1.Phase 4, Post-Marketing Safety Surveillance of the MF59-Adjuvanted Influenza Vaccines FLUAD® and VANTAFLU® in South Korean Subjects Aged ≥65 Years.
Byung Wook YOO ; Chang Oh KIM ; Allen IZU ; Ashwani Kumar ARORA ; Esther HEIJNEN
Infection and Chemotherapy 2018;50(4):301-310
BACKGROUD: Influenza vaccination is recommended for adults aged ≥65 years as they are at high risk of significant morbidity and mortality. This open-label, multicenter, post-marketing surveillance study assessed the safety of the MF59-adjuvanted trivalent inactivated subunit influenza vaccine, which is marketed as FLUAD® and VANTAFLU®, in South Korean subjects aged ≥65 years. MATERIALS AND METHODS: Solicited local and systemic adverse events (AEs) were collected from day 1 to 4 of the study. All unsolicited AEs and serious AEs (SAEs) were recorded from day 1 until study termination (day 29). RESULTS: Of the 770 subjects enrolled (FLUAD®, n = 389; VANTAFLU®, n = 381), 39% overall experienced any solicited AE. Local AEs were reported by 33% of subjects overall; with the most common events being injection-site pain (30%) and tenderness (27%). Systemic AEs were reported by 19% of subjects overall with the most common events being myalgia (11%) and fatigue (8%). CONCLUSION: These results show that the MF59-adjuvanted influenza vaccine known as FLUAD® or VANTAFLU® had acceptable safety profiles in older adults (aged ≥65 years) in South Korea.
Adult
;
Fatigue
;
Humans
;
Influenza Vaccines*
;
Influenza, Human*
;
Korea
;
Mortality
;
Myalgia
;
Vaccination
2.Phase 4, Post-Marketing Safety Surveillance of the MF59-Adjuvanted Influenza Vaccines FLUAD® and VANTAFLU® in South Korean Subjects Aged ≥65 Years.
Byung Wook YOO ; Chang Oh KIM ; Allen IZU ; Ashwani Kumar ARORA ; Esther HEIJNEN
Infection and Chemotherapy 2018;50(4):301-310
BACKGROUD: Influenza vaccination is recommended for adults aged ≥65 years as they are at high risk of significant morbidity and mortality. This open-label, multicenter, post-marketing surveillance study assessed the safety of the MF59-adjuvanted trivalent inactivated subunit influenza vaccine, which is marketed as FLUAD® and VANTAFLU®, in South Korean subjects aged ≥65 years. MATERIALS AND METHODS: Solicited local and systemic adverse events (AEs) were collected from day 1 to 4 of the study. All unsolicited AEs and serious AEs (SAEs) were recorded from day 1 until study termination (day 29). RESULTS: Of the 770 subjects enrolled (FLUAD®, n = 389; VANTAFLU®, n = 381), 39% overall experienced any solicited AE. Local AEs were reported by 33% of subjects overall; with the most common events being injection-site pain (30%) and tenderness (27%). Systemic AEs were reported by 19% of subjects overall with the most common events being myalgia (11%) and fatigue (8%). CONCLUSION: These results show that the MF59-adjuvanted influenza vaccine known as FLUAD® or VANTAFLU® had acceptable safety profiles in older adults (aged ≥65 years) in South Korea.
Adult
;
Fatigue
;
Humans
;
Influenza Vaccines*
;
Influenza, Human*
;
Korea
;
Mortality
;
Myalgia
;
Vaccination
3.Depression in Cancer Patients.
Sung Wan KIM ; Sam Yeon LEE ; Jae Min KIM
Journal of the Korean Society of Biological Psychiatry 2006;13(2):59-69
Bidirectional relationships exist between cancer and depression; the prevalence of depression in cancer patients is higher than in the general population, and depression predicts cancer progression and mortality. The mechanisms through which depression contributes to the progression of cancer are related with dysregulation of the hypothalamic-pituitary-adrenal axis and impairment of immune function. However, depression in cancer patients tends to be underdiagnosed and not appropriately treated. The methods of diagnosis and assessment of depression in cancer patents have been debated because physical symptoms of depression mimic both cancer symptoms per se and the side effects of cancer treatment. Many studies have shown that various psychosocial and/or pharmacological interventions are effective at improving depressive symptoms and quality of life in cancer patients. Furthermore, antidepressant treatments are effective for various physical symptoms related to cancer, such as fatigue, anorexia, pain, hot flashes, and itching. This article reviews and discusses current knowledge about depression in cancer patients.
