• Journal of Society of Preventive Korean Medicine
• /
• v.28 no.1
• /
• pp.31-42
• /
• 2024

Objective : In order to understand the changes in domestic approval regulations applicable to traditional Korean medical device companies, this article will explain the major amendments 「Regulation on Medical Device Approval Report Review, etc.」 from 2005 to the present on a year-by-year basis, and provide a counter plan to the recent changes in approval regulations. Methods : We analysed the changes in approval regulatory amendments related to the traditional Korean medical devices from 2005 to the present. Results : The Ministry of Food and Drug Safety is continuously improving medical device approval regulations to ensure the global competitiveness of domestic medical devices and contribute to the improvement of public health. Recent major approval regulatory amendments include the establishment of a review system for software medical devices and digital therapeutics, the recognition of real world evidence materials, the introduction of a biological evaluation of medical devices within a risk management process and a medical device approval licence renewal system. Conclusions : It is expected that the range of medical devices available to Korean medicine doctors will continue to expand in the future through the provision of non-face-to-face medical services and the development of advanced and new medical devices, as well as wearable medical devices and digital therapeutics. In order to increase the market entry potential of traditional Korean medical devices that incorporate advanced technologies such as digital technology and AI-based diagnosis and prediction technology, it is urgent that the government provide significant support to traditional Korean medical device companies to improve approval regulatory compliance.

• Korean Journal of Oriental Medicine
• /
• v.17 no.2
• /
• pp.107-113
• /
• 2011

Objectives : Sasang typology is extensively studied for the Sasang constitution diagnosis objectification with various data, for example, questionaires, reference materials, etc and analyzed with the several statistical methods. In this study, we used ROC-curve (Receiver Operating Characteristic curve) analysis to diagnose Sasang constitution, which is a kind of epidemiologic research methods and is away from traditional statistical methods. Methods : We collected personality questionnaire which consists of 15 items, from 24 oriental medical clinics. We analyzed the sensitivity and specificity using ROC curve method based on the score of personality questionnaire and also investigated classification accuracy and cut-off value of Sasang constitution. Results : The AUC (area under the ROC curve) value was 0.508 (p=.5511) for Taeeumin, 0.629 (p<.0001) for Soeumin and 0.604(p<.0001) for Soyangin, respectively. so the classification accuracy for Soeumin was highest Soeumin for over 30 points and Soyangin for below 28 points respectively. Conclusions : We suggest that Taeeumin is not classified easily in the ROC-curve analysis. We may classify Soeumin and Soyangin but the accuracy of Sasang constitutional diagnosis is still low.

• Journal of Haehwa Medicine
• /
• v.13 no.1
• /
• pp.311-320
• /
• 2004

In oriental medicine, Semen Persicae & Flos Carthami are frequently used materials for promoting blood circulation to remove blood stasis. Bang-Yak-Hap-Pyun(方藥合編) is widely used for clinical herbal prescription book. In Bang-Yak-Hap-Pyun(方藥合編), Semen Persicae is used 2g~6g. and Flos Carthami is used 1.2g~4g. the nuber of prescription Semen Persicae & Flos Carthami in Bang-Yak-Hap-Pyun is total 17. 2 in sang-tong(上統), 5 in jung-tong(中統), 10 in ha-tong(下統). The group of mostly used disease is about gynecology(婦人科) & five sense organs(五官科). The mostly quoted medical literature what prescription included Semen Persicae & Flos Carthami in Bang-Yak-Hap-Pyun is Dong-Yi-Bo-Gam.

• Proceedings of the Korean Society of Plant Biotechnology Conference
• /
• 2005.11a
• /
• pp.285-285
• /
• 2005

• Journal of Acupuncture Research
• /
• v.17 no.2
• /
• pp.153-168
• /
• 2000

Introduction : In spite of the use of Bee Venom aqua-acupuncture in the clinics, the scientific evaluation on effects is not enough. Bee Venom aqua-acupuncture is used according to the stimulation of acupuncture point and the chemical effects of Bee Venom. The aims of this study is to investigate the analgegic effects of the Bee Venom aqua-acupuncture, through the change of writhing reflex and the change of c-fos in secondary neurons in the spinal cord. Materials and Methods : Pain animal model was used acetic acid method. The changes of writhing reflex of the mice which were derived pain by injecting acetic acid into the abdomen, after stimulating Bee Venom aqua-acupuncture on Chungwan(CV12) were measured. We used Fos immunohistochemical technique to study the neuronal activity in the spinal cord. Results : 1. Expression of c-fos in superficial dorsal horn(SDH), nucleus proprius(NP) and neck of dorsal hom(N) on 6~9th thoracic spine decreased significantly at $2.5{\times}10-4$g/kg Bee Venom aqua-acupuncture, compared with saline-acetic acid group. 2. The numeral change of Fos-LI neurons on the NP, N, and ventral gray(V) on 6-9th thoracic spine, SDH on 9-11th thoracic spine, and SDH and V on 11~13th thoracic spine decreased significantly at Chungwan(CV12) Bee Venom aqua-acupuncture, compared with saline-acetic acid group. 3. The correlation between the numbers of writhing refleax and Fos-LI neurons in T6-13 segment was statistically statistically significant at Chungwan(CV12) Bee Venom aqua-acupuncture. Conclusion : This study shows that the Bee Venom aqua-acupuncture on Chungwan(CV12) decreases the numbers of Fos-LI neurons. As the analgegic effects of Bee Venom aqua-acupuncture is recognized. Bee Venom aqua-acupuncture treatment is expected for pain modulation. In order to use it in many ways, more researches are needed for the dose and stability of Bee Venom aqua-acupuncture.

