• Title/Summary/Keyword: Adverse drug events

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Association Between Body Mass Index and Clinical Outcomes According to Diabetes in Patients Who Underwent Percutaneous Coronary Intervention

  • Byung Gyu Kim;Sung-Jin Hong;Byeong-Keuk Kim;Yong-Joon Lee;Seung-Jun Lee;Chul-Min Ahn;Dong-Ho Shin;Jung-Sun Kim;Young-Guk Ko;Donghoon Choi;Myeong-Ki Hong;Yangsoo Jang
    • Korean Circulation Journal
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    • v.53 no.12
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    • pp.843-854
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    • 2023
  • Background and Objectives: We evaluated the effect of diabetes on the relationship between body mass index (BMI) and clinical outcomes in patients following percutaneous coronary intervention (PCI) with drug-eluting stent implantation. Methods: A total of 6,688 patients who underwent PCI were selected from five different registries led by Korean Multicenter Angioplasty Team. They were categorized according to their BMI into the following groups: underweight (<18.5 kg/m2), normal weight (18.5-24.9 kg/m2), overweight to obese (≥25.0 kg/m2). Major adverse cardiac and cerebrovascular events (MACCE), defined as a composite of death, nonfatal myocardial infarction, stroke, and target-vessel revascularization, were compared according to the BMI categories (underweight, normal and overweight to obese group) and diabetic status. All subjects completed 1-year follow-up. Results: Among the 6,688 patients, 2,561 (38%) had diabetes. The underweight group compared to normal weight group had higher 1-year MACCE rate in both non-diabetic (adjusted hazard ratio [HR], 2.24; 95% confidence interval [CI], 1.04-4.84; p=0.039) and diabetic patients (adjusted HR, 2.86; 95% CI, 1.61-5.07; p<0.001). The overweight to obese group had a lower MACCE rate than the normal weight group in diabetic patients (adjusted HR, 0.67 [0.49-0.93]) but not in non-diabetic patients (adjusted HR, 1.06 [0.77-1.46]), with a significant interaction (p-interaction=0.025). Conclusions: Between the underweight and normal weight groups, the association between the BMI and clinical outcomes was consistent regardless of the presence of diabetes. However, better outcomes in overweight to obese over normal weight were observed only in diabetic patients. These results suggest that the association between BMI and clinical outcomes may differ according to the diabetic status.

Phase I Clinical Trial of Prostate-Specific Membrane Antigen-Targeting 68Ga-NGUL PET/CT in Healthy Volunteers and Patients with Prostate Cancer

  • Minseok Suh;Hyun Gee Ryoo;Keon Wook Kang;Jae Min Jeong;Chang Wook Jeong;Cheol Kwak;Gi Jeong Cheon
    • Korean Journal of Radiology
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    • v.23 no.9
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    • pp.911-920
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    • 2022
  • Objective: 68Ga-NGUL is a novel prostate-specific membrane antigen (PSMA)-targeting tracer based on Glu-Urea-Lys derivatives conjugated to a 1,4,7-triazacyclononane-N,N',N''-triacetic acid (NOTA) chelator via a thiourea-type short linker. This phase I clinical trial of 68Ga-NGUL was conducted to evaluate the safety and radiation dosimetry of 68Ga-NGUL in healthy volunteers and the lesion detection rate of 68Ga-NGUL in patients with prostate cancer. Materials and Methods: We designed a prospective, open-label, single-arm clinical trial with two cohorts comprising six healthy adult men and six patients with metastatic prostate cancer. Safety and blood test-based toxicities were monitored throughout the study. PET/CT scans were acquired at multiple time points after administering 68Ga-NGUL (2 MBq/kg; 96-165 MBq). In healthy adults, absorbed organ doses and effective doses were calculated using the OLINDA/EXM software. In patients with prostate cancer, the rates of detecting suspicious lesions by 68Ga-NGUL PET/CT and conventional imaging (CT and bone scintigraphy) during the screening period, within one month after recruitment, were compared. Results: All 12 participants (six healthy adults aged 31-32 years and six prostate cancer patients aged 57-81 years) completed the clinical trial. No drug-related adverse events were observed. In the healthy adult group, 68Ga-NGUL was rapidly distributed, with the highest uptake in the kidneys. The median effective dose coefficient was calculated as 0.025 mSv/MBq, and cumulative activity in the bladder had the highest contribution. In patients with metastatic prostate cancer, 229 suspicious lesions were detected using either 68Ga-NGUL PET/CT or conventional imaging. Among them, 68Ga-NGUL PET/CT detected 199 (86.9%) lesions and CT or bone scintigraphy detected 114 (49.8%) lesions. Conclusion: 68Ga-NGUL can be safely applied clinically and has shown a higher detection rate for the localization of metastatic lesions in prostate cancer than conventional imaging. Therefore, 68Ga-NGUL is a valuable option for prostate cancer imaging.

