• Clinical and Experimental Vaccine Research
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• 제12권1호
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• pp.60-69
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• 2023

Purpose: Although the fast development of safe and effective messenger RNA (mRNA) vaccines against severe acute respiratory syndrome coronavirus 2 has been a success, waning humoral immunity has led to the recommendation of booster immunization. However, knowledge of the humoral immune response to different booster strategies and the association with adverse reactions is limited. Materials and Methods: We investigated adverse reactions and anti-spike protein immunoglobulin G (IgG) concentrations among health care workers who received primary immunization with mRNA-1273 and booster immunization with mRNA-1273 or BNT162b2. Results: Adverse reactions were reported by 85.1% after the first dose, 94.7% after the second dose, 87.5% after a third dose of BNT162b2, and 86.0% after a third dose of mRNA-1273. They lasted for a median of 1.8, 2.0, 2.5, and 1.8 days, respectively; 6.4%, 43.6%, and 21.0% of the participants were unable to work after the first, second, and third vaccination, respectively, which should be considered when scheduling vaccinations among essential workers. Booster immunization induced a 13.75-fold (interquartile range, 9.30-24.47) increase of anti-spike protein IgG concentrations with significantly higher concentrations after homologous compared to heterologous vaccination. We found an association between fever, chills, and arthralgia after the second vaccination and anti-spike protein IgG concentrations indicating a linkage between adverse reactions, inflammation, and humoral immune response. Conclusion: Further investigations should focus on the possible advantages of homologous and heterologous booster vaccinations and their capability of stimulating memory B-cells. Additionally, understanding inflammatory processes induced by mRNA vaccines might help to improve reactogenicity while maintaining immunogenicity and efficacy.

• 핵의학기술
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• 제18권2호
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• pp.57-61
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• 2014

국내 갑상선암 환자의 발병률이 증가함에 따라 방사성요오드 치료가 필요한 환자가 증가하고 있다. 방사성 요오드 치료에 이용되고 있는 캡슐용기들 중 1.1 GBq과 5.5 GBq의 국산제품에 설계도면을 바탕으로 차폐체를 구현한 후 366 keV 이상에 감마선들에 대하여 캡슐용기의 방사선 누설선량을 GEANT4 전사모사를 이용하여 평가하였다. 치료용 I-131 캡슐용기 누설선량을 측정하기 위해 각각의 용기에 대하여 용기 표면에서 10 cm 거리 및 100 cm 거리에서의 누설선량을 측정하였다. 용기표면에서 10 cm 거리와 100 cm 거리에서의 누설선량 측정은 방사형으로 발생되는 방사선을 위치별로 측정하기 위해 $10{\times}10{\times}10cm^3$ 부피의 정육면체 형태의 물 팬텀(phantom)을 상부, 상부측면, 측면, 하부측면, 하부 다섯 방향에 설치하여 누설선량을 계산하였다. 용기별로 5개 방향에서 용기표면으로 부터 10 cm, 100 cm 거리에서 전산모사를 수행한 결과 법적 허용기준인 10 cm 거리에서 2.0 mSv/h, 100 cm 거리에서 0.02 mSv/h 이하의 선량 규정과 비교하였을 때 법적기준치보다 현저히 낮은 누설선량이 방출되는 것을 확인하였다.

• 대한한의학회지
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• 제38권3호
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• pp.170-184
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• 2017

Objectives: The objective of this study was to summarize randomized clinical trials (RCTs) that have assessed efficacy and safety of mahuang and ephedrine on treatment of obesity and to propose better process of study. Methods: NLM Medline (pubmed), the Cochrane library, Scopus, Science Direct, RISS, KISS were systemically searched for clinical trials investigating the efficacy, safety of mahuang and ephedrine on treatment of obesity from 2000 to 2017. Results: 16 RCTs met all the inclusion criteria. In most reports, mahuang and ephedrine significantly reduced body weight, body fat mass. There were no serious adverse events associated with mahuang and ephedrine in all studies. Conclusions: In appropriate dose of mahuang and ephedrine for healthy adult was safe, and weight loss effect of mahuang and ephedrine was better than control group. Improved clinical practice guidelines should be developed for safe use of mahuang and ephedrine.

