• 폴리머
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• 제33권3호
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• pp.219-223
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• 2009

전기방사 공정을 이용하여 제조된 나노파이버는 나노 소자, 필터, 방호닦, 항균성 드레싱 및 약물전달 등 다양한 분야에서 이용되고 있다. 약물전달시스템(drug delivery system, DDS)은 기존 의약품의 부작용을 최소화하며 그 효능 및 효과를 극대화할 수 있어야 하고 필요한 양의 약물을 원하는 환부에 효율적으로 전달할 수 있어야 한다. 본 연구에서는 전기유체역학공정의 하나인 전기방사공정을 이용하여, poly($\varepsilon$-carprolactone)(PCL) poly(ethylene oxide(PEO)를 나노파이버 매트로 만들었으며, 고분자와 동시 방사된 Rhodamine B의 방출량을 측정하였다. PCL/Rhodamine B/PEO/PCL 나노파이버 매트는 전기방사 시간을 통한 두께 조절을 통하여 약물전달 거동이 조절될 수 있음을 확인하였으며, 실제 Peptide를 PEO와 동시 전기방사시켜 얻어진 나노파이버 peptide가 방출되는 거동을 확인하였다. PCL/Peptide/PEO/PCL시스템에서 방출된 peptide는 약물방출 시험 후에도 약물로서의 활성도를 잃지 않았으며, 이러한 나노파이버를 이용한 Peptide 방출메커니즘은 새로운 약물전달시스템으로 적용 및 응용될 수 있을 것으로 예상된다.

• 한국임상약학회지
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• 제10권1호
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• pp.30-37
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• 2000

Adverse drug reactions (ADR) may result in increased hospital admissions, morbidity and mortality, adding extra cost to healthcare expenditures. Thus, it is critical to activate ADR monitoring and reporting program in tertiary hospitals in developing countries such as Korea. This study was performed to identify the types of ADR being reported in a tertiary hospital, Samsung Medical Center, and to find out the ways to improve current ADR monitoring system. Of 464 ADR reports submitted to the pharmacy department during the 6-month survey period, $97.8\%$ of the reports were from out patient and $48.5\%$ were from patients aged between 50 and 60. The medical department with the highest frequency in ADR reporting was Internal Medicines $(35.6\%)$. The most common ADR manifestations were gastrointestinal complaints $(43.4\%)\;and\;75\%$ of the reported cases were mild in their severity. The most common drugs suspected of causing ADR were CNS drugs which accounted for $32.8\%$. In terms of causality assessment, $85.1\%$ of the reports were probable cases by WHO causality assessment criteria. In regards to sources of report, $75.6\%$ of ADR were reported by physicians and $24.4\%$ by nurses. There were no ADR reported by pharmacists. In conclusion, there is an urgent need to improve ADR monitoring system for inpatient and to motivate pharmacist involvement in ADR monitoring and reporting in Korea.

• 한국자원식물학회지
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• 제31권4호
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• pp.322-329
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• 2018

최근 식품의약품안전처에서 그동안 의약외품으로 분류되었던 '탈모 증상 완화' 관련 제품이 기능성 화장품의 범주에 포함됨에 따라서 관련 산업계에 큰 관심 중 하나라고 할 수 있다. 본 연구에서는 기존 의약품들의 한계점인 부작용의 위험률이 적으면서 탈모를 과학적으로 조절시켜줄 수 있는 객관적인 근거를 제시할 수 있는 천연물 유래 신소재를 발굴하고자, 오리나무 가지로부터 분리한 oregonin은 강력한 활성산소종 소거능을 가지며 탈모와 연관성이 높은 모유두 세포의 사멸을 명확하게 조절함을 확인하였다. 결론적으로 oregonin을 포함한 오리나무 추출물은 두피에서 발생한 활성산소를 강력하게 제거하는 효능을 기반으로 하여, 산화적 스트레스에 의한 모유두세포의 사멸 억제 및 조절을 통하여 탈모방지 효과를 기대할 수 있는 천연 탈모 방지 및 양모 신소재로서의 개발가능성이 있는 것으로 확인하였다.

