1.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 2023;86(1):33-46
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 μg/25 μg) 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, ineffectiveo 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.
2.A Korean Post-Marketing Surveillance Study of Dolutegravir Single-Agent Tablets in Patients with HIV-1
Sungshin KWON ; Jung-Eun CHO ; Eun-Bin LEE ; Yeon-Sook KIM ; Jang-Wook SOHN
Infection and Chemotherapy 2022;54(4):711-721
Background:
The integrase strand transfer inhibitor dolutegravir has been indicated in Korea since 2014 for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in combination with other antiretroviral agents. This regulatory post-marketing surveillance (PMS) study evaluated the real-life safety and effectiveness of dolutegravir in patients with HIV-1 in clinical practice in Korea.
Materials and Methods:
This open-label PMS study examined data from consecutive patients (aged ≥12 years) with HIV-1 infection receiving dolutegravir according to locally approved prescribing information; treatment-naïve and treatment-experienced patients were permitted. Data regarding patient demographics, medical history, clinical characteristics, medications (HIV-related and concomitant), and comorbidities were extracted from patient records over a 1-year treatment period. Outcomes included the safety of dolutegravir (primary endpoint) and real-life effectiveness according to the Physician Global Assessment (PGA) and the proportion of patients with plasma HIV-1 RNA count <50 copies/mL at 48 weeks.
Results:
Of 147 patients treated with dolutegravir at 18 centers in Korea (August 2014 – August 2020), 139 were eligible for the safety analyses and 75 for effectiveness analyses.Patients (mean age 47 years) were mostly male (92.8%) and received dolutegravir in combination with nucleoside reverse transcriptase inhibitor (70.5%) or protease inhibitors (21.6%). Adverse events (AEs) (n = 179 in total) were mostly mild in severity, with the most common being nasopharyngitis (5.0%), dyspepsia (5.0%), pruritus (4.3%), and rash (4.3%).Of 16 adverse drug reactions (ADRs), the most frequent were rash, diarrhea, headache, insomnia, and somnolence (1.4% each). Of 2 serious ADRs, only 1 (gastroenteritis) was unexpected, and both resolved. The risk of experiencing an AE while receiving dolutegravir appeared to be especially increased in patients receiving concomitant medications for other conditions. Dolutegravir effectively suppressed HIV-1 (93.3% of patients had plasma HIV-1 RNA <50 copies/mL), and 100% of patients showed symptom improvement based on physician global assessment.
Conclusion
Results of this PMS study showed that dolutegravir administered as highly active antiretroviral therapy was well tolerated and effective in patients with HIV-1 infection.
3.Relapsing polychondritis presenting with inflammatory pseudotumor.
Yeong Hee EUN ; Hyeri SEOK ; In Seub SHIN ; Seung Eun LEE ; You Bin LEE ; Jaejoon LEE
The Korean Journal of Internal Medicine 2016;31(5):1003-1005
No abstract available.
Cranial Nerve Diseases
;
Granuloma, Plasma Cell*
;
Polychondritis, Relapsing*
4.A Case Report of Duodenal Diaphragm Misdiagnosed as a Bulimia.
Yong Joo LEE ; Eun Kyeong LEE ; Kyeong Bin RHO ; Yun Lyeon KIM ; Suk Ja CHOI ; Yong Joo KIM
Korean Journal of Gastrointestinal Endoscopy 1995;15(3):545-551
Duodenal diaphragm is a rare congenital anomaly among the congenital duodenal obstructions. Its symptom and sign usually appear since birth if obstruction is complete. The clinical manifestations of incompletely obstructive duodenal diaphragm are intermittent vomiting, abdominal pain and poor weight gain. Diagnosis may be delayed in this case. Authors experienced a case of incomplete duodenal diaphragm with a central hole. A 29 months old girl presented failure to thrive, intermittent episodes of bloating, abdominal discomfort and occasional vomiting. The patient vomited every 10-14 days, then the abdominal pain and distention were relieved. She overate for about 10 days until the next projectile vomiting. The vomitus frequently contained food ingested several days previously. Plain x-ray films of abdomen showed marked gastric distention. Upper gastrointestinal series revealed marked distention of the duodenum with windsock configuration and radiolucent line at the third portion of the duodenum. On gastroscopic examination, gastric bezoar impacting the pyloric canal and antrum was noted. At operation, we found mucosal membrane in the third portion of the duodenum and bezoar(Chinese cabbage) above the membrane. Side-to-side duodeno-jejunostomy was performed and bezoar was removed. She was discharged on the 13th postoperative day without any complication.