• Nuclear Engineering and Technology
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• 제54권7호
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• pp.2606-2613
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• 2022

Spent resin often exceeds radiation limits for safe disposal, creating a need for commercial-scale treatment techniques to reduce resin radioactivity. In this study, the radiological safety of a commercialized spent resin treatment device with a treatment capacity of 1 ton/day was evaluated. The results confirm that the device is radiologically safe in the event of an accident. This device desorbs ¹⁴C from the spent resin, allowing disposal as low-level waste instead of intermediate-level waste. The device also reduces overall waste by recycling the extracted ¹⁴C. Potential accident scenarios were explored to enable dose assessments for both internal and external exposure while preventing further spillage of the device and processing the spilled resin. The scenarios involved the development of a surface fracture on the resin mixture separator and microwave systems, which were operated under pressure and temperature of 0-6 bar and 0-150 ℃, respectively. In the case of accidents with separator and microwave device, the maximum allowable working time of worker were derived, respectively, considering external and internal exposures. When wearing the respirator corresponding to APF 50, in the case of the microwave device accident scenario, the radiological safety was confirmed when the maximum worker worked within 132.1 h.

• Journal of Chest Surgery
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• 제13권4호
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• pp.346-355
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• 1980

It has been proposed that wide individual variation in response to heparin be not considered in the conventional set protocol for the control of heparin and protamine during extracorporeal circulation. In this paper, two protocol of heparin and protamine therapy were compared to assess the role of the Activated Clotting Time [ACT] in relation to heparin, protamine, and postoperative blood loss and transfusion. The study groups consisted of the 31 patients [adults 15 and children 16] anticoagulated with the conventional heparin protocol and the 31 patients [adults 15 and children 16] anticoagulated with ACT protocol during extracorporeal circulation. In the conventional heparin protocol, two mg of heparin per kg was administered initially with an additional 0.75 mg of heparin per kg every 30 minutes of extracorporeal circulation, and reversal was accomplished with protamine in a dose of 1.5 times the total milligram of heparin. In the ACT protocol, two mg of heparin per kg was administered initially with an additional dose of heparin enough to reach an ACT of 480 seconds [within safe zone 300 to 600 seconds] from the patient`s dose response curve every 1 hour of extracorporeal circulation, and reversal was done with protamine in a dose of 1.3 times the milligram of the residual heparin. The results were summarized as follows. After a dose of 2 mg per kg of heparin, the patient`s ACT varied from 240 to 600 seconds in adults and from 240 t~ 660 seconds in children. In the ACT group the total amount of heparin administered was markedly reduced when compared to the conventional group, and less protamine was required to neutralize heparin. The dose of heparin administered decreased from 7.07 [SE 0.42] mg/kg of the conventional group to 4.92 [SE 0.32] mg/k8 of the ACT group in adults and from 10.17 [SE 1.15] mg/kg to 5.23 [SE 0.24] mg/kg in children, which represent 30.4% and 48.6% decrease respectively. The dose of protamine administered for reversal decreased from 10.6 [SE 0.63] mg/kg of the conventional group to 3.35 [SE 0.35] mg/kg of the ACT group in adults and from 15.7 [SE 1.70] mg/kg to 3.26 [SE 0.27] mg/kg in children, which represent 68.4% and 79.2% respectively. The ratio of protamine to heparin administered in the conventional group was 1.50:1 in adults and 1.54:1 in children, but in the ACT group 0.68:1 in adults and 0.62:1 in children. Postoperative blood loss and transfusion revealed no statistically significant difference between the two groups. Although six patients in the conventional group and one in the ACT group needed re-exploration for continuous hemorrhage, no case of generalized oozing was encountered, and in each case a definite bleeding site was identified. Author would like emphasizing the value of the ACT protocol in controlling heparin and protamine administration during extracorporeal circulation.

