• Translational and Clinical Pharmacology
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• 제26권3호
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• pp.118-127
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• 2018

The safety and efficacy of fimasartan have been evaluated through post-marketing surveillance in real world clinical practice. The multi-center, prospective, open-label and non-interventional study. A total of 3,945 patients (3,729 patients for safety assessment and 3,473 patients for efficacy assessment) were screened in patients with essential hypertension in 89 study centers from 9 September 2010 through 8 September 2016. Among the total patients, 2,893 patients (77.6%) were administered fimasartan for 24 weeks or longer and were classified as 'patients with long-term follow-up', and the additional safety and efficacy analysis were performed. The improvement was defined as systolic blood pressure (SBP) controlled to ${\leq}140mmHg$ or decreased SBP differences ${\geq}20mmHg$ after treatment or diastolic blood pressure (DBP) controlled to ${\leq}90mmHg$ or decreased DBP differences ${\geq}10mmHg$ after treatment. Adverse drug reactions (ADRs) were reported in 3.8% patients; dizziness, and hypotension were the most frequently reported ADRs in total patients. The results of patients with long-term follow-up were comparable with total patients. The overall improvement rate in all efficacy assessment at the last visit was 87.1% (3,025/3,473 patients). The overall improvement rate of the patients with long-term follow-up was 88.9%. Fimasartan was well tolerated, with no new safety concerns identified and an effective treatment in the real world clinical practice for Korean patients with hypertension.

• 한방안이비인후피부과학회지
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• 제25권2호
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• pp.20-37
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• 2012

Objectives : The primary purpose of present study is to evaluate the effect of a supplement of Bee Larva on tinnitus. the second is to comparatively evaluate safety of this supplement. Methods : Among those patients who visited Semyung Oriental Medical Center from January 11st, 2010 to February 20th, 2010, we screened 45 patients considered suitable for this study after some examinations and consent of the patients. they were devided into 2 groups. Group A took 5 tablets of this supplement everyday for 4 weeks, group B, placebo, in the same way. for 4 weeks, we checked changes in intensity, duration, extent of tinnitus on daily life and sleep and THI(Tinnitus Handicap Inventory) score. to evaluate safety of this supplement, adverse events, assessment of vital sign, hematologic examination were recorded. Result : Through 4 weeks of the clinical trial, we found that this supplement is effective on tinnitus and it improves intensity, duration and extent (its influence on daily life) of tinnitus, influence of tinnitus on sleep and THI score more effectively than the placebo drug. Also, in the assessment of the safety of the study the supplement of bee Larva and placebo drug, there were no adverse events and side effects over the average which need treatment for it. Moreover, there were not any abnormal findings in change of blood pressure and hematologic examination. Conclusion : According to this experiment, we confirmed that the supplement of bee Larva can be used effectively and safely on tinnitus.

• 대한한의학회지
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• 제43권3호
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• pp.150-163
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• 2022

Objectives: This research aimed to develop a guideline for evaluating safety and performance of electronic warm-acupuncture apparatus. With the development of medical devices like electronic warm-acupuncture apparatus with improved performance, convenience and safety measures compared to traditional warm-acupuncture needling, safety and performance guideline is a necessity. Methods: By referring to existing standards and guidelines of other electronic devices for Korean medicine with heating function, guideline for safety and performance assessment of electronic warm-acupuncture apparatus was drafted Results: The guideline, presents explanation for adequate temperature and settings of the apparatus, and safety measurements providing against thermal runaway situations along with guidelines for the manual. Guideline for detailed test method for the performance of the apparatus such as accuracy of temperature increase and the timer, and safety unit was also provided. The test items and suggested test methods for the requirements of biological, electrical and electromagnetic safety were referred to Korean approval documents of ministry of Food and Drug Safety. Conclusion: We proposed the relevant items to verify performance and safety of warm-acupuncture apparatus to assure patient safety and improve the quality of currently developing devices for application in clinical field.

• 한국임상약학회지
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• 제20권3호
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• pp.213-220
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• 2010

Therapeutic duplication (TD) is a serious problem that frequently occurring primarily in the ambulatory setting in Korea. Implementation of concurrent drug utilization review (DUR) is a promising way to reduce inappropriate prescription and dispensing, and improve patient safety. This study was aimed to develop the process of DUR module of TD. Sixty-five drug ingredients classified into the drug category of the antipyretic, analgesic, and anti-inflammatory drug approved in Korea (The KFDA-dess nated classification codes of 114 or 264) were reviewed for this purpose. The drug ingredients (and products) were reclassified based on WHO's Anatomical, Therapeutic and Chemical (ATC) classification system. The clinical practice guidelines, textbooks and product labels on therapeutic uses of these drugs in Korea and several fores n countries were reviewed. If the drugs were categorized into the same therapeutically duplicable class, they were defined not to be used concurrently because the concurrent use was "therapeutically duplicated (unnecessary or even harmful)". Among the studied drug products, the following 5 drug classes were considto beas "therapeutic duplication": (1), on-t tooid DURnti-inflammatory drugs (NSAIDs, including s Dicylates), (2),Anilidts, (3),Opioids, (4) Ergot Dk Doids and (5) 5-$HT_1$ receptor agonot s. Therefore, concurrent prescribing or dispensing of more than 2 drug ingredients any in the above same classes should be considered as TD and needed to be warrant for careful review by pharmacists before dispensing.

