• The Journal of Korean Medicine
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• v.25 no.3
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• pp.78-89
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• 2004

Background : A report published by the National Institute of Toxicological Research (NITR) in January 2004 about toxic hepatitis in Korea contained the result of analysis on 55 cases of severe toxic hepatitis from 7 university hospitals for 8 months. NITR claimed that the extrapolated annual frequency of severe toxic hepatitis in Korea was 1904 cases per year. They also claimed that the most frequent etiology of severe toxic hepatitis were herbal medications and similar plant preparations (61.7%), contrasted with traditional therapeutic preparations and healthy foods (29.1%). I have investigated that report to be certain of the result because it is a very important subject for public health and society in Korea. Results : The NITR report has too many problems to have faith in its results. They include the following: 1. The report uses only 55 cases to estimate annual prevalence rate of severe toxic hepatitis in Korea. 2. There was a large regional preponderancy in the NITR report (2 cases in Seoul from a population of 10.17 million, 19 cases in Gwangju from a population of 1.4 million) 3. There was another preponderancy that selected much fewer cases caused by western medication (9.1%) than other reasons. 4. The NITR report used a modified scale than that officially recognized to diagnose toxic hepatitis. 5. There was a mistake using the scale to adapt the right indications. 6. They collected cases before beginning the study, although it was a prospective study. There was also not any questionnaire or other materials concerned with alcohol, drugs, or history of past liver disease. Conclusions : NITR is one of the important official arms of the government of Korea. Nevertheless, there is a severe problem in validity because of selection bias, uncertain accuracy, and insufficiency of raw materials in the report. Therefore it seems incorrect to generalize the results of the report and there is a lack of confidence in it as a national study publishing by the NITR.

• Journal of Pharmacopuncture
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• v.20 no.3
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• pp.179-193
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• 2017

Objectives: Nigella sativa (black seed or black cumin), which belongs to the Ranunculacea family, is an annual herb with many pharmacological properties. Among its many active constituents, thymoquinone (TQ) is the most abundant constituent of the volatile oil of Nigella sativa (N. sativa) seeds, and it is the constituent to which most properties of this herb are attributed. Methods: PubMed-Medline, Scopus, and Web of Science databases were searched to identify randomized control trials (RCTs) investigating the therapeutic effects of N. sativa and/or TQ. In this review, we investigated the clinical uses of N. sativa and TQ in the prevention and the treatment of different diseases and morbidity conditions in humans. Results: Black seed and TQ are shown to possess multiple useful effects for the treatment of patients with several diseases, such as inflammatory and auto-immune disorders, as well as metabolic syndrome. Also, other advantages, including antimicrobial, anti-nociceptive and anti-epileptic properties, have been documented. The side effects of this herbal medicine appear not to be serious, so it can be applied in clinical trials because of its many advantages. Conclusion: Some effects of N. sativa, such as its hypoglycemic, hypolipidemic and bronchodilatory effects, have been sufficiently studied and are sufficiently understood to allow for the next phase of clinical trials or drug developments. However, most of its other effects and applications require further clinical and animal studies.

• The Journal of Korean Medicine
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• v.17 no.1 s.31
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• pp.447-464
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• 1996

