• Title/Summary/Keyword: Adverse drug events

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Assessment of Inappropriate Medication Use and Dosage in Elderly Patients (입원 노인환자의 부적절 약물사용현황 및 용량적절성 평가)

  • Hong, Yu-Rhee;Lee, Suk-Hyang
    • YAKHAK HOEJI
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    • v.54 no.3
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    • pp.205-214
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    • 2010
  • This study aimed to evaluate the patterns of inappropriate medication use and inappropriate dosage in elderly patients in Korea. A retrospective study was performed for the elderly 65 years or older admitted from January 2007 to December 2007 in a medical center, Seoul, Korea. Potentially inappropriate medication (PIM) use in the elderly was evaluated using Beers criteria. Eighteen drugs out of Beers criteria were included in the formulary of the institute. Inappropriate dosage was set using Beers criteria, CMS (the Centers for Medicare& Medicaid Services) guideline, Geriatric Dosage Handbook. As results, the patients with PIM were 2,172 during the study period. The commonly used inappropriate medications were drugs for the nervous system (n=1237, 44.78%), the alimentary System (n=663, 24.54%) and the cardiovascular system (n=494, 18.28%). The elderly patients with prescription of inappropriate dosage were 10% out of patients with PIMs. The commonly inappropriate dosage drugs were digoxin (n=75, 27.27%), diazepam (n=70, 22.55%) and ferrous sulfate (n=66, 24.00%). Logistic regression analysis showed the number of PIM, days of hospital stay as predictors related to inappropriate dosage use. In conclusion, CNS drugs were frequently prescribed as PIM and inappropriate dosages were identified. It is needed to develop a means of decreasing adverse drug events in elderly.

Successful treatment with vedolizumab in an adolescent with Crohn disease who had developed active pulmonary tuberculosis while receiving infliximab

  • Choi, Sujin;Choi, Bong Seok;Choe, Byung-Ho;Kang, Ben
    • Journal of Yeungnam Medical Science
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    • v.38 no.3
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    • pp.251-257
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    • 2021
  • Vedolizumab (VDZ) has been approved for the treatment of inflammatory bowel diseases (IBDs) in patients aged ≥18 years. We report a case of a pediatric patient with Crohn disease (CD) who was successfully treated with VDZ. A 16-year-old female developed severe active pulmonary tuberculosis (TB) during treatment with infliximab (IFX). IFX was stopped, and TB treatment was started. After a 6-month regimen of standard TB medication, her pulmonary TB was cured; however, gastrointestinal symptoms developed. Due to the concern of the patient and parents regarding TB reactivation on restarting treatment with IFX, VDZ was started off-label. After the second dose of VDZ, the patient was in clinical remission and her remission was continuously sustained. Ileocolonoscopy at 1-year after VDZ initiation revealed endoscopic healing. Therapeutic drug monitoring conducted during VDZ treatment showed negative antibodies to VDZ. No serious adverse events occurred during the VDZ treatment. This is the first case report in Korea demonstrating the safe and effective use of VDZ treatment in a pediatric CD patient. In cases that require recommencement of treatment with biologics after recovery of active pulmonary TB caused by anti-tumor necrosis factor agents, VDZ may be a good option even in pediatric IBD.

Homeopathic mother tincture of Conium initiates reactive oxygen species mediated DNA damage and makes HeLa cells prone to apoptosis

  • Bishayee, Kausik;Mukherjee, Avinaba;Paul, Avijit;Khuda-Bukhsh, Anisur Rahman
    • CELLMED
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    • v.2 no.3
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    • pp.26.1-26.5
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    • 2012
  • Adverse side-effects and lack of scientific validation of some chemotherapeutic agents prevent the use of many traditional medicines claimed to have anti-cancer effects. Ethanolic extract of Conium maculatum has long been used in traditional and alternative systems of medicine including homeopathy for the treatment of glandular enlargements, cancerous tumours or hard lumps of testicles, prostate, ovaries, breasts and/ or uterus, particularly in the breast. However, if and how it acts still remains scientifically unknown. This study aims to test if Conium extract (CE), used as mother tincture of Conium in homeopathy, has demonstrable anti-cancer potentials without having much cytotoxicity in normal cells. Cytotoxicity of the drug was tested by conducting MTT assay on both normal (peripheral blood mononuclear cells) and HeLa cells. We also evaluated DNA fragmentation and DNA damage by DAPI and diphenylamine assay. The LDH activity assay was done to evaluate the percentages of apoptosis and necrosis. ROS accumulation also was evaluated to pin-point the actual events of apoptosis. Administration of drug clearly demonstrated its anti-cancer potentials as evidenced by the DNA damage analysis. The ROS activity also increased in case of the CE treated cells. LDH data revealed that the mode of cell death was mainly apoptotic and not necrotic. CE appears to induce apoptosis of cancer cells through ROS mediated pathway, and has negligible cytotoxicity against normal cells.

