• Tuberculosis and Respiratory Diseases
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• 제78권4호
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• pp.321-325
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• 2015

Background: The adverse effects of the phosphodiesterase-4 inhibitor roflumilast, appear to be more frequent in clinical practice than what was observed in chronic obstructive pulmonary disease (COPD) clinical trials. Thus, we designed this study to determine whether adverse effects could be reduced by starting roflumilast at half the dose, and then increasing a few weeks later to $500{\mu}g$ daily. Methods: We retrospectively investigated 85 patients with COPD who had taken either $500{\mu}g$ roflumilast, or a starting dose of $250{\mu}g$ and then increased to $500{\mu}g$. We analyzed all adverse events and assessed differences between patients who continued taking the drug after dose escalation and those who had stopped. Results: Adverse events were reported by 22 of the 85 patients (25.9%). The most common adverse event was diarrhea (10.6%). Of the 52 patients who had increased from a starting dose of $250{\mu}g$ roflumilast to $500{\mu}g$, 43 (82.7%) successfully maintained the $500{\mu}g$ roflumilast dose. No difference in factors likely to affect the risk of adverse effects, was detected between the dose-escalated and the discontinued groups. Of the 26 patients who started with the $500{\mu}g$ roflumilast regimen, seven (26.9%) discontinued because of adverse effects. There was no statistically significant difference in discontinuation rate between the dose-escalated and the control groups (p=0.22). Conclusion: Escalating the roflumilast dose may reduce treatment-related adverse effects and improve tolerance to the full dose. This study suggests that the dose-escalated regimen reduced the rate of discontinuation. However, longer-term and larger-scale studies are needed to support the full benefit of a dose escalation strategy.

• Journal of Preventive Medicine and Public Health
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• 제34권1호
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• pp.9-20
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• 2001

Objectives : To explore the relationship between Percutaneous Transluminal Coronary Angioplasty(PTCA) volume and the associated immediate outcome. Methods : A total of 1,379 PTCAs were peformed in 25 hospitals in Korea between October 8 and December 31 in 1997. Data from 1,317 PTCAs (95.5%) were collected through medical record abstraction. Inter-observer reliability of the data was examined using the Kappa statistic on a subsample of 110 PTCA procedures from five hospitals. Intra-observer reliability of the data was also examined. PTCA success and immediate adverse outcomes were selected as the outcome variables. A successful PTCA was defined as a case that shows less than 50% diameter stenosis and more than 20% reduction of diameter stenosis. Immediate adverse outcomes included deaths during the same hospitalization, emergency coronary artery bypass graft (CABG) within 24 hours after PTCA, and acute myocardial infarction within 24 hours after PTCA. The numbers of PTCAs performed in 1997 per hospital were used as the volume variables. Results : Without adjusting for patient risk factors that may affect outcomes, procedures at high volume hospitals ($\geq200$ cases per year) had a greater success rate (P=0.001) than low volume hospitals. There was a marginally significant difference (P=0.070) in major adverse outcome rates between high and low volume hospitals. After adjusting for risk factors, there were significant differences in procedural failure and major adverse outcome rates between high and low volume hospitals. Conclusions : After adjusting for patient clinical risk factors, the hospital volume of PTCA was associated with immediate outcomes. It is recommended that a PTCA volume per year be established in order to improve the immediate outcome of this procedure in Korea.

• 한국산학기술학회논문지
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• 제21권8호
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• pp.87-97
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• 2020

본 연구는 노인허약의 유의미한 부정적 결과요인들을 검증해 그 인과적 관계를 실증하는 데 연구 목적을 두었다. 이를 검증하기 위해 본 연구는 전국노인실태조사 자료 중 2017년도 조사 자료를 활용하되 본 연구에서 설정한 가설 검증에 필요한 9개 변수만을 추출해서 활용하였다. 가설 검증 결과를 요약하면 다음과 같다. 6가지의 허약요인의 하위 변수들을 위계적 회귀분석에 투입해 부정적 결과요인의 하위 변수인 일상생활활동 장애, 도구적 일상생활활동 장애, 의료서비스 이용에의 영향관계에 대한 실증 결과 일상생활활동 장애에 미치는 영향 실증 결과에서는 최종 모형에서 신체활동, 감정 조절, 사회적 지지가 유의한 영향변수로 검증되었고 도구적 일상생활활동 장애에 미치는 영향 실증 결과에서는 최종 모형에서 신체활동, 감각기능, 인지력, 감정 조절, 사회적 지지가 유의한 영향변수로 검증되었으며 의료서비스 이용에 미치는 영향 실증 결과에서는 최종 모형에서 영양, 신체활동, 감각기능, 감정 조절, 사회적 지지가 유의한 영향변수로 검증되었다. 본 연구의 가설 검증 결과에 기초할 때 장애나 의료서비스 이용과 같은 부정적 결과에 영향을 미치는 노인허약요인을 구체적으로 식별해 그에 상응하는 개별화된 건강관리프로그램의 개발 및 실행이 필요하다.

