Accelerated national lot release on COVID-19 vaccines in Republic of Korea.

Independent quality testing of samples from vaccine lots is part of quality assurance, especially to ensure the consistency of production lot by lot. Effective national lot release system that ensures the quality of each lot of vaccine before it is on the market is important because vaccines are intended to healthy people. In order to respond more quickly to public health crises such as the COVID-19 pandemic, the MFDS implements accelerated national lot release for rapid vaccination in Republic of Korea. For the accelerated system, improvement has been made in terms of timing of application for lot release and required documents. In addition, the processing period has been shortened and sampling method and test items have been streamlined. A thorough preparation for accelerated lot release has been developed by establishing test methods for a new platform in advance. As a result, a total of 43.88 million doses have been released within eight days on average. The accelerated lot release system has contributed significantly to rapid COVID-19 vaccination in Korea.

Simplified Free Gingival Graft Around Implants Using Medical Grade Tissue Cyanoacrylate: A Case Series Report.

The free gingival graft (FGG) procedure using suturing techniques has been widely utilized to effectively increase the amount of attached keratinized gingiva. However, conventional suturing procedures are time-consuming and technique-sensitive. Simplified FGG procedure around teeth and dental implants using medical grade tissue adhesive (cyanoacrylate) is known to overcome drawbacks of traditional suture techniques. However, the clinical application of cyanoacrylate as a means of stabilizing the graft has not been a common practice. The aim of this report demonstrates simplified FGG procedures around dental implants using cyanoacrylate with follow-up results.

Client-Centered Breastfeeding-Promotion Strategies: Q Methodology.

Fewer Korean women are choosing the 6 months of exclusive breastfeeding that are recommended for obtaining its maximal benefits despite an increasing effort to promote breastfeeding. Successful breastfeeding education and counseling need to be segmentally designed on the basis of client characteristics. This study explored the perceptions of breastfeeding in pregnant and 6 month postpartum Korean women using the Q methodology, a useful research approach to examine personal perceptions, feelings, and values about a concept or phenomenon of interest and identify typologies of perspectives. The Q sample consisted of 38 statements representing the universe of viewpoints on breastfeeding. The P sample (N = 49) included women who shared their perceptions of breastfeeding and filled each grid with a statement in the Q sorting table. Data were analyzed using the PC-QUANL program. Varimax (orthogonal) rotation revealed four factors that explained 53.0% of variance: maternal privilege (Factor 1), option based on emotion (Factor 2), option if efficient (Factor 3), and option if I have sufficient problem-solving skills (Factor 4). Korean women have changed their attitudes toward breastfeeding, with all participants viewing breastfeeding as optional. Breastfeeding-promotion campaigns and education need to consider societal norms and changes in women's beliefs and perceptions.

Therapeutic effects of bee venom and its major component, melittin, on atopic dermatitis in vivo and in vitro.

BACKGROUND AND PURPOSE: Atopic dermatitis (AD) is a multifactorial skin condition with complex interactions of innate and adaptive immune responses. There are several existing therapies for AD, including topical glucocorticosteroids, emollients, phototherapies, calcineurin inhibitors and immunosuppressants, such as cyclosporine A. Although these therapies reduce inflammation, they also cause serious side effects. Therefore, it is necessary to develop new therapeutic approaches for AD treatment without side effects. There are several studies on natural materials or toxins, such as herbs, ginseng extract and snake venom, for AD treatment. However, treatment of AD with bee venom and its major component, melittin has rarely been studied. EXPERIMENTAL APPROACH: Effects of bee venom and melittin were studied in a model of AD in vivo induced by 1-chloro-2,4-dinitrobenzene (DNCB) in female Balb/c mice and in cultures of human keratinocytes, stimulated by TNF-α/IFN-γ. The potential pharmacological effects of bee venom and melittin on these in vivo and in vitro AD-like skin disease models were studied. KEY RESULTS: Bee venom and melittin exhibited potent anti-atopic activities, shown by decreased AD-like skin lesions, induced by DNCB in mice. In vitro studies using TNF-α/IFN-γ-stimulated human keratinocytes showed that bee venom and melittin inhibited the increased expression of chemokines, such as CCL17 and CCL22, and pro-inflammatory cytokines, including IL-1ß, IL-6 and IFN-γ, through the blockade of the NF-κB and STAT signalling pathways. CONCLUSIONS AND IMPLICATIONS: Our results suggest that bee venom and melittin would be suitable for epicutaneous application, as topical administration is often appropriate for the treatment of AD.

