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An Open-Label, Multicentre, Observational, Post-Marketing Study to Monitor the Safety and Effectiveness of Umeclidinium/Vilanterol in Korean Patients

  • Eun-Yeong Cho;Jung-Eun Cho;Eun-Bin Lee;Seung Soo Yoo;Jung Hyun Chang
    • Tuberculosis and Respiratory Diseases
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    • v.86 no.1
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    • pp.33-46
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    • 2023
  • Background: Umeclidinium/vilanterol (UMEC/VI; ANORO ELLIPTA, GSK) is a commonly used dual bronchodilator. This study evaluated the safety and effectiveness of UMEC/VI in Korean patients with chronic obstructive pulmonary disease (COPD) over a 6-year period. Methods: This was an open-label, multicentre, observational, post-marketing surveillance study. A total of 3,375 patients were enrolled consecutively in 52 hospitals, by 53 physicians, between July 2014 and July 2020. Patients who were administered UMEC/VI (fixed-dose 62.5 ㎍/25 ㎍) at least once and were monitored for safety and effectiveness were included in the analysis. Incidence and severity of adverse events (AEs) reported after administrating at least one dose of UMEC/VI were monitored, including unexpected adverse events (UAEs) and adverse drug reactions (ADRs). Effectiveness of UMEC/VI after 24 weeks of administration was also assessed using physician's evaluation (effective, ineffective/no change, worsening, indeterminable) and lung function improvement. Results: Of 3,375 patients, 3,086 were included in the safety assessment group (mean age±standard deviation: 69.76±8.80 years; 85.9% male [n=2,652]; 73.1% aged ≥65 years [n=2,255]). The overall incidence of AEs was 28.8% (n=890), of which 2.2% (n=67) were ADRs. Serious AEs and UAEs were reported in 181 (5.9%) and 665 (21.6%) patients, respectively, and two patients (<0.1%) reported unexpected severe ADR. Of the 903/3,086 patients analysed for effectiveness, most (82.8%, n=748) showed overall disease improvement after UMEC/VI treatment. Conclusion: This study confirmed UMEC/VI administered to Korean patients according to the prescribing information was well-tolerated and can be considered an effective option for COPD treatment.

A case study of the antibiotics-associated Pseudomembranous Colitis treated with Yijoong-tang (Lizhong-tang) (항생제로 유발된 Pseudomembranous Colitis환자의 이중탕(理中湯) 치료 1례)

  • Choi, Won-woo;Kim, Mi-young;Kim, Young-jee;Lee, Seung-yeop;Min, In-kyu;Hong, Jin-woo;Na, Byong-jo;Jung, Woo-sang
    • The Journal of the Society of Stroke on Korean Medicine
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    • v.8 no.1
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    • pp.58-62
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    • 2007
  • Objective : Stroke patients tend to take antibiotics due to infection resulting from complication. One of many side effects from using antibiotics is diarrhea, which infact causes anaerobic organism dysfunction resulting Pseudo-Membranous Colitis (P.M.C). To treat P.M.C, antibiotics and antibacterial agents are usually used. But they may cause other side effects, therefore extreme caution must be taken. Methods : We treated an antibiotic induced P.M.C patient who diagnosed by sigmoid scopy with only Yijoong-tang (Lizhong-tang) without antibiotics and observed patients stool aspects. Results and Conclusion : Patiensts symptom was improved after 7days, and we can see the improvement by follow-up sigmoid scopy. This case may give us a possibility of that oriental medical treatments as complementary and alternative medicine to standard antibiotic treatment.

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A Study on Projection for Apophyseal Joints Diagnosis in X-ray Thoracic Bone Oblique Projection (X-ray 등뼈의 사위 촬영에서 돌기사이관절의 진단을 위한 촬영법 연구)

  • Jun-Heang Lee
    • Journal of the Korean Society of Radiology
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    • v.17 no.3
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    • pp.351-357
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    • 2023
  • This Study Rreceived Subjective Evaluation ROC Evaluation from five projection. of projection. at a University Hospital to Obtain and Diagnose Sharp images of apophyseal joints and Vertral arch of Thoracic vertebrae from thoracic X-ray projection. In the Subjective evaluation, the highest Score was obtained by raising the phantom from Supine to LAO by 70° and scoring 20 points at 5° with the X-ray Tube facing the head. In addition, he scored the highest score of 19 points at 8° with the Prone Phantom standing 60° with RAO and the X-ray Tube facing the head. For Objective Evaluation, the Signal-to-noise ratio, was calculated. ROI was set at 1,564 mm2 to obtain the image signal average value (Mean value) and the Standard deviation (SD value). Objective Evaluation The signal-to-noise ratio, was the highest at 5° toward the head in the LPO 70° position of the phantom in the lying position of the Thoracic spine projection, and the Thoracic Spine was the highest at 8° toward the head of the RAO posture of 5,645.

