Cardiotonic Pills$^{(R)}$ in patients with chest pain and discomfort. Cardiotonic Pills$^{(R)}$ are composed of Salviae Miltiorrhizae Radix (丹蔘), Notoginseng Radix (三七根) and Borneolum (龍腦). Major effects of Salviae Miltiorrhizae Radix and Notoginseng Radix are vasodilatation, sedation and analgesic action. Borneolum has an antibacterial effect, and can stimulate the central nervous system. All of these substances are oriental herbs that have been used for a long time in east Asia. Cardiotonic Pills fi received Investigational New Drug (IND) approval from the Food and Drug Administration (FDA) in the USA and 40 million people in the world take this pill. We performed a phase IV clinical study to confirm its efficacy and safety in patients who have probable cardiogenic or psychogenic chest pain or chest stifling. Methods: This study was planned for a multi-center clinical trial including four university hospitals of oriental medicine in Korea. This was the first time to evaluate the 'planning treatment according to diagnosis (辨證施治)' of chest pain or chest discomfort according to oriental medical guidelines. The patients who were included in this trial were adult volunteers from 20 to 70 years old who had chest pain or chest discomfort more than twice during a recent month, and we received written consent to participate in this study from all of them. After administration of Cardiotonic Pills$^{(R)}$ for 8 weeks, number of occurrences, duration, appearance and degree of chest pain or chest discomfort was observed and degree of symptoms (severity of illness, global improvement) were measured using a patient's global assessment composite scale. Results: In the patient's global assessment scale, the severity of illness of the Cardiotonic Pills$^{(R)}$ group (n=25) was 14/25=0.56 but of the placebo group (n=25) was 7/25=0.28 (p-value=0.0449). This result indicates Cardiotonic Pills$^{(R)}$have a positive effect on the symptoms of chest pain and discomfort. However, the global improvement of the Cardiotonic Pills$^{(R)}$group was 23/25=0.92, and of the placebo group was 22/25=0.88 (p-value=0.6374). The total symptom score of the Cardiotonic Pills$^{(R)}$ group was $1.68\pm20.06$, and of the placebo group was $16.76\pm72.l4$(p-value=0.2285). The number of symptom events of the Cardiotonic Pills$^{(R)}$ group was $72\pm29.78$, and of the placebo group (n=25) was $10.80\pm38.42$ (p­value=0.3660). We could not find any effects on the other factors examined besides the severity of illness, beyond the difference of standard deviations. Conclusions: Cardiotonic Pills$^{(R)}$ significantly reduced chest pain and chest discomfort in patients. Therefore, we expect that Cardiotonic Pills$^{(R)}$ will be helpful for patients with chest pain and chest discomfort not only caused by heart disease but also by other diseases.

• 대한본초학회지
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• 제27권2호
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• pp.1-16
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• 2012