Hyperemesis gravidarum is one of the most common symptom in the early pregnancy and if it cause severe malnutrition by means of heavy vomiting as a basic sign of disease of pregnant syndrome, appropriate treatments are necessary. In the clinics the methods of treatment of hyperemesis gravidarum include herb-medication usually. But herb-medication therapy is rather difficult because during pregnancy it may cause vomiting by the smell and taste of herbs. So the author investigated the literatures referred to the external treatments of hyperemesis gravidarum excluding herb-medication and the results obtained here were as follows. 1. The external methods of treatment of hyperemesis gravidarum are various and include moxibustion, the method of applying drug at the umbilicus, ear-acupuncture method, pressure massage therapy, naso-spray method, acupoint injection, intervenous injection 2. Among the external methods of treatment of hyperemesis gravidarum , the method of applying drug at the umbilicus is most variable and almost all prescriptions use Zingiber officinalis Rose, characteristically. 3. Ear-pressure massage method to treat the hyperemesis gravidarum uses the car-acupoints of Gan, We, Shin-mun, Gyo-gam. 4. Among the external methods of treatment of hyperemesis gravidarum , moxibustion, pressure massage, and acupoint injection select frequently Nae-gwan(PC6), Chok-samni(ST36) and Chung-wan(CV12). 5. In the both the internal and external methods of treatment of hyperemesis gravidarum one have to differentiate syndromes in the viewpoint of oriental medicine and treat with the principls of treatment and prescriptions which are fit to each differentiation model under the principle of regulating the stomach and relieving vomiting.

• YAKHAK HOEJI
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• v.56 no.5
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• pp.333-345
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• 2012

A product labelling is one of key tools in ensuring that a patient uses drugs safely and effectively in self-care without professional support. This study aimed to explore the readability and comprehensibility of the information contained on two package inserts of medicines. Two package inserts were tested with first year college students. Fifty-one potential consumers underlined words they could not understand and answered 10 scenario questions. Any differences among groups with different characteristics were statistically tested. Secondly, the readability of two package inserts was assessed with comparison to the level of the 6th grade Korean textbooks. As results, more than 80% of participants properly replied to straightforward questions concerning indication, dosage, duplication, use in pregnancy and contraindication, and 73% about formulation. Less than half answered correctly in multiple choice questions about pediatric use (41%) and side effects (35%). Little discrepancy was observed in the comprehensibility between participants' characteristics. Drug inserts contained about 20% more professional-level words than 6th grade textbooks. In conclusion, Korean consumers may face challenges to understand drug information due to professional terminology and outdated expressions in the current package inserts. To secure safe and effective use of over-the-counter agents, greater efforts should be made to develop more consumer friendly labels. In the other hand, educational supports are required to prepare consumers in a proper level of knowledge for the safe use of drugs.

• Quality Improvement in Health Care
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• v.5 no.1
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• pp.58-75
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• 1998

Background : In Korea, the rational use of antibiotics are rarely controlled, and their patterns of utilization are not understood. In order to reduce the excessive use and to improve the appropriate use of antibiotics, it is necessary to accurately determine present uses of antibiotics in hospitals. Methods : Analysis of the use of prescription drugs was performed on NFMI(National Federation of Medical Insurance) 1994 medical expense claim data. A stratified sampling by types of hospitals, departments, and diseases was obtained from 1994 August data. Patients with secondary diseases were excluded. In this study, 2,697 adults with URI, 6,397 children with URI, 704 adults with bronchitis, and 1,838 children with bronchitis were included. Results : Most patients were prescribed medication (95.2-99.6%). Of the patients prescribed medication, more than 85% of URI patients and more than 91% of bronchitis patients were prescribed antibiotics. Antibiotics expenses accounted for 14% of total medical expenses in adults and 9% of total medical expenses in children. In adults with URI, antibiotics expenses accounted for 52% of drug expenses. Of the patients prescribed antibiotics, average number of antibiotics used was 1.6-1.7. For patients who are prescribed antibiotics, drug expenses were 62-97% greater than patients not prescribed antibiotics. When children were prescribed antibiotics, the highest price of drugs prescribed were 3.4-fold greater. In addition, the number of drugs prescribed also increased by more than one. Elderly patients, more than 60 years, were prescribed antibiotics less frequently. Children less than 10 years and elderly patients greater than 60 years old were prescribed fewer antibiotics than other patients. And they were prescribed medications for longer days than other patients. Conclusion : This study demonstrated that the average rate of prescribing antibiotics was higher in Korea than other countries. Measures to reduce overuse of antibiotics and to improve the appropriate prescription of antibiotics must be considered for cost effective treatment and overall health of people.