Single-cell RNA sequencing identifies distinct transcriptomic signatures between PMA/ionomycin- and αCD3/αCD28-activated primary human T cells

  • Jung Ho Lee;Brian H Lee;Soyoung Jeong;Christine Suh-Yun Joh;Hyo Jeong Nam;Hyun Seung Choi;Henry Sserwadda;Ji Won Oh;Chung-Gyu Park;Seon-Pil Jin;Hyun Je Kim
    • Genomics & Informatics
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    • v.21 no.2
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    • pp.18.1-18.11
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    • 2023
  • Immunologists have activated T cells in vitro using various stimulation methods, including phorbol myristate acetate (PMA)/ionomycin and αCD3/αCD28 agonistic antibodies. PMA stimulates protein kinase C, activating nuclear factor-κB, and ionomycin increases intracellular calcium levels, resulting in activation of nuclear factor of activated T cell. In contrast, αCD3/αCD28 agonistic antibodies activate T cells through ZAP-70, which phosphorylates linker for activation of T cell and SH2-domain-containing leukocyte protein of 76 kD. However, despite the use of these two different in vitro T cell activation methods for decades, the differential effects of chemical-based and antibody-based activation of primary human T cells have not yet been comprehensively described. Using single-cell RNA sequencing (scRNA-seq) technologies to analyze gene expression unbiasedly at the single-cell level, we compared the transcriptomic profiles of the non-physiological and physiological activation methods on human peripheral blood mononuclear cell-derived T cells from four independent donors. Remarkable transcriptomic differences in the expression of cytokines and their respective receptors were identified. We also identified activated CD4 T cell subsets (CD55+) enriched specifically by PMA/ionomycin activation. We believe this activated human T cell transcriptome atlas derived from two different activation methods will enhance our understanding, highlight the optimal use of these two in vitro T cell activation assays, and be applied as a reference standard when analyzing activated specific disease-originated T cells through scRNA-seq.

Value of Nutritional Screening Tools Versus Anthropometric Measurements in Evaluating Nutritional Status of Children in a Low/Middle-Income Country

  • Shaimaa Sayed;Mortada H. F. El-Shabrawi ;Eman Abdelmonaem ;Nehal El Koofy;Sara Tarek
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.26 no.4
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    • pp.213-223
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    • 2023
  • Purpose: Pediatric patients in low-income countries are at a high risk of malnutrition. Numerous screening tools have been developed to detect the risk of malnutrition, including the Subjective Global Nutritional Assessment (SGNA), Pediatric Yorkhill Malnutrition Score (PYMS), Screening Tool for the Assessment of Malnutrition in Pediatrics (STAMP), and Screening Tool for Risk of Nutritional Status and Growth (STRONGkids). However, anthropometry remains the main tool for assessing malnutrition. We aimed to identify the value of four nutritional screening tools versus anthropometry for evaluating the nutritional status of children. Methods: We conducted a cross-sectional study of 1,000 children aged 1-12 years who visited the outpatient clinic of Cairo University Pediatric Hospital. Each participant was evaluated using anthropometric measurements (weight, length/height, and weight for length/height) as well as the PYMS, STAMP, STRONGkids, and SGNA screening tools. The sensitivities and specificities of these four tools were assessed using anthropometry as the gold standard. Results: Of the patients, 1.7% were underweight, 10.2% were wasted, and 35% were stunted. STRONGkids demonstrated the highest sensitivity (79.4%) and a high specificity (80.2%) for detecting malnutrition compared with weight for height, followed by STAMP, which demonstrated lower sensitivity (73.5%) but higher specificity (81.4%). PYMS demonstrated the lowest sensitivity (66.7%) and the highest specificity (93.5%), whereas SAGA demonstrated higher sensitivity (77.5%) and lower specificity (85.4%) than PYMS. Conclusion: The use of nutritional screening tools to evaluate the nutritional status of children is valuable and recommended as a simple and rapid method for identifying the risk of malnutrition in pediatric patients.

