• Journal of Korean Medicine Rehabilitation
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• v.23 no.4
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• pp.95-115
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• 2013

Objectives The aim of this review is to provide fundamental data for low back pain scales which can be used in clinical trial. Methods We investigated the latest studies on chronic low back pain via PubMed. And we also investigated domestic studies through "http://oasis.kiom.re.kr". 95 research papers were analyzed. Scales were classified into pain scale, function scale, generic health status scale and psychological scale. Results 1) According to foreign clinical studies, Visual Analog Scale (VAS) and Numerical Rating Scale (NRS) were used 18 times as pain scale. Oswestry Disability Index (ODI) was used 20 times as function scale, Roland-Morris Disability Questionnaire (RMDQ) was 17, and Hannover Functional Ability Questionnaire (HFAQ) was used 3 times. 36-item Short Form Health Survey (SF-36) was used 13 times as generic health status scale, Euroqol-5 Dimentions Questionnaire (EQ-5D) was 11, and 12-item Short Form Health Survey (SF-12) was used 3 times. Fear-Avoidance Beliefs Questionnaire (FABQ) was used 9 times as psychological scale, Pain Catastrophizing Scale (PCS) and Tampa Scale for Kinesiophobia (TSK-R) both were used 3 times. 2) According to domestic clinical studies, VAS was used 37 times as pain scale, NRS was 11, and Short Form McGill Pain Questionnaire (SF-MPQ) was used 6 times. ODI was used 30 times as function scale, RMDQ was 2 times only. SF-36 was used once as generic health status scale and Beck's Depression Inventory (BDI) was used 3 times as psychological scale. Conclusions We recommend VAS or NRS as a measure to evaluate pain, and ODI as a measure to evaluate functional disability. And we also recommend SF-36 or SF-12 and EQ-5D as a measure to evaluate generic health status. Finally, we recommend FABQ for use in measuring psychological scale.

• Nutrition Research and Practice
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• v.5 no.4
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• pp.313-321
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• 2011

The Korea Food and Drug Administration (KFDA) revised the Health Functional Food Act in 2008 and extended the form of health functional foods to general food types. Therefore, this study was performed to investigate consumers' perceptions of the expanded form of health functional food and to predict consumption patterns. For this study, 1,006 male and female adults aged 19 years and older were selected nationwide by multi-stage stratified random sampling and were surveyed in 1:1 interviews. The questionnaire survey was conducted by Korea Gallup. The subjects consisted of 497 (49.4%) males and 509 (50.6%) females. About 57.9% of the subjects recognized the KFDA's permission procedures for health functional foods. Regarding the health functional foods that the subjects had consumed, red ginseng products were the highest (45.3%), followed by nutritional supplements (34.9%), ginseng products (27.9%), lactobacillus-containing products (21.0%), aloe products (20.3%), and Japanese apricot extract products (18.4%). Opinions on expanding the form of health functional foods to general food types scored 4.7 points on a 7-point scale, showing positive responses. In terms of the effects of medicine-type health functional foods versus generic health functional foods, the highest response was 'same effects if the same ingredients are contained' at a rate of 34.7%. For intake frequency by food type, the response of 'daily consistent intake' was 31.7% for capsules, tablets, and pills, and 21.7% for extracts. For general food types, 'daily consistent intake' was 44.5% for rice and 22.8% for beverages, which were higher rates than those for medicine types. From the above results, consumers had positive opinions of the expansion of health functional foods to generic forms but are not expected to maintain accurate intake frequencies or amounts. Thus, continuous promotion and education are needed for proper intake of generic health functional foods.

