Search

Background: Despite the increasing population of elderly individuals in Korea, there are no evidence‐based geriatric nursing practice guidelines. Aim: This study aimed to identify and prioritize topics related to the development of evidence‐based geriatric nursing practice guidelines in long‐term care facilities in Korea. Methods: To identify potential topics, 89 nurses responded to a questionnaire on activities that require further evidence and/or standardization in the long‐term care facility setting. To prioritize these topics, 14 geriatric nursing experts completed surveys to prioritize five categories. Results: The collected data included 240 clinical topics, which were classified into 41 subcategories and 18 main categories. According to topic prioritization by the geriatric nursing experts, the following were the most heavily weighted categories: fall prevention, position change and prevention of pressure ulcers. Conclusions: The development of standardized guidelines based on these results may help improve the quality of geriatric care and quality of life of older individuals. The small number of respondents may be a limitation of this study, and further study is needed to expand the population. Implications for nursing and health policy: The development of evidence‐based nursing guidelines based on the present findings will help improve the quality of nursing in long‐term care facilities. Additionally, health policies and systems, such as introduction of a fee for nursing services for older individuals based on the evidence, are worth considering. [ABSTRACT FROM AUTHOR]

Objectives This study aimed to evaluate the effect of the prospective drug utilization review (DUR) system introduced in Korea in December 2010 as a real-time method to improve patient safety, in terms of changes in prescribing practices, adverse drug events (ADEs), and ADE-related healthcare expenditure, using non-steroidal anti-inflammatory drugs (NSAIDs) and their common ADEs as a guide. Study design We used an interrupted time-series study design using generalized estimating equations to evaluate changes in prescription rate and ADE-related healthcare expenditure. Cox regression analysis was used to evaluate the probability of NSAID-associated ADEs. Methods A total of 154,585 outpatients with musculoskeletal or connective tissue disorders, without pre-existing gastric bleeding or ulcers were included in this study. The primary outcome was the level and trend change in prescription rate, drug–drug interactions, coprescribed gastro-protective drugs, and defined daily dose (DDD) of NSAIDs. The secondary outcome was the probability of ADEs and changes in ADE-related healthcare expenditure. Results There was a significant trend change after introducing the DUR system in terms of drug–drug interactions (−3.6%) and coprescribed gastro-protective drugs (+0.6%). The mean DDD of NSAIDs increased by 0.2. The probability of ADEs decreased overall (−1.7%) and in the high-risk group (age ≥65 years; −9.6%); however, only the latter was significant. There was no significant trend or level change in ADE-related health expenditure. Conclusions The introduction of the DUR system was associated with more efficient prescribing, including a reduction in drug–drug interactions and an increase in the use of gastro-protective drugs. The system had a positive effect on patient outcome but was not associated with reduced ADE-related costs. Further studies are needed to evaluate the long-term effects of the DUR system in Korea. [ABSTRACT FROM AUTHOR]

Campylobacter jejuni is one of the major causative pathogens of outbreaks or sporadic cases of diarrhoeal diseases worldwide. In this study, we compared the phenotypic and genetic characteristics of C. jejuni isolates of human and food-producing animal origins in Korea and examined the genetic relatedness between these two groups of isolates. Regardless of isolation source, all C. jejuni isolates harboured four virulence genes, cadF, cdtB, ciaB and racR, whereas the wlaN and virB11 genes were more frequently observed in human isolates. Antimicrobial susceptibility testing showed that the majority of C. jejuni isolates displayed high-level resistance to fluoroquinolone (95.2%) or tetracycline (76.2%) antibiotics, and 12.4% of isolates exhibited multidrug resistance (more than three classes of antibiotics tested). Pulsed-field gel electrophoresis ( PFGE) of all Campylobacter isolates revealed 51 different SmaI- PFGE patterns and six major clusters containing both human and animal isolates. These results indicate that genetically diverse strains of C. jejuni with antimicrobial drug-resistance and virulence properties have prevailed in Incheon. Nevertheless, some particular populations continue to circulate within the community, providing the evidence for an epidemiological link of C. jejuni infections between humans and food-producing animals. Therefore, the continued monitoring and surveillance of C. jejuni isolates of human and food-producing animal origins are required for public health and food safety. [ABSTRACT FROM AUTHOR]