Item development process and analysis of 50 case-based items for implementation on the Korean Nursing Licensing Examination.

PURPOSE: The purpose of this study was to improve the quality of items on the Korean Nursing Licensing Examination by developing and evaluating case-based items that reflect integrated nursing knowledge. METHODS: We conducted a cross-sectional observational study to develop new case-based items. The methods for developing test items included expert workshops, brainstorming, and verification of content validity. After a mock examination of undergraduate nursing students using the newly developed case-based items, we evaluated the appropriateness of the items through classical test theory and item response theory. RESULTS: A total of 50 case-based items were developed for the mock examination, and content validity was evaluated. The question items integrated 34 discrete elements of integrated nursing knowledge. The mock examination was taken by 741 baccalaureate students in their fourth year of study at 13 universities. Their average score on the mock examination was 57.4, and the examination showed a reliability of 0.40. According to classical test theory, the average level of item difficulty of the items was 57.4% (80%-100% for 12 items; 60%-80% for 13 items; and less than 60% for 25 items). The mean discrimination index was 0.19, and was above 0.30 for 11 items and 0.20 to 0.29 for 15 items. According to item response theory, the item discrimination parameter (in the logistic model) was none for 10 items (0.00), very low for 20 items (0.01 to 0.34), low for 12 items (0.35 to 0.64), moderate for 6 items (0.65 to 1.34), high for 1 item (1.35 to 1.69), and very high for 1 item (above 1.70). The item difficulty was very easy for 24 items (below -2.0), easy for 8 items (-2.0 to -0.5), medium for 6 items (-0.5 to 0.5), hard for 3 items (0.5 to 2.0), and very hard for 9 items (2.0 or above). The goodness-of-fit test in terms of the 2-parameter item response model between the range of 2.0 to 0.5 revealed that 12 items had an ideal correct answer rate. CONCLUSION: We surmised that the low reliability of the mock examination was influenced by the timing of the test for the examinees and the inappropriate difficulty of the items. Our study suggested a methodology for the development of future case-based items for the Korean Nursing Licensing Examination.

Relevance of the test content of the Korean Nursing Licensing Examination to nursing job.

PURPOSE: This study aimed at identifying if there is a relevance of content of the Korean Nursing Licensing Examination (KNLE) revised in 2014 to nursing job. It will be able to provide the validity of revised content of the KNLE. METHODS: From October 13 to November 13, 2015, print version of 8 duties with 49-tasks, 155-job item questionnaires were distributed to 1,305 hospital nurses and 202 nursing faculties in Korea. Results were treated by descriptive statistics and comparison analysis. There were responses from 946 nurses or professors (72.5%). RESULTS: The relevance of test content of KNLE to nursing job was shown to be valid with over 3 points out of 4 point Likert scale in all items: from 3.23 at lowest to 3.64 at top. CONCLUSION: Above results showed that the revised version of KNLE in 2014 was valid to test the nursing students' knowledge for job performance.

The job analysis of Korean nurses as a strategy to improve the Korean Nursing Licensing Examination.

PURPOSE: This study aimed at characterizing Korean nurses' occupational responsibilities to apply the results for improvement of the Korean Nursing Licensing Examination. METHODS: First, the contents of nursing job were defined based on a focus group interview of 15 nurses. Developing a Curriculum (DACOM) method was used to examine those results and produce the questionnaire by 13 experts. After that, the questionnaire survey to 5,065 hospital nurses was done. RESULTS: The occupational responsibilities of nurses were characterized as involving 8 duties, 49 tasks, and 303 task elements. Those 8 duties are nursing management and professional development, safety and infection control, the management of potential risk factors, basic nursing and caring, the maintenance of physiological integrity, medication and parenteral treatments, socio-psychological integrity, and the maintenance and improvement of health. CONCLUSION: The content of Korean Nursing Licensing Examination should be improved based on 8 duties and 49 tasks of the occupational responsibilities of Korean nurses.

