BACKGROUND: With the approval of topical retapamulin ointment in 2011, it was officially required to conduct a post-marketing surveillance (PMS) study to obtain further data of its safety profile and effectiveness, in accordance with the requirement of the Korean Ministry of Food and Drug Safety (MFDS). OBJECTIVE: This study had prospectively designed to monitor safety and tolerability with the effectiveness of topical retapamulin in clinical practices. METHODS: Open label, multi-center, non-interventional observational study was done from May 2011 to October 2015. All subjects had bacterial skin infections of locally approved prescribing information accordingly. The study mainly focused on safety issues in the local target population (3,612 eligible subjects). And, drug effectiveness was also evaluated by physicians. RESULTS: The incidence of adverse events (AEs) and adverse drug reactions (ADRs) were 2.53% and 0.97%, respectively. In terms of the incidence of unexpected AEs and ADRs, 1.45% and 0.33%, and for the incidence of serious AEs, 0.28%, whereas no serious ADRs reported. And, the effectiveness of topical retapamulin rate was 96.1% (1,697 of total 1,765 subjects). CONCLUSION: Topical retapamulin is to be well-tolerated and effective in patients with bacterial skin infections of locally approved prescribing information.
Anti-Bacterial Agents ; Drug-Related Side Effects and Adverse Reactions ; Health Services Needs and Demand ; Humans ; Incidence ; Observational Study ; Prospective Studies ; Skin ; Skin Diseases

BACKGROUND: Individual particulate respirator use may offer protection against exposure to particulate matter < 2.5 µm in diameter (PM(2.5)). Among elderly Korean women, we explored individual particulate respirator use and cardiopulmonary function.METHODS: Recruited in Seoul, Korea, 21 elderly, non-smoking women wore particulate respirators for six consecutive days (exlcuding time spent eating, sleeping, and bathing). We measured resting blood pressure before, during, and after respirator use and recorded systolic and diastolic blood pressure, mean arterial blood pressure, pulse pressure, and lung function. We also measured 12-hour ambulatory blood pressure at the end of the 6-day long experiment and control periods. Additionally, we examined physiological stress (heart rate variability and urinary 8-hydroxy-2′-deoxyguanosine) while wearing the particulate respirators. Person- and exposure-level covariates were also considered in the model.RESULTS: After the 6-day period of respirator use, resting blood pressure was reduced by 5.3 mmHg for systolic blood pressure (P = 0.013), 2.9 mmHg for mean arterial blood pressure (P = 0.079), and 3.6 mmHg for pulse pressure (P = 0.024). However, particulate respirator use was associated with changes in physiological stress markers. A parasympathetic activity marker (high frequency) significantly decreased by 24.0% (P = 0.029), whereas a sympathetic activity marker (ratio of low-to-high frequency) increased by 50.3% (P = 0.045). An oxidative stress marker, 8-hydroxy-2′-deoxyguanosine, increased by 3.4 ng/mg creatinine (P = 0.021) during the experimental period compared with that during the control period. Lung function indices indicated that wearing particulate respirators was protective; however, statistical significance was not confirmed.CONCLUSION: Individual particulate respirator use may prevent PM(2.5)-induced blood-pressure elevation among elderly Korean women. However, the effects of particulate respirator use, including physiological stress marker elevation, should also be considered.TRIAL REGISTRATION: Clinical Research Information Service Identifier: KCT0003526

PURPOSE: Nipple-sparing mastectomy (NSM) has become increasingly popular due to improved cosmesis without compromising oncologic safety. Radial and inframammary incisions are usually used to achieve NSM, with periareolar incisions usually being avoided because of the risk to nipple-areola complex viability. In an attempt to maximize esthetic effects, we performed NSM through periareolar incision with immediate reconstruction. We report our initial experience. METHODS: This case series consisted of all consecutive patients (n = 34) who underwent NSM through a periareolar incision in our institution between August 2017 and December 2018. All patients underwent NSM through periareolar incision followed by immediate reconstruction with an implant or deep inferior epigastric perforator flap. Patient demographics, tumor and treatment characteristics, and short-term postoperative outcomes were reviewed. RESULTS: The mean patient age was 46.74 ± 6.69 years (range, 38–62 years), and the mean operation time was 96.68 ± 28.00 minutes. Indications included in situ cancer in 12 cases and invasive cancer in 22 cases. There was 1 major complication (postoperative hematoma) requiring operative reintervention. No other complications including fistula, implant exposure, or reconstruction failure was observed. At the time of writing, no case of local recurrence has been observed. CONCLUSION Our initial report shows that NSM with immediate reconstruction may successfully be performed through periareolar incision. This method maximizes esthetic effects and may be an appropriate surgical option for NSM.