Background and Objective Caffeic acid phenethyl ester (CAPE) has numerous potentially beneficial properties, including antioxidant, immunomodulatory and anti-inflammatory activities. However, the effect of CAPE on periodontal disease has not been studied before. This study was designed to investigate the efficacy of CAPE in ameliorating the production of proinflammatory mediators in macrophages activated by lipopolysaccharide (LPS) from Prevotella intermedia, a pathogen implicated in periodontal disease. Material and Methods LPS from P. intermedia ATCC 25611 was isolated by using the standard hot phenol-water method. Culture supernatants were assayed for nitric oxide (NO), interleukin (IL)-1β and IL-6. We used real-time polymerase chain reaction to quantify inducible NO synthase, IL-1β, IL-6, heme oxygenase (HO)-1 and suppressors of cytokine signaling (SOCS) 1 mRNA expression. HO-1 protein expression and levels of signaling proteins were assessed by immunoblot analysis. DNA-binding activities of NF-κB subunits were analyzed by using the enzyme-linked immunosorbent assay-based kits. Results CAPE exerted significant inhibitory effects on P. intermedia LPS-induced production of NO, IL-1β and IL-6 as well as their mRNA expression in RAW264.7 cells. CAPE-induced HO-1 expression in cells activated with P. intermedia LPS, and selective inhibition of HO-1 activity by tin protoporphyrin IX attenuated the inhibitory effect of CAPE on LPS-induced NO production. CAPE did not interfere with IκB-α degradation induced by P. intermedia LPS. Instead, CAPE decreased nuclear translocation of NF-κB p65 and p50 subunits induced with LPS, and lessened LPS-induced p50 binding activity. Further, CAPE showed strong inhibitory effects on LPS-induced signal transducer and activator of transcription 1 and 3 phosphorylation. Besides, CAPE significantly elevated SOCS1 mRNA expression in P. intermedia LPS-stimulated cells. Conclusion Modulation of host response by CAPE may represent an attractive strategy towards the treatment of periodontal disease. In vivo studies are required to appraise the potential of CAPE further as an immunomodulator in the treatment of periodontal disease. [ABSTRACT FROM AUTHOR]

Summary: Sarcopenia is the age-related reduction of skeletal muscle mass in older individuals. Respiratory muscle strength may be related to skeletal muscle mass and, thus, the present study attempted to estimate the risk of sarcopenia relative to decreased pulmonary function. The present findings demonstrated that low pulmonary function was associated with low muscle mass in community-dwelling older adults. Introduction: Lean body mass is related to pulmonary function in patients with chronic obstructive pulmonary disease (COPD). However, the relationship between muscle mass and pulmonary function in healthy older adults has yet to be clarified. Thus, the present study investigated the association of pulmonary function with muscle mass in an older community-dwelling Korean population. Methods: This study included 463 disease-free subjects over 65 years of age who underwent anthropometric measurements, laboratory tests, spirometry, and the estimation of appendicular skeletal muscle (ASM) mass in the 2008-2011 Korea National Health and Nutrition Examination Survey (KNHANES). Low muscle mass was defined as the value of ASM divided by height squared (ASM/height) that was less than two standard deviations (SD) below the sex-specific mean of the young reference group. Results: Forced expiratory volume in 1 s (FEV1[L]) and forced vital capacity (FVC[L]) were positively correlated with ASM/height in males ( p < 0.001 and p = 0.001, respectively) but not in females ( p = 0.360 and p = 0.779, respectively). A univariate logistic regression analysis revealed that males with low FEV1 or FVC were more likely to have low muscle mass (odds ratio [OR] = 3.11, 95 % confidence interval [CI] 1.62-5.99 for FEV1; OR = 1.99, 95 % CI 1.13-3.53 for FVC); similar results were found for females, but the significance was lower (OR = 11.37, 95 % CI 0.97-132.91 for FEV1; OR = 7.31, 95 % CI 1.25-42.74 for FVC). After adjusting for age, smoking, and moderate physical activity, a low FEV1 value was associated with low muscle mass in both males (OR = 2.90, 95 % CI 1.50-5.63) and females (OR = 9.15, 95 % CI 1.53-54.77). Conclusions: Using nationally representative data from the 2008-2011 KNHANES, low pulmonary function was found to be associated with low muscle mass in community-dwelling older Korean adults. [ABSTRACT FROM AUTHOR]