Anorexia
;
Axis, Cervical Vertebra
;
Depression*
;
Diagnosis
;
Fatigue
;
Hot Flashes
;
Humans
;
Mortality
;
Prevalence
;
Pruritus
;
Quality of Life
4.A Case of Hyponatremin Encephalopathy Developed after Transsphenoidal Pituitary Sergery in Menstruant Woman.
Yeo Joo KIM ; Mi Rim KIM ; Moon Seok NAM ; Yong Sung KIM ; Jung Bae JIN ; Sang Hyun PARK ; Jun Hong KANG ; Sung Bin HONG ; Byoung Yun JUN
Journal of Korean Society of Endocrinology 1998;13(3):439-445
A 41-year-old female complaining of easy fatigue, headache, thickened extremities and deepened facial folds was admitted to the hospital. As early as 6 years ago, she had been told by family members that her voice was changed and both hands was thickened. Cranial plain radiography indicated ballooning of sella turcica. Sella MRI disclosed 2.2cm sized pituitary tumor with suprasellar extension. The pituitary tumor with hypothalamic extension was removed via a transsphenoidal approach. The postoperative course was uneventful until hyponatremia with sudden headache and respiratory arrest was developed. The case was due to hyponatremic encephalopathy on the basis of the clinical course and symptoms, and 3% hypertonic saline was infused for 12 hours until the hyponatremia was corrected. We have experienced a mortality case of hyponatremic encephalopathy in which surgieal removal of a pituitary tumor from a female acromegalic patient in menstruant period was followed by the sudden occurrence of hyponatremia, which in turn was later associated with marked brain edema.
Adult
;
Brain Edema
;
Extremities
;
Fatigue
;
Female
;
Hand
;
Headache
;
Humans
;
Hyponatremia
;
Magnetic Resonance Imaging
;
Mortality
;
Pituitary Neoplasms
;
Radiography
;
Sella Turcica
;
Voice
5.Evidence from a Multidimensional Health Assessment Questionnaire (MDHAQ) of the Value of a Biopsychosocial Model to Complement a Traditional Biomedical Model in Care of Patients with Rheumatoid Arthritis.
Theodore PINCUS ; Jacquelin R CHUA ; Kathryn A GIBSON
Journal of Rheumatic Diseases 2016;23(4):212-233
Patient self-report questionnaires such as a multidimensional health assessment questionnaire (MDHAQ) have advanced knowledge concerning prognosis, care, course and outcomes of rheumatoid arthritis (RA). The MDHAQ may overcome some limitations of a "biomedical model," the dominant paradigm of contemporary medical services, including limitations of laboratory tests, radiographs, joint counts, and clinical trials, to predict and depict the long-term course and outcomes of RA. A complementary "biopsychosocial model" captures components of a patient medical history on patient questionnaires as quantitative, standard, "scientific" scores for physical function, pain, fatigue, and other problems, rather than as 'subjective" narrative descriptions. A rationale for a biopsychosocial model in RA includes the importance of a patient history in diagnosis and management compared to biomarkers in many chronic diseases such as hypertension and diabetes. Some important observations which support a biopsychosocial model in RA based on patient questionnaires include that MDHAQ physical function scores are far more significant than radiographs or laboratory tests to predict severe RA outcomes such as work disability and premature death; patient self-report measures are more efficient than tender joint counts and laboratory tests to distinguish active from control treatments in RA clinical trials involving biological agents; and MDHAQ scores are more likely than laboratory tests to be abnormal at presentation and to document incomplete responses to methotrexate at initiation of biological agents. Patient questionnaires can save time for doctors and patients, and improve doctor-patient communication. A standardized database of MDHAQ scores consecutive patients over long periods might be considered by all rheumatologists in routine clinical care.
Arthritis, Rheumatoid*
;
Biological Factors
;
Biomarkers
;
Chronic Disease
;
Complement System Proteins*
;
Diagnosis
;
Fatigue
;
Humans
;
Hypertension
;
Joints
;
Methotrexate
;
Mortality, Premature
;
Prognosis
6.Functional and clinical importance of a large sized ostium secundum defect in a middle aged female cadaver: a case report.