Overview of the Interaction between Warfarin and Korean Herbal Medicine (와파린과 상호작용하는 한약재에 대한 고찰)

  • Lee, In;Park, Sang-Moo;Park, Seung-Chan;Kim, Do-Hyung;Cho, Min-Kyoung;Han, Chang-Woo;Kwon, Jeong-Nam;Hong, Jin-Woo
    • The Journal of Internal Korean Medicine
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    • v.33 no.2
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    • pp.160-171
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    • 2012
  • Background and Objective : Warfarin is the standard anticoagulation treatment for atrial fibrillation, venous thromboembolism (VTE), and mechanical heart valves. Close monitoring of the International Normalized Ratio (INR) is required due to the drug's very narrow therapeutic window. Many factors can affect INR levels. Drug and food interactions are frequently cited as causes of adverse events with warfarin. We discussed interactions between herbs and warfarin studied in this research. Methods : In this review, PubMed was used to search medical journals. Keywords "warfarin AND interaction" were applied. Results : 55 articles were included. The possibility of correlation between warfarin and single herbal medicines such as Salviae Miltiorrhizae Radix, Angelicae Gigantis Radix, Ginseng Radix Alba, Lycii Fructus, Ginkgo Folium, Menthae Herba, Trigonellae semen was suggested. Furthermore, some herbal compounds interacting with warfarin were reported. The conclusion of studies reporting the effect of herbal medicine on warfarin were controversial due to small size or quality of research. Conculsions : We suggest that we should prescribe therapeutic herbal medicines to patients using warfarin more carefully and do INR follow-up regularly.

Potentially Inappropriate Medications and Regimen Complexity on Readmission of Elderly Patients with Polypharmacy: A Retrospective Study

  • Sunmin Lee
    • Korean Journal of Clinical Pharmacy
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    • v.33 no.1
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    • pp.1-7
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    • 2023
  • Background: Along with the increase in the elderly population, concerns about polypharmacy, which can cause medication-related problems, are increasing. This study aimed to find out the association between drug-related factors and readmission in elderly patients within 30 days after discharge. Methods: Data of patients aged ≥65 years who were discharged from the respiratory medicine ward of a tertiary hospital between January and March 2016 were retrospectively obtained. The medication regimen complexity at discharge was calculated using the medication regimen complexity index (MRCI) score, comorbidity status was assessed using the Charlson comorbidity index (CCI), potentially inappropriate medications (PIMs) were evaluated based on the Beer 2019 criteria, and adverse drug events (ADEs) were examined using the ADE reporting system. Multivariable logistic regression analysis was used to evaluate the effect of medication-related problems on hospital readmission after controlling for other variables. Results: Of the 206 patients included, 84 (40.8%) used PIMs, 31 (15%) had ADEs, and 32 (15.5%) were readmitted. The mean age, total medications, MRCI, CCI, and PIMs in the readmission group were significantly higher than those in the non-readmission group. Age significantly decreased the risk of readmission (odds ratio [OR], 0.89; 95% confidence interval [CI], 0.84-0.96) after adjusting for sex, length of hospital stay, and ADEs. The use of PIMs (OR, 2.38; 95% CI, 1.10-5.16) and increased CCI (OR, 1.50; 95% CI, 1.16-1.93) and MRCI (OR, 1.04; 95% CI, 1.01-1.07) were associated with an increased occurrence of readmission. Conclusion: PIMs were associated with a significantly greater risk for readmission than MRCI.

The Efficacy and Safety of Moclobemide Twice Daily : An Open Trial in Patients with Major Depressive Disorder (1회 2회 분복 투여하는 Moclobemide의 효과와 안전성 : 주요우울장애 환자에서 개방 시험)