Objective : To investigate the current status of prescription drugs in Oriental medical institutes and to draw up a future plan for the revitalization of Oriental medical health insurance, this survey has been performed. Method : The survey has been made with 321 doctors working at Oriental medical institutes in Daegu and Kyungbuk areas for a period of 3 month from June 1, 2010 until September 1, 2010. Result : 1. When it comes to the current status of the use of herbal drugs in Oriental Health insurance, most of doctors surveyed prescribe insurance drugs, and they prescribe insurance drugs to patients, who are less than 20% of total patients visiting their clinics. 2. The awareness of Herbal Health Care Drugs is investigated. When it comes to the understanding of the difference between insurance drugs(powder type drugs) and granular type drugs, doctors admit that they differ only in one aspect, whether or not their being covered by health insurance. Based on the survey results on the understanding of insurance coverage of granular type drugs, doctors, even though they long for granular type drugs to be accepted as insurance drugs, are worrying whether the number of outpatients might dwindle due to increased insurance co-payments. They also point out that the biggest obstacles in the expansion of the granular type drugs as insurance drugs are the lack of understanding of the government and the objection of the Health Insurance Review and Assesment service (HIRA) for fear of increased insurance claims. 3. Upon investigation on Oriental medicine doctors' understandings of herbal pharmaceutical industry, it is found that doctors' responses on pharmaceutical industry are not all positive ones('new product development and neglect of R&D infrastructure' and 'smallness of industry'). When it is investigated what area needs the greatest improvement in herbal pharmaceutical industry, 'securing sufficient capital, good manufacturing, and strengthening quality control', is the highest. 4. When it is asked what are the most needed in order to improve herbal health insurance medicine, responses such as 'the increase in the accessibility to and the utilization of Oriental medical clinics through the diversification of the means of prescriptions', 'the improvement of insurance benefits(cap adjustments)', 'increase the proportion of high quality medicinal plants', 'the ceiling of co-payments(deductible) at 20,000 won or more', 'expansion of the choices of formulations', 'formulational expansions of tablets and pills', and finally 'admittance and expansion of granular type drug as insurance drug' are the highest. 5. Upon investigating the general characteristics of the current status of the usage of Oriental health care herbal drugs, the followings are observed. First, the frequency of use of health insurance drugs by the doctors who use health insurance with general characteristics shows similar differences in case of total monthly sales amount (p<0.001), average number of daily patients (p<0.05). Secondly, as to the willingness of the expanded usage of insurance drugs, similar differences are observed in case of total monthly sales amount (p<0.05). 6. Upon investigating the general characteristics of the perception of Herbal health care drugs, the followings are observed. First, inspecting general characteristics and insurance claims due to increased co-payments(deductible amount) reveals similar differences in case of working period (p<0.01) and in case of total monthly sales amount (p <0.01). Secondly, inspecting general characteristics and the obstacles that hinder granular type drugs from being accepted as health care insurance drugs shows similar differences in case of working period (p<0.05). 7. Upon investigating the general characteristics of the understanding of Oriental Herbal pharmaceutical companies, the followings are observed. First, opinions on the general characteristics of pharmaceutical companies, when examined with variance analysis, shows similar differences in case of total monthly sales amount (p<0.05). Secondly, when opinions are examined on general characteristics and the problems of herbal pharmaceutical companies, similar differences are found in case of working period (p<0.01) and in case of total monthly sales amount (p<0.001). Lastly, opinions on the general characteristics and reforms of pharmaceutical companies, similar differences are observed in case of working period (p<0.001). 8. Upon investigating the general characteristics of the improvement of insurance Herbal drugs, the followings are observed. First, regarding general characteristics and insurance benefits, similar differences are observed in case of working period (p<0.05), in case of total monthly sales amount (p<0.05), and in case of average number of daily patients (p<0.01). Secondly, opinions on the general characteristics and the needs for the improvement of Herbal insurance drugs are examined in 5 different aspects, which are the approval of granular type drugs as insurance drugs, the expanded practices of the number of prescription insurance drugs, the needs of a variety of formulations, the needs of TFT of which numbers of Oriental medical doctors are members for the revision of the existing system, and the needs of adjusting the current ceiling of the fixed amount and the fixed rate. When processed by the analysis of variance, the results show similar differences in case of average number of daily patients (p<0.01). Conclusion : From the results of this study the first measures to take are, to reform overall insurance benefit system, including insurance co-payment system(fixed rate cap adjustment), to expand the number of the herbal drugs to be prescribed matching with insurance benefit accordingly, and to revitalize herbal medicine insurance system through the change of various formulations. In addition, it is recommended to improve the effectiveness of herbal medicine by making plans to enhance the efficacy of herbal medicine and by enabling small pharmaceutical companies to outgrow themselves.