• Proceedings of the Korean Society of Propulsion Engineers Conference
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• 2012.05a
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• pp.350-355
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• 2012

Past few years have seen the growing importance of micro shock tubes in various engineering applications. A pharma ballistic technique is one such application which uses micro shock tube to accelerate drug particles and penetrate into skin, thus avoiding the usual injection drug delivery system. But for the efficient design of such instruments requires the detailed knowledge of shock characteristics and flow field inside a micro shock tube. Due to many factors such as boundary layer, low Reynolds number and high Knudsen number shock propagation inside micro shock tubes will be quite different from that of the well established macro shock tubes. In the present study, experimental studies were carried out on a micro shock tube of 3 mm diameter to investigate flow characteristics and shock propagation. Pressure values were measured at different locations inside the driven section. From the experimental values other parameters like shock velocity, shock strength were found and shock wave diagram was constructed.

• The Korea Journal of Herbology
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• v.33 no.1
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• pp.9-15
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• 2018

Objectives : The root bark of Dictamnus dasycarpus has been frequently used to treat patients with skin diseases in Korea. Recently, wild root of D. dasycarpus are reported to induce liver injury. Methods : Traditional uses of D. dasycarpus for skin diseases were analysed bibliographically. In addition, reported cases were collected and analysed using pubmed and national digital library. Results : In taiwan, D. dasycarpus revealed to be one of major herbs for skin diseases and many researchers in worldwide had reported its dermatological efficacies. Reported cases related in liver injury described that hepatocellular or cholestatic liver injury were seen in patients eating wild root of D. dasycarpus. In addition, 6 cases in worldwide and 1 case in Korea showed that patients with drug induced liver injury (DILI) ingested not root bark of D. dasycarpus but prescriptions containing root bark of D. dasycarpus. These mean that wild root of D. dasycarpus (Bongsam or Bongwhangsam) was estimated to be closely related in DILI. Whereas, it was difficult to confirm direct correlation between root bark of D. dasycarpus used as herbal medicine by doctor of Korean medicine and DILI. Conclusions : these results imply that wild root of D. dasycarpus is closely related in DILI and strong recommendation not to take it without consultation by experts is needed. In addition, although there are no evidences of direct correlation between root bark of D. dasycarpus and DILI, doctor of Korean medicines should pay attention to use root bark of D. dasycarpus in their clinics.

• The Korean Society of Law and Medicine
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• v.21 no.1
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• pp.223-259
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• 2020

With COVID-19 spreading rapidly around the world, research and development issues on treatments and vaccines for the virus are of high interest. Among them, Remdesivir was the first to show noticeable therapeutic effects and began clinical trials, with each country authorizing the use of the drug through emergency approval. However, Gilead Co., Ltd., the developer of Remdesivir, received a lot of criticism from civic groups for submitting the application for the marketing authorization as an orphan drug. This is because when a new drug got a marketing authorization as an orphan drug could be granted an exclusive status for seven year. The long-term exclusive status of an orphan drug comes from the policy purpose of motivating pharmaceutical companies to develop treatment opportunities for patients suffering from rare diseases, which was not appropriate to apply to infectious disease treatments. This paper provides a review of the problems and improvement directions of the domestic system through comparative legal consideration against the United States, Europe and Japan for the statutes which give exclusive status to medicines. The domestic system has a fundamental problem that it does not have explicit provisions in the statute in the manner of granting exclusive status, and that it uses the review system to give it exclusive status indirectly. In addition, in the case of orphan drugs, the "Rare Diseases Management Act" and the "Regulations on Examination of Items Permission and Reporting of Drugs" provide overlapping review periods, and despite the relatively long monopoly period, there seems to be no check clause to recover exclusive status in the event of a change in circumstances. Given that biopharmaceuticals are difficult to obtain patents, the lack of such provisions is a pity of domestic legislation, although granting exclusive rights may be a great motivation to induce drug development. In the United States, given that the first biosimilar also has a one-year monopoly period, it can be interpreted that domestic legislation is quite strictly limited to granting exclusive status to biopharmaceuticals. The need for improvement of the domestic system will be recognized in that it could undermine local pharmaceutical companies' willingness to develop biopharmaceuticals in the future, and in that it is also necessary to harmonize international regulations. Taking advantage of the emergence of COVID-19 as an opportunity, we look again at the problems of the domestic system that grants exclusive rights to medicines and hope that an overall revision of the relevant legislation will be made to establish a unified legal basis.