• 한국임상약학회지
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• 제25권1호
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• pp.50-55
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• 2015

Background: Phosphodiesterase Type 5 Inhibitors (PDE5Is), which are prescription drug in South Korea, have been concerned about misuse, overuse and illegal provision of the drugs. This study was performed to investigate utilization and safety of illegal Phosphodiesterase Type 5 Inhibitors (PDE5Is), and related factors among South Korean men. Methods: A questionnaire survey was conducted from May to July in 2013 among 1,500 nationally representative general males using computer-assisted telephone interview (CATI). The questionnaire included the characteristics of population, the characteristics of PDE5Is use, the experience with the use of illegally obtained PDE5Is, and adverse events after PDE5Is use. Results: Among study population, the 1,015 (67.7%) men answered that they have used the illegally obtained PDE5Is. Younger age, single, lower frequency of PDE5Is use in a lifetime was associated with an increased use of illegally obtained PDE5Is. The men experienced adverse events after PDE5Is use is 528 (35.2%). The most common adverse event was mild to moderate hot flashes. Conclusion: We need to enhance awareness about the risk of illegally obtained PDE5Is use, especially in younger men and single. Proactive educations and public relations on safe use of PDE5Is for proper patients are needed.

• Gut and Liver
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• 제12권6호
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• pp.694-703
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• 2018

Background/Aims: Limited data exist comparing the safety and efficacy of direct-acting antivirals (DAAs) in hepatitis C virus (HCV) monoinfected and HCV/human immunodeficiency virus (HIV) coinfected patients in the real-world clinic practice setting. Methods: All HCV monoinfected and HCV/HIV coinfected patients treated with DAAs between January 2014 and October 2017 in community clinic settings were retrospectively analyzed. Pretreatment baseline patient characteristics, treatment efficacy, factors affecting sustained virologic response at 12 weeks (SVR12) after treatment, and adverse reactions were compared between the groups. Results: A total of 327 patients were included in the study, of which 253 were HCV monoinfected, and 74 were HCV/HIV coinfected. There was a statistically significant difference observed in SVR12 when comparing HCV monoinfection and HCV/HIV coinfection (94% and 84%, respectively, p=0.005). However, there were no significant factors identified as a predictor of a reduced response. The most common adverse effect was fatigue (27%). No significant drug interaction was observed between DAA and antiretroviral therapy. None of the patients discontinued the treatment due to adverse events. Conclusions: In a real-world setting, DAA regimens have lower SVR12 in HCV/HIV coinfection than in HCV monoinfection. Further studies involving a higher number of HCV/HIV coinfected patients are needed to identify real predictors of a reduced response.

• Archives of Plastic Surgery
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• 제48권5호
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• pp.483-493
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• 2021

Background Direct-to-implant (DTI) breast reconstruction after nipple-sparing mastectomy (NSM) with the use of acellular dermal matrix (ADM) provides reliable outcomes; however, the use of ADM is associated with a higher risk of complications. We analyzed our experiences of post-NSM DTI without ADM and identified the predictive factors of adverse surgical outcomes. Methods Patients who underwent NSM and immediate DTI or two-stage tissue expander (TE) breast reconstruction from 2009 to 2020 were enrolled. Predictors of adverse endpoints were analyzed. Results There were 100 DTI and 29 TE reconstructions. The TE group had a higher rate of postmastectomy radiotherapy (31% vs. 11%; P=0.009), larger specimens (317.37±176.42 g vs. 272.08±126.33 g; P=0.047), larger implants (360.84±85.19 g vs. 298.83±81.13 g; P=0.004) and a higher implant/TE exposure ratio (10.3% vs. 1%; P=0.035). In DTI reconstruction, age over 50 years (odds ratio [OR], 5.43; 95% confidence interval [CI], 1.50-19.74; P=0.010) and a larger mastectomy weight (OR, 1.65; 95% CI, 1.08-2.51; P=0.021) were associated with a higher risk of acute complications. Intraoperative radiotherapy for the nipple-areolar complex increased the risk of acute complications (OR, 4.05; 95% CI, 1.07-15.27; P=0.039) and the likelihood of revision surgery (OR, 5.57; 95% CI, 1.25-24.93; P=0.025). Conclusions Immediate DTI breast reconstruction following NSM is feasible in Asian patients with smaller breasts.