• 한국임상약학회지
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• 제28권4호
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• pp.293-299
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• 2018

Background: 3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) effectively reduce serum levels of low-density lipoprotein (LDL) and total cholesterol. High-intensity statins are recommended for all patients aged ${\leq}75$ with clinical atherosclerotic cardiovascular disease (ASCVD), diabetes mellitus aged 40-75 with ${\geq}7.5%$ estimated 10-year ASCVD risk and LDL-C ${\geq}190mg/dL$. High-intensity statins associated with more frequent adverse events (AEs) compared to moderate- to low-intensity statins. The aim of this study was to compare AEs between high-intensity and moderate- to low-intensity statin group using the Korea Adverse Event Reporting System (KAERS) database. Methods: Adults (${\geq}18years$) with statin-associated AEs from July 2009-June 2014 were included. Only AEs classified as "certain", "probable" and "possible" based on the WHO-Uppsala Monitoring Center criteria were analyzed. Results: In total, 247 AEs from 196 patients [high-intensity statin group (HG), n = 25 (13%); moderate- to low-intensity statin group (MLG), n = 171 (87%)] were included. Mean age was higher in HG compared with MLG ($67{\pm}14$ vs $62{\pm}12$). The HG showed a significant higher frequency of liver/biliary system disorders (37% vs 14%, p = 0.001). Hepatic function abnormal was reported more frequently in HG compared to MLG (26% vs 9%, p = 0.006). Conclusion: According to KAERS data, liver/biliary system disorders were more frequently reported in HG compared to MLG.

• 한국임상약학회지
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• 제32권1호
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• pp.1-7
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• 2022

Objective: The purpose of this study was to detect signals of Adverse Events (AEs) after varenicline treatment using spontaneous AEs reporting system in Korea. Methods: This study was conducted by Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) reported from January 2013 to December 2017 through Korea Adverse Event Reporting System. Signals of varenicline that satisfied the data-mining indices, proportional reporting ratio, reporting odds ratio and information component were defined. The detected signals were checked whether they included in drug labels in South Korea and United States of America (USA). Results: A total number of drug AE reports associated with all drugs in the KIDS-KD reported between January 2013 and December 2017 was 2,665,429. Among them, the number of AE reports associated with varenicline was 1,398. Eighteen meaningful signals of varenicline were detected that satisfied with the criteria of data-mining indices. Finally, two signals such as hypotonia, incorrected dose administered were not included in the drug labels. Conclusion: New AE signals of varenicline that were not listed on the drug labels in South Korea and USA were detected. However, further pharmacoepidemiological studies such as randomized controlled trial are needed to evaluate the causality of the signals of varenicline.

• 한국임상약학회지
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• 제33권2호
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• pp.122-127
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• 2023

Background: This study was aimed to identify the safety signals of metoclopramide in Korea Adverse Event Reporting System (KAERS) database by proportionality analysis methods. Methods: The study was conducted using Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) reported from January 2013 to December 2017 through KAERS. Signals of metoclopramide that satisfied the data-mining indices of proportional reporting ratio (PRR), reporting odds ratio (ROR) and information component (IC) were defined. The detected signals were checked whether they included in drug labels in the Ministry of Food and Drug Safety (MFDS), U.S. Food and Drug Administration (FDA) and Micromedex^®. Results: A total number of drug AE reports associated with all drugs of data in this study was 2,665,429. Among them, the number of AE reports associated with metoclopramide was 22,583. Forty-two meaningful signals of metoclopramide were detected that satisfied with the criteria of data-mining indicies. Especially neurological signals including extrapyramidal reactions, represented in the safety letter of regulatory agencies were identified in this study. Conclusion: Neurological signals of metoclopramide including extrapyramidal reactions were detected. It is believed that this search for signals can contribute to ensuring safety in the use of metoclopramide.

