• Journal of The Korean Society of Clinical Toxicology
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• v.21 no.2
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• pp.128-134
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• 2023

Purpose: The Prescott nomogram has been utilized to forecast hepatotoxicity from acute acetaminophen poisoning. In developing countries, emergency medical centers lack the resources to report acetaminophen concentrations; thus, the commencement and cessation of treatment are based on the reported dose. This study investigated risk factors that can predict acetaminophen detection after 15 hours for safe treatment termination. Methods: Data were collected from an urban emergency medical center from 2010 to 2020. The study included patients ≥14 years of age with acute acetaminophen poisoning within 15 hours. The correlation between risk factors and detection of acetaminophen 15 hours after ingestion was evaluated using logistic regression, and the area under the curve (AUC) was calculated. Results: In total, 181 patients were included in the primary analysis; the median dose was 150.9 mg/kg and 35 patients (19.3%) had acetaminophen detected 15 hours after ingestion. The dose per weight and the time to visit were significant predictors for acetaminophen detection after 15 hours (odds ratio, 1.020 and 1.030, respectively). The AUCs were 0.628 for a 135 mg/kg cut-off value and 0.658 for a cut-off 450 minutes, and that of the combined model was 0.714 (sensitivity: 45.7%, specificity: 91.8%). Conclusion: Where acetaminophen concentrations are not reported during treatment following the UK guidelines, it is safe to start N-acetylcysteine immediately for patients who are ≥14 years old, visit within 15 hours after acute poisoning, and report having ingested ≥135 mg/kg. Additional N-acetylcysteine doses should be considered for patients visiting after 8 hours.

• Journal of Chest Surgery
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• v.24 no.3
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• pp.253-260
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• 1991

The adequacy of anticoagulation with heparin during cardiopulmonary bypass, and precise neutralization with protamine at the conclusion of cardiopulmonary bypass, were important. In sixty children undergoing cardiopulmonary bypass, ACT and heparin dose-response curve were studied. Total dose of heparin before bypass were 2.80$\pm$0.74 mg/kg and the amount of protamine administered after bypass were 3.0$\pm$1.23 mg/kg. So protamine: heparin ratio was 1.07: l.c After administration of protamine which dose is calculated with heparin dose-response curve, ACTs were returned to normal range[mean 114.8 $\pm$13 second]. The heparin sensitivity and its half-life do not have relationship with age, weight, height, surface area and urine amount during operation. And there are too much individual variations in heparin sensitivity and its half-life. So conventional heparin protocols can overestimate or underestimate the amount of heparin and protamine. Heparin dose-response curve makes it possible to maintain anticoagulation in a safe range during bypass with adequate amount of heparin individually. At the conclusion of bypass, this curve can be used to predict the precise amount of protamine amount of protamine needed for neutralization of the heparin. But heparin dose-response curve to be used clinically, further studies will be needed about relationship between ACT and heparin level in the high range, influence of hemodilution and hypothermia to ACT and discrepancy between true adequate amount of protamine and calculated amount by heparin dose-response curve.

• Clinical and Experimental Pediatrics
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• v.49 no.1
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• pp.14-17
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• 2006

Infants who are born prematurely or with low birth weight should be immunized at the same postnatal chronologic age. They should receive BCG, DTaP, IPV vaccines according to the same recommended schedule as full term infants. Hepatitis B vaccine schedule is modified when hepatitis B vaccine is administered a infant with birth weight less than 2,000 g. The recommended standard dose of each vaccine should be administered. Proportion of children experiencing vaccine-related adverse events dose not differ between full-term and preterm infants. Immunization with routinely recommended childhood vaccines is safe for preterm and low birth weight infants.

• Journal of Pharmacopuncture
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• v.17 no.2
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• pp.46-56
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• 2014

Objectives: This study was performed to examine the single-dose toxicity of Samgihwalryeok pharmacopuncture. Methods: Forty six-week-old Sprague-Dawley (SD) rats were divided into four groups of 10 rats each; each group was then sub-divided into two smaller groups, one of five males and the other of five females. Group 1 (G1, control) received 1.0 mL of normal saline solution, while group 2 (G2, low-dose group), group 3 (G3, mid-does group, and group 4 (G4, high-dose group) received 0.1, 0.5, and 1.0 mL of Samgihwalryeok pharmacopuncture, respectively. Results: No mortalities or clinical signs were observed in the four groups. Also, no significant changes in body weights were observed among the group, and no significant differences in hematology/biochemistry, necropsy, or histopathology results were noted. Conclusion: The above findings suggest that treatment with Samgihwalryeok pharmacopuncture is relatively safe. Further studies on this subject are needed.

