Objectives: . This study was conducted to evaluate the user satisfaction, efficacy, and safety of round window (RW) vibroplasty using the Vibrant Soundbridge (VSB) in patients with persistent mixed hearing loss after mastoidectomy. Methods: . The study included 27 patients (mean age, 58.7 years; age range, 28–76 years; 11 men and 16 women) with mixed hearing loss after mastoidectomy from 15 tertiary referral centers in Korea. The VSB was implanted at the RW. The Korean translation of the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire and the Korean version of the International Outcome Inventory for Hearing Aids (K-IOI-HA) questionnaire were used to evaluate user satisfaction as the primary outcome. The secondary outcome measures were audiological test results and complication rates. Results: . The mean scores for ease of communication (61.3% to 29.7% to 30.2%), reverberation (62.1% to 43.1% to 37.4%), and background noise (63.3% to 37.7% to 34.3%) subscales of the APHAB questionnaire significantly decreased after VSB surgery. The mean K-IOI-HA scores at 3 and 6 months after surgery were significantly higher than the mean preoperative score (18.6 to 27.2 to 28.1). The postoperative VSB-aided thresholds were significantly lower than the preoperative unaided and hearing aid (HA)-aided thresholds. There was no significant difference between preoperative unaided, preoperative HA-aided, and postoperative VSB-aided maximum phonetically balanced word-recognition scores. None of the 27 patients experienced a change in postoperative bone conduction pure tone average. One patient developed temporary facial palsy and two developed surgical wound infections. Conclusion . RW vibroplasty resulted in improved satisfaction and audiological test results in patients with mixed hearing loss after mastoidectomy, and the complication rate was tolerable.

PURPOSE: To evaluate the efficacy and safety of BOTULAX® in subjects with essential blepharospasm.METHODS: In this study, a total of 250 subjects with essential blepharospasm were enrolled at 15 investigational sites and a total of 220 subjects completed the study. The efficacy and safety were evaluated at weeks 4 and 16 after treatment compared with baseline. In total, 240 subjects were enrolled, treated with the investigational product, and evaluable for the primary efficacy assessment at week 4 after treatment; these subjects were included in the intention-to-treat (ITT) population. With the ITT set as the main efficacy set, efficacy assessment included Jankovic rating scale (JRS), functional disability score, investigator evaluation of global response and quality of life. Safety assessment including the incidence of adverse events was also performed.RESULTS: In terms of the primary efficacy endpoint (i.e., change in JRS total score at week 4 after treatment from baseline [ITT set]), mean change indicated a statistically significant reduction (p < 0.0001) and demonstrated the non-inferiority of the test drug to similar drugs. In terms of the secondary efficacy endpoints, mean change in JRS total score at week 16 after treatment and mean change in functional disability score at weeks 4 and 16 after treatment both exhibited a statistically significant reduction compared with baseline (p < 0.0001 for all). Among the 249 subjects treated with the investigational product in this study, 44 (17.67%) experienced 76 treatment emergent adverse events but no serious adverse events were observed.CONCLUSIONS: Based on the study results, BOTULAX® is considered to be an effective and safe treatment for essential blepharospasm.

Background: To evaluate the facial asymmetry, three-dimensional computed tomography (3D-CT) has been used widely. This study proposed a method to quantify facial asymmetry based on 3D-CT. Methods: The normal standard group consisted of twenty-five male subjects who had a balanced face and normal occlusion. Five anatomical landmarks were selected as reference points and ten anatomical landmarks were selected as measurement points to evaluate facial asymmetry. The formula of facial asymmetry index was designed by using the distances between the landmarks. The index value on a specific landmark indicated zero when the landmarks were located on the three-dimensional symmetric position. As the asymmetry of landmarks increased, the value of facial asymmetry index increased. For ten anatomical landmarks, the mean value of facial asymmetry index on each landmark was obtained in the normal standard group. Facial asymmetry index was applied to the patients who had undergone orthognathic surgery. Preoperative facial asymmetry and postoperative improvement were evaluated. Results: The reference facial asymmetry index on each landmark in the normal standard group was from 1.77 to 3.38. A polygonal chart was drawn to visualize the degree of asymmetry. In three patients who had undergone orthognathic surgery, it was checked that the method of facial asymmetry index showed the preoperative facial asymmetry and the postoperative improvement well. Conclusions The current new facial asymmetry index could efficiently quantify the degree of facial asymmetry from 3D-CT. This method could be used as an evaluation standard for facial asymmetry analysis.

