• 대한한방부인과학회지
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• 제34권1호
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• pp.1-14
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• 2021

Objectives: We studied for the adjustment of the patterns of 'The Diagnostic Tool for Climacteric and Postmenopausal Syndrome Pattern Identification (hereinafter CaPSPI)' (studyI) and the correlation between CaPSPI and Korean medicine doctors' diagnosis which was carried out without knowing the results of CaPSPI (studyII). Methods: The studyI followed the previous study method in 2018 (2018-3). The studyII was conducted from June 1, 2019 to July 10, 2020 with ◯◯ University Korean Medicine Hospital IRB's approval (2019-4). Doctors' diagnosis was conducted face-to-face with the subjects. Doctors' diagnosis was carried out based on the Kupperman's questionnaire, 'Diagnosis System of Oriental Medicine (hereinafter DSOM)' and four examinations (四診) records. The diagnosis was marked with 0 for 'no', 1 for 'somewhat', 2 for 'yes' and 3 for 'very yes'. The correlation between CaPSPI and the mean of doctors diagnostic scores were investigated statistically. Results: The studyI showed that heart-heat (心火) pattern was added. The Factor loading coefficient for heart-heat was 0.551 to 0.789, and the Cronbach's coefficient was 0.896. The studyII showed that the diagnosis (Kappa statistic) of two doctors showed statistically significant concordance (all eight patterns), with correlation of them were 0.3 or higher. And the correlation between the CaPSPI score and the mean of doctors' diagnostic score showed a statistically significant correlation, with liver qi depression (肝鬱) being the highest at 0.552 and dual deficiency of the heart-spleen (心脾兩虛) being the lowest at 0.301. Conclusions: Since the diagnosis results of CaPSPI showed a significant correlation with the diagnosis of Korean traditional medicine experts, it was believed that the CaPSPI results can be trusted and used for clinical purposes.

• 대한약침학회지
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• 제18권1호
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• pp.56-62
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• 2015

Objectives: The purpose of the study is to assess both the approximate lethal dose and the single dose intramuscular injection toxicity of Danggui (Angelica gigantis radix) pharmacopuncture (DGP) in Sprague-Dawley (SD) rats. Methods: The experiments were conducted at the good laboratory practice (GLP) laboratory, Biotoxtech Co., which is a laboratory approved by the ministry of food and drug safety (MFDS). The study was performed according to the GLP regulation and the toxicity test guidelines of the MFDS (2009) after approval of the institutional animal care and use committee of Biotoxtech. Single doses of DGP were injected intramuscularly into the rats in three test groups of 6 week old SD rats (5 male and 5 female rats per groups) in the amounts of 0.1, 0.5, and 1.0 mL/animal for groups 2, 3, and 4, respectively, and normal saline solution in the amount of 1.0 mL/animal was injected intramuscularly into the rats (5 male and 5 female rats) in the control group. Observations of the general symptoms and weight measurements were performed during the 14 day observation period after the injection. Hematologic and serum biochemical examination, necropsy, and a local tolerance test at the injection site were done after the observation period. Results: No death was observed in three test groups (0.1, 0.5 and 1.0 mL/animal group). In addition, the injection of DGP had no effect on general symptoms, weights, hematologic and serum biochemical examination, and necropsy. The results from the local tolerance tests at injection site showed no treatment related effects in the SD rats. Conclusion: The results of single dose intramuscular injection of DGP suggest that the approximate lethal dose is above 1.0 mL/animal for both male and female SD rats and that intramuscular injection of DGP may be safe.