As of September 2020, SARS-CoV-2 has infected over 30 million people worldwide, and the death toll has now risen to 950,000. Given that Povidone-iodine (PVP-I) had consistently been showing the virucidal efficacy against various types of viruses, such as SARS-CoV, MERS-CoV, and Ebola, we conducted this study to figure out the virucidal effect against SARS-CoV-2 by using a viral plaque assay. We performed Kill-Time assays to assess the viral inactivation of SARS-CoV-2 contaminants after the application of the PVP-I product (Betadine® Throat Spray, PVP-I 0.45%). This test consisted of clean and dirty conditions and was designed to check the viral titers at a contact time of 60 seconds, which were evaluated by plaque-reduction rates in Vero cells. This PVP-I product fully achieved ≥4 log 10 reductions in viral titers under both clean and dirty conditions. This level of reduction, ≥4 log 10 (99.99%), in viral titers presented to be effective in terms of virucidal efficacy, according to the European standards, EN14476. This study revealed the virucidal efficacy of Betadine® Throat Spray against SARS-CoV-2 virus. Given that the convenience and availability of this product, we think that it may contribute to inhibit viral infection and transmissibility as an active type of personal protective equipment (PPE) by managing the hygiene of patients and medical professionals.

BACKGROUND: Individual particulate respirator use may offer protection against exposure to particulate matter < 2.5 µm in diameter (PM(2.5)). Among elderly Korean women, we explored individual particulate respirator use and cardiopulmonary function. METHODS: Recruited in Seoul, Korea, 21 elderly, non-smoking women wore particulate respirators for six consecutive days (exlcuding time spent eating, sleeping, and bathing). We measured resting blood pressure before, during, and after respirator use and recorded systolic and diastolic blood pressure, mean arterial blood pressure, pulse pressure, and lung function. We also measured 12-hour ambulatory blood pressure at the end of the 6-day long experiment and control periods. Additionally, we examined physiological stress (heart rate variability and urinary 8-hydroxy-2′-deoxyguanosine) while wearing the particulate respirators. Person- and exposure-level covariates were also considered in the model. RESULTS: After the 6-day period of respirator use, resting blood pressure was reduced by 5.3 mmHg for systolic blood pressure (P = 0.013), 2.9 mmHg for mean arterial blood pressure (P = 0.079), and 3.6 mmHg for pulse pressure (P = 0.024). However, particulate respirator use was associated with changes in physiological stress markers. A parasympathetic activity marker (high frequency) significantly decreased by 24.0% (P = 0.029), whereas a sympathetic activity marker (ratio of low-to-high frequency) increased by 50.3% (P = 0.045). An oxidative stress marker, 8-hydroxy-2′-deoxyguanosine, increased by 3.4 ng/mg creatinine (P = 0.021) during the experimental period compared with that during the control period. Lung function indices indicated that wearing particulate respirators was protective; however, statistical significance was not confirmed. CONCLUSION Individual particulate respirator use may prevent PM(2.5)-induced blood-pressure elevation among elderly Korean women. However, the effects of particulate respirator use, including physiological stress marker elevation, should also be considered.TRIAL REGISTRATION: Clinical Research Information Service Identifier: KCT0003526

OBJECTIVE: The purpose of this study was to report the authors' preliminary experience using the Amplatzer Vascular Plug (AVP) (St. Jude Medical, Plymouth, MN, USA) for parent artery occlusion of the internal carotid artery (ICA) or vertebral artery (VA). MATERIALS AND METHODS: Between September 2008 and December 2015, we performed 52 therapeutic parent artery occlusions (PAOs) by an endovascular technique. Among them, 10 patients underwent PAO of the carotid or vertebral arteries using AVPs. Clinical and radiographic data of these patients were retrospectively reviewed. RESULTS: The devices were used for VA dissection that presented with subarachnoid hemorrhage (SAH) in five patients, traumatic arteriovenous fistula (AVF) in two patients, spontaneous AVF in one patient, recurrence of carotid-cavernous fistula (CCF) in one patient, and symptomatic unruptured giant ICA aneurysm in one patient. The devices were used in conjunction with detachable and/or pushable coils and in the extracranial segments of the ICA or VA. Complete occlusion of the parent artery was achieved in all patients. There was one intra-procedural rupture of the VA dissection during coiling prior to using the device. CONCLUSION: Results from the current series suggest that the AVP might be used for therapeutic PAO in the extracranial segments of the ICA or VA.
Aneurysm ; Arteries* ; Arteriovenous Fistula ; Carotid Artery, Internal ; Endovascular Procedures ; Fistula ; Humans ; Parents* ; Recurrence ; Retrospective Studies ; Rupture ; Subarachnoid Hemorrhage ; Vertebral Artery*