• 한국식품위생안전성학회지
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• 제26권1호
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• pp.57-63
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• 2011

다양한 식품첨가물의 사용과 소비가 증가하고 있으며, 최근 어린이기호식품을 통한 타르색소 등 첨가물의 섭취량이 늘어가고 있다. 본 연구는 시중 유통중인 학교 주변 어린이기호식품을 대상으로 식용색소 황색 제 4호(Y4), 황색 제5호(Y5), 청색 제1호(B1), 청색 제2호(B2), 적색 제2호(R2), 적색 제3호(R3), 적색 제40호(R40), 적색 제102호(R102), 녹색 제3호(03)등 국내 허용된 타르색소 9종에 대한 실태조사를 실시하고 모니터링 분석을 통하여 노출량, 위해성 평가를 수행하였다. 그 결과, 어린이기호식품 82종(과자류 3종, 캔디류 71종, 초콜릿 4종, 음료류 4종)을 통한 타르색소의 섭취수준이 매우 낮고 상위섭취군(95th percentile)에서도 일일섭취허용량(ADI)의 0~3.56%에 불과하였다. 결론적으로 어린이기호식품 섭취에 따른 어린이의 타르색소에 대한 위해성 수준은 매우 낮은 것으로 판단되며, 타르색소 9종 각각의 일일추정섭취량(EDI)이 평균적으로 FAO/WHO에서 권장하는 양보다 낮아 안전한 수준으로 평가되었다. 그러나 어린이기호식품에 사용되는 식품첨가물은 보편적으로 몇 가지 첨가물이 복합적으로 사용되고 있어 어린이의 식품첨가물 섭취에 대한 지속적인 모니터링과 그에 따른 적절한 관리가 필요할 것이다.

• 한국식품위생안전성학회지
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• 제26권4호
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• pp.448-453
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• 2011

본 연구는 학교주변에서 유통되는 어린이기호식품 중 빙과류, 음료류, 캔디류를 대상으로 인공감미료 4종(삭카린나트륨, 아스파탐, 아세설팜칼륨, 수크랄로스)의 사용실태와 사용량을 분석하였다. 이에 따른 어린이의 일일추정섭취량 (Estimated Daily Intake, EDl)을 산출하여 일일섭취허용량 (Acceptable Daily Intake, ADI)과 비교함으로써 위해성평가를 실시하였다. 어린이기호식품 섭취에 대한 인공감미료 4종의 함량을 분석한 결과, 빙과류, 음료류, 캔디류의 평균 함량은 삭카린나트륨의 경우 각각 0.41, 0.47, 0.00 mg/kg, 아스파탐은 0.00, 20.54, 197.09 mg/kg, 아세설팜칼륨은 0.00, 28.10, 0.00 mg/kg, 수크랄로스는 9.99, 1.40, 0.00 mg/kg으로 나타났다. 섭취량 분석 결과, 그 수준이 평균적으로 매우 낮고 상위섭취군(95th)에서도 ADI의 0~2.66%에 불과한 것으로 나타나 어린이기호식품 섭취에 따른 어린이의 인공감미료에 대한 위해성 수준은 매우 낮은 것으로 판단된다.

• 한국식품위생안전성학회지
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• 제27권1호
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• pp.1-17
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• 2012

T-2 toxin and HT-2 toxin, belong to type A trichothecences, are the most toxic mycotoxins among the trichothecene family. These mycotoxins are commonly found in cereals such as maize, wheat, barley, oats and rice, and their occurrence in food can be of concern. This review investigated the current trends of patents and researches on T-2 toxin and HT-2 toxin pertaining to natural occurrence, toxicity, metabolism, risk assessment, analytical and screening methods, and reduction/detoxification techniques. As compared with other $Fusarium$ mycotoxins, there are limited data for natural occurrence and risk assessment, and regulatory limit and official analytical methods on T-2 toxin and HT-2 toxin in domestic and foreign countries. In particular, selective deacetylation at the C3 and/or C4 positions of T-2 toxin by carboxyesterase present in foods was reported to cause the disappearance of T-2 and the extremely high HT-2 recoveries. Currently, regulatory limits for T-2 and HT-2 are under discussion in EU. For enforcement purposes it is essential to have available precise and reliable analytical methods applicable at the regulatory levels for the T-2 toxin and HT-2 toxin and relevant commodities. In addition, a further study on natural occurrence, risk assessment and reduction/detoxification techniques will be recommended.