• 한방비만학회지
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• 제17권1호
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• pp.37-45
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• 2017

최근 비만이 전 세계적인 문제로 대두되면서 임상 연구의 해석에 필요한 중요 자료를 제시해 줄 수 있는 동물 모델을 이용한 생리학적 기전 연구에 대한 관심이 높아지고 있다. 인삼은 많은 동물 실험에서 항비만 또는 항당뇨 효과가 보고되었으나 인체의 임상에서 비만을 연구한 논문은 거의 없는 실정이다. 이 연구에서는 신체계측치수와 대사지표를 활용한 동물 모델에서의 인삼의 항비만 효과의 근거수준을 평가하고자 한다. 전임상 단계에서 비만에 대한 인삼의 효과를 연구한 대조군 연구, 비교 연구를 포함시키고자 한다. 실험적으로 비만을 유도하는 도중 혹은 이후에 인삼을 투여하고, 일차평가변수는 신체계측치수, 이차평가변수는 지방조직의 무게, 섭취음식의 총량, 대사지표 등을 포함한다. 언어, 출판일 등 특별한 제한 없이 MEDLINE, Embase, PubMed, Web of Science, Scopus를 통해 논문 검색을 시행한다. 본 연구에서의 자료 수집은 개인 정보를 포함하지 않으며, 사생활 침해의 우려가 없으므로 윤리적 승인 대상에서 제외된다. 연구의 전체과정을 수행한 후 연구결과는 연관 저널에 출간하거나 관련 학회에 발표할 예정이다. 본 연구 프로토콜은 the Collaborative Approach to Meta-Analysis and Review of Animal Data from Experimental Studies (CAMARADES) website (http://www.camarades.info)에 등록되었다.

• Asian-Australasian Journal of Animal Sciences
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• 제13권3호
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• pp.381-389
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• 2000

The Jindo is a Korean native dog, well-known for its hunting and guarding abilities. When he gives his devotion to one individual, he gives it whole-heartedly. He is not tempted easily and impetuous. The breed was not developed. but the dog retained their original qualities -loyal, alert, fearless, obedient, watchful, intelligent, energetic- to survive in the harsh environment of the Jindo island. The dog had been spread over the entire Korean peninsula from the time unknown, and the ones in the Jindo island, isolated until lately, survived and maintained their original characteristics. They are now spread over the entire Jindo County consisted of many islands, whence the breed name came. The Jindo comes in a variety of colors and color combinations, with the fawn and white colorings predominant. The dog is one of the Korean natural monuments, protected by law since early 1960s. The Jindo gained official approval by the Federation Cynologique Internationale as a hunting dog. Apart from the basic housetraining, the dog rarely gets training. Many people have attempted to preserve its pure bloodlines and original qualities. Today, there are a total of 10,356 Jindoes being raised over the entire Jindo County, and many more are kept elsewhere. A research into genetic characteristics of the Jindo is now going on, using the technique of isozyme electrophoresis. The Jindo Dog Breeding Management Center has been reinforced lately, and in addition to their routines, the Center is to work on the breeding of the Jindo. Efforts should be made in the future to produce stable, trustworthy Jindoes according to their proposed use and to modify their temperament in order to make it more widely acceptable as a pet and companion dog in the strangers home.

• 의료법학
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• 제15권2호
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• pp.63-89
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• 2014

In 1976, the Dalkon Shield-intrauterine device injured several thousand women in U.S.A. which caused the changes of medical deivce regulation. The Medical Device Regulation Act or Medical Device Amendments of 1976 (MDA) was introduce. As part of the process of regulating medical devices, the MDA divides medical devices into three categories. The class II, and III devices which have moderate harm or more can use the section 510 (k), premarket notification process if the manufacturer can establish that its device is "substantially equivalent" to a device that was marketed before 1976. In 21 U.S.C. ${\S}$ 360k(a), MDA introduced a provision which expressly preempts competing state laws or regulations. After that, the judicial debates had began over the proper interpretation and application of Section 360(k) In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that manufacturer approved by the Food and Drug Administration (FDA)'s pre-market approval process are preempted from liability, even when the devices have defective design or lack of labeling. But the Supreme Court ruled in Medtronic Inc. v. Lora Lohr that the manufactures which use the section 510 (k) process cannot be preempted and in Bausch v. Stryker Corp. that manufactures which violated the CGMP standard are also liable to the damage of patient at the state courts. In 2009, the Supreme Court ruled in Wyeth v. Levine that patients harmed by prescription drugs can claim damages in state courts. This may cause a double standard between prescription drugs and medical devices. FDA Preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding Food and Drug Administration approved products. FDA Preemption has been a highly contentious issue. In general, consumer groups are against it while the FDA and pharmaceutical manufacturers are in favor of it. This issues also influences the theory of product liability of U.S.A. Complete immunity preemption is an issue need to be more declared.

