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Background Adverse events (AEs) not listed on drug labels have recently been reported in young girls vaccinated against HPV, but signal detection related to the human papillomavirus (HPV) vaccine has never been conducted in South Korea using the Korea Adverse Event Reporting System database of Korea Institute of Drug Safety & Risk Management at Ministry of Food and Drug Safety. Objective To analyze signals associated with HPV vaccines using the Korean spontaneous AEs reporting system and data-mining methods and compare the results to current vaccine label information in South Korea and the United States of America, United Kingdom, European Union, and Japan to detect signals not currently listed on the labels. Setting We evaluated the Korea Institute of Drug Safety & Risk Management database from January 2005 to December 2016. After pre-screening the data, the adjusted total numbers of HPV-related AE reports and AEs were 2566 and 4748 and those of all other vaccine-related AE reports and AEs were 21,878 and 120,688, respectively. Methods Three data mining algorithms (proportional reporting ratio, reporting odds ratio and information component) were used to assess AEs. A signal was defined when the criteria for all three indicators were satisfied. The detected signals were compared to the label information of HPV vaccines from South Korea, the United States of America, United Kingdom, European Union, and Japan. Main outcome measure Signals of AE after HPV vaccination, which met all three data mining indices. Results In this study, we found a total 97 signals of AE after HPV vaccination. Of these, 78 AEs were already present on the HPV vaccine labels of South Korea and the following 19 AEs were not listed: neuralgia, tremor, neuritis, depersonalization, axillary pain, personality disorder, increased salivation, peptic ulcer, circulatory failure, hypotension, peripheral ischemia, cerebral hemorrhage, micturition disorder, facial edema, ovarian cyst, weight increase, pain anxiety, oral edema, and back pain. Moreover, AE information on the current HPV vaccine labels of South Korea, the United States of America, United Kingdom, European Union, and Japan was inconsistent. When comparing the 19 AE signals that were not listed on the drug label in South Korea with the labels from the other countries, neuritis, axillary pain, cerebral hemorrhage, facial edema, pain anxiety, and back pain appreared on the U.S. Food and Drug Administration HPV vaccine labels but not on the United Kingdom labels, and hypotension was listed only on labels in the European Union and Japan. Conclusions South Korea should develop a system for proactively updating HPV labels. These results also suggest potential research directions such as vaccination label expansion, pharmacovigilance studies, and identification of causality in AEs associated with HPV vaccination.

Background We investigated the effects of corticosteroids on the 90-day mortality outcomes in patients with pulmonary tuberculosis who were admitted to the intensive care unit (ICU) because of acute respiratory failure (ARF). Methods The medical records of 124 patients who had pulmonary tuberculosis with ARF and were admitted to the ICU at our tertiary referral center in South Korea between March 1989 and December 2014 were retrospectively analyzed. The 90-day mortality rate in this population was analyzed after adjustments with the inverse probability of treatment weighted (IPTW) method. Results The mean patient age was 62 years, and the 90-day mortality rate was 49.2% (61/124). Adjuvant steroids were used in 70 (56.5%) patients. The 90-day mortality rate was similar irrespective of corticosteroid use (48.6%, steroid group; 50.0%, nonsteroid group). The use of adjuvant steroids was not associated with the unadjusted 90-day mortality (odds ratio [OR], 0.94; 95% confidence interval [CI], .46-1.92; P = .875). In a comparison using an adjusted IPTW approach of the 90-day mortality between the 2 groups, we found that corticosteroid use was independently associated with reduced 90-day mortality (OR, 0.47; 95% CI, .22-.98; P = .049). Conclusions The study results showed that corticosteroids could reduce the 90-day mortality rate in critically ill pulmonary tuberculosis patients with ARF.