Measurement of Proton Beam Dose-Averaged Linear Energy Transfer Using a Radiochromic Film

  • Seohyeon An;Sang-il Pak;Seonghoon Jeong;Soonki Min;Tae Jeong Kim;Dongho Shin;Youngkyung Lim;Jong Hwi Jeong;Haksoo Kim;Se Byeong Lee
    • Progress in Medical Physics
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    • v.33 no.4
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    • pp.80-87
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    • 2022
  • Purpose: Proton therapy has different relative biological effectiveness (RBE) compared with X-ray treatment, which is the standard in radiation therapy, and the fixed RBE value of 1.1 is widely used. However, RBE depends on a charged particle's linear energy transfer (LET); therefore, measuring LET is important. We have developed a LET measurement method using the inefficiency characteristic of an EBT3 film on a proton beam's Bragg peak (BP) region. Methods: A Gafchromic EBT3 film was used to measure the proton beam LET. It measured the dose at a 10-cm pristine BP proton beam in water to determine the quenching factor of the EBT3 film as a reference beam condition. Monte Carlo (MC) calculations of dose-averaged LET (LETd) were used to determine the quenching factor and validation. The dose-averaged LETs at the 12-, 16-, and 20-cm pristine BP proton beam in water were calculated with the quenching factor. Results: Using the passive scattering proton beam nozzle of the National Cancer Center in Korea, the LETd was measured for each beam range. The quenching factor was determined to be 26.15 with 0.3% uncertainty under the reference beam condition. The dose-averaged LETs were measured for each test beam condition. Conclusions: We developed a method for measuring the proton beam LET using an EBT3 film. This study showed that the magnitude of the quenching effect can be estimated using only one beam range, and the quenching factor determined under the reference condition can be applied to any therapeutic proton beam range.

Marked Corridor 20 Meters Brief Walking Aerobic Exercise Improves the Quality of Life and Functional Capability of Stroke Survivor Outpatients in Tertiary Hospitals in Osogbo, Nigeria

  • Ojo, Israel Arogundade;Dominic, Olufunmilola Leah;Adeyemi, Wale Johnson
    • Journal of the Korean Society of Physical Medicine
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    • v.17 no.2
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    • pp.41-51
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    • 2022
  • PURPOSE: The functional limitations in stroke survivors promote sedentary lifestyles and quality of life inadequacies, but there is increasing evidence that this could be minimized by physical exercise. Therefore, this study examined the effects of physical exercise on the quality of life (QoL) and functional capacity (ability to stand up from a sitting position) among stroke survivors drafted from two tertiary hospitals in Osogbo, Nigeria. METHODS: A purposive sampling technique was used to select 21 registered right or left outpatient hemiplegic stroke survivors in a pre- and post-test experimental research design. The research questions were presented using descriptive statistics of frequency, percentage, mean and standard deviation, while an Analysis of Variance (ANOVA) was used to test the study hypothesis at the .05 alpha level for significance. RESULTS: Compared to the baseline (week 0), there were significant increases in the general quality of life, healthy well-being, physical exercise, pain perception, and environmental domains of QOL among the survivors in week four. Moreover, a significant increase was observed in these indices in week eight, compared to week four, except for the pain perception domain. Compared to the baseline, there was a significant decrease in the time it took the stroke survivors to stand up from a sitting position in week four. A significant decrease was observed in this index in week eight compared to week four. CONCLUSION: Marked corridor 20 meters brief walking exercise for eight weeks significantly improved the quality of life and ability to stand up from a sitting position in stroke survivors in Osogbo, Nigeria.

Development of an Occupational Safety and Health (OSH) Guide for Safely Cleaning Contaminated Machinery, Equipment, and Parts Used in the Electronics Manufacturing Process (전자산업 공정에서 사용한 부품, 기계류 세정(cleaning) 작업 안전보건 가이드)