Three-dimensional (3D) printing technology, with additive manufacturing, can aid in the production of various kinds of patient-specific medical devices and implants in medical fields, which cannot be covered by mass production systems for producing conventional devices/implants. The simulator-based medical image demonstrates the anatomical structure of the disease, which can be used for education, diagnosis, preparation of treatment plan and preoperative surgical guide, etc. The surgical guide is used as a patient-specific medical device for guiding incision, resection, insertion, and marking. As 3D printers can output materials that can be inserted into the human body, the patient-specific implant device that reflects the patient's anatomy and surgical plan could be of relevance. In addition, patient-specific aids, including gibs, splints, prostheses, and epitheses, could be used for a better outcome. Finally, bio-printing is also used to cultivate cells to produce functional artificial tissues.

OBJECTIVES: The purpose of this study was to establish normative data for healthy Korean adults by measuring the maximal strength and endurance scores of the tongue, lip, and cheek, and to examine correlations between these measurements. MATERIALS AND METHODS: This study included 120 subjects that were divided into three groups according to age: young (20-39 years), middle-aged (40-59 years), and older (over 60 years); and by gender. Measurements were taken using the Iowa Oral Performance Instrument (IOPI). RESULTS: The mean maximal tongue strengths were as follows: young men (46.7±10.2 kPa) and women (32.1±7.9 kPa), middle-aged men (40.9±9.3 kPa) and women (36.9±8.6 kPa), and older men (35.2±9.0 kPa) and women (34.5±6.9 kPa). The mean tongue endurance scores were: young men (28.8±12.6 seconds) and women (20.8±13.5 seconds), middle-aged men (17.0±8.5 seconds) and women (15.3±5.2 seconds), and older men (15.8±6.7 seconds) and women (17.9±8.1 seconds). The mean maximal lip strengths were: young men (11.6±3.0 kPa) and women (11.4±3.8 kPa), middle-aged men (11.4±4.2 kPa) and women (11.1±5.1 kPa), and older men (14.5±3.9 kPa) and women (11.7±2.6 kPa). The mean lip endurance scores were: young men (41.1±23.9 seconds) and women (22.4±21.7 seconds), middle-aged men (24.3±10.3 seconds) and women (30.5±13.4 seconds), and older men (24.9±11.0 seconds) and women (12.8±7.6 seconds). The mean maximal cheek strengths were: young men (24.5±4.6 kPa) and women (20.5±4.3 kPa), middle-aged men (25.2±6.4 kPa) and women (21.2±5.5 kPa), and older men (22.4±5.3 kPa) and women (18.0±4.8 kPa). The mean cheek endurance scores were: young men (47.8±24.4 seconds) and women (43.9±25.0 seconds), middle-aged men (27.3±11.3 seconds) and women (20.0±14.6 seconds), and older men (21.7±14.5 seconds) and women (17.2±11.4 seconds). CONCLUSION: The data collected in this study will provide an important database of standardized measurements for maximal strength and endurance scores of the tongue, lip and cheek in healthy, normal Koreans.
Adult ; Cheek* ; Female ; Humans ; Iowa ; Lip* ; Male ; Tongue*

