• 대한예방한의학회지
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• 제22권3호
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• pp.11-19
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• 2018

Objectives : The aim of this study is to investigate the current research trend of herbal medicine based on the published articles in pharmacoepidemiologic journals. Methods : A total of 3 electronic journals, Pharmacoepidemiology and Drug Safety(PDS), Drug Safety and Journal of Pharmacoepidemiology and Risk Management(JPERM) from January 2013 to August 2018 were used for searching articles about herbal medicine. Selected articles were reviewed and classified under 5 categories-collection of adverse events in herbal medicine, statistical modeling and methodology, pharmaco-epidemiologic outcome study, drug utilization review(DUR), risk management system and regulation. Results : A total of 8 articles were finally included for analysis. 2 articles were categorized in collection of adverse events in herbal medicine, 1 was statistical modeling and methodology, 2 were pharmacoepidemiologic outcome study and 3 were risk management system and regulation. There was no article in DUR. And then pharmacoepidemiologic research trends of herbal medicine were summarized in classification of 5 categories. Conclusions : To sum up with these 8 articles of herbal medicine in pharmacoepidemiologic journals, herbal medicine was of interesting concern among researchers. The need for research on safety and risk management of herbal medicine is steadily increasing, pharmacoepidemiologic research about herbal medicine must be activated in Korea.

• 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.

• Biomaterials and Biomechanics in Bioengineering
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• 제1권3호
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• pp.131-150
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• 2014

Vascular stenting has a great attention as a treatment for coronary arteries diseases as compared with percutaneous balloon angioplasty. In-stent restenosis and thrombosis are side effects resulting from using bare metal stent (BMS). Employing platelet therapy allowed to reduce the rate of thrombosis, however, the rate of restenosis remains a major problem. In 2002, drug-eluting stents (DESs) were introduced as an effort to reduce the restenosis. The commercially available DESs continue to suffer from coating defects that might lead to a series of adverse effects. Most importantly, multiple concerns remain regarding the polymer coating integrity on metal surfaces or the relation of polymer irregularities to longterm adverse events.

• 대한임상약리학회:학술대회논문집
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• 대한임상약리학회 1997년도 정기총회 및 추계학술대회
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• pp.38-38
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• 1997

• Korean Journal of Acupuncture
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• 제25권2호
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• pp.95-105
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• 2008

Objectives : This study is to establish the appropriate assessment of causalities from adverse events (AEs) which are related to acupuncture treatment. Methods : We assessed thirty AEs which were caused in the early phase trial on concomitant use of acupuncture and herbal medicines. We scored each AE on the questionnaire in Naranjo and SNU algorithm scale which are for drug causality assessment in pharmacoepidemiology. Results : In Naranjo scale, there were consistencies among the evaluators qualitatively with "Probable", "Possible" degree. In reliability test, parameters, such as, gamma and kendall's tau-b revealed the degrees of 73%, and 32%, respectively. There were disaccordant tendency in SNU algorithm scale. Conclusion : A new algorithm which reflects acupuncture properties should be developed and elucidated.

• 한국임상약학회지
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• 제15권2호
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• pp.94-99
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• 2005

The aim of this study was to evaluate the safety and efficacy of treatment of mesoglycan. This study was conducted between September 2003 and May 2004. A total of 292 patients with vascular disorders including cerebral infarction were enrolled. The patients were administered with 50-100mg of mesoglycan by an oral route everyday for eight weeks. Subjective physicians' assessments of efficacy had ratings of 'improvement', 'invariability', 'exacerbation' and 'not being able to assess'. An improvement was observed in 241 patients out of 274; 18 patients were rules out. The efficacy rate was influenced statistically significantly by the duration of therapy (p=0.0392) and daily mean drug dose (p<0.0001). The adverse events were reported in 8 patients (9 cases) out of 292 patients: skin/appendages disorders (0.7%), liver/biliary system disorders (0.7%), cardiovascular system disorders (0.7%), neurologic disorders (0.3%). respiratory disorders (0.3%) and gastrointestinal system disorders (0.3%). There showed no serious adverse events. These results indicate that mesoglycan was well tolerated and effective for the prevention of vascular disorders.

