Objective: This study aimed to analyze the important medical adverse events (IMEs) of cyclosporine and tacrolimus using the reports in US FDA adverse event reporting system (FAERS) and to detect related signals. Methods: The FAERS database was used to analyze the IMEs reported for cyclosporine or tacrolimus during 2017-2021. Reporting odds ratio (ROR) and information component were used to analyze signals for adverse events of both drugs. It was investigated whether the detected signals were present on drug labels in Korea and the United States. Results: Among the total 24,688 reports, the reports on tacrolimus accounted 75.8%. Mean age of the patients was 47.9 years old and median number of adverse events was 2.0 per report. The number of patients hospitalized for adverse events was 7,979 (25.3%). Among the adverse reactions reported on the cyclosporine and tacrolimus, 576 and 1,363 events were detected as signals for cyclosporine and tacrolimus, respectively, and of these, IMEs accounted for 44.8 and 59.2%, respectively. The IMEs related with infections/infestations, renal/urinary disorders, and blood and lymphatic system disorders were reported frequently for both drugs. The most frequently detected IMEs were renal impairment for cyclosporine and acute kidney injury for tacrolimus. Among the top 3 IMEs for each reported SOC for cyclosporine and tacrolimus, 9 and 2 unexpected adverse events were identified, respectively. Conclusion This study identified the IMEs and signals of cyclosporine and tacrolimus, and detected unidentified adverse events in a drug information database.

No abstract available.
Biopsy* ; Prostate*

BACKGROUNDS/AIMS: The aim of this study is to clarify the safety and feasibility of laparoscopic hepatectomy, through comparing the early and late periods of perioperative outcomes. METHODS: We retrospectively analyzed 138 patients who underwent laparoscopic hepatectomy from January 2003 to June 2011, at Yeungnam University Hospital. We divided the total patients to early period (from January 2003 to February 2007, n=49) and late period (from March 2007 to June 2011, n=89) groups and compared the perioperative outcomes including the mean operation time, intra-operative blood loss, postoperative hospital stay, intensive care unit (ICU) stay, and duration of liver function test (LFT) normalization. RESULTS: The mean operation time was 308 minutes (range: 140-510) in the early group and 193 minutes (range: 40-350) in the late period group (p<0.001). The mean intraoperative blood loss was 171 ml (range: 50-1,200) in the early and 44 ml (range: 0-400) in the late group (p=0.005). The postoperative hospital stay was 9.7 days (range: 4-31) in the early and 6.8 days (range: 2-9) in the late period (p<0.001). The ICU stay hour was 21.6 hours (range: 0-120) in the early and 2.8 hour (range: 0-24) in the late period (p<0.001). The duration of LFT normalization was 5.7 days (range: 0-39) in the early and 2.1 days (range: 0-20) in the late period (p=0.003). The perioperative outcomes in the late period were better than the early period, which showed a statistically significant difference. CONCLUSIONS: Laparoscopic hepatectomy is feasible and can be safely performed in selected patients but requires a long experience in open liver resection and mastery of laparoscopic surgical skills.
Hepatectomy ; Humans ; Intensive Care Units ; Laparoscopy ; Length of Stay ; Liver ; Liver Function Tests ; Postoperative Hemorrhage ; Retrospective Studies

BACKGROUND: Helicobacter pylori (H. pylori) infection may cause systemic inflammation and increase the production of tumor necrosis factor-alpha, interleukin-1, and interleukin-6. Unfortunately, bone mineral density also may be affected by these cytokines. This study aimed to evaluate the association between bone mineral density and H. pylori infection. METHODS: A cross-sectional study evaluated 1,126 men undergoing a comprehensive health screening in a private Korean screening center. Subjects' sera were tested for H. pylori antibodies (immunoglobulin G) using an enzyme-linked immunosorbent assay, and bone mineral densities (g/cm2) of the lumbar spine, femoral neck, and total femur were obtained using dual-energy X-ray absorptiometry. To evaluate the difference in bone mineral density according to H. pylori infection status, the adjusted mean bone mineral densities at each site were compared after adjusting for potential confounders, including age, sex, body mass index, smoking, alcohol consumption, and exercise. RESULTS: H. pylori infection was associated with a significant decrease in mean lumbar bone mineral density (H. pylori-positive, 1.190 g/cm2; H. pylori-negative, 1.219 g/cm2; P=0.006), which was greatest among men who were > or =50 years old (H. pylori-positive, 1.193 g/cm2; H. pylori-negative, 1.233 g/cm2; P=0.006). However, no significant association was observed in the bone mineral densities of the total femur and femoral neck. CONCLUSION: In men, H. pylori infection was negatively associated with lumbar bone mineral density. This association may be useful in the early detection, prevention, and management of male osteoporosis.
Absorptiometry, Photon ; Alcohol Drinking ; Antibodies ; Body Mass Index ; Bone Density ; Cross-Sectional Studies ; Cytokines ; Enzyme-Linked Immunosorbent Assay ; Femur ; Femur Neck ; Helicobacter pylori* ; Helicobacter* ; Humans ; Inflammation ; Interleukin-1 ; Interleukin-6 ; Male ; Mass Screening ; Osteoporosis ; Risk Factors* ; Smoke ; Smoking ; Spine ; Tumor Necrosis Factor-alpha

