• Clinical and Experimental Pediatrics
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• 제57권4호
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• pp.164-170
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• 2014

Influenza causes acute respiratory infections and various complications. Children in the high-risk group have higher complication and hospitalization rates than high-risk elderly individuals. Influenza prevention in children is important, as they can be a source infection spread in their communities. Influenza vaccination is strongly recommended for high-risk children with chronic underlying circulatory and respiratory disease, immature infants, and children receiving long-term immunosuppressant treatment or aspirin. However, vaccination rates in these children are low because of concerns regarding the exacerbation of underlying diseases and vaccine efficacy. To address these concerns, many clinical studies on children with underlying respiratory diseases have been conducted since the 1970s. Most of these reported no differences in immunogenicity or adverse reactions between healthy children and those with underlying respiratory diseases and no adverse effects of the influenza vaccine on the disease course. Further to these studies, the inactivated split-virus influenza vaccine is recommended for children with underlying respiratory disease, in many countries. However, the live-attenuated influenza vaccine (LAIV) is not recommended for children younger than 5 years with asthma or recurrent wheezing. Influenza vaccination is contraindicated in patients with severe allergies to egg, chicken, or feathers, because egg-cultivated influenza vaccines may contain ovalbumin. There has been no recent report of serious adverse events after influenza vaccination in children with egg allergy. However, many experts recommend the trivalent influenza vaccine for patients with severe egg allergy, with close observation for 30 minutes after vaccination. LAIV is still not recommended for patients with asthma or egg allergy.

• Journal of Preventive Medicine and Public Health
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• 제40권4호
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• pp.278-284
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• 2007

Despite extensive researches and pre-market clinical trials, only limited information on the adverse drug reactions (ADRs) of a drug can be collected at the time of market approval from regulatory agency. ADRs constitute a major public health problem. Post-marketing surveillance of drugs is important to detect signals for ADR. In Korea, one of the main methods for monitoring the safety of marketed drugs is spontaneous reporting system of suspected ADRs. Re-examination and re-evaluation system are in force for monitoring safety of new market approval drugs and currently under marketing drugs, respectively. Recently, regional pharmacovigilance centers were designated from Korean Food and Drug Administration for facilitating ADR surveillance. Over recent years, with the development of information technology, there has been an increased interest in establishing data mining system for detecting signals from Health Insurance Review Agency database. The purpose of this paper is to review the current status of Korean ADR surveillance system and suggest the possible solutions for developing active pharmacovigilance system in Korea.

• Asian Pacific Journal of Cancer Prevention
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• 제15권17호
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• pp.7195-7200
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• 2014

Background: The aim of this study was to evaluate how CYP2C19 affects icotinib and metabolite' exposure, and to determine whether the exposure and EGFR genotype influences survival time, tumor metastasis and adverse drug reactions. Materials and Methods: 274 NSCLC patients who accepted 125mg icotinib/t.i.d. were chosen from a phase III study. Blood samples were obtained in $672^{nd}$ ($4^{th}$ week) and $1,680^{th}$ hours ($10^{th}$ week), and plasma was used to quantify the concentration of icotinib and blood cells were sampled to check the genotypes. Clinical data were also collected at the same time, including EGFR genotypes. Plasma concentrations were assessed by HPLC-MS/MS and genotype by sequencing. All data were analyzed through SPSS 17.0 and SAS 9.2. Results: CYP 2C19 genotypes affected bio-transformation from icotinib to M24 and M26, especially in poor-metabolisers. Higher icotinib concentrations (>1000 ng/mL) not only increased patient PFS and OS but also reduced tumor metastasis. Patients with mutant EGFR experienced a higher median PFS and OS (234 and 627 days), especially those with the 19del genotype demonstrating higher PR ratio. Patients who suffered grade II skin toxicity had a higher icotinib exposure than those with grade I skin toxicity or no adverse effects. Liver toxic reactions might occur in patients with greater M20 and M23 plasma concentrations. Conclusions: CYP2C19 polymorphisms significantly affect icotinib, M24 and M26 exposure. Patients with mutant EGFR genotype and higher icotinib concentration might have increased PFS and OS and lower tumor metastasis. Liver ADR events and serious skin effects might be respectively induced by greater M20, M23 and icotinib concentrations.

• 정신신체의학
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• 제30권2호
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• pp.66-72
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• 2022

클로자핀은 치료 저항성 조현병 약물치료의 "최적 표준(gold standard)"으로 받아들여지고 있다. 클로자핀은 다른 항정신병약물에서 흔히 나타나는 추체외로 증후군, 지연이상 운동증을 거의 일으키지 않고 고프로락틴의 일시적인 상승만 보이는 한편, 발열 등의 약물 이상반응이 흔하게 나타난다. 치료 시작 시기에 드물게 무과립구증, 신경이완제 악성증후군과 같은 치명적인 부작용과 연관된 발열이 발생할 수 있으며, 이 경우 클로자핀을 즉시 중단해야 한다. 그러나 발열의 양성 원인은 생명을 위협하는 부작용보다 훨씬 빈번하므로 치료 시작 시기에 발열을 보이는 경우 무조건 클로자핀을 중단하는 것은 타당하지 않다. 또한, 치료 유지 시기에도 언제든지 발열은 발생할 수 있다. 특히 폐렴의 위험은 시간이 지남에 따라 감소하지 않으며, 클로자핀은 다른 항정신병약물 보다 폐렴의 위험이 높으므로 항상 이를 염두에 두고 치료제 모니터링을 통하여 약물 용량을 결정하는것이 권장된다.