  • Seunghee Lee;Soyeon Kim;Kyung Ehi Zoh;Yeong Woo Hwang;Kyong-Hui Lee;Kwang Jae Chung;Dong-Uk Park
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.33 no.4
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    • pp.419-426
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    • 2023
  • Objectives: This study aims to develop an Occupational Safety and Health (OSH) guide for the safe cleaning of contaminated machinery, equipment, and parts used in the electronics manufacturing process. Methods: A literature review, field investigations, and discussions were conducted. An initial draft of an OSH guide was developed and reviewed by experts with significant experience in maintenance work in the electronics manufacturing process in order to refine the guide. Results: Workers involved in cleaning processes with chemicals, solvents, and abrasive blasting can face exposure to a wide range of chemicals, abrasives, and noise. Identifying potential risks associated with each cleaning technique was an essential first step toward enhancing safety measures. The OSH guide comprises approximately eleven to twelve sections spanning 20-25 pages. It includes engineering and administrative protocols systematically organized to address the necessary actions before, during, and after cleaning tasks, depending on the technique. It is recommended that airline respirator masks be used in conjunction with an air purification system to ensure adherence to air quality standard "D" for atmosphere level. The use of an oil-free air compressor is advised, preferably a stationary model that does not rely on fuel sources like diesel. Conclusions: This OSH guide is designed to protect workers involved in maintenance activity in the electronics industry and aligns with global standards, such as those from the International Organization for Standardization (ISO) and Semiconductor Equipment and Material International, ensuring a higher level of safety and compliance.

Successful minimally invasive management using transcatheter arterial embolization in a hemodynamically stable elderly patient with mesenteric vascular injury in a hybrid emergency room system in Korea: a case report

  • So Ra Ahn;Joo Hyun Lee;Sang Hyun Seo;Chan Yong Park
    • Journal of Trauma and Injury
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    • v.36 no.4
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    • pp.435-440
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    • 2023
  • Mesenteric injury occurs rarely in cases associated with blunt abdominal trauma. Despite its low incidence, mesenteric injury can lead to fatal outcomes such as hypovolemic shock due to hemoperitoneum or sepsis due to intestinal ischemia, or perforation-related peritonitis. For mesenteric injuries, especially those involving massive bleeding, intestinal ischemia, and perforation, the standard treatment is surgery. However, in the case of operative management, it should be borne in mind that there is a possibility of complications and mortality during and after surgery. The usefulness of transcatheter arterial embolization (TAE) is well known in solid organs but is controversial for mesenteric injury. We present a 75-year-old man with mesenteric injury due to blunt abdominal trauma. Initial abdominal computed tomography showed no hemoperitoneum, but a mesenteric contusion and pseudoaneurysm with a diameter of 17 mm were observed near the origin of the superior mesenteric artery. Since there were no findings requiring emergency surgery such as free air or intestinal ischemia, it was decided to perform nonoperative management with TAE using microcoils in hybrid emergency room system. TAE was performed successfully, and there were no complications such as bleeding, bowel ischemia, or delayed bowel perforation. He was discharged on the 23rd day after admission with percutaneous catheter drainage for drainage of mesenteric hematoma. The authors believe that treatment with TAE for highly selected elderly patients with mesenteric injuries has the positive aspect of minimally invasive management, considering the burden of general anesthesia and the various avoidable intraoperative and postoperative complications.

Growth hormone treatment for children with mucopolysaccharidosis I or II

  • Minji Im;Chiwoo Kim;Juyoung Sung;Insung Kim;Ji-Hoon Hwang;Min-Sun Kim;Sung Yoon Cho
    • Journal of Genetic Medicine
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    • v.20 no.2
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    • pp.60-69
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    • 2023
  • Purpose: Despite enzyme replacement therapy (ERT) and/or allogeneic hematopoietic stem cell transplantation, individuals with mucopolysaccharidosis (MPS) I or II often experience significant growth deficiencies. This study aimed to assess the safety and efficacy of recombinant human growth hormone (hGH) treatment in children diagnosed with MPS I or II. Materials and Methods: A total of nine pediatric patients-four with MPS I and five with MPS II-underwent treatment with ERT and hGH at Samsung Medical Center. Results: The mean hGH dose administered was 0.26±0.03 mg/kg/week. In the MPS I group, three patients showed an increase in height Z-score from -4.09±0.83 to -3.68±0.43 after 1 year of hGH treatment, and to -3.10±0.72 by the end of the hGH regimen. In the MPS II group, while the height Z-score of four patients decreased according to standard growth charts, it improved from 1.61±1.79 to 2.71±1.68 based on the disease-specific growth chart through hGH treatment. Two patients discontinued hGH treatment due to lack of efficacy after 22 and 6 months each of treatment, respectively. No new-onset neurological symptoms or necessity for prosthetic or orthopedic surgery were reported during hGH treatment. Conclusion: This study provides insights into the impact of hGH on MPS patients, demonstrating its potential to reverse growth deceleration in some cases. Further research is needed to explore the long-term effects of hGH on changes in body composition, muscle strength, and bone health in this population.