• Toxicological Research
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• v.22 no.2
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• pp.153-156
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• 2006

The acute toxicity of STB-HO-BM was evaluated in Sprague Dawley (SS) rats and beagle dogs. STB-HO-BM was administered orally to rats at dose levels of 0 and 2,000mg/kg/day and to dogs at dose levels of 0, 500, 1,000 and 2,000 mg/kg/day. In these experiments, there were no death and clinical changes which were related to STB-HO-BM administration. In addition, there were no significant changes between control and treated groups in body weights and autopsy findings. In conclusion, the administration of STB-HO-BM 2,000 mg/kg in SD rats and up to 2,000mg/kg in beagle dogs was proved to be safe, and it is thought that STB-HO-BM may not show any toxicity in its clinical use.

• Korean Journal of Oriental Medicine
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• v.15 no.1
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• pp.79-83
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• 2009

In this study, we investigated the single dose toxicity and safety about water-extracted Galgeuntang. To evaluate single dose toxicity, 20 male and 20 female ICR mice were observed survival rates, general toxicity, changes of body weight for 14 days after single oral administration of 0 (control group), 1250, 2500 and 5000mg/kg Galgeuntang. And after 14 day, We observed autopsy. Compared with the control group, we could not find any toxic alteration in all treated groups (1250, 2500 and 5000 mg/kg). LD50 of Galgeuntang might be over 5000mg/kg and it is very safe to ICR mice.

• Journal of Pharmacopuncture
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• v.19 no.4
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• pp.336-343
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• 2016

Objectives: This study was conducted to analyze the single-dose toxicity and the safety of Mahwangcheonoh pharmacopuncture extracts. Methods: Six-week-old Sprague-Dawley rats were used for this study. Doses of Mahwangcheonoh pharmacopuncture extracts were set at 0.25 mL (low-dose), 0.5 mL (medium-dose) and 1.0 mL (high-dose) for the test groups. A dose of 1.0 mL of normal saline solution was set for the control group. During 14 days, general symptoms, mortalities, and changes in hematology, blood biochemistry and histopathology of all rats were observed. Results: No death was observed in all test groups. Any abnormal symptom was not observed in all of the groups. No significant changes in weight between the control group and the test groups were observed. In addition, no significant differences in the hematology signs, the blood biochemistry levels and the histopathological signs related to the Mahwangcheonoh pharmacopuncture extracts injection were observed. Conclusion: The findings of this study indicate that Mahwangcheonoh pharmacopuncture at doses of 1.0 mL or less may be consider safe and non-toxic. So, it can be used for therapy of obesity sufficiently. But further studies on this subject must be performed to confirm and verify this conclusion.

• Toxicological Research
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• v.24 no.1
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• pp.79-86
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• 2008

This study was conducted to obtain information of the oral dose toxicity of low molecular fucoidan (LMF) in male and female mice. In order to calculate 50% lethal dose ($LD_{50}$) and approximate lethal dose (LD), test material was once orally administered to male and female ICR mice at dose levels of 2000, 1000, 500, 250, 125 and 0 (vehicle control) mg/kg (body wt.). The mortality and the changes on body weight, clinical signs, gross observation and organ weight and histopathology of principle organs were monitored 14 days after LMF treatment. We could not find any mortalities, clinical signs, body weight changes and gross findings. In addition, significant changes in the organ weight and histopathology of principal organs were not observed except for some sporadic findings. The results obtained in this study suggest that LMF may not be toxic in mice and may be therefore safe for clinical use. The $LD_{50}$ and approximate LD in mice after single oral dose of LMF were considered over 2000 mg/kg in both female and male mice.

• The Korean Journal of Applied Statistics
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• v.33 no.2
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• pp.137-145
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• 2020

Phase I clinical trials (Dose Finding Studies) are the first step in administering new drugs developed through animal experiments or in vitro experiments to humans. An important area of interest in designing Phase I clinical trials is determining the dose that provides the greatest efficacy and acceptable safe dose to the patient. In this paper, we propose a method to determine the maximum tolerated dose considering efficacy and safety using Biased coin design and stopping rule. The proposed method is compared with existing methods through simulation.

• Journal of Food Hygiene and Safety
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• v.15 no.3
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• pp.267-270
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• 2000

This study was designed to predict the risk of a hazard chemical, vinyl chloride, by applying dose-response assessment that are one of the major process in practicing risk assessment. After extrapolating from the high dose exposure of vinyl chloride based upon animal carcinogenic data to the low dose exposed to human using several mathematical models, we calculated the cancer potency factors as well as virtually safe dose and the resulted values were compared. This process will provide the new insight to assess the risk of a chemical accurately imposed to human in the future.