Comparison of the One-year Follow-up Results after Coronary Bypass Surgery versus Percutaneous Coronary Intervention with Drug-eluting Stents in Patients with Left Main Coronary Artery Disease (좌주간지 병변에 대한 약물방출스텐트시술과 관상동맥우회수술의 1년 추적결과 비교)

  • Choi, Jin-Ho;Lim, Cheong;Park, Kay-Hyun;Chung, Eui-Suk;Chung, Woo-Young;Chae, In-Ho;Choi, Dong-Ju
    • Journal of Chest Surgery
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    • v.41 no.2
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    • pp.210-215
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    • 2008
  • Background: Drug-eluting stents are contributing to the exponential growth of percutaneous coronary intervention, and even in the patients with left main coronary artery disease, owing to the decreased restenosis rate. Our study aimed at comparing the one-year results after coronary artery bypass grafting versus percutaneous coronary intervention with drug-eluting stents in patients with left main coronary artery disease. Material and Method: Those patients who underwent coronary bypass surgery or stenting at our hospital under the diagnosis of left main coronary artery disease were divided in two groups. The variables for comparison were the preoperative disease severity, the length of the hospital stay, the early mortality and the cumulative incidence of mortality, myocardial infarction and repeated revascularization. Result: There were 101 cases in the surgery group and 78 cases in the stent group. Age, gender, the risk factors, the left ventricular ejection fraction and the proportion of acute coronary syndrome showed no significant differences between the two groups. The surgery group showed a more severe condition according to the Euroscore, a greater incidence of urgency, a longer hospital stay and a greater incidence of multi-vessel disease. The early mortality and one-year cumulative mortality were not different between the groups. The Euroscore-matched comparison for the surgery group (41 patients) and the stent group (78 patients) showed no significant differences in the Euroscore, age, gender, risk factors and the proportion of acute coronary syndrome. The surgery group in the Euroscore-matched comparison showed more multi-vessel disease and a longer hospital stay. The surgery group showed lower early mortality and lower one-year cumulative mortality, but this was statistically insignificant (0% vs 2.6%, respectively, p=0.55; 0% vs 6.6%, respectively, p=0.30). The rates of repeated revascularization and major adverse events (death or myocardial infarct) were lower in the CABG group, but this was not statistically significant (13.3% vs 6.3%, respectively, p=0.48; 10.0% vs 0%, respectively, p=0.09). Conclusion: Percutaneous coronary intervention using drug-eluting stents in low-risk patients with left main coronary artery disease resulted in a shortened length of the hospital stay, as compared with that of the CABG group of patients. However, the patients who underwent percutaneous coronary intervention using drug-eluting stents showed a tendency for an increased rate of repeated revascularization and higher one-year cumulative mortality. Further studies with large populations and longer follow-up will be necessary to reaffirm our findings.

The Effects of the Combined Use of Haloperidol and Nimodipine on Plasma HVA, 5-HIAA in Male Chronic Schizophrenics (남자 만성 정신분열병환자에서 Haloperidol과 Nimodipine의 병합사용이 혈장 HVA와 5-HIAA에 미치는 영향)

  • Kim, Hyeong-Seob;Choi, Ai-Kyung;Jee, Sung-Hak;Kim, Soo-Dong;Park, Sung-Deok;Kim, Kwang-Hyeon
    • Korean Journal of Biological Psychiatry
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    • v.3 no.1
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    • pp.88-95
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    • 1996
  • In an open labeled study, two fixed doses of nimodipine(45mg and 90mg daily) were added to the usual antipsychotic drug treatment (Haloperidol : mean dose=25mg/day) in 20 male chronic schizophrenics for 5 weeks. The purposes of this study were to evaluate the therapeutic effects and the effect an the changes of plasma homovanillic acid(HVA) and 5-hydroxyindoleacetic acid(5-HIAA) levels. The results were as follows : 1) Total BPRS score and thought cluster, paranoid cluster subscores showed linear decreasing trend over the course of the study(P<0.05). Especially the thought cluster and paranoid cluster subscores were significant difference between 45mg and 90mg dose of nimodipine(P<0.05). The improvement rates were 45,45% of 90mg and 11.11% of 45mg, but there was no significant difference between the 45mg and 90mg dose of nimodipine. 2) The scores of extrapyramidal symptoms and adverse events-somatic symptoms showed a linear decreasing trends over the course of study. 3) The changes in the mean plasma HVA and 5-H1AA concentrations by the dosages and durations of combining of nimodipine were not statistically significant. 4) There was no statistical significance in plasma HVA and 5-HIAA of the improved, non-improved goroup. Nimodipine has a possibility os on adjunctive agent for treatment resistant schizophrenics, elderly patients and liable patients for the Side effects to usual antipsychotic drugs. So we suggest that the dosage of nimodipine must be above 90mg/day in the treatment of schizophrenia.