• 대한한방내과학회지
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• 제35권1호
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• pp.37-49
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• 2014

목적 및 방법 : 본 연구에서는 한의학에서 전통적으로 신경보호 약물로 사용되어온 총명탕 물 추출물의 급성 독성증상을 관찰하기 위하여 한국식품의약품안전청 고시 제 2009-116호에 따라 암수 ICR마우스 단회 경구투여 독성 실험을 실시하였다. 반수치사량, 개략적치사량, 표적장기 등을 관찰하기 위하여, 수율 9.70% 총명탕 물 추출물 2,000, 1,000 및 500 mg/kg을 암수 마우스에 단회 경구 투여하고, 투여 후 14일 동안의 임상증상, 사망례, 체중 및 증체량의 변화 및 부검소견을 관찰하였으며, 투여 14일 후 14개 주요 실질 장기에 대한 중량 및 조직병리학적 관찰을 실시하였다. 또한 별도의 암수 매체 대조군을 두어 그 결과를 비교하였다. 결 과 : 본 실험의 결과, 설치류 최대 한계투여 용량인 2,000 mg/kg까지 총명탕 물 추출물 투여와 관련된 사망례가 인정되지 않았으며, 암수 매체 대조군을 포함하여, 모든 실험군에 걸쳐 산발적으로 관찰된 일부 우발적인 육안부검 및 조직병리학적 소견을 제외하고, 총명탕 물 추출물 투여와 관련된 임상증상, 체중 및 장기 중량의 변화, 14개 주요장기에 대한 육안부검 및 조직병리학적 소견이 인정되지 않았다. 결 론 : 따라서 마우스 단회 경구투여 독성실험에서 총명탕 물 추출물의 반수치사량 및 개략적 치사량은 각각 설치류 투여 한계용량인 2,000 mg/kg 이상으로 관찰되어, 매우 안전한 약물로 판단되며, 임상사용에는 별 다른 문제를 일으키지는 않을 것으로 판단된다.

• 동의생리병리학회지
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• 제24권1호
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• pp.134-142
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• 2010

Although BinSo-San(BSS), a mixed herbal formula consisted of 11 types of medicinal herbs and have been used as anti-inflammatory agent, In the present study, the acute toxicity (single oral dose toxicity) of lyophilized BSS aqueous extracts was monitored in male and female mice after oral administration according to Korea Food and Drug Administration (KFDA) Guidelines (2005-60, 2005). In order to observe the 50% lethal dose ($LD_{50}$), approximate lethal dosage (ALD), maximum tolerance dosage (MTD) and target organs, test articles were once orally administered to female and male ICR mice at dose levels of 2000, 1000, 500, 250 and 0 (control) mg/kg (body wt.) according to the recommendation of KFDA Guidelines (2005-60, 2005). The mortality and changes on body weight, clinical signs and gross observation were monitored during 14 days after dosing according to KFDA Guidelines (2005-60, 2005) with organ weight and histopathology of 12 types of principle organs. We could not find any mortality, clinical signs and changes in the body weights except for dose-independent increases of body weight and gains restricted in 1000 mg/kg of BSS extracts-dosing female group. Hypertrophic changes of lymphoid organs.thymus, spleen and popliteal lymph nodes were detectedat postmortem observation with BSS extracts dose-dependent increases of lymphoid organ weights, and hyperplasia of lymphoid cells in these all three lymphoid organs at histopathological observations. These changes are considered as results of pharmacological effects of BSS extracts or their components, immunomodulating effects, not toxicological signs. In addition, some sporadic accidental findings such as congestion spots, cyst formation in kidney, atrophy of thymus and spleen with depletion of lymphoid cells, and edematous changes of uterus with desquamation of uterus mucosa as estrus cycles were detected throughout the whole experimental groups including both male and female vehicle controls. The significant (p<0.01) increases of absolute weights of kidney and pancreas detected in BSS extracts 1000 mg/kg-treated female group are considered as secondary changes from increases of body weights. The results obtained in this study suggest that the BSS extract is non-toxic in mice and is therefore likely to be safe for clinical use. The LD50 and ALD of BSS aqueous extracts in both female and male mice were considered as over 2000 mg/kg because no mortalities were detected upto 2000 mg/kg that was the highest dose recommended by KFDA and OECD. In addition, the MTD of BSS extracts was also considered as over 2000 mg/kg because no BSS extracts-treatment related toxicological signs were detected at histopathological observation except for BSS or their component-related pharmacological effects, the immunomodulating effects detected in the present study.

