• Archives of Plastic Surgery
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• v.46 no.4
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• pp.375-380
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• 2019

Breast tissue expanders (TEs) with magnetic infusion ports are labeled "MR Unsafe." Therefore, patients with these implants are typically prevented from undergoing magnetic resonance imaging (MRI). We report a patient with a total submuscular breast TE who inadvertently underwent an MRI exam. She subsequently developed expander exposure, requiring explantation and autologous reconstruction. The safety profile of TEs with magnetic ports and the use of MRI in patients with these implants is surprisingly controversial. Therefore, we present our case report, a systematic literature review, and propose procedural guidelines to help ensure the safety of patients with TEs with magnetic ports that need to undergo MRI exams.

• Korean Journal of Clinical Pharmacy
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• v.30 no.1
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• pp.11-18
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• 2020

Background: Nivolumab and pembrolizumab are antagonists of the programmed death-ligand 1 (PD-L1) receptor that function as immuno-oncological agents. This study aimed to evaluate the safety and efficacy of nivolumab and pembrolizumab in elderly patients in outpatient settings. Methods: The safety and efficacy of nivolumab and pembrolizumab were compared retrospectively among patients at the Veterans Health Service (VHS) Medical Center in Seoul, South Korea, from September 1, 2017 to August 25, 2018. Results: Eighty-seven patients were selected for the study. The median progression-free survival was 63 days for nivolumab (95% confidence interval (CI), [14 to 282]) vs. 243 days for pembrolizumab (95% CI, [22 to 348]) (p =0.04). The objective response rate (ORR) was 0% in the nivolumab group vs 5.6% in the pembrolizumab group (p =0.310). All the patients exhibited treatment-related adverse effects. More than 89% of the patients exhibited diseases of the gastrointestinal (GI) tract. Pneumonia, of grades three or higher, was the most common adverse effect, followed by weakness and anorexia. Conclusions: There was no statistically significant difference between the nivolumab group and the pembrolizumab group with respect to the ORR. The incidence and severity of the adverse effects in this study were higher than those of previous studies; however, these adverse effects are generally manageable in a real-world clinical setting. Further randomized controlled studies will be necessary to confirm these results in elderly patients.

• Journal of Acupuncture Research
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• v.30 no.5
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• pp.211-217
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• 2013

Objectives : The purpose of this study was to prove the clinical safety of Sweet Bee Venom(BV) and observe the physical reaction(percentage of localized itching & pain) after Sweet BV treatment. Methods : This study was carried out on 130 patients who had been injected with Sweet BV in Koran Medicine Hospital of Woosuk University from March 20, 2012 to June 30, 2013. Patients were treated with Sweet BV daily and we checked the physical reaction. After that, we analyzed those according to treatment times and body parts of injection. Results : 37 patients(28.46 %) complained localized itching and 41 patients(31.54 %) complained localized pain after Sweet BV injection. In 37 patients who complained localized itching, 8 patients were experienced itching in the first treatment. And 27 patients were experienced itching in the 1st~5th treatment. Wrist, ankle and toe were the highest percentage of localized itching. Finger was the highest percentage of localized pain. Knee showed a relatively higher percentage of itching, pain, itching & pain than other body parts. Conclusions : This study suggested that Sweet BV treatment was relatively safe treatment and doctors should explain the physical reaction before treating patients. Further studies are needed to propose a guideline for safety and treatment.

• The Journal of Internal Korean Medicine
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• v.35 no.2
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• pp.145-156
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• 2014

Objectives : The aim of this study was to compare Tianwangbuxin-dan to Fluoxetine for antidepressive efficacy and safety in poststroke depression (PSD). Methods : A randomized, double blinded, non-inferiority trial was conducted. 113 PSD patients were recruited from a stroke center. Except for the 25 excluded patients, 88 PSD patients were randomly given either Tianwangbuxin-dan 1100 mg or Fluoxetine 20 mg per a day for 16 weeks. PSD was evaluated using Beck's depression inventory (BDI) and Hamilton depression rating scale (HDRS) and followed every fourth week. Repeated measure analysis of variance (ANOVA) was used to compare and contrast the depression scores of the two groups and to compare them among the evaluation times, at the beginning, $4^{th}$, $8^{th}$, $12^{th}$ and $16^{th}$ weeks. In addition, independent t-tests were used to find the difference between two groups at every evaluation time. Results : Finally, 88 PSD patients were included in the study, 63 PSD patients completed the procedure and 25 PSD patients were dropped out by the incompliance or withdrawal of consent. Tianwangbuxin-dan (or Fluoxetine) improved the depression of stroke patients and the efficacy of Tianwangbuxin-dan was not inferior to that of Fluoxetine. In addition, there was no significant side effect in two groups. Conclusions : This study showed that antidepressive efficacy and safety of Tianwangbuxin-dan in PSD patients.