Abdomen
;
Abdominal Pain
;
Bezoars
;
Bulimia*
;
Child, Preschool
;
Diagnosis
;
Diaphragm*
;
Duodenal Obstruction
;
Duodenum
;
Failure to Thrive
;
Female
;
Humans
;
Membranes
;
Parturition
;
Vomiting
;
Weight Gain
;
X-Ray Film
5.The Plasma Catecholamine Levels and Prognosis in Severe Traumatic Brain Injury Patients.
Byung Kyu PARK ; Dong Won KIM ; Eun Ik SON ; Jung Kyo LEE ; Man Bin YIM ; In Hong KIM
Journal of Korean Neurosurgical Society 1990;19(10-12):1329-1338
Activation of the sympathetic nervous system in mediating the stress response attends traumatic brain injury. Plasma dopamine(DA), epinephrine(E), norepinephrine(NE) levels were measured in 26 severe traumatically brain injured patients to determine whether catecholamine levels obtained within 24 hours after injury provide reliable prognostic endogenous markers of outcome. Patient outcome was determine at 1 week using the Glasgow Coma Scale(GCS) and at the time of discharge the Glasgow Outcome Scale(GOS), 7 patients with diseases except those with a severe traumatic brain injury were selected as a control group. Firstly, we analyzed the difference of the average DA, E, and NE between the control group and severe traumatic brain injury patients. Secondly, we analyzed the difference of the average catecholamine levels in the 3 groups according to admission GCS scores(respectively 3~4, 5~7, 8~9). Third, we analyzed the difference of the average catecholamine levels in the 5 groups according to GOS scores at 1 week(respectively dead, 3~4, 5~7, 8~11, >11). Finally, we analyzed the difference of the average catecholamine levels in the 5 groups according to GOS at the time of discharge. As a result, there was no statical difference between the level of DA in the control group and those of the severe brain injury patients. But the level of E an NE in the experimental group were higher than the control group(respectively p<0.03, p<0.04). The admission GCS score correlated highly with the catecholamine levels(NE : r=0.69, p<0.001 ; E ; r=0.42, p<0.03 ; DA ; r=0.42, p<0.03). In patients with admission GCS of 3 to 4, NE levels increaed fourfold above other group(p<0.005). In the 13 patients with GCS scores of 3 or 4 on admission. NE levels predicted outcome at 1 week. All two patients with NE levels less then 750 pg/ml were survived, while 10 of 11 with NE levels greater than 750 pg/ml were died(p<0.02). The levels of NE was significantly higher in patients who died than in those with better outcome(p<0.02). Therefore, these findings indicated that the level of circulating NE is an excellent endogenous marker that appear to reflect the extent of brain injury and that may predict the likelihood of recovery.
Brain
;
Brain Injuries*
;
Coma
;
Dopamine
;
Epinephrine
;
Humans
;
Negotiating
;
Norepinephrine
;
Plasma*
;
Prognosis*
;
Sympathetic Nervous System
6.Early Surgery Extraventricular Drainage, Cisternal Drainage with Nimodipine Irrigation and Intravenous Nimodipine for Ruptured Intracranial Aneurysms.
