• The Korean Society of Law and Medicine
• /
• v.17 no.2
• /
• pp.125-144
• /
• 2016

All forms of Clinical trial should be fully equipped with protection systems for experimental subjects considering their uncertainty and various risks. Existing laws have some regulations in pharmaceutical affairs act and medical device act. Nonetheless, there is a limit to protect the subjects considering law objective to perform administration of medicine. Furthermore, the clinical trial on minor has no direct regulations in pharmaceutical affairs act, but prescribes certain portion in clinical trial assessment guideline on infants or medicine clinical trial management standard, however there is a limit because that is just recommendation not having legal effectiveness. The legislative solution would be possible for legal problems of clinical trial on minor by examining treatment system on minor in organ transplant act and clinical trial on minor in other foreign laws stronger than usual medical practice in terms of degree of human body invasion. I suppose that the control system of clinical trial being done focusing on the pharmaceutical affairs act, medical device act and other guidelines in existing laws system should be resolved by legislating 'trial subject protection law', in addition, this would be well balanced in organ transplant act on protection system of minor organ donors. Furthermore, the judgement on the consent ability and spontaneity in clinical trial on minor should be judged considering maturity and mentality of minor by clinical trial institutional review board based on legislative solution mentioned above.

• The Korean Society of Law and Medicine
• /
• v.20 no.2
• /
• pp.111-140
• /
• 2019

The Bioethics and Safety Act provides a set of rules to regulate biobanks and research activities using human biological material, but the law seems to be defective in several folds. The law requires that, prior to collection or use of human biological materials, researchers should obtain the informed consent of the donors, but the law does not obligate biobanks to do so. Even in cases where the law requires informed consent, the ordinance of the Ministry of Health and Welfare allows open (or blanket) consent. In addition, a new article in the Act, Article 42-2 which will take effect from October 24, 2019, allows medical institutions to provide biobanks with remaining biospecimens collected in the course of diagnosis and treatment, unless the donors express their intent to opt-out, without obtaining specific consent from them. Given the need to protect the autonomy of donors and the unique characteristics of biobanks and research activities that use human biological materials, this paper concludes that such open consent-based law may not be suitable to protect the autonomy of the donors and that the broad consent requirement may be a desirable policy option. The paper acknowledges that the international community has long questioned whether broad consent (as well as open consent) is an effective choice to regulate the use of human biological materials. The paper stresses that the baseline requirement in designing the law is that the secondary use of human biological materials should be based on informed consent of the donors; the core value of the law should be a governance structure that promotes transparency and protects donor participation.

• The Korean Society of Law and Medicine
• /
• v.20 no.2
• /
• pp.43-82
• /
• 2019

In Korea surrogate medical decision makings happen without legal grounds. The purpose of this article is to research the issues in preparing policies for decision-making on behalf of unrepresented patients. As aspects of comparative law, there are two approaches. One of them is to regulate default surrogate list. If no agent or guardian has been appointed, some legislatures provide that members of patient's family who is reasonably available, in descending order of priority of not, may act as surrogate: (1) the spouse, unless legally separated; (2) an adult child; (3) a parent; or (4) an adult brother or sister. If none of them is eligible to act as surrogate, some legislatures allow close friends to make health-care decisions for adult individuals who lack capacity. On the other hand there are other legislatures which provide no surrogate decision maker list but oblige the responsible authority to determine with advice of family members or friends of the patient. In the end the first approach can not guarantee that the surrogate decision maker like family members or friends will determine in the best interest of the patient.

• Journal of Physiology & Pathology in Korean Medicine
• /
• v.18 no.1
• /
• pp.84-92
• /
• 2004

The present study examined the effects of Taekunyukmijiwhang-tang (TV) on blood pressure and renal function in nitric oxide (NO)-dependent hypertensive rats. A phamacological inhibition of nitric oxide synthase (NOS) for 4-6 weeks produces renal vasoconstriction, renal dysfunction, and progressive severe hypertension. Treatment of rats with NG-Nitro-L-arginie methylester (L-NAME) (100 mg/L, 6 weeks), which is a nonspecific NOS inhibitor, cause a sustained increase in systolic blood pressure (SBP), along with the decrease in expression of ecNOS in the kidney and thoracic aorta. The expression of Na, K-ATPase α1 subunit in the kidney was also reduced in the L-NAME induced hypertensive rats group. The renal functional parameters including urine osmolality (Uosm), creatinine clearance (Ccr), which is an index of glomerular filtration (GFR) were decreased in rat with L-NAME induced hypertension. while solute-free water reabsoption (TcH₂O) was unchanged in all experimental group. However, the group combined treated with TV and L-NAME did not develop hypertension and expression of ecNOS in the aorta was restored. The expression of Na/sup +/, K/sup +/-ATpase α1 subunit in the kidney was markedly restored in L-NAME-induced hypertension rats by administration of TV along with the restoration of urinary volume (UV) and sodium excretion (UNaV), whlie Na/sup +/, K/sup +/-ATPase /β1 subunit was not altered. These results suggest that TV attenuates an increase in SSP in the L-NAME induced hypertension and restores partially renal function, which seems to be caused by up-regulation of expression of Na/sup +/, K/sup +/-ATPase α1 subunit in the kidney and ecNOS in thoracic aorta.