• Korean Journal of Bronchoesophagology
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• v.19 no.1
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• pp.19-24
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• 2013

Objective The objective was to evaluate changes in swallow safety and dietary status after the transcutaneous injection of botulinum toxin into the upper esophageal sphincter in a series of outpatients with dysphagia. Methods Patients who were at risk for aspiration and who had an unsuccessful trial of swallowing therapy were admitted to the study. All patients showed significant pooling of fluids in the pyriform sinus. All patients were treated in the office; none had previous esophageal dilatation. The upper border of the cricoid cartilage was identified using standard electromyogram procedures and botulinum toxin was injected. Outcomes were assessed using the penetration-aspiration scale, NIH swallowiwng safety score, patients' short-term and long-term subjective impressions of their ability to swallow, and change in dietary status. Results Ten patients underwent an instrumental evaluation of swallowing function. Of the 10 patients, 9 showed an overall improvement in their ability to take an oral diet safely. The penetration-aspiration scale, NIH swallowiwng safety score, patients' short-term and long-term subjective impressions of their ability to swallow, and change in dietary status were significantly improved after office-based botox injection. Conclusion Office-based EMG guided botox injection to the cricopharyngeus muscle is a simple, safe, and effective tool for dysphagia patients. Injection of Botox in the office should be considered when the dysphagia pattern is aspiration after swallow.

• The Journal of the Convergence on Culture Technology
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• v.6 no.1
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• pp.69-82
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• 2020

This study is a descriptive research study to compare the safety perception between patients and nurses and to identify the factors affecting the nurses' safety management activities in tertiary hospitals. Data were collected with structured questionnaires from 147 patients and 147 nurses from a university hospital in J city, Gyeongnam, from July 24 to September 23, 2019, and analyzed using SPSS 23.0. The result showed that the patient's safety perception was significantly higher than the nurse's perception. The significant factors affecting patient management activity were nurse's educational level, position, effective communication, patient safety perception, and perception of importance on patient safety management. In the multiple regression analysis, knowledge about 'effective communication', and 'concerned about patient safety management', explained 54.8% of the nurses' patient management activity. Based on the results of this study, it is emphasized that nurses need to develop strategies to improve the communication and attention between patients and hospital members to improve patient safety management activities in tertiary hospitals.

• Journal of Acupuncture Research
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• v.29 no.4
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• pp.35-42
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• 2012

Objectives : This study was to observe clinical application of auto-microneedle therapy system (AMTS) in patients with peripheral facial paralysis. Methods : 27 peripheral facial paralysis patients were observed after taking AMTS at Facial Palsy Center, Kyung Hee University Oriental Medicine Hospital from March 1, 2011 to January 9, 2012. We assessed the symptoms of facial paralysis with Yanagihara unweighted grading system, Sunnybrook facial grading system(SBGS) and facial disability index(FDI), and observed adverse events and total safety of the treatment. Results : The scores of facial palsy scales increased after AMTS in Yanagihara grading system and Sunnybrook facial grading system. AMTS-related adverse events were mild pain(5.9%) and fatigue(3.5%), which needed no extra treatment. The total safety evaluation was between 'safe' and 'nearly safe' level. There were no other serious adverse events. In addition, patients were satisfied with subjective improvement including facial tingling and numbness. Conclusions : AMTS can be applied as an adjunctive treatment for patients with peripheral facial paralysis due to its safety and clinical usefulness. It is easier to stimulate wide skin area in a short time. Further clinical research is required to investigate the effectiveness of ATMS in a more rigorous RCTs.