• 의료법학
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• 제21권2호
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• pp.209-244
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• 2020

TMS와 tDCS는 자기와 전류를 통하여 뇌에 자극을 가함으로서 환자나 개별 이용자의 질병을 치료하고, 이외에도 건강을 관리하거나 증진시킬 수 있는 비침습적 기기를 말한다. 이들 기기의 효과와 안전성은 몇몇 질병에서 입증되고 있으나, 아직도 이에 대한 연구는 진행 중이다. 점차 증가하고 있는 이들 기기의 활용도에 비해 TMS와 tDCS를 직접 규율하는 입법례를 찾기는 어렵다. 미국, 독일, 일본의 TMS와 tDCS에 대한 법적 규율을 살펴보면, TMS는 중등도의 위해도를 가진 의료기기로 승인되어 있는 반면, tDCS는 아직 의료기기로 승인된 상태는 아니다. 하지만, 최근 FDA 가이드집이나 유럽 MDR 규정의 변화, 미국의 리콜사례, 독일과 일본의 관련 법 규정, 전문가 그룹의 제언 등을 검토하면, tDCS도 조만간 의료기기로 승인되어 규율될 것으로 보인다. 물론, tDCS를 의료기기가 아닌 일반제품으로 보더라도 다른 법률과 제도를 통하여 제품의 안전성과 효과를 규제할 수는 있다. 그러나 이 기기가 인간의 뇌에 미칠 수 있는 여러 영향을 고려할 때, 이를 독자적으로 규율할 필요성이 크다. 우리도 TMS와 tDCS를 규율하는 명시적 법률은 없으나, 이 두 기기는 식약처 고시에 따라 3등급 의료기기로 판정된다. 그리고 TMS는 가이드 라인에 따라 미국 FDA 지침에 의해 안전성과 성능을 평가하도록 하고 있다. 하지만, tDCS는 아직 이에 대한 구체적 지침은 존재하지 않는다. tDCS 기기가 일부 병원에서, 그리고 개별 구매자를 통하여 가정에서 사용되고 있는 현실을 고려하면, 이러한 규제의 공백은 신속히 보완되어야 한다. 장기적으로는 비침습적 뇌자극기기를 독자적으로 규율할 수 있는 법적 시스템의 정비가 필요하다.

• 한국방사선학회논문지
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• 제17권6호
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• pp.881-887
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• 2023

본 연구는 한국에서 상용화된 인공지능(AI) 기반 의료 영상 장치의 발전과 현재 동향을 분석하는 것을 목표로 한다. 2023년 9월 30일 기준으로 한국 식품의약품안전처에 허가, 인증 및 신고된 AI 기반 의료기기는 총 186개로, 이 중 138개가 영상의학과와 관련된 제품이었다. 본 연구는 2018년부터 2023년까지의 연도별 허가 추세, 장비 유형, 적용 부위, 주요 기능 등을 종합적으로 고찰하였다. 연구 결과, AI 의료기기는 2018년 4개 제품에서 시작하여 2023년까지 꾸준한 성장세를 보였으며, 특히 2020년 이후 급격한 증가세를 나타내었다. 이는 AI 기술의 발전과 의료분야의 수요 증가가 상호 작용한 결과로 볼 수 있다. 장비별로는 CT, X-ray, MR 순으로 AI 의료기기가 개발되었으며, 이는 각 장비별 이미지의 특성과 임상적 중요성을 반영한다. 본 연구에서는 흉부, 뇌신경, 근골격계 등 특정 부위에 대한 AI 의료기기 개발이 활발한 것을 확인하였고, 주요 기능별로는 의료영상 분석, 탐지 및 진단 보조, 영상 전송 등이 주를 이루었다. 이러한 결과는 AI의 패턴 인식 및 데이터 분석 능력이 의료영상 분야에서 중요한 역할을 하고 있음을 시사한다. 또한, 본 연구는 한국 제품이 국제적인 인증, 특히 미국 FDA와 유럽 CE 인증을 받은 사례를 조사하였다. 그 결과, 다수의 제품이 두 기관의 인증을 받았으며, 이는 한국의 AI 의료기기가 국제적 수준에 부합하며, 글로벌 시장에서의 경쟁력을 갖추고 있음을 보여준다. 본 연구는 AI 기술이 의료영상 분야에서 미치는 영향과 그 발전 가능성을 분석함으로써, 향후 연구 및 개발 방향에 중요한 시사점을 제공한다. 하지만, 규제 측면, 데이터의 질과 접근성, 임상적 유효성 등의 도전 과제도 지적되어, 이러한 문제들에 대한 지속적인 연구와 개선이 요구된다.