BACKGROUND: For autologous hematopoietic stem cell transplantation (HSCT), the volume of infused and DMSO contained in graft are the major causes of complications related to infusion. In this study, we evaluated feasibility of cryopreserving peripheral blood stem cell collects (PBSCC) at high cell concentration. METHODS: PBSCC from 40 patients with multiple myeloma or lymphoma were split and cryopreserved at two different concentrations of TNCs; one for standard concentration (SC) (2x108 cells/mL) and the other for high concentration (HC) (3x108 cells/mL). The viability of total nucleated cells and CD34+ cell count were examined before cryopreservation and after thawing. CFU-GM was examined with thawed products. Data were analyzed as two groups between good mobilizer (GM) and poor mobilizer (PM). RESULTS: There were no differences in TNC viability between SC and HC of all patients (P=0.0656) and PM (P=0.9658), however HC of GM showed significantly lower viability than SC (P=0.0314). CD34+ cell viability did not differ between SC and HC. CD34+ cell recovery was decreased in HC of all patients (P=0.459) and GM (P=0.0164), but no differences between SC and HC in PM (P=0.9658). CFU-GM clonogenic efficiency between SC and HC was not different in all patients (P=0.0635) and PM (P=0.8984), but was decreased in HC of GM (P=0.0427). CONCLUSION: Cryopreservation of PBSCC at 3x108 cells/mL seems to have minimal adverse effect on the quality of PBSC after thawing, particularly in PM. This approach may help to reduce infusion related complications while decreasing the cost of processing and storage of PBSCC.
Antigens, CD34 ; Cell Count ; Cell Survival ; Cryopreservation ; Dimethyl Sulfoxide ; Feasibility Studies* ; Granulocyte-Macrophage Progenitor Cells ; Hematopoietic Stem Cell Transplantation ; Humans ; Lymphoma ; Multiple Myeloma ; Peripheral Blood Stem Cell Transplantation ; Stem Cells* ; Transplants

BACKGROUND/AIMS: In patients with liver cirrhosis, drugs acting on the central nervous system can lead to hepatic encephalopathy and the effects may be prolonged. Recently, misuse of propofol has been reported and the associated risk of death have become an issue. Propofol is commonly used during sedative endoscopy; therefore, its safety in high-risk groups must be further investigated. We performed a pilot study of the safety and efficacy of propofol during endoscopy in Korean patients with cirrhosis. METHODS: Upper gastrointestinal endoscopy was performed under sedation with propofol along with careful monitoring in 20 patients with liver cirrhosis and 20 control subjects. The presence or development of hepatic encephalopathy was assessed using the number connection test and neurologic examination. RESULTS: Neither respiratory depression nor clinically significant hypotension were observed. Immediate postanesthetic recovery at 5 and 10 minutes after the procedure was delayed in the cirrhotic patients compared with the control group; however, at 30 minutes, the postanesthetic recovery was similar in both groups. Baseline psychomotor performance was more impaired in cirrhotic patients, but propofol was not associated with deteriorated psychomotor function even in cirrhotic patients with a minimal hepatic encephalopathy. CONCLUSIONS: Sedation with propofol was well tolerated in cirrhotic patients. No newly developed hepatic encephalopathy was observed.
Adult ; *Endoscopy, Gastrointestinal ; Female ; Hepatic Encephalopathy/chemically induced ; Humans ; Hypnotics and Sedatives/*adverse effects ; *Liver Cirrhosis ; Male ; Middle Aged ; Propofol/*adverse effects ; Republic of Korea

PURPOSE: The prevalence of macrolide-resistant Mycoplasma pneumoniae (MRMP) has increased worldwide. The aim of this study was to estimate the proportion of MRMP in a tertiary hospital in Korea, and to find potential laboratory markers that could be used to predict the efficacy of macrolides in children with MRMP pneumonia. METHODS: A total of 95 patients with M. pneumoniae pneumonia were enrolled in this study. Detection of MRMP was based on the results of specific point mutations in domain V of the 23S rRNA gene. The medical records of these patients were reviewed retrospectively and the clinical course and laboratory data were compared. RESULTS: The proportion of patients with MRMP was 51.6% and all MRMP isolates had the A2063G point mutation. The MRMP group had longer hospital stay and febrile period after initiation of macrolides. The levels of serum C-reactive protein (CRP) and interleukin-18 in nasopharyngeal aspirate were significantly higher in patients who did not respond to macrolide treatment. CRP was the only significant factor in predicting the efficacy of macrolides in patients with MRMP pneumonia. The area under the curve for CRP was 0.69 in receiver operating characteristic curve analysis, indicating reasonable discriminative power, and the optimal cutoff value was 40.7 mg/L. CONCLUSION: The proportion of patients with MRMP was high, suggesting that the prevalence of MRMP is rising rapidly in Korea. Serum CRP could be a useful marker for predicting the efficacy of macrolides and helping clinicians make better clinical decisions in children with MRMP pneumonia.
Biomarkers ; C-Reactive Protein* ; Child* ; Drug Resistance, Microbial ; Genes, rRNA ; Humans ; Interleukin-18 ; Korea ; Length of Stay ; Macrolides* ; Medical Records ; Mycoplasma pneumoniae* ; Pneumonia* ; Pneumonia, Mycoplasma* ; Point Mutation ; Predictive Value of Tests ; Prevalence ; Retrospective Studies ; ROC Curve ; Tertiary Care Centers