Anatomy & Cell Biology 2017;50(2):152-154
Atrial septal defect (ASD) is one of the common congenital anomalies of the heart in humans. Its complications depend on the size of the defect and can manifest at any age. The common symptoms of ASD include dyspnea and fatigue. Most of the ASDs are associated with morbidity and mortality, Earlier the treatment, it is better to the patient. I saw a large ostium secundum defect in the heart of an adult female cadaver during dissection classes for undergraduate medical students. The interatrial septum had large defect at the region where fossa ovalis should have been located. It was about 1.25 inches in diameter and oval in shape. This type of large septal defect might result in cyanosis, stroke or death of the patient at any age.
Adult
;
Cadaver*
;
Cyanosis
;
Dyspnea
;
Fatigue
;
Female*
;
Heart
;
Heart Septal Defects, Atrial
;
Humans
;
Middle Aged*
;
Mortality
;
Stroke
;
Students, Medical
7.Karoshi Related to Labor Intensity and Risk of Cardiovascular Events: A Case Report.
Ning-guo LIU ; Tao WANG ; Pingf HUANG ; Zhi-qiang QING ; Jian-hua ZHANG ; Yi-jiu CHEN
Journal of Forensic Medicine 2015;31(5):343-346
Karoshi remains one of the most troublesome issues in forensic identification. It is rather a social medicine than a clinical disease. Japanese scholars pioneered examining the relation between sud- den cardiac death (SCD) and chronic fatigue from long time and/or high-tension work. In the current case, a 55-year-old man, whose job was loading and carrying heavy cement bags, was found dead after 11 days of continuous hard work. His family members sued the cement factory for his death and claimed for compensation. The problem was the difficulty of identifying the causative relation without the precedent or the relevant regulations. However, the forensic problems were finally acknowledged after autopsy and calculation of labor intensity. The lawsuit was won as the first case pertaining to Karoshi in the Chinese court.
Autopsy
;
Death, Sudden, Cardiac/etiology*
;
Fatigue/mortality*
;
Forensic Pathology
;
Humans
;
Male
;
Middle Aged
;
Risk Factors
;
Workload/legislation & jurisprudence*
8.Clinical Evaluation of Coronary Artery Fistula.
Sak LEE ; Young Hwan PARK ; Han Ki PARK ; Sang Hyun LIM ; You Sun HONG ; Byung Chul CHANG ; Meyun Shick KANG ; Bum Koo CHO
The Korean Journal of Thoracic and Cardiovascular Surgery 2005;38(10):699-704
BACKGROUND: Coronary artery fistula is rare congenital anomaly, which account for 0.27~0.40% of all congenital heart diseases. We report the clinical observations of 45 patients with coronary artery fistula. MATERIAL AND METHOD: We reviewed all patients presented with or without symptoms of coronary artery fistula between 1987 and 2004. Age ranged from 1 to 83 years. Twenty-six patients were female. The patients were divided into 2 groups according to the presenting symptoms. Twelve patients were in group A (asymptomatic) and 33 patients in group B (symptomatic). The most common clinical presentation in group B was angina (18) followed by dyspnea (7), atypical chest pain (5), syncope (1), fatigue (1), and palpitation (1). Twenty-five patients were associated with other cardiac diseases, which were atrial septal defect (4), coronary artery occlusive disease (6), hypertension (12), and valvular heart disease (2). RESULT: Patients were followed-up for a mean period of 64.8+/-62.7 months. There was no complication related to coronary artery fistula during the follow-up period in both group. There was no mortality related to coronary artery fistula. CONCLUSION: In symptomatic patients, early surgical treatment is recommended considering the low perioperative morbidity. In asymptomatic patients receiving medical treatment, close follow up may be necessary.
Chest Pain
;
Coronary Vessels*
;
Dyspnea
;
Fatigue
;
Female
;
Fistula*
;
Follow-Up Studies
;
Heart Diseases
;
Heart Septal Defects, Atrial
;
Heart Valve Diseases
;
Humans
;
Hypertension
;
Mortality
;
Syncope
9.Lifestyle and Health State in Individuals with Frequent Nocturnal Sleep Interruption.