Byung Kyu KIM ; Man Bin YIM ; Eun Ik SON ; Dong Won KIM ; Jung Kyo LEE ; In Hong KIM
Journal of Korean Neurosurgical Society 1990;19(10-12):1276-1285
During the eleven months from September, 1989 to July, 1990, a total of 118 subarachnoid hemorrhage(SAH) patients were admitted. Among these, in 2 cases, the etiology was unknown and another 8 cases of Hunt & Hess clinical grade V patients died in the emergency room or intensive care unit within 24 hours after admission. The remaning 108 cases were managed with protocol as follows. 1) Surgery was done within 9 days after the SAH(total 67 cases) : Extraventricular drainage(EVD) was performed and a cisternal drainage(CD) catheter was positioned during surgery. EVD, CD nimodipine irrigation(0.4mg) through the CD catheter, and intravenous injection(IV) of nimodipine(1~2mg/hr)continued for 13days after the SAH. 2) Surgery was done after the 9th SAH day due to late transfer neurology or other hospitals or posterior circulation aneurysms(32 cases), and 9 cases refused surgery : Nimodipine was used orally(240mg/day) in 35 cases and an IV route(1~2mg/hr) in 6 cases. Total management outcome and results were obtained as follows. 1) A total unsatisfactory management outcome was 18.52%(serve disabled : 4.63%, vegetative : 0.93%, death : 12.96%. In the surgical cases only, 40.8%, 1.02%, 9.19%, respectively). 2) An unsatisfactory surgical outcome in cases following surgery after the 9th SAH day was 6.24%(severe disabled : 3.12%, death : 3.12%). 3) An unsatisfactory management outcome in cases of admission grades I & II following surgery within the 9th SAH day or those non-surgical patients was 19.15%(severe disabled : 4.25%, death : 14.89%. In surgical cases only 2.33%, 9.30%, respectively). 4) An unsatisfactory management outcome in cases of admission grades III & IV with surgery within the 9th SAH day or non-surgical patients was 29.63%(severe disabled : 7.41%, vegetative : 3.70%. death : 18.52%. In surgical cases only 9.09%, 4.55%, 13.64%, respectively). One case of admission grade V died. 5) Causes of unsatisfactory outcome were vasospasm : 9 cases(8.33%), SAH itself : 4 cases, rebleeding : 3 cases, surgical complication : 1 case, medical complication : 1 case, anesthesia : 1 case, and head trauma : 1 case. 6) Complications in management protocol with EVD, CD, CD nimodipine irrigation, and IV of nimodipine were transient hypotension(1 case) and meningitis(5 cases). These complications were improved without sequelae with discontinuing the IV of nimodipine and using antibiotics. We concluded that this protocol may improved the total management outcome of aneurysmal SAH patients, especially poor grade patients(Hunt & Hess grade III & IV) without significant complications. However, in spite of this protocol, the leading cause of an unsatisfactory outcome is vasospasm.
Anesthesia
;
Aneurysm
;
Anti-Bacterial Agents
;
Catheters
;
Craniocerebral Trauma
;
Drainage*
;
Emergency Service, Hospital
;
Humans
;
Intensive Care Units
;
Intracranial Aneurysm*
;
Neurology
;
Nimodipine*
7.Linac Based Radiosurgery for Cerebral Arteriovenous Malformations.
Sung Yeal LEE ; Eun Ik SON ; Ok Bae KIM ; Tae Jin CHOI ; Dong Won KIM ; Man Bin YIM ; In Hong KIM
Journal of Korean Neurosurgical Society 2000;29(8):1030-1036
No abstract available.
Intracranial Arteriovenous Malformations*
;
Radiosurgery*
8.Comparison of Extended-Spectrum beta-Lactamase-Producing Escherichia coli and Klebsiella pneumoniae Bloodstream Infection Epidemiology.
Phill Hoon YOON ; Eun Bin CHO ; Su Ji KIM ; Yeon Hee LEE ; Yiel Hea SEO ; Yoon Soo PARK
Korean Journal of Nosocomial Infection Control 2014;19(2):45-51
BACKGROUND: Extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli and Klebsiella pneumoniae are main pathogens of bloodstream infection. We compared the epidemiology of ESBL-producing E. coli and K. pneumoniae. METHODS: From January 2003 through March 2007, we retrospectively investigated the clinical characteristics and comorbidities of patients with bloodstream infection by ESBL-producing E. coli and K. pneumoniae. RESULTS: During the study period, 79 patients (54 with E. coli and 25 with K. pneumoniae) with blood cultures positive for ESBL-producing E. coli or K. pneumoniae were studied. When comparing the source of bloodstream infections, urinary tract infections (UTIs) were more commonly caused by E. coli (24% vs. 0; P=0.007), and respiratory tract and soft tissue infection (36% vs. 15%; P=0.04, 12% vs. 0; P=0.03, respectively) were more commonly associated with K. pneumoniae. Among hospital-acquired bloodstream infection, third-generation cephalosporin was more commonly used in patients with E. coli than patients with K. pneumoniae (81% vs. 24%, P<0.001). Medical devices (central venous catheter and urinary catheter) were more commonly used in patients with K. pneumoniae. CONCLUSION: ESBL-producing E. coli bloodstream infection is more common in urinary tract infections. ESBL-producing K. pneumoniae is more common in respiratory tract infections and in skin and soft tissue infections. In hospital-acquired infections, ESBL-producing E. coli bloodstream infection is more common in biliary tract infection. ESBL-producing E. coli was more commonly associated with prior frequent antibiotics use and K. pneumoniae was more commonly associated with use of medical devices.