A digital approach to fabricating an abutment replica to control cement volume in a cement-retained implant prosthesis.

If a cement-retained implant prosthesis is placed on an abutment, excess cement should be minimized or removed to prevent periimplant inflammation. Various methods for fabricating an abutment replica have been introduced to maintain tissue health and reduce clean-up time. The purpose of this article is to present an alternative technique for fabricating an abutment replica with computer-aided design/computer-aided manufacturing (CAD/CAM) technology.

Retrospective study of sintered porous-surfaced dental implants placed in the augmented sinus.

The purpose of this study was to analyze clinical and radiographic outcomes of sintered porous-surfaced dental implants placed in partially edentulous posterior maxillae. The study group consisted of 42 partially edentulous patients who received sinus augmentation using the lateral window technique or crestal approach at Catholic University Hospital of Daegu and one private clinic. The 42 patients received a total of 92 sintered porous-surfaced dental implants in the edentulous posterior maxillae. All implants were restored with fixed prostheses. Of the 92 implants, 17 implants were restored with individual (nonsplinted) crowns, while 75 implants were splinted to other implants. Panoramic views and periapical radiographs using the standardized long-cone paralleling technique were taken at the first visit, postoperatively, at the time of prosthesis seating, and at a follow-up visit. Survival rates of implants in relation to location, length, diameter, crown-to-implant (C/I) ratio, and type of prosthesis were investigated. Statistical data were analyzed using software with the chi-square test. Of the 92 implants, 8 (8.7%) were removed, and the cumulative survival rate was 91.3% after a maximum 9-year functional period (mean: 72.8 months; range: 11 to 107 months). There were no statistical differences in relation to the location of implants, C/I ratio, or type of prosthesis. However, there were statistical differences in relation to the length and diameter of implants. Average crestal bone loss was 0.68 mm at 1-year follow-up and 1.13 mm at final examination. All implants were inserted in the augmented maxillary sites. The cumulative survival rate of sintered porous-surfaced implants in posterior maxillae was 91.3%. Sintered porous-surfaced implants showed satisfactory results in the edentulous posterior maxillae.

Benefit of the replaceable bony window in lateral maxillary sinus augmentation: clinical and histologic study.

PURPOSE: This retrospective study demonstrates, by clinical and histologic evaluation, the benefit of the replaceable bony window as a homologous bony barrier in lateral sinus augmentation. MATERIALS AND METHODS: A total of 103 maxillary sinus augmentations were performed using a piezoelectric device and a Er,Cr:YSGG laser apparatus. The detached bony windows were repositioned over various bone grafts. Sixteen bone biopsy specimens were harvested at the time of uncovering or implant placement. RESULTS: Three sinuses developed postoperative infections (2.91%). After 6 to 8 months of healing, uncovering procedures were carried out. Radiographically, reconstruction of the lateral sinus wall was observed in all cone-beam computed tomogram. Clinically, complete bone healing between the replaceable bony window and the lateral sinus wall was observed in all cases, except for the 3 infected sinuses (100 sinuses, 97.09%). Histologically, favorable new bone formation was observed in all specimens without any fibrous connective tissue invagination. More mature bone was observed along the floor of the replaceable bony window than at the center of the graft site. CONCLUSION: This study demonstrates that the replaceable bony window acts as an osteoinductive homologous barrier membrane over various bone graft materials and accelerates new bone formation in lateral sinus augmentation.

Ligation of the left hepatic vein for dilated intrahepatic collaterals late after fontan operation.