We investigated awareness in dental hygienists of bisphosphonate-related osteonecrosis of the jaw ( BRONJ) in patients with osteoporosis and cancer and assessed the situation in systemic history investigations to broaden the scope of the dental hygienists' BRONJ awareness as a basis for contributing to preventing this disease. The study was carried out through a survey; 217 dental hygienists responded to the survey. They worked at 12 university and general hospitals, 10 dental hospitals and 35 dental clinics, for a total of 57 institutions in Seoul. The survey consisted of 37 questions: general characteristics ( J Oral Maxillofac Surg 65: 2007; 369), systemic history investigations (Ruggiero et al. J Oral Maxillofac Surg 62: 2004; 527) and awareness of BRONJ (Park et al. J Korean Dent Assoc 49: 2011; 389). Among them, 79.7% were aware of BRONJ. Recognition was highest among those from 25 to 35 years old ( P < 0.05). In terms of work experience, those with 5-10 years experience showed the highest awareness ( P < 0.05). In terms of institutions type, dental clinics showed lower awareness than general and dental hospitals ( P < 0.05). It was found that 55.3% of the dental hygienists had been educated about BRONJ. Those aged 25-35 years were the most educated. In terms of institutions, dental clinic staff were the least educated. The degree of understanding about BRONJ was analysed with the average score of 6.14 points. According to these results, dental hygienists working in university hospitals and general hospitals had more opportunity to receive training than those working in dental clinics. Thus, it is considered that the development of professional training programs about BRONJ for all dental hygienists is necessary. [ABSTRACT FROM AUTHOR]

Objective:To identify clinical factors that can explain the differences in treatment outcome, and examine the value of human papillomavirus infection as a prognostic biomarker in stage IVa tonsillar carcinomas.Methods:Fifty-nine patients with tonsillar carcinoma classified as stage IVa were retrospectively analysed for survival outcomes according to various clinical factors. Human papillomavirus infection was evaluated using a human papillomavirus DNA chip test and immunohistochemical staining for p16 and p53.Results:Lower disease-free survival rates were associated with increasing local invasiveness and nodal status. Although human papillomavirus positivity and p16 expression was more common in locally advanced tonsillar carcinomas with advanced nodal status, the overall survival rate was better for patients with human papillomavirus positive, p16-positive tumours.Conclusion:The disease-free survival rate may differ according to local tumour invasiveness and nodal status, even for stage IVa tonsillar cancers. Human papillomavirus infection may be a useful biomarker for predicting treatment outcomes for stage VIa tumours. [ABSTRACT FROM PUBLISHER]

Objectives This study investigated the association between bone mineral density ( BMD) and periodontitis in a representative sample of Korean adults. Material and Methods Of 36 188 individuals who participated in the Korea National Health and Nutrition Examination Survey in 2008, 2009, and 2010, 9977 participants aged ≥40 years were included in this cross-sectional study. The associations of BMD of lumbar spine, total femur, and femoral neck with periodontitis were investigated using logistic regression analysis. Additionally, dose-response relationships with BMD divided into quintiles and the association between osteoporosis and periodontitis were investigated. Results With the set of Community Periodontal Index ( CPI) ≥ 3 as a dependent variable, logistic regression analysis revealed that a decrease of BMD was significantly associated with higher odds of periodontitis [range of adjusted odds ratios ( AORs); 1.15-1.20, P < 0.001 for all BMD sites]. Similarly, these associations were also found in the CPI 4 model. With regard to dose-response relations, the lower the BMD quintile, the higher the AORs appeared with statistical significance in the CPI ≥ 3 model. ( P for trend < 0.001) Participants with osteoporosis had 2.26 and 1.91 times higher odds for CPI ≥ 3 and CPI 4, respectively, than those with normal BMD, indicating a significant association between the two diseases. Conclusions Our results suggest that BMD is significantly associated with periodontitis. [ABSTRACT FROM AUTHOR]

