Aceclofenac is a non-steroidal anti-inflammatory drug (NSAIDs) for inflammatory diseases. In this report, we report a serious adverse event (AE) occurred during the phase I clinical trial for a new sustained-release (SR) formulation of aceclofenac. There was a serious adverse event (AE), agranulocytosis, induced by aceclofenac SR form. An open-labeled, repeated-doses, randomized, crossover study was conducted at Kyung Hee University Hospital and 26 Korean healthy male volunteers were enrolled. All subjects received both aceclofenac SR 200 mg once daily and aceclofenac IR 100 mg twice daily for 4 days with 11 days washout period. After 11 days washout period, one subject showed a serious decrease in the segment neutrophil (267/mm3) on a laboratory test prior to the reference drug administration in period 2. We first report a case of agranulocytosis, during a phase I clinical trial.
Agranulocytosis* ; Cross-Over Studies ; Humans ; Male ; Neutrophils ; Volunteers

Alcohol has been used as sedatives historically. The effect of alcohol on sleep is different according to its dose, timing of ingestion, and drinking frequency. Sleep problems may play a role in the development and course of alcohol-related disorders. Insomnia in alcohol-dependent patients is common and early treatment of insomnia may reduce the rate of relapse. Sleep apnea, restless legs syndrome, periodic limbs movement disorder, and altered circadian rhythm may be more frequent in this patients. Management of sleep and alcohol problems is important in treating alcohol-related disorder and sleep disorders, respectively.
Alcohol-Related Disorders ; Circadian Rhythm ; Drinking ; Eating ; Extremities ; Humans ; Hypnotics and Sedatives ; Movement Disorders ; Recurrence ; Restless Legs Syndrome ; Sleep Apnea Syndromes ; Sleep Wake Disorders ; Sleep Initiation and Maintenance Disorders

Background: The coronavirus disease 2019 (COVID-19) pandemic has impacted various aspects of daily living and has influenced the life of every individual in a unique way.Acute myocardial infarction (AMI) is associated with high morbidity and mortality; thus, timely treatment is crucial to prevent poor prognosis. Therefore, an immediate emergency department (ED) visit is required; however, no domestic studies have reported the effect of COVID-19 on ED visits by patients with AMI. Therefore, this study aimed to assess the changes in the pattern of ED visits by patients with AMI by comparing visits during the COVID-19 outbreak period to those during two control periods. Methods: This nationwide, retrospective study used registry data of the National Emergency Department Information System. The ‘outbreak period’ was defined as the period between February 21, 2020 and April 1, 2020, while the ‘control period’ was defined as the same time period in the preceding two years (2018 and 2019). The primary outcome of our study was the number of patients admitted to the ED owing to AMI during the outbreak and control periods. Secondary outcomes were time from symptom onset to ED visit, length of ED stay, and 30-day mortality following admission. Results: During the outbreak period, 401,378 patients visited the ED; this number was lower than that during the control periods (2018: 577,548; 2019: 598,514). The number of patients with AMI visiting the ED was lower during the outbreak period (2,221) than during 2018 (2,437) and 2019 (2,591). Conclusion The COVID-19 pandemic has caused a reduction in ED visits by patients with AMI. We assume that this could likely be caused by misinterpretation of AMI symptoms as symptoms of respiratory infection, fear of contracting severe acute respiratory syndrome coronavirus 2, and restrictions in accessing emergency medical care owing to overburdened healthcare facilities. This study sheds light on the fact that healthcare and emergency medical staff members must work towards eliminating hurdles due to this pandemic for patients to receive timely emergency care, which in turn will help curb the growing burden of mortality.