• Archives of Craniofacial Surgery
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• v.22 no.1
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• pp.1-10
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• 2021

Botulinum toxin type A (BoNT-A), onabotulinumtoxinA (Botox) was approved by the United States Food and Drug Administration for temporary improvement of glabellar lines in patients 65 years and younger in 2002, and has also been used widely for aesthetic purposes such as hyperhidrosis, body shape contouring, and other noninvasive facial procedures. BoNT-A inhibits presynaptic exocytosis of acetylcholine (ACh)-containing vesicles into the neuromuscular junction at cholinergic nerve endings of the peripheral nervous system, thereby paralyzing skeletal muscles. ACh is the most broadly used neurotransmitter in the somatic nervous system, preganglionic and postganglionic fibers of parasympathetic nerves, and preganglionic fibers or postganglionic sudomotor nerves of sympathetic nerves. The scientific basis for using BoNT-A in various cosmetic procedures is that its function goes beyond the dual role of muscle paralysis and neuromodulation by inhibiting the secretion of ACh. Although the major target organs for aesthetic procedures are facial expression muscles, skeletal body muscles, salivary glands, and sweat glands, which are innervated by the somatic or autonomic nerves of the peripheral cholinergic nerve system, few studies have attempted to directly explain the anatomy of the areas targeted for injection by addressing the neural physiology and rationale for specific aesthetic applications of BoNT-A therapy. In this article, we classify the various cosmetic uses of BoNT-A according to the relevant component of the peripheral nervous system, and describe scientific theories regarding the anatomy and physiology of the cholinergic nervous system. We also review critical physiological factors and conditions influencing the efficacy of BoNT-A for the rational aesthetic use of BoNT-A. We hope that this comprehensive review helps promote management policies to support long-term, safe, successful practice. Furthermore, based on this, we look forward to developing and expanding new advanced indications for the aesthetic use of BoNT-A in the future.

• Natural Product Sciences
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• v.27 no.4
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• pp.217-227
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• 2021

This study is a record of ethnomedicinal knowledge in Begumganj province focussed on medicinal plants and their local uses for primary health care. The aim was to document and preserve the ethnomedicinal knowledge used by traditional healers of Begumganj upazila, Bangladesh, to treat human diseases and evaluate the relative efficacy of the medicinal plants. The uses of medicinal plants were documented as an ethnomedicinal data sheet using direct observation, field interview, plant interview and group interview techniques from December 2012 to January 2014 in the study area. Data were collected from 98 traditional healers through a questionnaire survey and analyzed through informant consensus factor and fidelity level. This study revealed comprehensive relationship among various diseases and families, forms and parts of plants and modes of preparation. Overall, 75 plant species under 71 genera of 47 families were documented, which are used to treat 41 diseases. Data analysis revealed that 41.33%, 14.67%, 36% and 8% of the medicinal plant species were herbs, shrubs, trees, and climbers, respectively. Leaves were the most used parts, followed by stem, root, fruit, bark, latex and rhizome. The most frequently treated diseases were dysentery, rheumatism and skin diseases. This is the first ethnobotanical survey, which recorded the importance of medicinal plants in Begumganj upazila, Bangladesh. This study can contribute to preserving the indigenous knowledge on the traditional use of medicinal plants in this region and new drug development with attracting future generations towards traditional healing practice.