A 17-year-old male presented with two episodes of syncope, cyanosis, and exercise intolerance 13 years after the Fontan operation. Echocardiography and magnetic resonance imaging showed dilated intrahepatic collaterals, which drained into the atrium through the left hepatic vein, and 24-hour Holter monitoring revealed sinus node dysfunction. We performed ligation of the left hepatic vein using intrahepatic collaterals as channels draining hepatic venous blood into the Fontan pathway, and implanted an epicardial dual chamber pacemaker. At one-year follow-up, the patient remained asymptomatic and his cardiac performance was much improved.

Flapless transcrestal sinus augmentation using hydrodynamic piezoelectric internal sinus elevation with autologous concentrated growth factors alone.

PURPOSE: The purpose of this retrospective study was to evaluate the success rate of implants and the amount of sinus augmentation using the flapless hydrodynamic piezoelectric internal sinus elevation (HPISE) technique with autologous concentrated growth factors (CGF) alone. MATERIALS AND METHODS: A total of 11 maxillary sinuses were augmented using the HPISE technique through the flapless transcrestal approach. Sixteen implants (average 11.38 mm in length and 4.83 mm in diameter), with 2 different surfaces, were placed simultaneously with CGF alone. Plain panoramic radiograms and cone-beam computed tomograms (CBCT) were taken in all patients to evaluate the sinus augmentation preoperatively and postoperatively. RESULTS: The sinus membranes were successfully elevated, averaging 13.95 ± 6.61 mm in immediate postoperative CBCT without any iatrogenic perforation. After an average 23.8 weeks, the average bone gain above the sinus floor was 8.23 ± 2.88 mm in the axial aspect of CBCT. No complications were recorded in any patients during the follow-up period. CONCLUSION: The flapless transcrestal approach to the sinus augmentation using the HPISE technique with autologous CGF alone could be an alternative to the lateral approach, even at severely resorbed edentulous posterior maxilla with insufficient bone height.

Comparative histomorphometric analysis of maxillary sinus augmentation with absorbable collagen membrane and osteoinductive replaceable bony window in rabbits.

PURPOSE: The aim of this animal study was to evaluate, through histomorphometric evaluation, bone regeneration in rabbit maxillary sinuses with absorbable collagen membranes and osteoinductive replaceable bony windows over bone grafts. MATERIALS AND METHODS: Bilateral sinus augmentation procedures were performed in 16 adult male rabbits. The rabbits were randomly assigned to 4 groups of 4 rabbits each. Rectangular replaceable bony windows were made with a piezoelectric thin saw insert. In control group, grafted ß-tricalcium phosphate (ß-TCP) was covered by absorbable collagen membranes. In experimental groups, ß-TCP was grafted and covered by replaceable bony windows. The rabbits were killed at 1, 2, 4, and 8 weeks postoperatively. The augmented sinuses were stained with hematoxylin-eosin and Masson trichrome stains and examined, under light microscopy, for newly formed bone and soft tissue changes in the maxillary sinuses. RESULTS: Histologically, significantly higher and faster new bone formation was observed in the augmented sinuses of the experimental groups, receiving homologous replaceable bony windows than in those of the control group receiving collagen membranes. CONCLUSION: This study demonstrates that, for augmentation, the use of the homologous replaceable bony window over bone graft material on the maxillary sinus accelerates bone regeneration.

Identification of KCNN2 as a susceptibility locus for coronary artery aneurysms in Kawasaki disease using genome-wide association analysis.

Kawasaki disease (KD) is often complicated by coronary artery lesions (CALs), including aneurysms. Because of the complications associated with KD, this disorder is the leading cause of acquired heart disease in children from developed countries. To identify genetic loci that confer a higher risk of developing CALs, we performed a case-control association study using previous genome-wide association study data for samples from KD cases only (n=186) by grouping KD patients without CALs (control: n=123) vs KD patients with extremely large aneurysms (diameter>5 mm) (case: n=17). Twelve loci with one or more sequence variants were found to be significantly associated with CALs (P<1 × 10(-5)). Of these, an SNP (rs17136627) in the potassium intermediate/small conductance calcium-activated channel, subfamily N, member 2 (KCNN2) at 5q22.3 was validated in 32 KD patients with large aneurysms (diameter>5 mm) and 191 KD patients without CALs (odds ratio (OR)=12.6, P(combined)=1.96 × 10(-8)). This result indicates that the KCNN2 gene can have an important role in the development of coronary artery aneurysms in KD.