Background: The coronavirus disease 2019 (COVID-19) pandemic has impacted various aspects of daily living and has influenced the life of every individual in a unique way.Acute myocardial infarction (AMI) is associated with high morbidity and mortality; thus, timely treatment is crucial to prevent poor prognosis. Therefore, an immediate emergency department (ED) visit is required; however, no domestic studies have reported the effect of COVID-19 on ED visits by patients with AMI. Therefore, this study aimed to assess the changes in the pattern of ED visits by patients with AMI by comparing visits during the COVID-19 outbreak period to those during two control periods. Methods: This nationwide, retrospective study used registry data of the National Emergency Department Information System. The ‘outbreak period’ was defined as the period between February 21, 2020 and April 1, 2020, while the ‘control period’ was defined as the same time period in the preceding two years (2018 and 2019). The primary outcome of our study was the number of patients admitted to the ED owing to AMI during the outbreak and control periods. Secondary outcomes were time from symptom onset to ED visit, length of ED stay, and 30-day mortality following admission. Results: During the outbreak period, 401,378 patients visited the ED; this number was lower than that during the control periods (2018: 577,548; 2019: 598,514). The number of patients with AMI visiting the ED was lower during the outbreak period (2,221) than during 2018 (2,437) and 2019 (2,591). Conclusion The COVID-19 pandemic has caused a reduction in ED visits by patients with AMI. We assume that this could likely be caused by misinterpretation of AMI symptoms as symptoms of respiratory infection, fear of contracting severe acute respiratory syndrome coronavirus 2, and restrictions in accessing emergency medical care owing to overburdened healthcare facilities. This study sheds light on the fact that healthcare and emergency medical staff members must work towards eliminating hurdles due to this pandemic for patients to receive timely emergency care, which in turn will help curb the growing burden of mortality.

BACKGROUND: Valsartan is an angiotensin II receptor blocker and is used for patient with hypertension. Although response to valsartan varies each individual, there is no study about factors affecting the variability of valsartan response. METHODS: To investigate the effects of valsartan on the baseline characteristics of blood pressure, single group, open label, pre- and post-comparison clinical study was conducted. Total 21 male Korean volunteers were enrolled. Each subject was administered no drugs in first period and valsartan 80 mg (Diovan HCT) in second period. For pharmacodynamic analysis, 24 hours blood pressure changes were monitored by ambulatory blood pressure monitoring. Twenty-four hour blood pressure changes were matched to valsartan concentration and analyzed by correlation analysis. Changes in blood pressure pattern were also analyzed. Subjects were divided into responder, non-responder, and reverse responder according to pre- and post- 24 hours blood monitoring results. For determination of pharmacokinetic parameters, plasma concentration of valsartan was measured by a validated ultra-performance liquid chromatography-tandem mass spectrometry method. Pharmacokinetic parameters including area under the plasma concentration versus time curve from 0 hour to the last measurable concentration (AUCt), area under the plasma concentration versus time curve extrapolated to infinity, maximum plasma concentration (Cmax), and time required to reach maximum plasma concentration (Tmax) were calculated by noncompartmental models in the BA-CALC 2008 program ver. 1.0.0. RESULTS: There were no significant associations between blood pressure changes and pharmacokinetic parameters of valsartan. Blood pressure pattern change analysis showed significant results. For AUCt, total amount of absorbed valsartan was 25,808 +/- 6,863.0 ng.hr/mL, 20,683 +/- 8,782.7 ng.hr/mL, and 12,502 +/- 5,566.6 ng.hr/mL in responder, non-responder, and reverse responder, respectively (p = 0.041). In C max, maximum concentration of valsartan was 4,314 +/- 1,522.6 ng/mL, 2,588 +/- 1,273.9 ng/mL, and 2,056 +/- 1,075.5 ng/mL, respectively. CONCLUSIONS: These results showed that response to valsartan was not associated with blood concentration in healthy volunteers and changes in blood pressure patterns to valsartan might be associated with the amount of drugs which are absorbed to subjects.
Blood Pressure ; Blood Pressure Monitoring, Ambulatory ; Humans ; Hypertension ; Male ; Mass Spectrometry ; Plasma ; Receptors, Angiotensin ; Tetrazoles ; Valine ; Valsartan