Anti-Bacterial Agents
;
beta-Lactamases
;
Biliary Tract
;
Catheters
;
Comorbidity
;
Epidemiology*
;
Escherichia coli*
;
Humans
;
Klebsiella pneumoniae*
;
Pneumonia
;
Respiratory System
;
Respiratory Tract Infections
;
Retrospective Studies
;
Skin
;
Soft Tissue Infections
;
Urinary Tract Infections
9.A Study on the Current System of Occupational Physician in Korea.
Eun Joo LEE ; Soung Hoon CHANG ; Dong Bin SONG
Korean Journal of Occupational and Environmental Medicine 1989;1(1):32-38
According to law the employer who has over 50 workers in his enterprise should employ an occupational physician as industrial health manager. The main role of the occupational physician is emphasized to the prevention of occupational diseases rather than the treatment and he should be the team leader of industrial health personnel. But this ideal system in terms of stipulations has lots of problems in operation. Therefore this study was designed to prove the attitude of reception, real condition and work content of the occupational physician in enterprise. The survey was done in 500 stratified random sampled enterprises over the country from July through September in 1987 by mailing questionnaire. As a result of the response from 145 enterprises, more than 85% of enterprise displaced occupational physicians. Among the occupational physicians 43% of them has no allowance for their working as industrial health managers and are payed less than 100,000 won monthly. And 66% of them visited only once a month or none enterprise, where they were nominated as a occupational physician managers. The major work content of occupational physician was doing outpatient clinic or regular physical examination rather than prevention of occupational disease. And it shows a deep discrepancy with the object of law or the expect of enterprise in which industrial hygiene and health education are more stressed for prevention of occupational diseases. The most of industrial workers showed no interest in work of occupational physician. As a conclusion, the current system of industrial health manager has maintained on paper formally and is apt to fall into making outward show. It is urgent for government and enterprise to find a solution which can be practically used the system of occupational physician. The work content of occupational physician is required high advanced knowledge and experience, and it should be operated dual system by special field and nonspecial field.
Ambulatory Care Facilities
;
Health Education
;
Jurisprudence
;
Korea*
;
Occupational Diseases
;
Occupational Health
;
Physical Examination
;
Postal Service
;
Questionnaires
10.Correlation between obesity and pelvic organ prolapse in Korean women
Bo Hye KIM ; Soo Bin LEE ; Eun Duc NA ; Hyeon Chul KIM
Obstetrics & Gynecology Science 2020;63(6):719-725
Objective:
This study aimed to evaluate the correlation between obesity and pelvic organ prolapse (POP), both anatomically and symptomatically, in Korean women.
Methods:
We retrospectively reviewed 476 women who visited the urogynecology clinic between January 2013 and December 2016. All the enrolled women were Korean. We sought to evaluate the relationship between obesity and POP, both anatomically and symptomatically, by using a validated tool. Anatomic assessment was performed by a standardized Pelvic Organ Prolapse Quantification (POP-Q) system and symptomatic assessment was performed by a Pelvic Floor Distress Inventory (PFDI)-20 questionnaire. Obesity measurement was performed by measuring body mass index (BMI).
Results:
We enrolled 476 women in our study. There was no statistically significant correlation between BMI and POP-Q or PFDI-20 scores: Ba (P=0.633), Bp (P=0.363), C (P=0.277), Pelvic Organ Prolapse Distress Inventory-6 (P=0.286), Colorectal Anal Distress Inventory-8 (P=0.960), Urinary Distress Inventory-6 (P=0.355), and PFDI-20 (P=0.355). In addition, there was no statistically significant correlation between BMI and POP-Q or PFDI-20 in patients with severe (greater than stage III) POP. We also separately analyzed the differences in the POP-Q points and PFDI-20 scores between the obese and non-obese groups. There was no statistically significant difference between the groups.
Conclusion
We evaluated the correlation between obesity and POP using a validated tool. The present study revealed no significant correlation between obesity and POP severity anatomically or symptomatically in Korean women. This contrasts the results of most studies of Western women. Further studies in Asian women are required in order to confirm our results.