OBJECTIVES: The drug utilization review (DUR) system, which checks any conflict event of medications, contributes to improve patient safety. One of the important barriers in its adoption is doctors' resistance. This study aimed to analyze the impacts of doctors' resistance on the success of the DUR system. METHODS: This study adopted an augmented the DeLone and McLean Information System (D&M IS) Success Model (2003), which used doctors' resistance as a socio-technological measure. This study framework is the same as that of the D&M IS Success Model in that it is based on qualities, such as system, information, and services. The major difference is that this study excluded the variable 'use' because it was not statistically significant for mandatory systems. A survey of doctors who used computers to enter prescriptions was conducted at a Korean tertiary hospital in February 2012. RESULTS: This study is very meaningful in that it is the first study to explore the success factors of the DUR system associated with doctors' resistance. Doctors' resistance to the DUR system was not statistically associated with user usefulness, whereas it affected user satisfaction. CONCLUSIONS: The results indicate that doctors still complain of discomfort in using the DUR system in the outpatient clinical setting, even though they admit that it contributes to patient safety. To mitigate doctors' resistance and raise user satisfaction, more opinions from doctors regarding the DUR system have to be considered and have to be reflected in the system.
Drug Utilization Review* ; Humans ; Information Systems ; Medicare Assignment ; Outpatients ; Patient Safety ; Prescriptions ; Tertiary Care Centers

We assessed several emotional variables in patients experiencing conventional urodynamic and ambulatory urodynamic monitoring (AUM) to verify the hypothesis that AUM is tolerated as well as conventional urodynamics. A total of 33 women and 7 men from 23 to 72 years of age who were undergoing both procedures were prospectively included in this study. Prior to and immediately after the procedures, each patient completed a self-administered questionnaire. Answers were given on a visual analogue scale. The degree of anxiety was higher for conventional urodynamics than for AUM (p = 0.045), while the degree of boredom experienced during AUM was higher than that during conventional urodynamics (p= 0.013). There was no significant difference in the degree of shame or bother experienced by the patients during the two procedures. In general, patients tolerated both examinations extremely well. The examiner-rated degree of intolerance during conventional urodynamics was influenced by the subjective pain score (p=0.001), while all other emotional variables except bother were not significantly related with the degree of intolerance during AUM (p=0.007). A total of 74.4% and 84.6% responded that they were willing to repeat conventional urodynamics and AUM, respectively, which were not significantly different. Although AUM produced a significantly higher level of boredom than conventional urodynamics, our data demonstrates that patients are as tolerant of AUM as they are of conventional urodynamic procedures.
*Urodynamics ; Urination Disorders/*diagnosis/*urine ; Urinary Incontinence/diagnosis ; Questionnaires ; Pain Measurement ; Pain ; Monitoring, Ambulatory/*methods ; Middle Aged ; Male ; Humans ; Fluoroscopy/*methods ; Female ; Anxiety ; Aged ; Adult

A case of a 39-year-old woman with corrected transposition of the great vessels without significant intracardiac anomaly or coronary disease is reported. The clinical diagnosis of coronary arterial disese was supported in this patient by electrocardiographic changes of probable old anteroseptal myocardial infarction. Coronary arteriographic study showed the morphologic left coronary artery supplied the right-sided ventricle, and the right coronary artery supplied the left-sided ventricle, and the right coronary artery supplied the left-sided ventricle. Although the condition is theoretically compatible with a normal life span, few patient with this lesion survive past 40 years of age because of the subsequent heart block or functioning as a systemic ventricle.
Adult* ; Anterior Wall Myocardial Infarction ; Coronary Angiography* ; Coronary Disease ; Coronary Vessels ; Diagnosis ; Electrocardiography ; Female ; Heart Block ; Humans