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A Multicenter, Randomized, Open, Comparative Study for the Efficacy and Safety of Oral Moxifloxacin 400 mg Once a Day and Clarithromycin 500 mg Twice Daily in Korean Patients with Acute Exacerbations of Chronic Bronchitis (한국인의 만성 기관지염의 급성 악화 환자를 대상으로 한 Moxifloxacin 400mg 1 일 1회 요법과 Clarithromycin 500mg 1일 2회 요법의 치료효과 및 안전성 비교)

  • Kim, Seung-Joon;Kim, Seok-Chan;Lee, Sook-Young;Yoon, Hyeong-Kyu;Kim, Tae-Yon;Kim, Young-Kyoon;Song, Jeong-Sup;Park, Sung-Hak;Kim, Ho-Joong;Chung, Man-Pyo;Suh, Gee-Young;Kwon, O-Jung;Lee, Shin -Hyung;Kang, Kyung-Ho;Lee, Eh-Hyung;Hwang, Sung-Chul;Han, Myung-Ho
    • Tuberculosis and Respiratory Diseases
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    • v.49 no.6
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    • pp.740-751
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    • 2000
  • Background : Moxifloxacin is a newly developed drug which is more potent and safe compared to previous fluoroquinolones. This drug effectively eradicates organisms such as beta-lactamase-producing or other resistant bacteria. Moxifloxacin is known to be effective in treating respiratory infections such as Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Chlamydia pneumoniaeme, Legionella spp. and Mycoplasma pneumoniae. Methods : In a multicenter, randomized, open, comparative study, the efficacy and safety of oral moxifloxacin taken 400 mg once a day and clarithromycin taken 500 mg twice daily for 7 days were compared for the treatment of Korean patients with acute exacerbations of chronic bronchitis. Results : A total of 170 patients were enrolled, and they were divided into two groups: 87 in the moxifloxacin group and 83 in the clarithromycin group. Of those enrolled, 76 (35 for bacteriologic efficacy) in the moxifloxacin group and 77 (31 for bacteriologic efficacy) in the clarithromycin group were included in the efficacy analysis. All were included in the safety analysis. Clinical success was noted in 70 (92.1%) of 76 moxifloxacin-treated patients and 71 (92.2%) of 77 clarithromycin-treated patients. Bacteriologic success rate seemed to be higher in moxifloxacin group (73.5%) than in clarithromycin group (54.8%), but statistically insignificant (p=0.098). Drug susceptibility among organisms initially isolated was higher in moxifloxacin group on Streptococcus pneumoniae, Pseudomonas aeruginosa, Klebsiella pneumoniae (p<0.001). Adverse events were reported by 12.8% of 86 patients receiving moxifloxacin and 21.7% of 83 patients receiving clarithromycin. Headache (4.7% vs 4.8%, moxifloxacin group vs clarithromycin group, respectively) and indigestion (2.3% vs 6.0%, moxifloxacin group vs clarithromycin group, respectively) were the most frequent side effects in the two groups. Conclusion : This study demonstrated that for the treatment of acute exacerbations of chronic bronchitis a 7-day course of moxifloxacin 400 mg od was clinically equivalent and microbiologically superior to clarithromycin 500 mg bid.

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Off-pump Coronary Artery Bypass Surgery Versus Drug Eluting Stent for Multi-vessel Coronary Artery Disease (다혈관 관상동맥질환에서의 심폐바이패스를 사용하지 않은 관상동맥우회술과 약물용출 스텐트시술)

  • Lee, Jae-Hang;Kim, Ki-Bong;Cho, Kwang-Ree;Park, Jin-Shik;Kang, Hyun-Jae;Koo, Bon-Kwon;Kim, Hyo-Soo;Sohn, Dae-Won;Oh, Byung-Hee;Park, Young-Bae
    • Journal of Chest Surgery
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    • v.41 no.2
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    • pp.202-209
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    • 2008
  • Background: The introduction of Drug Eluting Stents (DES) decreased the number of patients referred for coronary artery bypass grafting (CABG). The impact of DES on CABG (Step 1) was studied and compared with the 1-year outcome after CABG with DES (Step 2). Material and Method: Surgical results for patients who underwent off-pump CABG (OPCAB) before the introduction of DES(n=298) were compared with those who underwent OPCAB after the introduction of DES (n=288) (Step 1). Postoperative 30-day and 1-year results were also compared between the patients who underwent percutaneous coronary intervention (PCI) using DES (n=220) and those who underwent OPCAB (n=255) (Step 2). Result: Since the introduction of DES, the ratio of CABG versus PCI decreased. In the CABG group, the number of high risk patients such as elderly patients (age 62 vs. 64, p=0.023), those with chronic renal failure (4% vs. 9%, p=0.021), calcification of the ascending aorta (9% vs. 15%, p=0.043), or frequency of urgent or emergent operations (12% vs. 22%, p=0.002) increased. However, there were no differences in the cardiac death and graft patency rates between the two groups (step 1). During the one-year follow up period, the rate of target vessel revascularization (12.3% vs. 2.4%, p<0.001) and major adverse cardiac events (MACE: death, myocardial infarct, TVR) were higher in the DES than the CABG group (13.6% vs 4.3%) (stage 2). Conclusion: Introduction of DES decreased the number of patients referred for surgery, and increased the comorbidity in patients who underwent CABG. DES increased the rate of target vessel revascularization, and the occurrence of MACE during the 1-year follow-up. However, there was no difference in the incidence of myocardial infarction and cardiac death between the two groups.