  • Yoon, Jin-Sang;Lee, Hyung-Young;Kook, Seung-Hee;Choi, Young
    • Korean Journal of Biological Psychiatry
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    • v.3 no.1
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    • pp.102-108
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    • 1996
  • This was an open trial to evaluate the efficacy and safety of moclobemide twice daily for treatment of Korean patients with major depressive disorder(DSM-III-R). The duration of the trial was 6 weeks with the initial dose of moclobemide being fixed lor the first two weeks at 300mg/day(150mg twice daily, each token after morning and evening meals). Thereafter, when necessary, the dose was allowed to increase to 600mg/day or decrease to 150mg/day according to the seventy of the depression and/or the tolerability of the drug. Hypnotics and/or sedatives from a benzodiazepine group could be concomitantly administered at usual dosage. Patients were assessed at baseline and at days 14, 28 and 42. Efficacy was primarily judged on the Hamilton Rating Scale for Depression(HAM-D) and Beck Depression Inventory(BDI). Patients had to score at least 17 respectively an both scales to enter the trial. Secondary efficacy parameters included Clinical Global Impression(CGI) for severity of illness and improvement. Safety and tolerability were judged on reported adverse events, vital signs and laboratory parameters. In addition, there was a series of questions and assessments for the psychiatrists and patients to complete at the end of the trial Twenty nine patients completing trial were included in the analysis of efficacy : of thirty one patients participating in the safety and tolerability analysis, those who withdraw voluntarily without particular reasons or violated the treatment schedule were not included. The efficacies as determined by HAM-D, BDI or CGI were found to be significant compared to baseline. The number of responders defined as patients with a total score of 10 or less or with a total score of 50% or less of the baseline score on HAM-D and BDI were 17(59%) and 18(62%) respectively. Regarding safety and tolerability, nine patients(29%) reported mild adverse events probably related to moclobemide : of these one patient dropped out because of poor tolerability : however, there were no appreciable changes in blood pressure, pulse rate, body weight or laboratory parameters for all patients over the trial period. Furthermore, the physicians' and patients' opinions at final evaluation showed that moclabemide has a good antidepressant effect as well as a favorable tolerability. In conclusion, a twice-daily dosage schedule with maclobemide is recommendable for the treatment of Korean patients with major depressive disorder since its efficacy and safety were demonstrated in this study.

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Efficacy and Safety of Sirolimus-Eluting Stent With Biodegradable Polymer UltimasterTM in Unselected Korean Population: A Multicenter, Prospective, Observational Study From Korean Multicenter Ultimaster Registry

  • Soohyung Park;Seung-Woon Rha;Byoung Geol Choi;Jae-Bin Seo;Ik Jun Choi;Sung-Il Woo;Soo-Han Kim;Tae Hoon Ahn;Jae Sang Kim;Ae-Young Her;Ji-Hun Ahn;Han Cheol Lee;Jaewoong Choi;Jin Soo Byon;Markz RMP Sinurat;Se Yeon Choi;Jinah Cha;Su Jin Hyun;Cheol Ung Choi;Chang Gyu Park
    • Korean Circulation Journal
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    • v.54 no.6
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    • pp.339-350
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    • 2024
  • Background and Objectives: UltimasterTM, a third-generation sirolimus-eluting stent using biodegradable polymer, has been introduced to overcome long term adverse vascular events, such as restenosis or stent thrombosis. In the present study, we aimed to evaluate the 12-month clinical outcomes of UltimasterTM stents in Korean patients with coronary artery disease. Methods: This study is a multicenter, prospective, observational registry across 12 hospitals. To reflect real-world clinical evidence, non-selective subtypes of patients and lesions were included in this study. The study end point was target lesion failure (TLF) (the composite of cardiac death, target vessel myocardial infarction [MI], and target lesion revascularization [TLR]) at 12-month clinical follow up. Results: A total of 576 patients were enrolled between November 2016 and May 2021. Most of the patients were male (76.5%), with a mean age of 66.0±11.2 years. Among the included patients, 40.1% had diabetes mellitus (DM) and 67.9% had acute coronary syndrome (ACS). At 12 months, the incidence of TLF was 4.1%. The incidence of cardiac death was 1.5%, MI was 1.0%, TLR was 2.7%, and stent thrombosis was 0.6%. In subgroup analysis based on the presence of ACS, DM, hypertension, dyslipidemia, or bifurcation, there were no major differences in the incidence of the primary endpoint. Conclusions: The present registry shows that UltimasterTM stent is safe and effective for routine real-world clinical practice in non-selective Korean patients, having a low rate of adverse events at least up to 12 months.

Pharmacokinetic Properties and Bioequivalence of Cefcapene Pivoxil Hydrochloride 75 mg in Korean Healthy Volunteers (건강한 한국인 피험자에서 Cefcapene Pivoxil Hydrochloride 75 mg 제제의 생물학적동등성시험)