• 한국임상약학회지
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• 제33권2호
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• pp.86-96
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• 2023

Background: Using KIDS-KAERS database (KIDS-KD) from 2016 to 2020, the aim is to investigate signals of adverse events of alpha-adrenoceptor antagonists and to present adverse events that are not included in the precautions for use when marketing approval. Methods: This study was conducted by disproportionality analysis. Data mining analysis was performed to detect signals of alpha-adrenoceptor antagonists, such as terazosin, doxazosin, alfuzosin, silodosin, and tamsulosin. The signal was defined by three criteria as proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). Detected signals were compared with product labeling and the European Medicines Agency-Important Medical Events list. Results: Out of the total number of 408,077 reports for adverse events, 6,750 cases were reported as adverse events of alpha-adrenoceptor antagonists. Dizziness, mouth dryness, hypotension postural, and oedema peripheral are identified as common adverse events of five alpha-adrenoceptor antagonists and are typically listed on drug labels. However, new signals were detected for pneumonia, chronic obstructive airway disease, eye diseases such as glaucoma and cataracts, fracture, and ileus of tamsulosin that were not previously listed on the drug labels in Korea. Conclusions: This study identified signals related to adverse drug reactions of alpha-adrenoceptor antagonists and presented serious adverse events, suggesting new adverse reactions to be aware of when using alpha-adrenoceptor antagonists.

• 산업융합연구
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• 제21권9호
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• pp.23-32
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• 2023

게임을 통해 건강을 증진할 수 있는 건강 기능성 게임(SGHs)에 대한 관심이 고조되고 있다. 디지털 치료제(DTx)는 유효성과 안전성을 확보한 치료제이기 때문에 전통적인 의약품 유통방식을 따라야 하지만, SGHs는 웰니스 제품으로 DTx에 비해 보급과 확산이 유연하다. 또한 SGHs는 일시적인 치료 효과가 아닌 지속적인 모니터링과 피드백을 통해 맞춤형 서비스를 제공할 수 있어 효과적이며, SGHs를 인지장애치료나 행동교정 등에 적용할 경우 오작동과 부작용이 경미하다. 본 연구는 SGHs의 지각된 혜택과 위험을 동시에 고려하는 밸런스 프레임워크(Valence Framework)를 기반으로 142명의 학부생을 대상으로 설문을 수집하여 지각된 혜택만이 SGHs 사용 의도에 통계적으로 유의한 정(+)의 영향을 준다는 점을 실증하였다. 이러한 결과를 바탕으로 일반 사용자를 대상으로 한 SGHs 수용에 있어 혜택(유효성)을 중심으로 홍보하고, 데이터 주도형 (data-driven) 접근방법의 중요성과 데이터 주도형 유통 및 분석 플랫폼 전략의 필요하다는 시사점을 제시하였다.

• 한국임상약학회지
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• 제34권2호
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• pp.126-133
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• 2024

Background: Medication's benefits and harms require careful management. Laws mandate pharmacists to provide essential medication details since inadequate counseling may pose risks. This study explores public expectations for pharmacist-provided side effect information to enhance safety. Methods: A self-developed questionnaire was created for participant to self-report, refined through pilot surveys with experts and laypersons. Nineteen items were categorized into four sections, using closed-ended questions. Adults over 20, having obtained prescription medications within the past year, were surveyed via convenience sampling. Data analysis employed descriptive statistics and T-tests using IBM SPSS Statistics 21 and Microsoft Excel. Results: The study involved 189 participants, with a slightly higher proportion of females (59.3%) than males (40.7%), predominantly in their 20s (45.0%) and college graduates (57.1%). Health professionals represented 76.2% of respondents. Over half visited pharmacies at least 5 times yearly for prescriptions. Indirect experience with side effects was more common (30.2%) than direct experience (17.5%). Most (82.0%) showed interest in media-reported side effect events. Satisfaction with pharmacist-provided side effect explanations was low (59.7%), but importance was high (98.9%). Preferences favored combined verbal and written explanations (65.1%), with a majority desiring explanations for common but less serious side effects (82.5%). Healthcare professionals found explanations significantly more sufficient than non-professionals did. Older individuals, those living with elderly, and frequent pharmacy visitors attributed greater importance to pharmacist-provided explanations. Conclusion: Koreans view pharmacist-provided medication side effect explanations as vital but find current services lacking. Enhancements in content and delivery methods are needed in pharmacy counseling to meet public expectations.