• Biomolecules & Therapeutics
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• 제14권1호
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• pp.56-65
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• 2006

Adverse drug events (ADEs) are the most common type of adverse events in medical practice. Hospital admissions related to ADEs cost high and should be monitored to prevent them. While concerns about the ADEs are increasing, the frequency and characteristics of admissions related to ADEs have not been reported in Korea. The objective of the study was to assess the rate of hospital admission related to ADEs and their characteristics through ADE signal-based retrospective reviews of medical records. As results, a total of 1,420 patients had ADE signals suggesting potential ADEs from 3,494 patients who discharged from an academic medical center over one month period. Six pharmacists independently assessed the presence of ADEs after the review of patients' medical records. Among the 3,494 discharges, 62 admissions (1.8%) were found to be realted to ADEs. Of admissions with ADEs, 83.9% were moderate (category F by the NCC MERP classification), 37.2% were preventable, and 85.5% were type A reaction. The most frequent suspected drugs causing ADEs were antineoplastics (48.9%), and the most frequent ADE signal detecting hospital admissions related to ADEs was white blood cell count (24.2%). Hospital admissions related to ADEs were found through screening the ADE signals. The ADE signal-based retrospective review could be a practical approach for identifying hospital admissions related to ADEs.

• 대한임상독성학회지
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• 제13권1호
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• pp.1-10
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• 2015

Purpose: The purpose of this study was to evaluate the usefulness of intravenous lipid emulsion as well as adverse events in acute poisoning patients. Methods: Literature was accessed through PubMed, EMBASE, Cochrane library, Web of science, and KoreaMed. All forms of literatures relevant to human use of intravenous lipid emulsion for acute poisoning were included. Cases reports or letters without description of clinical outcomes for each case were excluded. The literature search was conducted by two investigators in March, 2015, with publication language restricted to English and Korean. The effect, onset time, and adverse event of lipid emulsion and final outcome of each case were analyzed. Results: Eighty-one published articles were included, excluding articles whose title and abstract were not relevant to this study. No articles were classified as high level of evidence. Sixty-eight case reports were identified, consisting of 25 local anesthetics and 43 other drugs, such as tricyclic antidepressants and calcium channel blockers. Although most cases described significant clinical improvements, some of them showed no beneficial effect or worsening of clinical course. Several adverse events including hyperamylasemia and laboratory interference were reported. Conclusion: Although there were many case reports illustrating successful use of lipid for various drug poisonings, the effect cannot be estimated due to significant possibility of publication bias. Therefore, lipids might be considered in severe hemodynamic instability resulting from lipophilic drug poisoning, however further studies should follow to establish the use of lipid as the standard of care.

• 한국임상약학회지
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• 제31권2호
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• pp.104-114
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• 2021

Objective: To explore the perception of drug utilization review (DUR) system and DUR modernization pilot project among healthcare professionals and patients. Methods: We conducted 8 times of focus group interviews (FGI) between August 1, 2019 to December 31, 2019. The healthcare professionals and patients who participated in the DUR modernization pilot project were included in the present study. Based on the type of project participation or medical institution, the participants were divided into the following four groups: group 1, hospital; group 2, clinic; group 3, pharmacy; and group 4, patient. Within each group, interviews were conducted under a pre-defined agenda to identify the implicit perceptions of the participants; the contents of the interviews were, then, categorized. Results: Healthcare professionals established a consensus on the positive aspects of the DUR system and DUR modernization pilot project. However, substantial concerns remain, such as additional workload associated with monitoring adverse events or acquiring consents from patients. Furthermore, a difference of opinion over the DUR convenience system was observed. Among 3 DUR convenience system, the personal medication history review service was highly utilized, but pop-up hold function and communication system was rarely used. Conclusion: We observed that systematic intervention using the DUR system is effective for both healthcare providers and consumers. Adverse events caused by inappropriate drug use can be prevented by continuous patient monitoring. Therefore, the role of DUR system needs to be expanded to establish a safe drug management system.

• Journal of Dental Anesthesia and Pain Medicine
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• 제22권6호
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• pp.395-404
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• 2022

Hydroxyzine is one of the most popular oral sedatives used in pediatric dentistry. This study aimed to investigate the safety and possible side effects of sedation using hydroxyzine in pediatric dentistry. "Hydroxyzine," "Dental sedation," "Child," and "Safety" and their associated synonyms were searched using the Cochrane Library, Embase, PubMed, KISS, KMBASE, and KoreaMed databases. Academic information and portals of DBpia and RISS were also perused. Altogether, 340 papers were found, among which a total of 24 papers were selected according to the detailed criteria. Nine studies used hydroxyzine as monotherapy, and 10 studies compared its safety when hydroxyzine used as multitherapy. In addition, seven studies employed a drug regimen wherein hydroxyzine was one of the components. All these studies revealed that the adverse events specific to hydroxyzine usage were drowsiness and dryness of the mouth, and that there were respiratory complications due to a synergistic reaction of hydroxyzine. Although classified as a histamine blocker, hydroxyzine with its sedative, antiemetic, anticonvulsant, and anticholinergic properties is an oral sedative available without serious adverse events, If the proper dosage of the drug is used and its synergistic effects with other drugs are ascertained in the route of administration.