INTRODUCTION: Although it is well known that medical students are not getting an adequate amount of sleep, there have been only a few studies on the sleep patterns of medical students and the related factors. Therefore, the present study aimed to investigate the medical students' sleep patterns and the related factors. METHODS: A questionnaire package was administered to the 1st to 4th year medical students at one medical school. It consisted of questions asking about their lifestyles as well as Pittsburgh sleep quality index (PSQI), Epworth sleepiness scale (ESS), global assessment of recent stress scale (GASS), the center for epidemiologic studies-depression scale (CES-D), and Moudsley obsessive-compulsive inventory (MOCI). A total of 352 students (206 males and 146 females) responded to the survey and the result was analyzed using the independent t-test, the chi-square test, the paired t-test, Pearson's correlation and ANOVA. p-values of less than 0.05 were considered statistically significant in analyses. RESULTS: The weekend bedtime was significantly delayed (0 : 49 on weekday ; 1 : 34 on weekend ; t=-5.23, p<0.001), the weekend rise time was delayed (6 : 58 on weekday ; 9 : 30 on weekend ; t=-24.48, p<0.001) and the total sleep time was increased on weekends (5 : 36 on weekday ; 7 : 39 on weekend ; t=15.94, p<0.001). The PSQI score of all subjects was 6.43+/-2.64. PSQI was positively correlated with ESS (r=0.383, p<0.001), GASS (r=0.326, p<0.001), CES-D (r=0.393, p<0.001), and MOCI (r=0.247, p<0.001), but not with GPA (r=0.072, p=0.228. The more senior students had lower PSQI, GASS, CES-D, and MOCI score (p<0.05). CONCLUSION: Medical students were experiencing a lack of sleep during weekdays as they have a later bedtime and earlier rise time, and consequently had more hours of sleep on weekends. Overall, the medical students were experiencing poor sleep quality and sleep deprivation. Poor sleep quality is associated with psychological problems (daytime sleepiness, stress, depression, and obsessive tendency).
Depression ; Humans ; Life Style ; Male ; Surveys and Questionnaires ; Schools, Medical ; Sleep Deprivation ; Students, Medical*

An 86 year old woman was admitted complaining of dyspnea and right pleuritic pain with a 5 week durations. A physical examination, chest X-ray, and diagnostic thoracentesis upon admission revealed findings consistent with severe pneumonia and empyema on the right lung. Despite the insertion of a chest tube and negative suction via Emersion pump, the continuous air leakage was sustained, and a bronchopleural fistula (BPF) was found on the chest-CT. A flexible bronchoscopic occlusion with an Endobronchial Watanabe Spigot (EWS) was performed after 56 days of admission. An 5 mm diameter EWS was successfully inserted into the anterior segmental bronchus of the right upper lobe by flexible bronchoscope. There was no aAir leakage detected after this procedure. The patient was discharged 30 days after the EWS occlusion.
Aged, 80 and over ; Bronchi ; Bronchoscopes* ; Chest Tubes ; Dyspnea ; Empyema ; Female ; Fistula* ; Humans ; Lung ; Physical Examination ; Pneumonia ; Suction ; Thorax