• 대한한의학회지
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• 제42권3호
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• pp.44-55
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• 2021

Objectives: As the use of herbal medicinal products (HMPs) increases worldwide, systematic verification of the safety of HMPs is required. The induction of cardiotoxicity is one of the major factors in post-approval withdrawal of medicinal products, and drug-induced cardiotoxicity assessment is emerging as an important step in drug development. In the present study, we evaluated human ether-à-go-go-related gene (hERG) potassium channel-related cardiotoxicity to predict the risk of cardiac arrhythmia in thirteen herbal medicines known to have cardiac toxicity. Methods: We measured the inhibition rate of hERG potassium channel activity of 13 medicinal herbal extracts in hERG-expressing HEK 293 cells using an automated patch-clamping system. Quinidine was used as a positive control for inhibition of hERG activity. Results: Extracts of Evodiae Fructus, Strychni Semen, and Corydalis Tuber potently inhibited the activity of hERG, and IC₅₀ values were 3.158, 19.87, and 41.26 ㎍/mL, respectively. Cnidi Fructus, Ephedra Herba, Lithospermi Radix, Polygoni Multiflori Radix, Visci Ramulus et Folium, Asiasari Radix et Rhizoma, and Scolopendra weakly inhibited hERG activity, and the IC₅₀ value for each herbal medicine was more than 400 ㎍/mL. Aconiti Kusnezoffii Tuber and two types of Aconiti Lateralis Radix Preparata (Po and Yeom) had weak inhibitory activity against hERG, and the IC₅₀ values were more than 700 ㎍/mL. The IC₅₀ value of quinidine against hERG was 1.021 𝜇M. Conclusion: Evodiae Fructus, Strychni Semen, and Corydalis Tuber acted as potent inhibitors against hERG. These herbal medicines may cause cardiac arrhythmia through QT prolongation, so care should be taken when taking them.

• 한국식품위생안전성학회지
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• 제25권4호
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• pp.281-288
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• 2010

식품 중 아플라톡신 ($B_1+B_2+G_1+G_2$)의 기준은 곡류, 두류, 땅콩, 견과류 및 그 단순가공품 (분쇄, 절단 등), 곡류 가공품 및 두류가공품, 과자류 (땅콩 또는 견과류 함유식품), 장류, 고춧가루, 팝콘용 옥수수가공품, 기타 식품류 (찐쌀)에 대하여 15 ($B_1$은 10)${\mu}g/kg$ 이하로, 원유 및 우유류 중 아플라톡신의 기준은 $M_1$으로서 0.5 ${\mu}g/kg$ 이하로 설정되었다. 사과주스, 사과주스 농축액 중 파튤린의 기준은 50 ${\mu}g/kg$ 이하로 설정되어 있으며, 오크라톡신 A의 기준은 밀, 호밀, 보리, 커피콩, 북은 커피에 5 ${\mu}g/kg$, 인스턴트커피, 건포도 중 10 ${\mu}g/kg$, 포도주스, 포도주스 농축액, 포도주 중 2 ${\mu}g/kg$ 이하로 설정되었고, 푸모니신($B_1+B_2$)은 옥수수 중 4 mg/kg, 옥수수 단순가공품 및 옥수수 가루 중 2 mg/kg, 옥수수 가공품 중 1 mg/kg 이하로 설정되었다. 현재 식품 중 곰팡이독소에 대한 안전관리는 노출량 조사와 위해평가를 통해 합리적이고 과학적으로 설정되어 관리하고 있다.

• Safety and Health at Work
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• 제8권4호
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• pp.337-342
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• 2017

Background: Workplace violence (WPV) against healthcare workers (HCWs) employed in psychiatric inpatient wards is a serious occupational issue that involves both staff and patients; the consequences of WPV may include increased service costs and lower standards of care. The purpose of this review was to evaluate which topics have been focused on in the literature and which are new in approaching the concern of patient violence against HCWs employed in psychiatric inpatient wards, in the past 20 years. Methods: We searched for publications in PubMed and Web of Science using selected keywords. Each article was reviewed and categorized into one or more of the following four categories based on its subject matter: risk assessment, risk management, occurrence rates, and physical/nonphysical consequences. Results: Our search resulted in a total of 64 publications that matched our inclusion criteria. The topics discussed, in order of frequency (from highest to lowest), were as follows: "risk assessment," "risk management," "occurrence rates," and "physical/nonphysical consequences." Schizophrenia, young age, alcohol use, drug misuse, a history of violence, and hostile-dominant interpersonal styles were found to be the predictors of patients' violence. Conclusion: Risk assessment of violence by patients appeared the way to effectively minimize the occurrence of WPV and, consequently, to better protect mental HCWs. We found paucity of data regarding psychologic sequelae of WPV. According to these findings, we suggest the need to better investigate the psychologic consequences of WPV, with the aim of checking the effective interventions to assist HCW victims of violence and to prevent psychologic illness.