• 한국자원식물학회:학술대회논문집
• /
• 한국자원식물학회 2021년도 춘계학술대회
• /
• pp.59-59
• /
• 2021

Stachys sieboldii Miq. (SSM) and Acorus gramineus Soland. (AGS) have been used as traditional medicines for thousands of years in parts of Asia, including Korea, China, and Japan. Recent researches on SSM and AGS have documented a wide spectrum of therapeutic properties, including anti-inflammatory, anti-oxidative, neurodegenerative disease effects. However, the toxicity and safety of SSM and AGS, and their mixture (medicinal herber mixture, MHMIX) were not confirmed. Therefore, this study was performed to evaluate the acute toxicity and safety of SSM, AGS and MHMIX. SSM, AGS and MHMIX were orally administered at a dose of 5,000 mg/kg in ICR mice. Animals were monitored for the mortality and changes in the body weight, clinical signs and gross observation during the 14 days after dosing, upon necropsy. We also measured parameters of organ weight, clinical chemistry, and hematology. No dead and no clinical signs were found during the experiment period after administration of a single oral dose of SSM, AGS and MHMIX. There were no adverse effects on clinical signs, body weight, or organ weight and no gross pathological findings in any treatment group. Therefore, LD50 value of SSM, AGS and MHMIX may be over 5,000 mg/kg and it may have no side toxic effect to ICR mice. The results on the single-dose toxicity of SSM, AGS and MHMIX indicate that it is not possible to reach oral dose levels related to death or dose levels with any harmful side effects.

• 대한기관윤리심의기구협의회지
• /
• 제1권1호
• /
• pp.5-21
• /
• 2019

Purpose: Institutional review board (IRB) classifies risks of clinical trials into less than minimal risk, minor increase over minimal risk, and more than minimal risk. Based on classification and evaluation for risk, IRB decides whether permitting consent exemption or asking additional protection for clinical research subject or not. The purpose of this study is to analyze how IRB members evaluate minimal risk by sending questionnaire survey with 12 predetermined scenarios. Methods: IRB members and researchers (pediatrician, gastroenterologist, neurologist, and neurosurgeon) in 11 different hospitals were asked to answer survey questions via email or online. We analyzed the differences of answers among several subgroups in each predetermined scenarios. Result: Responders were 212 personnel(110 researchers and 102 IRB members) from 11 centers. There were significant differences between IRB members and researchers in response such as blood sampling, skin prick test, one time catheterization in a girl, spinal tapping in child, non-enhance MRI in child, non-enhance MRI with chrolal hydrate in a child, spinal tapping without anesthesia in adult, bioequivalence test, gastric endoscopy, and non-enhance CT. significant differences between medical IRB members and non-medical members were also revealed in one time catheterization in a girl, spinal tapping in a child, non-enhance MRI in a child, bioequivalence test. Depending on researchers' department, they responded differently in several questionnaires as well. Conclusions: We have found that IRB members and researchers evaluate the risks differently. Researchers compared to IRB members, medical IRB members compared to non-medical members answered less than minimal risk in many cases. In assessing and evaluating the risks associated with the study, medical IRB members answered predetermined scenarios as less dangerous compared to non-medical IRB members. Difference among researchers where also revealed significantly. Researchers answered predetermined scenarios as less dangerous compare to other department researchers, especially in predetermined scenarios containing procedures they are familiar with.

• Asian Pacific Journal of Cancer Prevention
• /
• 제16권5호
• /
• pp.1929-1934
• /
• 2015

Purpose: To determine the diagnostic yield of primary circulating tumor cells in women with suspicion of breast cancer, detected as a result of an abnormal mammography. Materials and Methods: Consecutive women presenting for breast biopsy as a result of a mammogram BiRADs of 3 or more, had an 8ml blood sample taken for primary circulating tumor cell (CTC) detection. Mononuclear cells were obtained using differential gel centrifugation and CTCs identified using standard immunocytochemistry using anti-mammoglobin. A test was determined to be positive if 1 CTC was detected. Results: A total of 144 women with a mean age of $54.7{\pm}15.6$ years participated, 78/144 (53.0%) had breast cancer on biopsy, 65/140 (46.3%) benign pathologies and 1(0.7%) non-Hogkins lymphoma. Increasing BiRADs scores were associated with increased cancer detection (p=0.004, RR 1.00, 4.24, 8.50). CTC mammoglobin positive had a sensitivity of 81.1% and specificity of 90.9%, with positive and negative predictive values of 90.9% and 81.1% respectively. Mammoglobin positive CTCs detected 87% of invasive cancers, while poorly differentiated cancers were negative for mammoglobin. Only 50% of in situ cancers and none of the intraductal cancers had CTCs detected. Menopausal status did not affect the diagnostic yield of the CTC test, which was higher in women with BiRADS 4 mammograms. There was a significant trend (p<0.0001 Chi squared for trends) in CTC detection frequency from intraductal, in situ and invasive (OR 1.00, 8.00, 472.00). Conclusions: The use of primary CTC detection in women suspected of breast cancer has potential uses, especially with invasive cancer, but it failed to detect intra-ductal cancer and 50% of in situ cancer. There was no difference in the diagnostic yield between pre and post menopausal women. To confirm its use in reducing biopsies in women with BIRADs 4a mammagrams and in the detection of interval invasive breast cancer, larger studies are needed.