BACKGROUNDS: The advent of laparoscopic abdominal surgery made it possible to perform a laparoscopic adrenalectomy (LA). We have successfully performed 10 such operations since November 21, 1995. We retrospectively compared the effectiveness and the safety of a laparoscopic adrenalectomy with the effectiveness and the safety of an open adrenalectomy (OA). METHODS: The 45 patients with adrenal diseases who underwent an adrenalectomy from March 1990 to January 1998 were included in this study. Ten (10) laparoscopic cases comprised the study group, and 17 of the 32 open adrenalectomy cases, performed by anterior approach, comprised the control group. RESULTS: No one died from an adrenalectomy. Nine cases (45%) from the OA group needed transfusions (average:661 ml), but one patient from the LA group, who had required a conversion to a celiotomy, required a transfusion (400 ml). The operating times were, on average, 191 minutes in the OA group and 230 minutes in the LA group (p = 0.0384). The average size of the masses was 6.5 cm. The first days of walking after the operation was 3.4 days for the OA group and 1.3 days for the LA group (p = 0.0002). The patients' former regular diets were started on days 6.9 and 3.2 for the OA and LA groups, respectively (p = 0.0001). Postoperative in-hospital days were 17.5 for the OA group and 7.9 for the LA group (p = 0.0001). CONCLUSIONS: In comparison with an open adrenalectomy, a laparoscopic adrenalectomy showed better convalescent features:that is, less chance of transfusion, earlier recovery, faster resumption of the former diet, shorter postoperative hospital stays, and cosmesis. We think and suggest that a laparoscopic adrenalectomy is a safe and effective procedure, and hopefully it will become the standard choice of operation for various adrenal diseases.
Adrenalectomy* ; Diet ; Humans ; Laparoscopy ; Length of Stay ; Retrospective Studies ; Walking

PURPOSE: The aim of this study was evaluating the efficacy of endoscopic Deflux(R) submucosal injection in children with primary vesicoureteral reflux (VUR). METHODS: Retrospective analysis of medical record was conducted on 38 children (59 ureters) who underwent endoscopic Deflux(R) injection due to primary VUR. Data were collected from March 2000 to February 2006. Mean infused amount of Deflux(R) was 0.77 cc. After Deflux(R) injection, patients were reassessed by voiding cystourethrogram (VCUG) 6 months later. RESULTS: The success rate of endoscopic Deflux(R) submucosal injection 6 months later by VCUG was 100% for grade 1 VUR, 87.5% for grade 2, 60% for grade 3, 26.6% for grade 4, 16.6% for grade 5, respectively and there was negatively significant correlation between success rate and grade of VUR (P<0.01). Degree of improvement of VUR by endoscopic Deflux(R) submucosal injection was not related to age at diagnosis, time to operation, existence of voiding dysfunction or constipation and infused amount of Deflux(R). However, group with anticholinergics medication had significantly lower success rate than non-medication group (P<0.047). CONCLUSION: Endoscopic Deflux(R) submucosal injection is effective therapy in patient with primary VUR, especially low grade VUR. It can be not only a useful substitute for prophylaxis with antibiotics, but also an effective management prior to ureteroneocystostomy in children with primary VUR.
Anti-Bacterial Agents ; Child ; Cholinergic Antagonists ; Constipation ; Humans ; Medical Records ; Retrospective Studies ; Vesico-Ureteral Reflux

A 61-year-old man was admitted to the emergency room complaining of a severe left exophthalmos caused by frontal and ethmoid sinus mucoceles that were visualized on a brain computerized tomogram. In addition, he had coexisting ankylosing spondylitis with a 20 year duration that resulted in total fixation of the cervical spine and progressive thoracic kyphosis. An unruptured anterior communicating artery aneurysm was found incidentally on the cerebral angiogram. We report that the anesthetic management for endoscopic sinus surgery of a frontal sinus mucocele in a patient with coexisting severe cervical spine ankylosing spondylitis and an unruptured cerebral aneurysm requires a detailed preoperative assessment of the airway, cardiac, pulmonary, and neurologic system. This case highlights the need for careful measures to avoid rupturing the cerebral aneurysm by the increased blood pressure induced by endotracheal intubation and the infiltration of an epinephrine-containing local anesthetic.
Blood Pressure ; Brain ; Emergencies ; Ethmoid Sinus ; Exophthalmos ; Frontal Sinus ; Humans ; Intracranial Aneurysm ; Intubation, Intratracheal ; Kyphosis ; Middle Aged ; Mucocele ; Spine ; Spondylitis, Ankylosing