Outcomes of mechanical valves in the pulmonic position in patients with congenital heart disease over a 20-year period.

BACKGROUND: Homografts or bioprosthetic valves have been preferred in the pulmonic position in patients with congenital heart disease. However, unsatisfactory long-term results have aroused interest in the use of mechanical valves. In this study, we investigated the long-term outcomes of mechanical valves implanted in the pulmonic position. METHODS: The medical records of 37 patients (27 male, 73%) who underwent 38 mechanical pulmonary valve replacements between October 1988 and February 2011 were reviewed, retrospectively. The median age of patients was 13.5 years (range, 7 months to 23 years), and the median number of prior operations per patient was 2 (range, 0 to 5). Tetralogy of Fallot was the most common diagnosis (n=23). The median valve size was 23 mm (range, 17 to 27 mm), and the median follow-up duration after pulmonary valve replacement was 24.6 months (range, 1.3 months to 22.5 years). Events were defined as the following: valve failure, thrombosis, embolism, bleeding, reoperation, and death. RESULTS: There was no in-hospital mortality, but there were 2 late deaths (1 heart failure and 1 traffic accident at 10.8 months and 8.7 years postoperatively, respectively). Excluding the traffic accident death, survival rates were 97%, 97%, and 97%, at 1, 5, and 10 years, respectively. Freedom from thromboembolism or bleeding events was 92%, 92%, and 78.8%, at 1, 5 and 10 years, respectively. Two reoperations were performed at 6.8 and 10.2 years postoperatively. Freedom from reoperation was 100%, 100%, and 85.7%, at 1, 5, and 10 years, respectively. CONCLUSIONS: Durability of mechanical valve in pulmonic position was excellent. Thromboembolism or bleeding events due to anticoagulation therapy were rare. In growing patients who have undergone prior sternotomies requiring a pulmonary valve replacement, a mechanical valve could be an attractive option.

Low pulmonary vascular compliance predisposes post-Fontan patients to protein-losing enteropathy.

BACKGROUND: Protein-losing enteropathy (PLE) is a life-threatening and poorly understood complication after the Fontan operation. We sought to determine the pre-operative risk factors for PLE which developed after the extracardiac conduit Fontan operation. METHODS: Two hundred thirty-five patients who underwent the extracardiac conduit Fontan operation as an initial Fontan type procedure (median age at operation: 3.5 years) were enrolled in this cross-sectional retrospective study. Pre-operative and peri-operative variables were surveyed through a review of medical records. RESULTS: Within the median follow-up duration of 5 years, 12 patients developed PLE (12/234, 5.1%) at a median interval of 2.2 years after the Fontan procedure, and 4 died of PLE at a median interval of 1.2 years (range 0.21-7.62) after diagnosis. Factors found to be related to the time to the development of PLE on univariate analysis were pulmonary vascular compliance (Cpv) (p=0.0019), central venous pressure at postoperative 12 hours (p=0.0026), days of ICU stay (P=0.0449), days of hospitalization (p=0.0135), and days of chest tube indwelling (p=0.0493). Multivariate analysis, however, showed that only Cpv (p=0.0367) remained significant. The range of Cpv was 8.8-26.1 mm(2)/m(2)/mmHg (median 17.9) in patients with PLE, and 6.6-122.3 mm(2)/m(2)/mmHg (median 26.8) in patients without PLE. CONCLUSIONS: Low pulmonary vascular compliance is associated with the development of PLE after the extracardiac conduit Fontan operation.

Bisphosphonates-related osteonecrosis of the jaw in Korea: a preliminary report.