  • Jeon, Ji-Young;Im, Yong-Jin;Hwang, Min-Ho;Kim, Yun-Jeong;Han, Su-Mi;Jo, Myeong-Jin;Kim, Hee-Sun;Kim, Sun-Young;Chae, Soo-Wan;Kim, Kang-Seog;Kim, Min-Gul
    • Korean Journal of Clinical Pharmacy
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    • v.22 no.1
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    • pp.9-12
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    • 2012
  • Background: Cefcapene pivoxil hydrochloride, is an ester-type oral cephem antibiotic. This study was performed to compare the pharmacokinetics and evaluate the bioequivalence of two cefcapene pivoxil hydrochloride 75 mg formulations. Method: In a randomized $2{\times}2$ crossover study, sixty healthy male volunteers were randomly assigned into two groups. After a single dose of 75 mg cefcapene pivoxil hydrochloride oral administration, blood samples were collected at specific time intervals from 0-12 hours. The plasma concentrations of cefcapene pivoxil hydrochloride were determined by LC-MS/MS. The pharmacokinetic parameters were determined from the plasma concentration-time profiles of both formulations. The pharmacokinetic parameters such as $AUC_{last}$, $AUC_{inf}$ and $C_{max}$, were calculated and the 90% confidence intervals for test/reference ratio for pharmacokinetic parameters were obtained by analysis of variance on logarithmically transformed data. Results: The mean value for $AUC_{last}$ in test and reference drug was $4053.1{\pm}876.5\;ng{\cdot}hr/mL$ and $3595.7{\pm}1029.1\;ng{\cdot}h/mL$, respectively. The mean value for $C_{max}$ in test and reference drug was $1324.9{\pm}321.4$ ng/mL and $1159.1{\pm}335.9$ ng/mL, respectively. The 90% confidence intervals of the $AUC_{last}$ and $C_{max}$ ratio for test drug and reference drug were log 1.09-log1.22 and log 1.09-log1.24, respectively. No adverse events were reported by subjects or found on analysis of vital signs or laboratory tests. Conclusion: This single dose study found that the test and reference products met the regulatory criteria for bioequivalence in these health volunteers. Both formulations were safe and well tolerated in 75 mg of cefcapene pivoxil hydrochloride.

Functional Dyspepsia (기능성 소화불량증)

  • Song, Kyung Ho
    • Korean Journal of Psychosomatic Medicine
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    • v.24 no.1
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    • pp.3-8
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    • 2016
  • Functional dyspepsia is one of the most common bowel disorders as prevalent of 7.7% Korean population. The cardinal manifestations include bothersome postprandial fullness, early satiation, epigastric burning or pain. These features are chronic and should be presented recurrently with no other compatible organic disease to explain the symptoms. Even though it is not life-shortening, functional dyspepsia usually make the health-related quality of life worse especially if other functional bowel disorder coexist. The coexistence of functional bowel disorders is called as 'overlap syndrome'. Anxiety, somatization and insomnia is more prevalent in overlap syndrome compared with sole functional bowel disorder. Therefore, it is worthwhile that physician interviews and elucidates whether the dyspeptic patient had other kinds of functional bowel disorders, and manages the underlying psychotic pathology. Placebo effect is large in functional dyspepsia, and there is only four kinds of prokinetics that is proven to be superior to placebo. Adverse events relating prolonged administration of prokinetics sometimes fatal or irreversible, physician willing to describe prokinetics should be familiar to the possible adverse effects and the relating risk factors. Pathologic acid reflux is not uncommon in functional dyspepsia, and acid-suppressant is equivalent to the prokientics in most of dyspeptic patients.

Tolerability, Safety and Effectiveness of Paliperidone ER in Patients with Schizophrenia : A 24-Week Interim Analysis of the 48-Week Open-Label, Prospective, Switch Study (조현병 환자에서 Paliperidone Extended Release의 효능, 안전성 및 내약성 : 48주 개방형, 전향적 연구의 24주 중간 분석)

  • Choi, You Ra;Jung, Dong Chung;Kim, Eun Young;Kim, Se Hyun;Lee, Hyun Jeong;Lee, Nam Young;Chang, Sung Man;Shim, Joo Cheol;Joo, Eun Jeong;Kim, Jae Jin;Lee, Sang Hyuk;Chung, Young Chul;Kim, Yong Sik;Ahn, Yong Min
    • Korean Journal of Biological Psychiatry
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    • v.20 no.1
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    • pp.12-20
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    • 2013
  • Objectives We investigated the tolerability, safety, and treatment response to flexible-dose paliperidone ER in patients with non-acute schizophrenia in whom previous antipsychotic drugs were ineffective. Methods This 24-week interim analysis of the 48-week multicenter, prospective, open-label study assessed effectiveness using the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression-Schizophrenia-Severity (CGI-SCH-S) Scale, Personal and Social Performance (PSP) and Drug Attitude Inventory (DAI). Safety and tolerability were assessed using the Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) and Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS). Results Effectiveness was assessed in 169 patients. Significant improvement in the PANSS total score was observed by week-1 and continued until week-24. The response rate was 33%. The CGI-SCH-S and PSP total scores significantly improved during 24 weeks ; however, no change occurred in the total DAI. Fifty-nine percent of patients reported adverse events, of which extrapyramidal symptoms were the most frequent (19.0%). The DIEPSS and LUNSERS scores were improved after 24 week. Conclusions Switching to the flexible-dose paliperidone ER from an ineffective antipsychotic drug was safe, tolerable, and showed a good treatment response in Korean patients with schizophrenia.