• Toxicological Research
• /
• 제23권1호
• /
• pp.87-96
• /
• 2007

Single and repeated-dose toxicity of anti-diabetic herb extract microcapsule (ADHEM) were evaluated according to Toxicity Test Guidelines of Korea Food and Drug Administration using Sprague-Dawley rats. For single-dose toxicity test, kneading ADHEM with sterilized water were administered orally once at dose levels of 0 and 2,000 mg/kg and examined for 14 days. No dead animals, clinical signs and abnormal necropsy findings were observed and also no significant difference in body weights was found. Therefore, the $LD_{50}$ of ADHEM was considered to be higher than 2,000 mg/kg in both male and female rats. For repeated-dose toxicity test, ADHEM were mixed with powder fodder and administerd orally for 28 days at dose levels of 0, 500, 1000 and 2000 mg/kg/day. No dead animals, clinical signs and significant difference in body weights were found. In hematology and serum biochemistry, all values were included within the normal ranges. In relative organ weights, kidney or liver were significantly increased in the 500, 1000 or 2000 mg/kg/day male groups, uterus was significantly increased in the 500 mg/kg/day female group and left adrenal glands were significantly decreased in the 2000 mg/kg/day female group. In histopathological examinations, vacuolation and microgranuloma in the liver, chronic progressive nephropathy and inflammation in the kidney were observed in the 500, 1000 or 2000 mg/kg/day both male and female groups. Therefore, the no observed adverse effect level (NOAEL) of ADHEM was considered to be lower than 500 mg/kg/day in both male and female rats.

• 대한약침학회지
• /
• 제17권1호
• /
• pp.27-34
• /
• 2014

Objectives: This experiment was conducted to examine the toxicity of Water soluble Carthmi-Flos herbal acupuncture (WCF) by administering a single intramuscular dose of WCF in 6-week-old, male and female Sprague-Dawley rats and to find the lethality dose for WCF. Methods: The experiment was conducted at Biotoxtech according to Good Laboratory Practices under a request by the Korean Pharmacopuncture Institute. This experiment was performed based on the testing standards of "Toxicity Test Standards for Drugs" by the Ministry of Food and Drug Safety. Subjects were divided into 4 groups: 1 control group in which normal saline was administered and 3 test groups in which 0.1, 0.5 or 1.0 mL of WCF was administered; a single intramuscular dose was injected into 5 males and 5 females in each group. General symptoms and body weights were observed/measured for 14 days after injection. At the end of the observation period, hematological and clinical chemistry tests were performed, followed by necropsy and histopathological examinations of the injected sections. Results: No mortalities were observed in any group. Also, symptoms, body weight, hematology, clinical chemistry and necropsy were not affected. However, histopathological examination of the injected part in one female in the 1.0-mL group showed infiltration of mononuclear cells and a multi-nucleated giant cell around eosinophilic material. Conclusion: Administration of single intramuscular doses of WCF in 3 groups of rats showed that the approximate lethal dose of WCF for all rats was in excess of 1.0 mL, as no mortalities were observed for injections up to and including 1.0 mL.