PURPOSE: Anti-tumor necrosis factor-alpha (TNF-alpha) medications represent a major advancement in the management of chronic inflammatory diseases. However, these agents are associated with increased risks of tuberculosis (TB) and other serious infections. The aim of this study was to evaluate the incidences of such disease among tertiary hospitals in Korea. MATERIALS AND METHODS: We retrospectively studied patients who received anti-TNF-alpha therapy; we reviewed serious infections including TB that developed within 6 months after initiation of anti-TNF-alpha therapy. Data concerning patient demographics, types of anti-TNF-alpha agents, concomitant immunosuppressive drugs use, and infection details were collected. RESULTS: A total 175 patients treated with infliximab (n=72) or adalimumab (n=103) with the following conditions were enrolled: Crohn's disease, 34 (19.4%); ulcerative colitis, 20 (11.4%); ankylosing spondylitis, 82 (46.9%); and rheumatoid arthritis, 39 (22.2%). There were 18 cases (6.0%) of serious infections. The most common site of serious infection was the intra-abdomen (n=6), followed by TB (n=3), skin and soft tissue (n=3), bone and joints (n=2), ocular neurons (n=2), lower respiratory tract (n=1), and urinary tract (n=1). Of the 175 patients, only 3 cases showed development of TB. Furthermore, of all those who developed TB, none had taken anti-TB chemoprophylaxis prior to treatment with an anti-TNF agent due to negative screening results. CONCLUSION: Serious infections with anti-TNF-alpha therapy were uncommon among tertiary hospitals in Korea; TB was the second most frequent infection. Nevertheless, there were no TB reactivations after anti-TB chemoprophylaxis. Accordingly, physicians should be aware of TB in subjects undergoing anti-TNF-alpha therapy, especially in countries with a high prevalence of TB.
Arthritis, Rheumatoid ; Chemoprevention ; Colitis, Ulcerative ; Crohn Disease ; Demography ; Humans ; Incidence* ; Joints ; Korea ; Mass Screening ; Methods ; Necrosis* ; Neurons ; Prevalence ; Respiratory System ; Retrospective Studies ; Skin ; Spondylitis, Ankylosing ; Tertiary Care Centers ; Tuberculosis* ; Tumor Necrosis Factor-alpha ; Urinary Tract

Asthma is not a homogeneous disease presenting variable clinical features, but a complex disorder consisting of many different disease entities characterized by variable air-flow limitation. To date, there are little effective preventive-strategies for the development of asthma, and it has been emphasized that early identification and intervention are the best ways to reduce the associated morbidities, quality of life, and socioeconomic burden. Predicting the natural course of asthma is still difficult, although various phenotypic approaches and predictive scores are developed and widely used. The present phenotypes and predictive scores may be reliable in the population, but those appear to be unreliable in each individual in real practice. Either undertreatment or overtreatment in childhood asthma is an important issue, because they are associated with poor compliance, increments of socioeconomic burdens, and poor quality of life. There is no doubt about the clinical efficacy of inhaled corticosteroid (ICS) in childhood asthma, but the negative effect of long-term use of ICS on the height is emerging. Therefore general physicians should consider an individualized management using specific phenotypes and endotypes, and regularly re-evaluate the drug-response, level of control, and adherence/compliance to avoid inadequate treatment.
Asthma* ; Child ; Compliance ; Humans ; Phenotype* ; Quality of Life