BACKGROUND AND OBJECTIVES: Glutaraldehyde (GA) has been used as a representative method of tissue preservation in cardiovascular surgery. However, GA has showed limited durability including calcification, mechanical failure and toxicity. To overcome those unsolved problems, we analyzed the crosslinking differences of primary amines, GA and genipin in their mechanical and biochemical properties with a single or double crosslinking agent for clinical application. MATERIALS AND METHODS: Samples were divided into 3 groups; control, single crosslinking fixation and double crosslinking fixation after decellurarization using bovine pericardium. For analysis of the biochemical and mechanical properties of each crosslinking method, tensile strength, percentage strain, thermal stability, resistance to pronase, nynhydrin and cytotoxicity test were studied. RESULTS: Combined hexamethylene diamine and suberic acid in the carbodiimide hydrochloride/N-hydroxysucinimide solution (EDC/NHS) after decellurarization, tensile strength and strain percentage were not statistically significant compared to the single crosslinking treated groups (p>0.05). Tissue crosslinking stability was weak in single treatment of diphenylphosphoryl azide, suberic acid, low concentration of EDC, hexamethylene diamine and procyanidin groups, but thermal stability and resistance to the pronase and ninhydrin were markedly increased in concentrated EDC/NHS or after combined double treatment with low concentration of GA or genipin (p<0.001). CONCLUSION: Single or double crosslinking with low concentration of carbodiimide, diphenylphosphonyl azide, procyanidin, suberic acid and hexane diamine were not as effective in mechanical, biochemical, cytotoxic and crosslinking properties compared to GA or genipin fixation, but their mechanical and chemical properties were much improved when combined with low concentrations of GA or genipin in the double crosslinking process.
Amines ; Azides ; Biflavonoids ; Bioprosthesis ; Caprylates ; Catechin ; Dicarboxylic Acids ; Glutaral ; Iridoids ; Ninhydrin ; Pericardium ; Proanthocyanidins ; Pronase ; Sprains and Strains ; Tensile Strength ; Tissue Preservation

Objectives: Prenatal cadmium (Cd) exposure may be associated with attention-deficit/hyperactivity disorder (ADHD) in children. Therefore, the objective of this study was to examine the relationship between Cd exposure during gestation and ADHD at 6 years of age. Methods: As part of an ongoing cohort study (the Environment and Development of Children study), 479 mother-child pairs from Seoul, Korea were included for analysis between 2008 and 2011. The whole blood concentration of Cd was analyzed using atomic absorption spectrophotometry. The parents were surveyed about ADHD behaviors in their children at age 6. Multivariable linear regression models were used to investigate the relationship between prenatal exposure to Cd and ADHD at 6 years of age. Results: Increased prenatal Cd concentrations were associated with increased scores for ADHD for girls, but not for boys, at age 6. A 2-fold increase in the prenatal Cd level was significantly associated with a 22.3% (95% confidence interval, 11.6 to 34.1) increase in ADHD in girls at 6 years of age, as indicated by the linear regression model. Conclusions Our results identified significant associations between prenatal Cd exposure and ADHD scores in 6-year-old girls.

Purpose: Advances in chemotherapeutic and targeted agents have increased pathologic complete response (pCR) rates after neoadjuvant systemic therapy (NST). Vacuum-assisted biopsy (VAB) has been suggested to accurately evaluate pCR. This study aims to confirm the non-inferiority of the 5-year disease-free survival of patients who omitted breast surgery when predicted to have a pCR based on breast magnetic resonance imaging (MRI) and VAB after NST, compared with patients with a pCR who had undergone breast surgery in previous studies. Methods The Omission of breast surgery for PredicTed pCR patients wIth MRI and vacuumassisted bIopsy in breaST cancer after neoadjuvant systemic therapy (OPTIMIST) trial is a prospective, multicenter, single-arm, non-inferiority study enrolling in 17 tertiary care hospitals in the Republic of Korea. Eligible patients must have a clip marker placed in the tumor and meet the MRI criteria suggesting complete clinical response (post-NST MRI size ≤ 1 cm and lesion-to-background signal enhancement ratio ≤ 1.6) after NST. Patients will undergo VAB, and breast surgery will be omitted for those with no residual tumor. Axillary surgery can also be omitted if the patient was clinically node-negative before and after NST and met the stringent criteria of MRI size ≤ 0.5 cm. Survival and efficacy outcomes are evaluated over five years.Discussion: This study seeks to establish evidence for the safe omission of breast surgery in exceptional responders to NST while minimizing patient burden. The trial will address concerns about potential undertreatment due to false-negative results and recurrence as well as improved patient-reported quality of life issues from the omission of surgery. Successful completion of this trial may reshape clinical practice for certain breast cancer subtypes and lead to a safe and less invasive approach for selected patients.