This study evaluates the future impact of climate change on hydrological components in a 8.54 km² mixed forest watershed located in the northwest of South Korea. Before future assessment, the SWAT (Soil Water Assessment Tool) model was calibrated using two years (2007-2008) and validated by using one year (2009) of daily observed streamflow, evapotranspiration, and soil moisture. Hydrological predicted values matched well with the observed values during calibration and validation (R² ≥ 0.6 and Nash-Sutcliffe efficiency ≥ 0.5). The MIROC3.2hires GCM (general circulation model) data of the SRES (special report on emissions scenarios) A1B and B1 scenarios of the IPCC (Intergovernmental Panel on Climate Change) were adopted for future assessment and downscaled using the LARS-WG (Long Ashton Research Station -- Weather Generator) stochastic weather generator after bias correction with 30 years (1970-2000) of ground measured data. The A1B scenario reflects a future world of very rapid economic growth, low population growth, and rapid introduction of new and more efficient technology. The B1 scenario reflects a very heterogeneous world. The underlying theme is that of strengthening regional cultural identities, with an emphasis on family values and local traditions, high population growth, and less concern for rapid economic development. As a result, the future changes in annual temperature, precipitation, and evapotranspiration showed an upward tendency and streamflow and soil moisture showed a downward tendency in both scenarios. [ABSTRACT FROM AUTHOR]

The aim of this study was to assess the potential impacts of climate change on hydrology and stream water quality for a 6642 km² mountainous dam watershed in South Korea using the Soil and Water Assessment Tool (SWAT). The model was calibrated for three years (1998-2000) and validated for another three years (2001-2003) using daily streamflow data at three locations and monthly stream water quality data at two locations. For future evaluation, the MIROC3.2 HiRes and ECHAM5-0M climate data by Special Report on Emissions Scenarios (SRES) A2, A1B, and B1 of the Intergovernmental Panel on Climate Change (IPCC) were adopted. The future biased data (2007-2099) were corrected using 30 years (1977-2006, baseline period) of weather data, and downscaled by the change factor (CF) statistical method. The future (2020s, 2050s, and 2080s) watershed hydrology and stream water quality were evaluated based on the 2000 data. The MIROC3.2 HiRes A1B 2080s temperature and precipitation showed an increase of +4.8° C and 34.4%, respectively, based on the 2000 data. The impacts of projected future climate change scenarios on the evapotranspiration, groundwater recharge, and streamflow were increases of +23.1%, +28.1%, and +39.8%, respectively. The future sediment load showed a general tendency to decrease in the A2, A1B, andB1 emission scenarios of the two GCM models. The increase of the future T-N load may come from the increase of the subsurface lateral flows from January to June and the groundwater recharges from January to July. The future T-P load showed an increase of +19.6% in the 2080s under the MIROC3.2 HiRes A1B scenario and a decrease of-48.4% in the 2050s under the ECHAM5-0M B1 scenario. [ABSTRACT FROM AUTHOR]

The aim of this study was to evaluate hydrologic impacts of potential climate and land use changes in a mountainous watershed in South Korea. The climatic data predicted by MIROC3.2 HiRes GCM A1B for three time periods (2010-2039, 2040-2069, and 2070-2099) were prepared using a change factor statistical downscaling method. The future land uses were predicted using the Conservation of Land Use and its Effects at Small regional extent (CLUE-s) model by establishing logistic regression model for five land use types with 11 driving forces represented by spatial information. By applying the climate and land use predictions to the Soil and Water Assessment Tool (SWAT), the watershed hydrologic components (including evapotranspiration, surface runoff, groundwater recharge, and streamflow) were evaluated. For the predicted 2070-2099 temperature and precipitation changes (+4.8° C and +34.4%), and 6.2% decrease in forest areas and 1.7% increase in urban areas, the combined land use with climate change scenario resulted in more streamflow change (+55.4%) than the single climate and single land use change scenario (+39.8% and +10.8%), respectively. The predicted large increase in future precipitation and the corresponding decrease in forest land are predicted to have substantial impacts on watershed hydrology, especially on surface runoff and streamflow. Therefore, to mitigate negative hydrologic impacts and utilize positive impacts, both land use and climate changes should be considered in water resource planning for the Chungju dam watershed. [ABSTRACT FROM AUTHOR]

To understand patients' perceptions of clinical trials (CTs) is the principal step in the enrollment of patients to CTs. However, these perceptions in eastern countries are very rare. From 12 February 2007 to 13 April 2007, we consecutively distributed the questionnaire to 842 cancer patients who initiated a first cycle of chemotherapy regardless of each treatment step in the Seoul National University Hospital. Younger age, higher educational degree, higher economic status, and possession of private cancer insurance were related with significantly higher awareness of CTs (P=0.001, P=0.006, P=0.002, and P=0.009, respectively). However, unlike awareness, perceptions on benefits of CTs were not changed according to age, educational degree, and economic status (P=0.709, P=0.920, and P=0.847, respectively). Willingness was also not changed according to age, educational degree, economic status, and private cancer insurance (P=0.381, P=0.775, P=0.887, and P=0.392, respectively). Instead, males and heavily treated patients had more positive perceptions on benefits (P=0.002 and P=0.001, respectively) and more willingness to participate in CTs (OR=1.17, 1.14-2.75: OR=1.59, 1.01-2.51, respectively). In summary, cancer patients' awareness of CTs, perceptions on the benefit in CTs, and willingness to participate are differently influenced by diverse medical and social conditions. This information would be very helpful for investigators to properly conduct CTs in eastern cancer patients. [ABSTRACT FROM AUTHOR]