OBJECTIVES: Bisphosphonates (BP) are widely used in medicine for inhibiting bone resorption; however bisphosphonate-related osteonecrosis of the jaw (BRONJ) is a major side effect of BP. To date, there have been no specific reports on the incidence of BRONJ among Koreans. This study investigated the preliminary results from a nationwide survey of BRONJ in the Departments of Oral and Maxillofacial Surgery (OMFS) at individual training hospitals. MATERIALS AND METHODS: A total of 15 OMFS departments (10 from dental schools, 4 from medical schools, and 1 from a dental hospital) participated in a multi-centric survey. This study assessed every BRONJ case diagnosed between January 2010 and December 2010. The patient age and BP type were evaluated. RESULTS: A total of 254 BRONJ cases were collected. The majority of BRONJ cases were associated with oral BP therapy, while 21.8% of the cases were associated with intravenous administration. Alendronate was the drug most frequently related to BRONJ (59.2% of cases), followed by risedronate (14.3%) and zolendronate (17.0%). The average age of BRONJ patients was 70.0±10.1 years, with a range of 38-88 years of age. With the number of BP patients in Korea reported to be around 600,000 in 2008, the estimated incidence of BRONJ is at least 0.04% or 1 per 2,300 BP patients. CONCLUSION: The results suggest that the estimated incidence of BRONJ in Korea is higher than the incidence of other countries. Future prospective studies should be carried out to investigate the exact epidemiological characteristics of BRONJ in Korea.

Minimally invasive sinus augmentation using ultrasonic piezoelectric vibration and hydraulic pressure: a multicenter retrospective study.

PURPOSE: The purpose of this study was to evaluate the success rate of implants and vertical bone gain of edentulous posterior maxilla using ultrasonic piezoelectric vibration and hydraulic pressure, namely the hydrodynamic piezoelectric internal sinus elevation (HPISE) technique through a crestal approach. MATERIALS AND METHODS: A total of 250 maxillary sinuses were augmented using HPISE and 353 implants (averaging 11.8 mm in length and 4.5 mm in diameter), with 12 different systems, were placed simultaneously with or without additional bone grafting. Plain radiograms and cone beam computed tomograms were taken in all patients to evaluate sinus augmentation. RESULTS: Membrane perforation was recorded at 10 of the 353 implant sites. The perforation rate was 2.83%. The total success rate of implantation was 97.2% after an average of 69.3 weeks of loading. CONCLUSION: The crestally approached sinus augmentation using ultrasonic piezoelectric vibration and hydraulic pressure is an additional method of maxillary sinus augmentation.

Systemic inflammatory stimulation by microparticles derived from hypoxic trophoblast as a model for inflammatory response in preeclampsia.

OBJECTIVE: To determine whether trophoblast-derived microparticles can induce different inflammatory responses of the peripheral blood mononuclear cells depending upon the state of trophoblast when the microparticles are generated. STUDY DESIGN: A trophoblast-derived cell line (ATCC no. CRL-1584) was cultured under normal or hypoxic conditions. Microparticles were isolated from the cell culture supernatants (microparticles from normal trophoblast; microparticles from hypoxic trophoblast). Peripheral blood mononuclear cells were cultured alone or cocultured with either microparticles from normal trophoblast or microparticles from hypoxic trophoblast. RESULTS: After 48 hours, the peripheral blood mononuclear cells cocultured with microparticles from normal trophoblast released higher concentrations of interleukin-6 than peripheral blood mononuclear cells cultured alone. The peripheral blood mononuclear cells cocultured with microparticles from hypoxic trophoblast showed higher concentration of interleukin-6 and tumor necrosis factor alpha than peripheral blood mononuclear cells cocultured with microparticles from normal trophoblast, after 24 hours and 48 hours. CONCLUSION: More intense and rapid inflammatory response of peripheral blood mononuclear cells was observed with microparticles from hypoxic trophoblast than with microparticles from normal trophoblast. This difference might explain the exaggerated systemic inflammatory response as a result of placental hypoxia in preeclampsia.