• 대한수의학회지
• /
• 제5권1호
• /
• pp.61-96
• /
• 1965

Observations were made on the blood picture of total 196 heads of healthy Korean cattles, including 98 males and 98 females in the purpose of determination of hematological values and its sex difference, and seasonal variations during one year period from December 1963 to November 1964. The blood sampling were scheduled by random in four different seasons and the sample size of both sex included in each season were designated to be same size. The ranges, averages or mean values of the erythrocytes, hemoglobin, hematocrit, mean corpuscular hemoglobin concentration, total white blood cell count and differential count were determined in this studies and their respective standard deviation, standard error of means, sex defferences and seasonal variations were as follows; 1. The erythrocyte count of male showed a range of $5.0{\times}10^6/c.mm$ to $8.75{\times}10^6/c.mm$ with a mean of $6.5{\pm}0.096{\times}10^6/c.mm$. Female showed a range of $5.0{\times}10^6/c.mm$ to $8.30{\times}10^6/c.mm$, with a mean of 6. $131{\pm}0.078{\times}10^6/c.mm$. There was a highly significant sex difference and seasomal variation was not found to be significant. 2. The hemoglobin value of male showed a range of 9.0g/100cc. to 14.5g/100cc. with a mean of $11.074{\pm}0.143g/100cc$. Female showed a range of 9.0g/100cc to 13.0g/100cc. with a mean of $10.745{\pm}0.034g/100cc$. There was a highly significant sex difference and seasonal variation was not found to be significant. 3. The hematocrit value of male showed a range of 28% to 45% and with a mean of $34.867{\pm}0.468%$. Female showed a range of 28% to 42% with a mean of $32.888{\pm}0.322%$. There was a highly significant sex difference and seasonal variation was not found to be significant. 4. The mean corpuscular hemoglobin of male showed a range of 14.4rr. to 19.6rr. with a mean of $17.1{\pm}0.112rr$. Female showed a range of 14.7rr. to 19.5rr. with a mean of $17.6{\pm}0.113rr$. 5. The mean corpusular volume of male showed a range of $42.5{\mu}^3$ to $62.2{\mu}^3$ with a mean of $53.9{\pm}0.419{\mu}^3$, Female showed a range of $44.2{\mu}^3$ to $60.0{\mu}^3$ with a mean of $53.8{\pm}0.375{\mu}^3$. 6. The mean corpuscular hemoglobin concentration of male showed a range of 28.1 % to 34.9% with a mean of $31.4{\pm}0.161%$. Female showed a range of 28.0% to 34.9% with a mean of $30.9{\pm}0.169%$. 7. The total leucocyte count of male showed a range of 4,000/c.mm to 13,100/c.mm. with a mean of $9,338{\pm}218.23/c.mm$. Female showed a range of 4,000/c.mm. to 14,000/c.mm. with a mean of $9,338{\pm}235.90/c.mm$. Six difference was not found to be significant and there was a highly significant seasonal variation. 8. The differential count of male, the means of neutrophil, stab, segmented cell, Iymphocyte, monocyte, eosinophil and basophil were $31.173{\pm}0.570%$, 0.3%. $30.867{\pm}0.564%$, $55.112{\pm}0.603%$, $3.745{\pm}0.082%$, $9.867{\pm}0.422%$ and 0.14% rspectively. Female showed means of $31.010{\pm}0.572%$, 0.2%, $30.806{\pm}0.569%$, $53.929{\pm}0.634%$, $4.082{\pm}0.109%$, $10.908{\pm}0.503%$ and 0.12% respectively. There were significant sex differences in monocyte and highly significant sex difference in eosinophil, and seasonal variation were found to be highly significant in neutrophil, monocyte and eosinophil. 9. Hematological comparison made between cattles infested with so called "small type piroplasma" and non-infested group. The result of investigation showed no significant difference upon the red blood cell, hemoglobin and hematocrit values between lighty infested group and non-infested group. 10. Age distribution of test group in this study ranged from 2 years to 6 years in both sex and their average age were $4.45{\pm}0.114$(male) and $4.50{\pm}0.116$(female). There found to be no significant sex difference and seasonal variations in the age of test group.

• 동의신경정신과학회지
• /
• 제29권2호
• /
• pp.111-119
• /
• 2018

Objectives: To investigate the characteristics of patients diagnosed with dementia or mild cognitive impairment who are treated by means of a blend between Western and Korean medicine. Methods: We searched for outpatients with dementia or mild cognitive impairment by means of a collaboration between Western and Korean medicine from August 1, 2015, to July 31, 2017, through electronic medical records in Wonkwang Hospital. The records were retrospectively analyzed according to the patients' demographic and clinical characteristics, pathway of medical care, diagnostic tests, treatment, and medical expenses. Results: Thirteen patients were included in the analysis. Among them, six patients were diagnosed with mild cognitive impairment, five with dementia, Alzheimer's type, one patient with frontotemporal dementia, and one patient with unspecified dementia. Twelve of the thirteen patients were over 60 years of age. The number of pathways from the Dept. of Neurology to the Dept. of Neuropsychiatry of Korean Medicine was almost the same as the opposite pathway. The most used diagnostic test in Korean medicine was a neuropsychological test such as SNSB, MMSE and GDS. In Western medicine, hematology and neuroimaging were frequently used for patients. Acupuncture in Korean medicine and medication in Western medicine were the most frequently used. In Korean medicine, uncovered service costs were much higher than covered service costs,. whereas, in Western medicine, covered service costs were higher than uncovered service costs. Conclusions: This study describes the basic characteristics of dementia and mild cognitive impairment patients treated by a collaboration between Western and Korean medicine. Based on these results, a clinical pathway of the collaborative practice system between Western and Korean medicine for dementia patients needs to be developed.