• Preventive Nutrition and Food Science
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• v.10 no.3
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• pp.285-289
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• 2005

In this double-blind, placebo-controlled trial, we assessed the efficacy and safety of beef tallow extract (BTE) including Cis-9-cetylmyristoleate in patients with arthritis. Between May and December 2003, we selected 80 patients (n=80) who showed/manifested arthritic symptoms and whose radiological findings were suggestive of arthritis, and randomly assigned them to placebo-controlled (n=40) and treatment group (n=40). The placebo (corn starch 350 mg) and BTE (208 mg) were orally administered to placebo-controlled and treatment group three times a day, respectively. We assessed the efficacy and safety based on the visual analogue scale (V AS) and modified knee society knee scores (MKSKS) at baseline and endpoint, respectively. To assess the safety, we monitored the adverse effects noted in liver, kidney, cardiovascular and gastrointestinal system for 3 weeks. Then, we performed not only a questionnaire study but also laboratory tests (e.g., liver function test, kidney function test, urinalysis, electrocardiography [EKG], complete blood cell counts [CBC] and chest X-ray). For statistical analysis, Student (-test and paired (-test were done using SPSS■ Version 11.0. Statistical significance was set at p < 0.05. The scores between V AS and MKSKS showed statistical significance (p < 0.05) with an improvement of $69.2\%$ (27/39) and $3.8\%$ (21/39) of treatment-group patients, respectively. Abnormal laboratory findings were noted in neither placebo-controlled nor treatment group. In conclusion, our results indicate that the administration of BTE was a safe and effective treatment regimen for patients with arthritis. In addition, the efficacy of BTE was more remarkable in alleviating the symptoms rather than improving the function.

• Childhood Kidney Diseases
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• v.27 no.1
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• pp.34-39
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• 2023

Purpose: This article was to collect data on the safety of coronavirus disease 2019 (COVID-19) vaccines in children with underlying medical conditions. Methods: We constructed a prospective cohort of children and adolescents aged 5 to 19 years who had received at least one dose of COVID-19 vaccine. Patients diagnosed with and treated for chronic kidney disease, autoimmune disease, or other chronic conditions at the Seoul National University Children's Hospital were recruited from June to December 2022. A mobile survey questionnaire was sent to their guardians. The presence of adverse events on the day (day 0), 3 weeks (day 21), and 6 months (day 180) after the 1st dose of COVID-19 vaccine was recorded by the guardians. Results: A total of 73 children participated. The median age was 14 years, and 64.4% of the patients were male. On the day of immunization, 65.8% of the patients reported at least one adverse event. Pain at the injection site, fatigue, headache, arthralgia, and myalgia were the most common symptoms. The prevalence of adverse events decreased over time (65.8% on day 0, 27.4% between days 0 and 21, and 24.6% between days 21 and 180). Severe acute respiratory syndrome coronavirus 2 infection after the 1st dose occurred in 17 patients (23.3%) and one of the patients (5.88%) was hospitalized due to infection. Conclusions: Adverse events after COVID-19 vaccination were generally mild in children and adolescents with underlying medical conditions. Our findings provide evidence for the safety of COVID-19 vaccination in the vulnerable pediatric population.

• Korean Journal of Clinical Pharmacy
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• v.33 no.4
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• pp.278-289
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• 2023

Background: Linezolid has been widely used in the treatment for multidrug-resistant tuberculosis. However, there are limitations to use it such as long treatment, because of related side effects, even adequate treatment period has been needed for remission of multidrug-resistant tuberculosis (MDR-TB). Method: The meta-analysis was performed based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria. To choose literatures, systematic literature reviews were conducted with databases of PubMed, Web of Science, and EMBASE. Results: Efficacy and safety of Linezolid were determined by 85% (95% CI=79~89%, p<0.05) in the sputum culture conversion and 55% (95% CI=45~64%, p<0.01) in side effects related to linezolid, respectively. In addition, I² was estimated by 72%. In the subgroup analysis, efficacy and safety by dose and region were analyzed. In the subgroup analysis, compared with the linezolid dose in groups greater than 600 mg/day and less than 600 mg/day, this study showed 85% (95% CI 79~90%, p>0.05) in 206 patients and 82% (95% CI 73~89%, p<0.05) in 297 patients, respectively. Also, in the subgroup analysis, adverse effects caused by linezolid occurred more than 50% of treated patients. Conclusion: Therapeutic efficacy of linezolid for MDR-TB patients was confirmed regardless of the initial dose of linezolid, especially for sputum culture conversion and it was recommended that the dose of linezolid has been more effective below 600 mg/day. However, it should be necessary to closely monitored for safety issues since serious side effects possibly occurred by administration of long period treatment.