s.h. jeong, i.k. bae, s.b. kwon, j.h. lee, h.i. jung, j.s. song, b.c. jeong, s.-j. kim and s.h. lee. 2004. Isolates obtained from various regions in Korea in 2002 were identified and their susceptibility to extended-spectrum cephalosporins, monobactams and/or cephamycins was studied along with any production of extended-spectrum β-lactamases (ESBLs). Bacteria identified by the conventional techniques and Vitek GNI card were Klebsiella pneumoniae and Escherichia coli. Using disk diffusion and double-disk synergy tests, we found that 39·2% of strains produced ESBLs. About 52% of isolates transferred resistance to ceftazidime by conjugation. Banding patterns of PCR amplification with the designed primers showed that 837- and 259-bp fragments specific to blaTEM genes were amplified in 63·3% of strains. 929- and 231-bp fragments ( blaSHV), 847- and 520-bp fragments ( blaCMY), 597- and 858-bp fragments ( blaCTX-M) were amplified in 61·5, 17·3 and 7·7% of strains respectively. About 51·9% of strains contained more than two types of β-lactamase genes. Especially, one strain contained blaTEM, blaCMY and blaCTX-M genes. Resistance mechanisms to β-lactams, comprising mostly ESBL production, lead to the resistance against even recently developed β-lactams in enterobacteria, which is now a serious threat to antibiotic therapy. The high prevalence of blaCMY genes and multidrug-resistant genes may also make therapeutic failure and lack of eradiation of these strains by extended-spectrum cephalosporins or cephamycins. [ABSTRACT FROM AUTHOR]

Abstract Aims: To investigate changes in the bacterial population and the safety of the biofilm at the end of the drinking water distribution system in Seoul (Korea), selective media and bacterial community analyses were applied to a semi-pilot galvanized iron pipe (GIP) model. Methods and Results: No total coliforms or faecal streptococci were detected on m-Endo or m-Enterococcus agar. No Salmonella spp. and Shigella spp. were detected on bismuth sulphite agar or Hektoen enteric agar, respectively. The latter two media detected coliforms, where m-Endo was negative. Biofilm formation started within 1 week (ca 104 CFU cm-2 ) and exceeded 105 CFU cm-2 within 6 weeks. Although the fatty acid methyl ester analysis revealed dynamic changes in bacterial composition, Micrococcus , Bacillus , and Pseudomonas spp. were persistent members of the biofilm community. Micrococcus spp. was detected most frequently and in high numbers. Conclusions: Coliforms and Enterococcus species can be recovered from biofilms in water distribution systems. Significance and Impact of the Study: This study illustrates the role of biofilms in the chronic deterioration of the water-distribution system in Seoul (Korea). [ABSTRACT FROM AUTHOR]

Focuses on the eradication campaign of classical swine fever in South Korea. Campaign for the wide use of vaccination and culling of infected animals to reduce the number of outbreaks; Mandate for a compulsory nationwide vaccination and testing to bring the disease under control; Ban of vaccination in the country.