Objective: This study’s aim is to verify the longitudinal effect of depressive symptoms on all-cause mortality depending on the age group. Methods: The Korean Longitudinal Study of Aging’s data from 2006 to 2016 were assessed using longitudinal data analysis, and 10,145 participants (age [mean±standard deviation], 61.7±11.1 years; males, 4,426 [43.6%]; females, 5,719 [56.4%]; middle-aged adults, 6,036 [59.5%]; older adults, 4,109 [40.5%]) were included at baseline. The chi-square test, log-rank test, factor analysis, and Cox proportional hazards models were used to investigate the association between depressive symptoms and mortality. To verify that which feelings and behaviors are associated with mortality, factor analysis was used to Center for Epidemiologic Studies Depression (CES-D) scale and it was divided into two factors: negative and positive affects. Results: The hazard ratio (HR) of all-cause mortality for the Q1 (high) of the negative affect factor was higher than the Q3 (low) of this factor (HR, 1.489; 95% confidence interval, 1.284–1.728). Additionally, the association between negative affect and all-cause mortality was stronger in middle-aged adults than older adults. Conclusion The study provided evidence of the longitudinal effect of depressive symptoms on all-cause mortality regardless of age. However, middle-aged adults could be more sensitive to negative feelings and behaviors than older adults.

BACKGROUND: Fiberoptic bronchoscope guided intubation is an important method of difficult airway management. The use of specific airways has been devised to assist the fiberoptic intubation. The authours compared effectiveness of separated airway with fiberoptic bronchoscope guided intubation and the hemodynamic responses. METHODS: 104 adult patients of American Society of Anesthesiologists grading (ASA) I-II who scheduled for surgery under general anesthesia were randomly divided into the Laryngoscope group (L group, n = 30) or the Fiberoptic bronchoscope group (F group, n = 36) or the Fiberoptic bronchoscope with separated airway (MF group, n = 38). A Fiberoptic bronchoscope guided intubation and a fiberoptic bronchoscope with separated airway and a direct laryngoscope was performed after inducing anesthesia. Intubation time, Jaw thrust incidence, mean blood pressure and heart rate after anaesthesia induction, at intubation and every two minute for a further 7 min were recorded. RESULTS: The intubation time was significantly shorter in the MF group (58.3 +/- 13.7 sec) than F group (71.9 +/- 22.1 sec). Jaw thrust incidence was lower in the MF group (60.5%) than F group (100%). The changes of MAPs and HRs during the observation were not significantly different in three group. CONCLUSIONS: Fiberoptic intubation using separated airway reduced intubation time and the incidence of jaw thrust.
Adult ; Airway Management ; Anesthesia ; Anesthesia, General ; Blood Pressure ; Bronchoscopes ; Heart Rate ; Hemodynamics ; Humans ; Incidence ; Intubation ; Jaw ; Laryngoscopes

This study was designed to assess the relative merits of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in multivessel coronary artery disease (MVCAD), particularly for Korean diabetics. Among 3,279 patients with MVCAD who were recommended for revascularization were enrolled from nine centers in Korea, 2,154 were selected after statistical adjustments for the disparities between two groups. Survival rates were not significantly different for three years between two groups. Among diabetic patients, the three-year mortality rate in PCI group was 1.9-fold higher than that of CABG group, although it was not statistically significant (PCI 19.8%, CABG 11.4%, p=0.14). The three-year mortality rate was similar between the two groups in non-diabetics (PCI 8.3%, CABG 10.0%, p=0.50). The 30-day rate of cerebrovascular event was higher in CABG group, for both diabetic (CABG 3.6%, PCI 0.0%, p<0.001) and non-diabetic patients (CABG 2.4%, PCI 0.0%, p<0.001). Short- and long-term revascularization rates were higher in PCI group than in CABG group. As a conclusion, this Korean registry demonstrates that PCI was associated with comparable survival rates and lower short-term morbidity, but a greater requirement for repeated revascularization compared with CABG in Korean diabetics.
*Angioplasty, Transluminal, Percutaneous Coronary ; Comparative Study ; *Coronary Artery Bypass ; Coronary Disease/*therapy ; Diabetic Angiopathies/*therapy ; Humans ; *Registries ; Research Support, Non-U.S. Gov't ; Retrospective Studies ; Stents