• Journal of Oriental Neuropsychiatry
• /
• v.14 no.2
• /
• pp.183-189
• /
• 2003

Hysterical aphonia is one of the frequent symptoms in conversion disorders. If it has a recent onset, a manifest induced factor, and a good premorbid adaptation, and another mental disorder is not accompanied, its prognosis is good. We report one case of hysterical aphonia that was bad prognosis. This patient was suffering traumatic event before and after onset, and major depressive disorder was accompanied. Having hysterical aphonia, the patient who had no progress after over an years medicine therapy and often felt strong suicidal urge, was successfully treated by TFT(Thought field therapy) and oriental medicine therapy. Several case studies on hypnotic cure of hysterical aphonia has been reported but they are uncommon internally and have good prognosis. In addition, there were no relevant studies concerning alternative therapy and oriental medication. Our case report is focused on treatment through these methods.

• Journal of Oriental Neuropsychiatry
• /
• v.14 no.2
• /
• pp.213-218
• /
• 2003

This is a case report of a patient with Tourett's disorder treated by Ukgan-san. We evaluated the patient Tourett's disorder by behavior and sound. His tic behaviors like eye blinking, shoulder shrugging, head jerking, facial frimace have been shown frequently, and His phonic tic symptoms like coughing, throat clearing, sniffing have been presented frequently, too. We diagnosed his condition as Wind-syndrome Caused by Hyperactivity of Liver-yang by patient's redish face, taut pulse, Left umbilical throb. So we treated the patient with Ukgan-san. and the score of Yale Global Tic Severity Scale(YGTSS) was 30 at the start of treatment. and the score of YGTSS was 3 at the end. We found that Ukgan-san was effective for the patient with Tourett's disorder.

• Journal of Physiology & Pathology in Korean Medicine
• /
• v.19 no.6
• /
• pp.1557-1562
• /
• 2005

A mechanism of hair cell damage caused by noise and ototoxic agents is mediated through generation of free radicals and reactive oxygen species (ROS). It is known that most of animals have defense systems to protect against ROS, and the cochlea of inner ear in animals also has ROS defense systems including several antioxidant enzymes such as superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPX), glutathione reductase (GR), and glutathione (GSH), which efficiently detoxifying ROS generated under normal condition. Steamed roots of Rehmannia glutinosa have been traditionally used in Oriental medicine for the treatment of auditory disease such as tinnitus, vertigo, and hearing loss as well as inflammatory diseases, hectic fever, night sweat, and headache. In the present study, we showed that the ethanol extract from steamed roots of R. giutinosa (ESRG) increased the antioxidant enzymes such as SOD, CAT, GPX, and GR activities and GSH level in HEI-OC1 auditory cells. This extract itself did not show any significant cytotoxicity up to $50{\mu}g/ml$. Our results further support the view that ESRG is promising sources of potential antioxidants. Future studies will be aimed at investigating the effects of ESRG on the regulation of cellular mechanisms and isolating and identifying the substances responsible for the regulation of antioxidant enzyme system from the plant extracts.

• Journal of Oriental Neuropsychiatry
• /
• v.23 no.2
• /
• pp.99-120
• /
• 2012

Objectives : The oriental medicine Jangwonhwan, a boiled extract of 12 medicinal herbs/mushrooms, has been prescribed to patients with cognitive dysfunction, as originally described in the Korean medical text, DonguiBogam(amnesia chapter). Recently, a modified formula of Jangwonhwan (LMK02-Jangwonhwan) consisting of seven medicinal plants/mushrooms, was shown to reduce the ${\beta}$-amyloid deposition in the brain of Tg-APPswe/PS1dE9 mouse model for Alzheimer's disease. The toxicity of LMK02-Jangwonhwan was investigated in SD rats, by a daily oral administration for 13 weeks and NOAEL(No observed adverse effect dose), a definite toxic dose and target organ, as well. Methods : Quality control of the tablet form of LMK02-Jangwonhwan was established by estimating the indicative components, Ginsenoside Rg3 of Red Ginseng and Decursin of Angelicagigas Nakai. The toxicity of LMK02-Jangwonhwan was investigated in 6 week old, specific pathogen free (SPF), Sprageu-Dawley rats by oral administration. Each test group consisted of 10 male and 10 female rats. The groups received doses of 500, 1,000 or 2,000 mg/kg/day of test substance for 13 weeks. The clinical signs, death rate, body weight, food consumption, ophthalmic examination, urinalysis, hematological and serum biochemistry, organ weight and pathological changes were examined and compared with those of the control group. Results : The 13-week repeated oral treatment doses didn't result in any specific symptoms or death. There were no significant changes in the rat's weight and food consumption. Further, ophthalmic examination, urinalysis, hematological, serum biochemistry test and organ weight revealed no significant differences. Conclusions : The no-observed-adverse-effect level(NOAEL) of LMK02 for male and female Sprague-Dawley rats was determined as 2,000mg/kg/day and the target organ wasn't confirmed. Because no significant adverse effects were observed, the target organ could not be determined.