• 핵의학기술
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• 제14권2호
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• pp.45-49
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• 2010

뇌조 조영술에 이용되는 방사성의약품들 중 최근에는 Tc-99m DTPA를 이용한 뇌 척수액 영상이 대부분이다. 하지만 Tc-99m DTPA는 사용 시 무균수막염, 근육강직, 경련 등 여러 부작용이 발생할 우려가 있다. 따라서 Tc-99m DTPA의 이러한 부작용의 발생을 사전에 예방하기 위하여 안정성검사를 시행하였으며 그 유용성을 알아보고자 한다. 방사성의약품 Vial검사는 2008년 12월 16일 - 2009년 12월 30일에 뇌조조영술을 시행한 환자(n=12)를 대상으로 시행하였으며, 시술시 사용한 vial내의 DTPA 성분 (Mallinckrodt사의 Techscan-DTPA사용), NaPertechnate radiation dose 및 volume, 생리 식염수량, 환자주사용 용량 및 activity 등을 측정하여 순수 DTPA의 양을 계산하였다. 방사성의약품의 내독소평가(Bacterial endotoxin)는 2008년 12월 16일-2009년 12월 30일에 뇌조 조영술을 시행한 환자(n=12)를 대상으로 하였고, 이 때 사용한 DTPA vial의 Pyrogen test (LAL test)를 시행하였다. 시약이 함유된 Positive/Negative control vial(표준액)에 normal saline 0.2 mL을 주입하고, 동일한 Test control vial(실험액)에 normal saline 0.1mL 와 Tc-99m DTPA 0.1 mL로 주입하였으며 Digital hot plate에서 $37.5^{\circ}C$로 1시간 반응시킨 후 응고여부를 표준액과 대조하여 관찰하였다. 안정적인 제조절차 준수는 보존제(방부제)가 없는 미 개봉한 CaNa3 DTPA kit를 사용하였으며 Tc-99m DTPA는 한 Vial당 한명의 환자선량으로 뽑아 투여한다. 이때 적정 용량을 맞추기 위해 0.9% NaCl 멸균 생리 식염수를 사용하여 희석하였다. 방사성의약품 Vial검사는 측정된 성분값들로 순수 DTPA의 양을 얻어내었으며 이는 2가지의 계산식을 이용하여 선량 대비 DTPA의 용량(평균 0.88 mg), 용량 대비 DTPA의 용량(평균 0.74 mg)을 도출해내었다. 방사성의약품의 내독소 평가에서는 동일한 조건으로 시험(n=12)을 시행한 결과 모두 Bacterial endotoxin이 기준치인 단위 선량 당 14 endotoxin units (EU)미만의 반응인 Negative(-)로 나왔다. 안정적인 제조절차 준수에서는 검사 관련 sheet를 만들어 작성 및 제조절차 준수 여부를 확인하였으며 결과 모두 준수하여 제조과정 내에서 방사성의약품에 의하여 발생할 수 있는 부작용이 없었다. Tc-99m DTPA를 이용한 Cisternography 검사 시 항상 방사성의약품의 안정성문제가 제기되어 왔다. 수막강 내 주입용 방사성의약품으로서 제조 및 사용 시 불안정한 취급으로 부작용이 발생할 우려가 있으며, 이에 따른 사용지침이 확립되어야 한다고 생각되었다. 수막강 내 주입용 방사선의약품으로써 free acid 혹은 sodium을 포함하는 DTPA는 적절하지 않으며, 반면 Calcium이 포함된 DTPA는 적절한 것으로 알려져 있다. 위와 같이 Techscan-DTPA(Mallinckrodt): CaNa3으로 간단하며 편리하게 안정성검사를 시행할 수 있었으며 각 검사결과(n=12) 안정성검사를 모두 통과하여 검사 시 동반될 수 있는 부작용은 나타나지 않았다. 앞으로 위와 같은 SOP (Standard Operating Procedures)를 적용하여 보다 쉽고, 편리하게 안정성검사를 시행할 수 있으리라 사료된다.