• 대한약침학회지
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• 제17권3호
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• pp.31-39
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• 2014

Objectives: This study was performed to analyze the toxicity and to find the lethal dose of the test substance Water-soluble Carthami-flos pharmacopuncture (WCF) when used as a single intravenous-dose in 6-week-old, male and female Sprague-Dawley rats. Methods: The experiment was conducted at Biotoxtech according to Good Laboratory Practices. 20 female and 20 male Spague-Dawley rats were divided into 4 groups of 5 female and 5 male animals per group. The rats in the three experimental groups received single intravenous injections with 0.125-mL, 0.25-mL and 0.5-mL/animal doses of WCF, Groups 2, 3, and 4, respectively, and the control group, Group 1, received a single intravenous injection with a 0.5-mL dose of normal saline. Clinical signs were observed and body weight measurements were carried out for 14 days following the injections. At the end of the observation period, hematology, clinical chemistry, histopathological tests and necropsy were performed on the injected parts. Results: No deaths occurred in any of the groups. Also, no significant changes in body weight, hematological parameters or clinical chemistry test results between the control group and the experimental groups were observed. Visual inspection after necropsy showed no abnormalities. Histopathological tests on the injected parts showed no significant differences, except for Group 1 females; however, the result was spontaneous generation and had no toxicological meaning because it was not dose-dependent. Therefore, this study showed that WCF had no effect on the injected parts in terms of clinical signs, body weight, hematology, clinical chemistry, and necropsy. Conclusion: As a result of single intravenous-dose tests of the test substance WCF in 4 groups of rats, the lethal dose for both males and females exceeded 0.5 mL/animal. Therefore, WCF is a relatively safe pharmacopuncture that can be used for treatment, but further studies should be performed.

• 한국소음진동공학회논문집
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• 제25권4호
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• pp.266-274
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• 2015

Vibration exposure of domestic high speed trains(KTX and ITX-saemaeulho) to passenger traveling on the Gyung-Bu line was measured to evaluate health effect which is based on ISO 2631-1. The vibration exposure was compared with the frequency weighted root mean square(r.m.s.) and vibration dose value(VDV) of the two trains’ vibration. It is concluded that vibration exposure of the two train during round trip of Busan-Seoul in single day is evaluated to be safe for the passenger’s health according to the health guidance caution defined on ISO 2631-1. Futhermore KTX’s vibration exposure is found to be significantly lower than ITX-saemaeulho thanks to lower vibration magnitude as well as shorter trip time.

• 대한약침학회지
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• 제17권2호
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• pp.41-45
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• 2014

Objectives: This study was performed to analyze the single-dose toxicity of neutral natured blood stasis pharmacopuncture extracts. Methods: All experiments were conducted at Biotoxtech, an institution authorized to perform non-clinical studies, under the regulations of Good Laboratory Practice (GLP). Sprague-Dawley rats were chosen for the pilot study. Doses of neutral natured blood stasis pharmacopuncture extracts, 0.1, 0.5 and 1.0 mL, were administered to the experimental group, and the same doses of normal saline solution were administered to the control group. This study was conducted under the approval of the Institutional Animal Ethics Committee. Results: In all 4 groups, no deaths occurred, and the neutral natured blood stasis pharmacopuncture extracts administered by intramuscular (IM) injection was over 1.0 mL/animal. No significant changes in the body weights between the control group and the experimental group were observed. To check for abnormalities in organs and tissues, we used microscopy to examine representative histological sections of each specified organ; the results showed no significant differences in any organs or tissues. Conclusion: The above findings suggest that treatment with neutral natured blood stasis pharmacopuncture extracts is relatively safe. Further studies on this subject should be conducted to yield more concrete evidence.