• Korean Journal of Clinical Pharmacy
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• v.16 no.2
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• pp.139-146
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• 2006

Objectives: Bio-equivalence(BE) test is important not only to ensure the quality of generic drugs, but also to promote drug substitution under the separation of prescribing and dispensing practice(SPD). This study was intended to investigate the perception of consumers, doctors, and pharmacists on the confidence of bio-equivalence(BE) assured drugs. Methods: Nation-wide telephone interview survey was conducted for 1,018 consumers, 800 doctors, and 806 pharmacists from September to October in 2003. Descriptive analysis and ${\chi}^2$ analysis were conducted. Results: Even though people showed higher confidence level for the Bioequivalent drugs compared with Bio-inequivalent drugs, the confidence was generally low. Among those asked about the therapeutic substitutability of original drugs by BE versions, 95.78% of pharmacists responded "positive", while only 39.33% of consumers and 31.13% of doctors said so. The elderly, the less educated, who takes chronic disease medicine, pays high cost of prescription drugs, and are in the low income responded less aware of that. Also most consumers got information such as effect of drugs from either media or doctors. Conclusions: In order for people to believe that BE drugs and original drugs are equivalent, we need to strengthen health education, and to clarify any misunderstanding. It is also necessary for the national policy to provide accurate information about drugs to the public.

• YAKHAK HOEJI
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• v.49 no.4
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• pp.255-259
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• 2005

Financial standing of National Health Insurance has been experiencing a grave deterioration during the last 4-5 years, and the yearly amount paid by the insurance for drug expense rose up to 4 trillion won recently. Furthermore, the ratio of drug expenses in the total expenditure of the insurance reached about $25\%$, showing the tendency to be levelled off. As a measure to improve the financial deterioration of the insurance and to encourage generic substitution among the health professionals, we compared pharmacokinetic parameters of brand name drug (Lamisil) and generic drug (Muzonal) containing terbinafine HCl in healthy volunteers. The area under the curve (AUC) of the two drugs showed $2220.4\pm784.7\;and\;2143.1\pm861.6hr{\cdot}ng/ml$ in the corresponding order and no statistically significant difference was identified. The peak concentration $(C_{max})$ of the generic drug demonstrated $566.6\pm246.2 ng/ml$ compared to $550.8\pm204.0$ of brand name drug, which was not significantly different either. Time to reach peak concentration showed about 6 minutes difference between the drugs, which has no clinical significance to the treatment of dermatomycosis and dermatophytosis.

• Mass Spectrometry Letters
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• v.4 no.3
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• pp.47-50
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• 2013

An ultra-fast generic LC-MS/MS method was developed for high-throughput quantification of discovery pharmacokinetic (PK) samples and its reliability was verified. The method involves a simple protein precipitation for sample preparation and the analysis by ultra-fast generic LC-MS/MS with the ballistic gradient program and selected reaction monitoring (SRM) mode. Approximately 290 new chemical entities (NCEs) (over 10,000 samples) from 5 therapeutic programs were analyzed. The calibration curves showed good linearity in the concentration range of 1, 2 or 5 to 2000 ng/mL. No significant ion suppression was observed in the elution region of all the NCEs. When approximately 300 plasma samples were continuously analyzed, the peak area of internal standard was constant and reproducible. In the repeated analysis of samples, the plasma concentrations and the area under the curve (AUC) were consistent with the results from the first analysis. These results showed that the present ultra-fast generic LC-MS/MS method is reliable in terms of selectivity, sensitivity, and reproducibility and could be useful for high-throughput quantification and other bioanalysis in drug discovery.

• Korean Journal of Oriental Medicine
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• v.16 no.1
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• pp.101-109
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• 2010

The medical and healthy paradigm is changing by various reasons such as improving of life quality, the limit of western medicine, demographic changes and so on. And the demand, interest and market size of traditional medicine(TM) and complementary and alternative medicine(CAM) are increasing continuously and there is a good traditional medicine called TKM(Traditional Korean Medicine) in Korea. TKM have differentiated characteristics like nature-friendly, systematic, preventive and personalized medicine from western medicine. TKM with these characteristics have possibility to increase national competitiveness and contribute to growth of economy. At this time, it is necessary to select key area of TKM R&D to increase competitiveness of TKM and to create new growth engine. In this paper, we suggest key area of TKM R&D through SWOT analysis, the analysis of world traditional medicine and expert's counsel. As a result, 3 key area and 10 specific fields of TKM R&D was selected, which they are 'the standardization for TKM technology and technique', 'the development of generic technology based on TKM' and 'the establishment of infrastructure for TKM information and material'. This study may contribute to make plan for TKM research and policy such as TKM middle and long term plan and TKM promotion plan.