Background This study investigated whether tumour necrosis factor (TNF) antagonists should be initiated within 3 weeks of latent tuberculosis infection (LTBI) treatment in patients with immune-mediated inflammatory disease (IMID). Methods Between June 2004 and October 2013, a total of 1521 IMID patients were screened for LTBI before initiating anti-TNF therapy at a tertiary referral centre in South Korea. Their medical records were retrospectively reviewed. Results A total of 411 patients received LTBI treatment before receiving TNF antagonists between June 2004 and October 2013. The mean age of the 411 study subjects was 44.5 years and 261 (63.5%) were male. Anti-TNF agent was initiated in 61 patients (14.8%) within 3 weeks after chemoprophylaxis for LTBI, but 3 weeks later in the remaining 350 patients (85.2%). These two groups were comparable in terms of baseline characteristics, but differed significantly in the mean duration of LTBI treatment before commencing anti-TNF therapy (8 vs 30 days, p 0.001). A total of six patients developed TB during the follow-up period and received anti-TNF agents 3 weeks after initiation of LTBI treatment. None of the patients who commenced TNF antagonist therapy within 3 weeks of LTBI treatment developed TB. Conclusions TNF antagonists may be initiated within 3 weeks of commencing LTBI treatment in IMID patients.

Background: The aim of this study was to compare mineral metabolism between anuric and nonanuric chronic hemodialysis patients, and determine the differences in phosphate control between the two groups. Methods: A total of 77 chronic hemodialysis patients were enrolled in this cross-sectional study from January 2012 to February 2012. Patient demographics, laboratory findings, medication histories, and vascular calcification scores were collected. We divided the patients into anuric and nonanuric groups according to the residual renal function and then compared their clinical features. Multivariate binary regression analysis was used in each group to determine the independent factors related to phosphate control. Results: The mean patient age was 59.27±13.95 years, and 57.1% of patients were anuric. In anuric patients, dialysis vintage was significantly longer, but the mean Kt/V was not different between groups. Serum phosphate, fibroblast growth factor (FGF)-23, and Ca/P products were significantly higher, and 1,25(OH)2D3 levels were significantly lower in the anuric patients, although the intact parathyroid hormone and 25(OH)D levels were not different. In anuric patients, LnFGF-23 [hazard ratio (HR) 2.894, 95% confidence interval (CI) 1.294–6.474, P=0.010] was an independent factor predictive of phosphate control. However, in the nonanuric patients, glomerular filtration rate (HR 0.409, 95% CI 0.169–0.989, P=0.047) and blood urea nitrogen (HR 1.090, 95% CI 1.014–1.172, P=0.019) were independent factors predictive of phosphate control. Conclusion: In chronic hemodialysis patients, preservation of residual renal function is a significant determinant of phosphate control, and the factors associated with phosphate control is different depending on the residual renal function status. In the anuric patients, FGF-23 is most significantly associated with phosphate control; however, glomerular filtration rate and blood urea nitrogen are more important than FGF-23 in the nonanuric HD patients.

Hazard Analysis Critical Control Points (HACCP), internationally recognized as an effective way of controlling foodborne hazards, has been progressively applied for the benefit of the food industry. However, HACCP is a difficult principle to apply. Failure to perform hazard analysis could render the entire HACCP plan ineffective. This paper describes a new analytical method using simple beta and triangular probability distributions to improve the hazard analysis stage of the HACCP plan. Developed in Microsoft® Excel (a spreadsheet program), the model calculates the risk level for the probability, i.e., the likelihood of occurrence of a specific hazard by using background information and data. A pork-cutting procedure was included in a case study. At a 50% percentile value in probability distribution, the highest risk was a biological hazard (e.g., foodborne pathogens growth) in the packaging steps, at a probability of 5.5 × 10−1. The lowest risk was a physical hazard in the packaging steps (e.g., foreign materials introduced by packaging damage), at a probability of 1.4 × 10−3. Despite certain shortcomings, this model, with further improvements, could be expected to increase the effectiveness of HACCP in controlling food safety.

Today many companies introduce new mobile office environments evolved from the recent rapid development in mobile device technologies. Most of the recent mobile office systems use a simple authentication scheme such as ID/Password. This method is easy to use, but it does not consider the user’s context. Thus it cannot provide appropriate security service required by the user’s proper contexts. Therefore, this paper proposes a context based authentication system which security level verification and uses fuzzy algorithm based on the importance of access authority control.