• 의료법학
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• 제13권1호
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• pp.125-153
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• 2012

The adult guardianship system has been introduced through amendments of Korean Civil Code for the first time in the March 2011(Act No. 10429, 7. 1. 2013. enforcement). The adult guardianship system has the main purposes to provide a lot of help vulnerable adults and elderly, and protect them on the welfare related with property act, treatment, care, etc. There could be a controversy about whether the protection Legal Guardian's consent(formerly known as the Mental Health Act) or permission of the Family Court(revised Civil Code) are required to, or the Mental Health Act should be revised, when mental patient will be hospitalized forcibly. The author proposes that mental patient with Adult guardians should be determined by Legal Guardian's consent and approval of the Family Court, but mental patient without Adult guardians could be determined by Legal Guardian's consent. The issue of Withdrawing of life-sustaining treatment could be occurred due to the aging society and the development of modern medicine, and this has provided difficult, various problems to mankind in Legal, ethical, and social welfare aspects. The need of Death with dignity law or Natural death law has been reduced for a revision of the Civil Code. Therefore, on the issue of Withdrawing of life-sustaining treatment, in the future, intervention of the court is necessary in accordance with the revised Civil Code Section, and Organ Transplantation Act and the brain death criteria may serve as an important criterion.

• 대한약침학회지
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• 제15권3호
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• pp.48-52
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• 2012

Objective: This study was performed to analyze the single-dose toxicity of Aconitum kusnezoffii Reichb. pharmacopuncture (AKRP). Methods: All experiments were conducted at the Korea Testing & Research Institute (KTRI), an institute authorized to perform non-clinical studies, under the regulations of Good Laboratory Practice (GLP). Twenty (20) Sprague-Dawley rats were chosen for the pilot study. The animals were divided into four groups of five animals per group: group 1 (G1) being the control group with each animal receiving an injection of 0.3 ml of saline and groups 2, 3, and 4 (G2, G3, and G4) being the experimental groups with each animal receiving an injection of 0.1, 0.2 or 0.3 ml of AKRP, respectively. This study was conducted with the approval of the Institutional Animal Ethics Committee. Results: No deaths occurred in any of the 4 groups, and the $LD_{50}$ of AKRP administered via IV was higher than 1.77 ml/kg. Some changes in the weights of the male rates were observed between the control group and the experimental groups, but no significant differences were noted in the weights of the female rats. To check for abnormalities in organs and tissues, we stained representative sections of each specified organ with Hematoxylin & Eosin for light microscopic examination. The results showed no significant differences in any of the organs or tissues. Conclusions: The above findings suggest that Aconitum kusnezoffii Reichb. pharmacopuncture is a relatively safe treatment. Further studies on the subject should be conducted to yield more concrete evidence.

• Clinical and Experimental Pediatrics
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• 제56권7호
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• pp.291-297
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• 2013