• Journal of Korean Medicine for Obesity Research
• /
• v.6 no.2
• /
• pp.59-73
• /
• 2006

Objectives: This study was conducted to investigate the effects of Uncoupling protein (UCP) polymorphisms on weight loss. We analyzed associations between polymorphisms of UCP-2, 3 and changes in percentage of obesity phenotypes (Body mass index and percent body fat) after treatment. Materials and Methods: A total of 207 Korean women (BMI over 25) were recruited from the obesity clinic in Kirin Oriental Medical Hospital (Seoul, Korea). All patients were treated with a very low calorie diet and oriental medical therapy for one month. The effect of UCP polymorphisms on changes in obesity-phenotypes were analyzed. For the genotyping of a single nucleotide polymorphism (SNPs), genomic DNA from each subject was extracted from whole blood and genotyped using the TaqMan Method. Associations between changes in percentage of obesity phenotypes (BMI and percent body fat) and UCP polymorphisms were analyzed using age-adjusted general linear model. Results and Conclusions: In this study, AG, GG type of UCP-2 -866A>G, CC, CT type of UCP-2 +4787C>T, CG, GG type of UCP-3 +2564C>G, AG, GG type of UCP-3 +3106A>G, and TC, CC type of UCP-3 +4589T>C played a role as a resistance gene to weight loss.

• The Journal of Korean Medicine
• /
• v.27 no.3 s.67
• /
• pp.222-226
• /
• 2006

Objective: The aim of this study was to introduce newly developed cooperation group standards of acupuncture needles for single use and to make a contribution to the future development of Korean Industrial Standards (KS) of acupuncture needles for single use. Results and Conclusion: Quality assurance and quality control with high safety profile is one of the most critical issues in medical device manufacturing. Up to now, proper attention has not been paid to this issue with respect to acupuncture needles for single use and their related devices. We, therefore, organized a committee to make guidelines to produce an acupuncture needle with high quality and safety. In the committee, we reviewed the topic from an historical viewpoint, and investigated the current situation of the standardization of acupuncture needles in other developed countries. Finally, we developed the cooperation group standards in advance of development of KS on the acupuncture needles for single use. The standards are composed of 12 sections describing: Scope, Normative references, Definitions, Materials, Configuration, Appearance and Cleanliness, Quality, Sterilization and Safety, Processing of Surface and Coating Material, Test, Packaging, and Labeling. We hope that the standards would be useful guidelines to produce high quality acupuncture needles and play an important role in the development of KS in the future.

• Korean Journal of Pharmacognosy
• /
• v.27 no.1
• /
• pp.37-41
• /
• 1996

The prescription, Kilkyungtang (KKT), which originally consists of twelve kinds of medicinal plant materials and was used as a decoction for the treatment of malignant tumors and two modified Kilkyungtangs (KKT-1 and KKT-2), supplemented by the additional crude drug to KKT (KKT-1:Houttuyniae herba, and KKT-2:Oldenlandiae diffusae herba) were investigated on their antitumoral properties, in vivo respectively. All KKTs were found to exhibit significant life time-prolonging effects when they were administered orally to Sarcoma-180 bearing ICR mice for 7 days. (ILS was estimated as 20% in KKT, 42% in KKT-1 and 57% in KKT-2). A profound lessening of tumor weights was also observed when KKTs were administered to $B16-F_0$ bearing C57B/6 mice.

• The Journal of Korean Medical History
• /
• v.23 no.1
• /
• pp.11-22
• /
• 2010

This study finds an interesting fact that five symptoms (smallpox, postpartum pain, eye disease, swollen symptom and parasite infection) mentioned in Ryu Ei-Tae Medicinal Tales and his prescriptions (steamed rice, loess, soybean sprouts, cinnabar, radish, sesame oil and pork) were dramatized on the basis of traditional Korean medicinal knowledge in the Joseon Dynasty. Based on the study of experience-based medicinal literatures popular in the Joseon period, it is confirmed that the prescriptions are actually effective. Also it is inferred that popular diseases at that time were abscess, difficult baby delivery, postpartum pain and parasite infection, which were regarded as almost incurable diseases to ordinary people. These stories also showed destitution of common people who could not afford to buy medicines at that time. As shown in the Ryu Ei-Tae Medicinal Fable, many people might try various ordinary materials around them such as soil or nose wax. One of the outcomes of this study is that the fact that the tales mentioned common materials easy to get in the surroundings such as steamed rice, sesame oil, soybean sprouts or radish could be interprets as care and consideration of medicinal doctors for ordinary people at that time.

• Journal of Physiology & Pathology in Korean Medicine
• /
• v.22 no.2
• /
• pp.427-430
• /
• 2008

Serious controls and cares using ID numbers and barcode needed throughly to have appropriate management in clinical tissues and nucleic acids inventories because these samples are the most essential and important materials in the experimental research laboratories. While almost all of the laboratories using and handling DNA samples as starting materials in their research, problems such as mixing up of two or more different samples together, contamination with other samples, and/or mistakes can occur, especially when it comes with large number of samples. These problems are rather frequent even though researchers pay more attentions to be far away from these obstacles. It has been such a long time since PCR became useful as an important and essential biological research tool among lots of bio-scientific research methods. In this research, we tried to set up a simple and cost-effective genotyping method using PCR and agarose gels, instead of expensive automated machines, for identification and discrimination among those DNA samples, as a kind of low level quality control and sample inventory management.