Aim The aim of this study was to evaluate the association of urinary tubular markers, interleukin-18 (IL-18) and angiotensinogen with albuminuria in early nephropathy of type 2 diabetics. Methods Urine levels of tubular markers (kidney injury molecule [KIM]-1, neutrophil gelatinase-associated lipocalin [NGAL] and liver-type fatty acid-binding protein [L-FABP]), proinflammatory marker (IL-18), and a marker of intrarenal renin-angiotensin system (RAS) status (angiotensinogen) were determined in 118 patients with type 2 diabetes mellitus and 25 non-diabetic controls with estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2. Results Urinary levels of KIM-1, NGAL, IL-18 and angiotensinogen were significantly higher in macroalbuminuria group compared with control and normo- and microalbuminuria groups but not significantly different between control and normoalbuminuria group. Urinary tubular markers were positively correlated with urinary IL-18 and angiotensinogen, respectively. The urinary albuminuria was correlated with all investigated urinary markers in univariate analysis. After adjusting for several clinical parameters, urinary KIM-1, NGAL and angiotensinogen were significantly associated with albuminuria. Conclusions The results of this study suggest that urinary tubular markers may be independently associated with albuminuria in the early stage of nephropathy in type 2 diabetics (eGFR ≥60 mL/min/1.73 m2) and may reflect inflammatory processing and the activation of the intrarenal RAS.

Primary or metastatic malignant melanoma can mimic benign blue nevus in rare cases, making the diagnosis challenging. Herein, we report an exceptionally rare case of blue nevus-like melanoma and its blue nevus-like metastasis which was detected by catheterized urine cytology. The patient presented with blue-colored papuloplaques on his temple which were diagnosed as blue nevus-like melanoma on punch biopsies. While he was admitted for administration of chemotherapy, hematuria was detected. Catheterized urine cytology revealed singly scattered oval to spindle-shaped pigmented cells with a moderate degree of variation in shape and size. Many of them had small nuclei with indiscernible to inconspicuous nucleoli while only a few cells showed nuclear enlargement and nuclear hyperchromasia, which could be diagnostic pitfalls. Most of the cells on the smear were positive for HMB45 immunostaining, which confirmed the diagnosis of metastatic blue nevus-like melanoma. To the best of our knowledge, the present case is the first report describing cytomorphologic findings of blue nevus-like metastasis of melanoma in the urine specimen.

Some patients present with restrictive chronic lung function decline after haematopoietic stem cell transplantation http://ow.ly/RpsAx

Secondary systemic (AA) amyloidosis is a severe complication of progressed Crohn disease (CD) characterized by the deposition of amyloid A in body organs and tissues. Various therapeutic approaches have been recommended, however there is still no effective treatment. Recently, several case reports have demonstrated the effects of anti-tumor necrosis factor-α therapy in patients with AA amyloidosis associated with CD. We report on a 35-year-old female patient with CD complicated by AA amyloidosis in the gastrointestinal tract and renal involvement, who was treated with infliximab. The infliximab therapy improved the gastrointestinal symptoms and decreased the serum creatinine.

1 , Min-Joo Song Malignant mesothelioma is a common, primary tumor that can invade pleura, and is associated with pre- vious exposure to asbestos. However, it poses considerable difficulties regarding its diagnosis and treatment, and thus, accurate history taking with respect to exposure to asbestos, and radiologic and pathologic exami- nations are essential. In addition, the involvement of a multidisciplinary team is recommended in order to ensure prompt and appropriate management using a framework based on radiotherapy, chemotherapy, sur- gery, and symptom palliation with end-of-life care. Because lymphocyte-dominant, exudative pleural effusion can occur in malignant mesothelioma, adenosine deaminase values may be elevated, which could be mis- taken for tuberculous pleurisy, and lead to an incorrect diagnosis and suboptimal treatment. The authors describe a case of malignant mesothelioma initially misdiagnosed as tuberculous pleurisy. As evidenced by the described case, malignant mesothelioma should be considered during the differential diagnosis of pa- tients with lymphocyte-dominant, exudative pleural effusion with a pleural lung lesion.

The use of tumor necrosis factor inhibitors (TNFi) increases a patient’s risk of developing tuberculosis (TB). There is no consensus on whether restarting a TNFi after treating an active TB infection caused by previous TNFi exposure is safe. We report the first case of TB recurrence after recommencing a TNFi in a 37-year-old woman with a history of active TB infection caused by previous TNFi treatment. (Korean J Med 2015;88:701-705)