Purpose: The aim of this study was to investigate prophylactic treatment effects in Korean patients with severe hemophilia A. Methods: A prospective study of 32 severe hemophilia A patients was conducted with the approval of the Institutional Review Board at the Eulji University Hospital. Two patients received primary prophylaxis; whereas, the other 30 patients were divided into 2 groups-secondary prophylaxis (n=15) and on-demand (n=15)-on the basis of their consent for secondary prophylaxis. A 20-25 IU/kg dose of factor VIII concentrate was administered to the primary and secondary prophylaxis group patients every 3 days for 1 year. The prophylactic effect was evaluated by observing changes in the Pettersson scores, annual number of total and joint bleeds, and factor VIII consumption for 1 year. Results: No moderate or severe bleeding was observed, and the Pettersson scores remained unchanged during the prophylaxis period in the patients who received primary prophylactic treatment. After the treatment was changed from on-demand to secondary prophylaxis, the annual number of total and joint bleeds in the secondary prophylaxis group decreased by $64.4%{\pm}13.0%$ and $70.0%{\pm}15.2%$, respectively. The average increase in Pettersson scores within 1 year was $0.5{\pm}0.8$ and $1.3{\pm}1.1$ in the secondary prophylaxis and on-demand groups, respectively. Prophylactic effects were also observed in patients >17 years who had nearly the same initial Pettersson scores. Conclusion: Intermediate-dose prophylactic treatment may delay hemarthropathy progression and prevent its occurrence in Korean severe hemophilia A patients.

• 대한약침학회지
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• 제17권2호
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• pp.67-72
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• 2014

Objectives: This study evaluated the single-dose toxicity of Saeng Maek San (SMS) in rats. Methods: All experiments were conducted at Biotoxtech (Chungwon, Korea), an institute authorized to perform non-clinical studies under the regulations of Good Laboratory Practice (GLP). A single-dose intravenous toxicity study was carried out on 40 6-week-old Sprague-Daley rats. The animals were randomly divided into the following four groups of ten animals each: Group 1 (G1) was the control group, with each animal receiving an intravenous injection of 1.0 mL of saline, and Groups 2, 3 and 4 (G2, G3 and G4) were the experimental groups, with the animals in the groups receiving an injection of 0.1, 0.5 and 1.0 mL of SMS, respectively. Mortality, clinical signs, body-weight changes and gross pathological findings were observed for 14 days following a single administration of SMS or saline. Organ weights, clinical chemistry and hematology were analyzed at 14 days. This study was conducted with the approval of the Institutional Animal Ethics Committee. Results: No deaths occurred in any of the four groups, indicating that the lethal dose of SMS in rats is greater than 1.0 mL/animal. Some changes in weights of male rats between the control group and the experimental groups were observed, but no significant changes in the weights of female rats were noted. To identify abnormalities in organs and tissues, we stained representative sections of each specified organ with hematoxylin and eosin for examination with a light microscope. No significant abnormalities were observed in any of the organs or tissues. Conclusion: The results suggest that intravenous injection of SMS is a safe method of treatment.

• Journal of Genetic Medicine
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• 제13권2호
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• pp.59-64
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• 2016

Gaucher disease type 1 (GD1) is an inherited lysosomal storage disorder caused by deficiency of acid ${\beta}$-glucosidase. The diminished enzyme activity leads to the accumulation of substrates and results in multi-systemic manifestations including hepatosplenomegaly, anemia, thrombocytopenia, and bone diseases. Enzyme replacement therapy (ERT) by infusion of recombinant protein has been the standard treatment for over 20 years. Despite the successful long-term treatment with ERT, several unmet needs remain in the treatment of GD1 such as severe pulmonary and skeletal manifestations. Substrate reduction therapy (SRT) reduces the accumulation of substrates by inhibiting their biosynthesis. Eliglustat, a new oral SRT, was approved in United States and Europe as a first-line therapy for treating adult patients with GD1 who have compatible CYP2D6 metabolism phenotypes. Although eliglustat is not yet available in Korea, introduction and summary of this new treatment modality are provided in this paper by review of literatures. Despite the fact that there are only limited studies to draw resolute conclusions, the current data demonstrated that eliglustat is not inferior to ERT in terms of its clinical efficacy. The approval of eligustat enables eligible adult GD1 patients to have the option of oral therapy although it still needs further studies on long-term outcomes. The individual patient should be assessed carefully for the choice of treatment modality when eliglustat becomes available in Korea. Furthermore, the clinical guidelines for Korean patients with GD1 regarding the use of eliglustat needs to be developed in near future.