• 한국임상약학회지
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• 제24권3호
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• pp.219-228
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• 2014

Objectives: This paper was aimed to investigate the adhesion control standards of pain relieving patch (PRP) drugs and to survey it's adverse effects on the skin of patients for safe use of PRP drugs. Methods: In this study, the related documents of PRP drugs of Korea pharmacopoeia (KP), United States pharmacopoeia (USP), Japanese Pharmacopoeia (JP), European pharmacopoeia (EP), and information web sites of the Ministry of Food and Drug Safety (MFDS) were surveyed. Also, the past and current labeling of PRP drugs marketed in the pharmacy was investigated and compared. Results: In KP and JP, the lower limit standard for PRP's adhesion control is established, but the upper limit standard is not designated. In USP and EP, neither the lower nor upper limit standard is established. The main reasons of skin adverse effects are considered as inherent adverse reactions of the applied drugs for PRP. Another reason is involved in patient's medication mistakes related to PRP's adhesion control, respiratory depression of skin according to physical skin closure, and microbial growth, etc. Conclusion: For safe use of PRP drugs, we proposed ensured guidelines like additional instructions of pharmacist's prescription and detailed labeling systems for usage of PRP drugs applied on skin.

• Korean Journal of Acupuncture
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• 제37권4호
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• pp.253-261
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• 2020

Objectives : This study aimed to evaluate adverse outcome associated with acupotomy and compare it with that of acupuncture. Methods : We retrospectively analyzed the chart records of 71 patients who received acupotomy at Daemyung Korean medical clinic from January 7, 2020 to March 6, 2020. We divided the acupotomy treatment area into 10, including the head, hand, chest, knees, shoulders, low back, neck, upper extremities, thighs, and feet. Furthermore, we investigated the adverse effect of acupotomy on those areas after treatment. Data were analyzed using descriptive statistics, and frequency analysis. Results : 'Bruise of specific region' accounted for the largest portion with 29 cases, followed by 24 cases of 'feeling tired and sleepy' and 17 cases of 'itch'. There were 16 cases of 'sustained pain' at the area of treatment, 11 cases of 'fatigue', 5 cases of 'swelling', 5 cases of 'dizziness', 4 cases of 'hematoma'. There were 3 cases of 'vertigo' and 2 cases of 'parathesia' and 'wide bruises', 'headache', 'gastric discomfort', 'bleeding', and 'skin rash' each. There was one case each that experienced 'unclear pronunciation', 'nausea', 'abnormal sweating', 'vomiting' and 'emotional/psychological reactions'. Conclusions : Adverse outcomes associated with acupotomy were mostly 'bruise of specific region', 'feeling tired and sleepy', 'itch', 'sustatained pain', and 'fatigue'. However, no adverse outcome or irreversible damage that have a serious effect on the body were observed.

• Clinical and Experimental Pediatrics
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• 제59권2호
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• pp.47-53
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• 2016

Food allergy is common and sometimes life threatening for Korean children. The current standard treatment of allergen avoidance and self-injectable epinephrine does not change the natural course of food allergy. Recently, oral, sublingual, and epicutaneous immunotherapies have been studied for their effectiveness against food allergy. While various rates of desensitization (36% to 100%) and tolerance (28% to 75%) have been induced by immunotherapies for food allergy, no single established protocol has been shown to be both effective and safe. In some studies, immunologic changes after immunotherapy for food allergy have been revealed. Adverse reactions to these immunotherapies have usually been localized, but severe systemic reactions have been observed in some cases. Although immunotherapy cannot be recommended for routine practice yet, results from recent studies demonstrate that immunotherapies are promising for the treatment of food allergy.

• 한국미생물생명공학회:학술대회논문집
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• 한국미생물생명공학회 2001년도 Proceedings of 2001 International Symposium
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• pp.146-148
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• 2001

The objective of this study was to investigate the behavior of ribonuclease A (RNase) at the water/methylene chloride interface. It was aimed at better understanding the denaturation of proteins upon emulsification. RNase was vulnerable to the interface-induced aggregation reactions that led to formation of water-insoluble aggregates upon emulsification. Biochemical analyses demonstrated that intermolecular covalent linkages might have been involved in the aggregation reactions. The protein instability observed with emulsification was traced to consequences of protein adsorption and conformational rearrangements at the interface. These results indicated that emulsifying aqueous protein solutions in organic solvents should be handled with care, since emulsification could bring denaturation and aggregation to proteins.

• 대한족부족관절학회지
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• 제27권2호
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• pp.67-70
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• 2023

Vaccines can cause adverse reactions, such as soreness, swelling, or redness at the injection site. Some reactions are associated with fever and rash, which are usually mild and transient, and serious side effects are rare. In particular, there are no reports of systemic infection following a COVID-19 vaccination. The authors present a case report of a patient who developed multiple abscesses caused by Staphylococcus aureus after a COVID-19 vaccination. The patient had no previous symptoms or signs of infection. The patient was controlled successfully after surgical and antibiotics treatment.

• 한국응용약물학회:학술대회논문집
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• 한국응용약물학회 2006년도 Proceedings of The Convention
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• pp.43-48
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• 2006