• The Korean Society of Law and Medicine
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• v.22 no.1
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• pp.91-124
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• 2021

In May 2019, the Ministry of Food and Drug Safety revised the "Pharmaceutical Determination and Adjustment Criteria" with the content of differentially calculating the price of generic drugs according to the registration of the drug substance and meeting the requirements for their own bioequivalence test. According to this revised rule, if their own bioequivalence test is not conducted, even the generic drugs that have already been approved would be lowered in price. I wondered whether this system was introduced with sufficient public legal considerations regarding its legislative purposes and means. Therefore, I reviewed the contents of the revised notice based on whether or not it is valid to determine and adjust the price of generic drugs in terms of the legitimacy of legislative purposes and the proportionality principle after introducing the history and background of the rule. First, I raised a question as to whether the purpose of preventing the overrun of generic drugs is indeed legitimate in terms of the legitimacy of the purpose. In order for the revised notice of "reduction of drug prices when the test requirements are not met," to meet the conformity principle, the premise that it is difficult to recognize safety and effectiveness through consignment (joint) bioequivalence test or that these tests are insufficient in safety and efficacy verification than their own test must be established. Nevertheless, it seems that suffficient review has not been carried out. In order to achieve the purpose of securing safety and effectiveness, the focus should be on 'reinforcement of the standards for bioequivalence test and the management of the bioequivalence test itself' rather than whether it is a their own test or a consignment (joint) test. Third, it is contrary to the necessity and substantiality principle that strict standards are uniformly applied to the products that can be considered to have been sufficiently verified for safety and effectiveness after a considerable period of time has passed after the product approval. In many cases, revised administrative legislations quickly enacted and amended in the state of lack of legal review or consensus, while the regulatory effects resulting from it are quite direct and specific to the regulated person. In this respect, I emphasized that the administrative legislative process also requires substantial review and prior control of the regulatory purposes and means, and that the participation of stakeholders in the legislative procedure is to be strengthened.

• Clinical and Experimental Pediatrics
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• v.50 no.10
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• pp.948-953
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• 2007

Acute renal failure is the generic term for an abrupt and sustained decrease in renal function resulting in retention of nitrogenous and non nitrogenous waste product. This may results in life threatening consequences including volume overload, hyperkalemia, and metabolic acidosis. Acute renal failure is both common and carries high mortality rate, but as it is often preventable, identification of patients at risk and and appropriate management are crucial. This review summarized the most recent information on definition, epidemiology, clinical causes and management of acute renal failure in pediatric patients.

• The Journal of Korea CHUNA Manual Medicine
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• v.4 no.1
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• pp.39-53
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• 2003

Objectives : The object is to the difference among the funtional disability scale for low back pain and to use Methods : I researched the contents of funtional disability scale for low back pain Results & Conclusions : 1. The funtional disability scale for low back pain is specific-condition and general-health 2. A proposal of set core of funtional disability scale for low back pain is back specific function, generic health state, pain, work disability, satisfaction 3. Oswestry disability index or Rolland disability questionnaire. wase used for standard specific-condition scale and SF-36 was used for standard general-health scale 4. SF-36 is able to use the funtional disability scale for low back pain independence 5. In the future, scale for low back pain shulod be standardized in multiple dimension by computer

• Journal of Physiology & Pathology in Korean Medicine
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• v.29 no.3
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• pp.218-222
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• 2015

Facial diagnosis based on quantitative facial features has been studied in many Korean medicine fields, especially in Sasang constitutional medicine. By the rapid growing of 3D measuring technology, generic and cheap 3D sensors, such as Microsoft Kinect, is popular in many research fields. In this study, the possibility of using Kinect in facial diagnosis is examined. We introduce the development of facial feature extraction system and verify its accuracy and repeatability of measurement. Furthermore, we compare Sasang constitution diagnosis results between DSLR-based system and the developed Kinect-based system. A Sasang constitution diagnosis algorithm applied in the experiment was previously developed by a huge database containing 2D facial images acquired by DSLR cameras. Interrater reliability analysis result shows almost perfect agreement (Kappa = 0.818) between the two systems. This means that Kinect can be utilized to the diagnosis algorithm, even though it was originally derived from 2D facial image data. We conclude that Kinect can be successfully applicable to practical facial diagnosis.