Background Mantle cell lymphoma (MCL) is a distinct subtype of B-cell lymphoma and comprises approximately 5-10% of all lymphomas. However, in Korea, MCL accounts for just 2% of B-cell lymphomas. In addition to the paucity of the disease, due to lack of feasibility of novel agents for this disease, clinical outcomes of the novel agents have yet to be defined in Korea. Methods We performed a retrospective study of MCL patients treated with ibrutinib in Korea. The primary endpoint of the analysis was progression free survival (PFS) out of ibrutinib treatment. Results Between 2013 to 2019, a total of 75 cases were eligible for analysis. Median age at diagnosis was 69 (range, 40 – 90) and 61 patients (81%) were male. Most patients had an advanced disease at diagnosis (II 10, III 10, IV 55). The received induction regimens were as follows, R-CHOP (N = 48); R-HyperCVAD/MA (N = 10); R-bendamustine (N = 5); VR-CAP (N = 3); others (N = 9) At time of ibrutinib treatment, median age was 71 (range, 41-92), and the median number of prior treatments was 1 (range, 1 – 6). Eleven patients (15%) had received salvage autologous stem cell transplantation. Complete and partial responses were achieved in 31 (41%) and 22 patients (29%), respectively. At a median follow-up duration of 30.5 months (95% CI 25.9 – 35.1), the estimated median PFS was 18.6 months (95% CI 11.0 – 26.2). Those who were classified as low- or intermediated-risk MIPI score at the time of ibrutinib start (24.4 vs. 9.9 months, p = 0.031) demonstrated superior PFS, and patients with tumor size < 5 cm (25.5 vs. 9.4 months, p = 0.092) demonstrated trends for prolonged PFS. Among elderly patients (≥ 65 yrs), those who had received ibrutinib as the first salvage treatment showed significantly prolonged PFS compared to those who had received ibrutinib as the later line of treatment (24.4 vs. 5.8 months, p = 0.015). Conclusions The response rate as well as the PFS data of the current study is similar to those of the Western reports. The current study provided additional evidence to support the use of ibrutinib in relapsed or refractory MCL, especially as the early salvage treatment. The compliance and safety data will be presented in the meeting. Funding Janssen, Korea. Disclosure All authors have declared no conflicts of interest. [ABSTRACT FROM AUTHOR]

This study assessed the impact of potential future climate change on the inflow to an agricultural reservoir and its downstream streamflow from reservoir operation for paddy irrigation using SLURP (semi-distributed land use-based runoff process), a physically based hydrological model. For a 366.5 km² watershed that includes two agricultural reservoirs located in the upper middle part of South Korea, the SLURP model was calibrated using six years (1998-2003) of daily streamfow records and validated using three years (2004-2006) of streamflow data, before the future analysis. The CCCma CGCM2 data of the SRES (special report on emissions scenarios) A2 and B2 scenarios of the IPCC (Intergovernmental Panel on Climate Change) was adopted for the future climate condition, and then the change factor method was used to downscale the future weather data through bias-correction. In addition, the future land covers were predicted with a modified CA (cellular automata)-Markov technique using a time series of Landsat land cover data, and the future vegetation information was predicted by linear regression between the monthly NDVI (normalized difference vegetation index) from NOAA AVHRR (advanced very high resolution radiometer) images and the monthly mean temperature data. The results for the future impact on reservoir storage showed that it would not have recovered to 100% by the end of the year (December) because of a decrease in precipitation and an increase in evaporation from July to September. Therefore, this reduced reservoir storage could bring a spring drought that causes an insufficient guarantee of water for rice paddy transplanting at the end of May. The future impact on the monthly streamflow of the watershed showed that the future streamflow for the three months of April, May, and June would increase because of a future increase in precipitation, and that the future streamflow for the next three months (July, August, and September) would decrease because of a future decrease in precipitation and increase in temperature. Considering the future decrease in the summer and autumn streamflows, the reservoir operation has to be more conservative when supplying water for paddy irrigation during this period and in the decision making process for reservoir releases during storm events. [ABSTRACT FROM AUTHOR]

Abstract: Objective: Tacrolimus has been shown to be an important immunosuppressive agent in organ and bone marrow transplantation. Previously, we reported that there were no statistically significant differences between the pharmacokinetic parameters of the oral formulation of generic tacrolimus (TacroBell) and the conventional formulation (Prograf). This study was designed to evaluate the efficacy and safety of oral capsules of TacroBell in de novo renal transplantation. Methods: Ninety-six renal transplant recipients from 9 transplantation centers in South Korea were enrolled between November 2005 and July 2007. De novo renal recipients ranged from 19–65 years old. Ninety-four patients who underwent renal transplantation were administered study drug at least one time in the intent-to-treat (ITT) analysis. This phase 4 clinical trial was a 26-week, open-label, noncomparative, multicenter study. Results: An acute rejection episode developed in 10/94 recipients (10.6%, 95% confidence interval, 4.4%–16.9%). There were no patient deaths during the study. The 6-month graft survival rate was 96.8%. Conclusion: Based on this study, treatment with TacroBell is considered to be efficient and safe after primary renal transplantation. [Copyright &y& Elsevier]