• 한국임상약학회지
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• 제22권1호
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• pp.41-46
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• 2012

Adverse drug reaction (ADR) is a global problem of major concern in health care. ADRs can be accrued in any organs or systems. However, cardiovascular ADRs could be a more serious problem if they are irreversible or severe. For this reason, this study was conducted to analyze pattern and severity of cardiovascular ADRs, and suspicious medication. Total 646 reports including cardiovascular ADRs reported to the KFDA between January and June 2010 were analyzed. Amlodipine besylate (36 reports, 3.3%), iopromide (29 reports, 2.7%), tramadol HCl (28 reports, 2.6%) were most suspicious drugs that occurred cardiovascular ADRs. The most common cardiovascular ADRs were hypotension( 236 reports, 33.1%), palpitation (134 reports, 18.8%), and hypertension (89 reports, 12.5%). The most frequent ADRs were occurred in the age group of more than 60. This result could be of help to prescribers and other healthcare providers to predict and prevent cardiovascular ADRs. Also this study suggested that patients with cardiovascular ADR risk factors should be intensively monitored during the medications.

• 한국임상약학회지
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• 제28권2호
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• pp.154-157
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• 2018

Levosulpiride is one of the most frequently prescribed medicines in Korea. An adverse drug reaction (ADR) after taking levosulpiride was reported at a community pharmacy in Korea. A 31-year-old woman reported the symptoms of lactation and amenorrhea after taking levosulpiride; an evaluation of whether these symptoms were caused by the medication was therefore necessary. Several tools can be used to determine if the ADR resulted from the administered drug or other factors, including the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) criteria, the Naranjo scale, and the Korean causality assessment algorithm (Ver. 2). The causality was evaluated as "possible" by the WHO-UMC and Naranjo scales, but as "probable" by the Korean causality assessment algorithm (Ver. 2). In conclusion, the information provided did not indicate definite causality and there were slight differences in the results obtained from each assessment method.

• Toxicological Research
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• 제35권4호
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• pp.319-330
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• 2019

Adverse drug reactions (ADRs) constitute key factors in determining successful medication therapy in clinical situations. Integrative analysis of electronic medical record (EMR) data and use of proper analytical tools are requisite to conduct retrospective surveillance of clinical decisions on medications. Thus, we suggest that electronic medical recording and human genetic databases are considered together in future directions of pharmacovigilance. We analyzed EMR-based ADR studies indexed on PubMed during the period from 2005 to 2017 and retrospectively acquired 1161 (29.6%) articles describing drug-induced adverse reactions (e.g., liver, kidney, nervous system, immune system, and inflammatory responses). Of them, only 102 (8.79%) articles contained useful information to detect or predict ADRs in the context of clinical medication alerts. Since insufficiency of EMR datasets and their improper analyses may provide false warnings on clinical decision, efforts should be made to overcome possible problems on data-mining, analysis, statistics, and standardization. Thus, we address the characteristics and limitations on retrospective EMR database studies in hospital settings. Since gene expression and genetic variations among individuals impact ADRs, pharmacokinetics, and pharmacodynamics, appropriate paths for pharmacovigilance may be optimized using suitable databases available in public domain (e.g., genome-wide association studies (GWAS), non-coding RNAs, microRNAs, proteomics, and genetic variations), novel targets, and biomarkers. These efforts with new validated biomarker analyses would be of help to repurpose clinical and translational research infrastructure and ultimately future personalized therapy considering ADRs.

• 한국임상약학회지
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• 제32권4호
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• pp.303-312
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• 2022

Objective: The purpose of the study was to analyze the difference in the importance and performance of the educational content of the community pharmacy practice and find the factors that influence it. Methods: A 5-point Likert scale questionnaire asked about the importance and performance of the pharmacy practice education items to community pharmacy preceptors, current students, and professors. Data were analyzed using Microsoft office 365 Excel and IBM SPSS 21.0. Results: A total of 117 people participated. The averages of importance and performance were 4.34±0.34 and 3.71±0.45, respectively. Except for the computational entry of prescriptions and medication history, the average score for the importance of all educational items was statistically significantly higher than the one for performance. Importance Performance Analysis (IPA) identified over-the-counter medication counseling, over-the-counter drug selection consultation, pharmacy management, adverse drug reaction monitoring, and understanding and implementation of drug use evaluation as the items that needed focused effort. Borich's needs were highest in the adverse drug reaction monitoring. Conclusions: Overall, high importance and low performance indicate a need for improvement in community pharmacy practice education. Since the demand for education was high in over-the-counter medication counseling, adverse drug reaction monitoring, and OTC drug selection consultation, various supports are urgently needed to strengthen pharmacy practice education in this area in the future.