Joon Sik SEO ; Jae Ho LEE ; Kang Kon LEE
Journal of the Korean Academy of Family Medicine 2006;27(12):967-974
BACKGROUND: Many studies have demonstrated that excessively long or short sleep duration and insomnia are associated with high risk of mortality. We intended to investigate the lifestyle and the state of health in frequently sleep interrupted people. METHODS: We have examined 2,540 subjects who visited a comprehensive medical testing center from January 2001 to June 2003. We divided into two groups of sleep disturbance into frequently interrupted group (two or more times per night) and infrequently interrupted group (less than twice per night). After frequency matching by age and sex, 1,900 subjects (each group of 950 subjects) were selected. Lifestyle, self-health perception, symptoms, clinical laboratory data and past history were compared by chi-square test and student's t-test. To identify the factors that influenced on sleep interruption, multiple logistic regression analysis was done. RESULTS: Sleep duration was not significantly different in both groups (P=0.486). The frequently interrupted group were likely to perceive themselves as bad state of health being in a (P=0.008) and to complain of various symptoms, i.e., fatigue (P<0.001), headache (P= 0.001), etc. Also, they had more incidence of mood disorders (P= 0.002), fatty liver (P=0.008), and arthritis (P=0.001) than the other group. By multiple logistic regression analysis, alcohol consumption (OR: 1.344, P= 0.007), irregular diet (OR: 1.325, P=0.003), and coffee intake (OR: 0.786, P= 0.013) were significantly different between the frequently interrupted group and the other group. CONCLUSION: Patients who complain of insomnia should be evaluated on both sleep duration and interruption. The evaluation of sleep interruption is needed in patients who perceive themselves as being in a bad state of health, who complain of various symptoms (fatigue, headache, etc.), or have a history of mood disorder, fatty liver, or arthritis.
Alcohol Drinking
;
Arthritis
;
Coffee
;
Diet
;
Fatigue
;
Fatty Liver
;
Headache
;
Humans
;
Incidence
;
Life Style*
;
Logistic Models
;
Mood Disorders
;
Mortality
;
Sleep Initiation and Maintenance Disorders
10.Combination of Gemcitabine and Cisplatin as First-Line Therapy in Advanced Non-Small-Cell Lung Cancer.
Nam Su LEE ; Jae Ho BYUN ; Sang Byung BAE ; Chan Kyu KIM ; Kyu Taeg LEE ; Sung Kyu PARK ; Jong Ho WON ; Dae Sik HONG ; Hee Sook PARK
Cancer Research and Treatment 2004;36(3):173-177
PURPOSE: The prognosis of patients with advanced non-small-cell lung cancer (NSCLC) is extremely poor. Many prospective randomized trials on patients with advanced NSCLC suggested systemic chemotherapy improves both the survival and quality of life. A phase II trial was conducted to evaluate the efficacy and safety profile of the combination chemotherapy of gemcitabine and cisplatin in advanced NSCLC. MATERIALS AND METHODS: Forty-four patients with locally advanced or metastatic NSCLC were enrolled. The patients received a cisplatin, 75 mg/m(2), infusion over 30 minutes on days 1, followed by a gemcitabine, 1, 250 mg/m(2), infusion over 30 minutes on days 1 and 8 every 3 weeks. RESULTS: The median age of the patients was 64 years (range: 27~75). Forty-one patients were assessable for response and toxicity analyses. The overall response rate was 53.6%, but with no complete remissions. The median time to progression was 5.6 months (range: 1~15.4). The median survival was 14.2 months (95% confidence interval (CI), 13.8~22.5). A total of 179 cycles were administered, with a median of 4 cycles of chemotherapy, ranging from 2 to 9 cycles. The most common hematological toxicities were NCI grades 3/4 neutropenia (24%) and thrombocytopenia (7.8%). The most common non-hematological toxicity was fatigue (42.4%). There were no life-threatening toxicity or treatment related mortalities. The median duration of follow up was 9.4 months, ranging from 1.6 to 30.3 months. CONCLUSION: In this trial, the combination of gemcitabine and cisplatin showed significant activity, with acceptable and manageable toxicities as a first-line regimen for patients with advanced NSCLC.
Cisplatin*
;
Drug Therapy
;
Drug Therapy, Combination
;
Fatigue
;
Follow-Up Studies
;
Humans
;
Lung Neoplasms*
;
Lung*
;
Mortality
;
Neutropenia
;
Prognosis
;
Prospective Studies
;
Quality of Life
;
Thrombocytopenia