• Journal of Korean Neurosurgical Society
• /
• 제54권5호
• /
• pp.399-404
• /
• 2013

Objective : The authors conducted a retrospective cohort study to determine prognostic factors and treatment outcomes of brain metastases (BM) from breast cancer (BC) after Gamma Knife radiosurgery (GKS). Methods : Pathologic and clinical features, and outcomes were analyzed in a cohort of 62 patients with BM from BC treated by GKS. The Kaplan- Meier method, the log-rank test, and Cox's proportional hazards model were used to assess prognostic factors. Results : Median survival after GKS was 73.0 weeks (95% confidence interval, 46.0-100.1). HER2+ [hazard ratio (HR) 0.441; p=0.045], Karnofsky performance scale (KPS) ${\geq}70$ (RR 0.416; p=0.050) and systemic chemotherapy after GKS (RR 0.282; p=0.001) were found to be a favorable prognostic factor of overall survival. Actuarial local control (LC) rate were $89.5{\pm}4.5%$ and $70.5{\pm}6.9%$ at 6 and 12 months after GKS, respectively. No prognostic factors were found to affect LC rate. Uni- and multivariate analysis revealed that the distant control (DC) rate was higher in patients with; a small number (${\leq}3$) of metastasis (HR 0.300; p=0.045), no known extracranial metastasis (p=0.013, log-rank test), or the HER2+ subtype (HR 0.267; p=0.027). Additional whole brain radiation therapy and metastasis volume were not found to be significantly associated with LC, DC, or overall survival. Conclusion : The treatment outcomes of patients with newly diagnosed BM from BC treated with GKS could be affected primarily by intrinsic subtype, KPS, and systemic chemotherapy. Therapeutic strategy and prognosis scoring system should be individualized based on considerations of intrinsic subtype in addition to traditionally known parameters related to stereotactic radiosurgery.

• Toxicological Research
• /
• 제22권4호
• /
• pp.445-452
• /
• 2006

Aralia elata, a common medicinal and culinary herb, has beer consumed for centuries without any reported adverse effects. However, due to its limited safety information, we decided to investigate the repeated-dose toxicity of ethanolic extract of Aralia elata. The test was administered once daily by the gavage to male and female rats at doses of 0, 250, 500 and 1,000 mg/kg/day for four weeks. Throughout the study, no treatment-related deaths or clinical signs were observed. Also, no apparent changes were detected in ophthalmoscopy, urinalysis, serum biochemistry, hematology and gross necropsy. The test result showed a significant decrease in body and heart weight of males treated with 250 mg/kg of extract of Aralia elata compared to normal control, a significant increase in relative brain weight and adrenal weight in females treated with 250 mg/kg of extract compared to normal control. However, all these changes were not considered toxicologically important due to irrelevant dose-response relationship to gross and microscopic findings. Histopathologically, abnormal changes were not observed in any target organs. On the basis of these results, the NOAEL of extract of Aralia elata was estimated to be more than 1,000 mg/kg/day under the tested conditions.

• Toxicological Research
• /
• 제29권4호
• /
• pp.263-278
• /
• 2013

The silkworm extract powder contain 1-deoxynojirimycin (DNJ), a potent ${\alpha}$-glycosidase inhibitor, has therapeutic potency against diabetes mellitus. Therefore, natural products containing DNJ from mulberry leaves and silkworm are consumed as health functional food. The present study was performed to evaluate the safety of the silkworm extract powder, a health food which containing the DNJ. The repeated toxicity studies and gentic toxicity studies of the silkworm extract powder were performed to obtain the data for new functional food approval in MFDS. The safety was evaluated by a single-dose oral toxicity study and a 90 day repeated-dose oral toxicity study in Sprague-Dawley rats. The silkworm extract powder was also evaluated for its mutagenic potential in a battery of genetic toxicity test: in vitro bacterial reverse mutation assay, in vitro chromosomal aberration test, and in vivo mouse bone marrow micronucleus assay. The results of the genetic toxicology assays were negative in all of the assays. The approximate lethal dose in single oral dose toxicity study was considered to be higher than 5000 mg/kg in rats. In the 90 day study, the dose levels were wet at 0, 500, 1000, 2000 mg/kg/day, and 10 animals/sex/dose were treated with oral gavage. The parameters that were monitored were clinical signs, body weights, food and water consumptions, ophthalmic examination, urinalysis, hematology, serum biochemistry, necropsy findings, organ weights, and histopathological examination. No adverse effects were observed after the 90 day administration of the silkworm extract powder. The No-Observed-Adverse-Effect-Level (NOAEL) of silkworm extract powder in the 90 day study was 2000 mg/kg/day in both sexes, and no target organ was identified.