• Journal of Physiology & Pathology in Korean Medicine
• /
• v.20 no.3
• /
• pp.548-556
• /
• 2006

This study was to evaluate the effect of Samjayangchin-tang (STYCT) on mouse Th1 and Th2 cells' differentiation and ovalbumin (OVA)-induced allergic inflammation. The proliferation of mouse CD4 T cells and the secretion of Th1/Th2 cytokines under the influence of STYCT extract were measured as well as the amount of ${\beta}-hexosaminidase$ in RBL-2H3 cells and the levels of $TNF-{\alpha}$ and IL-6 secretion in Raw264.7 cells. BALB/c mice were orally administered with STYCT extract and simultaneously inoculated with OVA to induce allergic reaction and measure the level of total IgE, OVA-specific IgE and the production of IFN- g, IL-4, IL-5 by the spleen cells. When mouse CD4 T cell were stimulated with anti-CO3 and anti-CD28 for 48 hours in various concentrations of STYCT extract, it decreased proliferation of CD4 cells. CD4 T cells under Th1/Th2 polarizing conditions for 3 days with STYCT resulted in mild decrease of IFN- g in Th1 cells and significant decrease of IL-4 in Th2 cells. STYCT extract had a dose-dependent inhibitory effect on antigen-induced release of ${\beta}-hexosaminidase$ in RBL-2H3 cells. Treatment of STYCT extract on LPS stimulated Raw 264.7 cells showed dose-dependent decrease in IL-6 production. Oral administration of STYCT extract on OVA-induced allergic mice showed an inhibitory effect on the levels of total serum IgE and OVA-specific IgE by 53% and 44%, respectively. Culture of spleen cells with OVA resulted in significant increase of IFN- g by 54% and significant decrease of IL-4 and IL-5 by 42%, and 29%, respectively. The results show that STYCT does not strongly induce mouse T cells to transform into Th1 or Th2 but it has an anti-allergic effect in vitro, and that it also corrects the unbalance between the reactions of Th cells in allergic diseases.

• Journal of Physiology & Pathology in Korean Medicine
• /
• v.19 no.5
• /
• pp.1204-1212
• /
• 2005

Lung cancer is one of the common malignant tumors in the world. It occurs more increasingly due to the serious air pollution, heavy smoking, expoure to ionized radiation, pollution with heavy metal, and owing to well advanced diagnostic skill, etc. Also lung cancer has the limitation of medical care because metastasis is already shown up in more than half cases when it is first detected through medical examination. Although it is treated with chemoradiation, the rate of deaths from lung cancer is high as well, because blood has a lot of toxicity which give side effects. So it has a low rate of cure. So, the ways of various treatment is being researched to raise the rate of care and decrease the side effects recently, and one of the results is inducing apoptosis which makes use of molecularbiologic diagnosis of lung cancer's cell and using oriental medicine drugs. The purpose of this study is whether apoptosis would happen on the human lung carcinoma cell by treated with Junglyeokdaejosape-tang, Junglyeok-tang Junglyeokdaejosape-tang and Junglyeok-tang has been prescribed for cough, chest pain, and many other similar cases. Cough and chest pain is shown in early lung cancer. That is why we used these prescriptions. Apoptosis happend on the human lung carcinoma A549 cells treated with Jeongiyeokdaejosapye-tang, Jeonglyeok-tang. The concentration-dependent inhibition of cell viability was observed and apoptosis was confirmed by DNA fragmentation. Bcl-2 and COX-2 mRNA expression decreased, but Bax mRNA expression increased, so it was identified with the case of indomethacin known to enhance apoptotic DNA fragmentation. Also expression of the p21, p53, cyclin E, cyclin D1, cytochrome c, caspase-3, and caspase-9 protein increased and the activity of caspase-3 increased, as well. Last, fragmentation of the PARP was shown. The previous and present results indicated that apoptosis of A549 cells by above-mentioned drugs is associated with the blockage of G1/S progression.