• Journal of Chest Surgery
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• v.41 no.3
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• pp.320-328
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• 2008

Background: Numerous surgical devices for mitral repair have been used in the past with good results. In this study we describe a simple annuloplasty technique with using a new device ($Mitracon^{(R)}$). The aim of this study was to assess its efficacy and surgical results with using $Mitracon^{(R)}$. Material and Method: From May 2003 to October 2005, 46 patients (21 women and 25 men (mean age of $51.4{\pm}17.8$ years) with mitral regurgitation from various causes were treated with either the $Mitracon^{(R)}$ (the $Mitracon^{(R)}$ group) or the Capentier Edward rigid ring (the CE group). The median follow-up duration was 18.9 months. Result: The mean grade of mitral regurgitation before and immediately after surgery in the $Mitracon^{(R)}$ group and the CE group decreased from $3.2{\pm}0.8$ to $0.6{\pm}0.7$ and $3.4{\pm}0.7$ to $0.3{\pm}0.5$, respectively. There were no significant changes in the ejection fraction either between the two groups or before and immediately after surgery. No deaths were seen in either group. Early postoperative echocardiography of all 46 patients showed only trivial mitral regurgitation or none at all. Echocardiography at a median of 18.9 months also showed no progression in mitral regurgitation. The mean grade of mitral regurgitation in the $Mitracon^{(R)}$ group at this time point decreased from $3.2{\pm}0.8$ to $0.8{\pm}0.7$ (p<0.05). The CE group also showed a similar degree of decrease from $3.4{\pm}0.7$ to $0.3{\pm}0.6$ (p<0.05). The mitral valve area in the $Mitracon^{(R)}$ group at 1 year follow-up was $3.3{\pm}0.9cm^2$. The mitral valve area in the CE group was $2.7{\pm}0.6cm^2$. The mean mitral pressure gradient in the $Mitracon^{(R)}$ group at 1 year follow-up was $3.1{\pm}1.3$ mmHg. The mean pressure gradient in the CE group was $4.5{\pm}2.1$ mmHg, although any statistical significant difference for this between the groups was not reached. Conclusion: The present study showed the described technique to be safe and effective in the intermediate term. Because long term results are unavailable, a more extensive prospective randomized multicenter trial may be warranted to determine whether this procedure should be generally applied for repair of mitral valve disease.

• Tuberculosis and Respiratory Diseases
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• v.49 no.6
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• pp.740-751
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• 2000

Background : Moxifloxacin is a newly developed drug which is more potent and safe compared to previous fluoroquinolones. This drug effectively eradicates organisms such as beta-lactamase-producing or other resistant bacteria. Moxifloxacin is known to be effective in treating respiratory infections such as Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Chlamydia pneumoniaeme, Legionella spp. and Mycoplasma pneumoniae. Methods : In a multicenter, randomized, open, comparative study, the efficacy and safety of oral moxifloxacin taken 400 mg once a day and clarithromycin taken 500 mg twice daily for 7 days were compared for the treatment of Korean patients with acute exacerbations of chronic bronchitis. Results : A total of 170 patients were enrolled, and they were divided into two groups: 87 in the moxifloxacin group and 83 in the clarithromycin group. Of those enrolled, 76 (35 for bacteriologic efficacy) in the moxifloxacin group and 77 (31 for bacteriologic efficacy) in the clarithromycin group were included in the efficacy analysis. All were included in the safety analysis. Clinical success was noted in 70 (92.1%) of 76 moxifloxacin-treated patients and 71 (92.2%) of 77 clarithromycin-treated patients. Bacteriologic success rate seemed to be higher in moxifloxacin group (73.5%) than in clarithromycin group (54.8%), but statistically insignificant (p=0.098). Drug susceptibility among organisms initially isolated was higher in moxifloxacin group on Streptococcus pneumoniae, Pseudomonas aeruginosa, Klebsiella pneumoniae (p<0.001). Adverse events were reported by 12.8% of 86 patients receiving moxifloxacin and 21.7% of 83 patients receiving clarithromycin. Headache (4.7% vs 4.8%, moxifloxacin group vs clarithromycin group, respectively) and indigestion (2.3% vs 6.0%, moxifloxacin group vs clarithromycin group, respectively) were the most frequent side effects in the two groups. Conclusion : This study demonstrated that for the treatment of acute exacerbations of chronic bronchitis a 7-day course of moxifloxacin 400 mg od was clinically equivalent and microbiologically superior to clarithromycin 500 mg bid.

• Pediatric Infection and Vaccine
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• v.20 no.3
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• pp.139-146
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• 2013

Objective: As per the requirement of Korean Food and Drug Administration, this post-marketing surveillance was conducted in Korea to evaluate the safety and reactogenicity of Poliorix$^{TM}$ following its introduction in 2006. Methods: In this open, multicenter study, the vaccine was administered as per the current practice of Korean doctors and in reference to the guidebook by the Korean Pediatric Society and as indicated in the Korean label which was as follows - for primary vaccination three doses were given to infants at ages 2, 4 and 6 months whereas, for the booster dose a single dose was given to children aged 4-6 years. Safety data during this six year surveillance was collected using diary cards which were distributed to the parents to record adverse events. Results: A total of 639 subjects were enrolled into the study. Of these, 617 subjects and 22 subjects received the vaccine as a primary and booster dose, respectively. At least one unsolicited symptom was reported in 11.4% (73/639) of the subjects during the 7-day follow-up period; upper respiratory tract infection (2.5%;16/639) was the most frequently reported unsolicited symptom. One subject reported at least one unsolicited symptom (gastroenteritis) of grade 3 intensity within the 31-day post-vaccination period. Approximately 1.7% (11/639) of subjects reported 13 serious adverse events (SAEs). All SAEs were resolved by the end of the study. Conclusion: In Korea, primary and booster vaccination with Poliorix$^{TM}$ was well-tolerated in healthy subjects when administered according to the prescribing information as part of routine clinical practice.

• Journal of the Korean Academy of Child and Adolescent Psychiatry
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• v.16 no.2
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• pp.279-285
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• 2005

Objectives : This study was performed to evaluate the efficacy and safety of MPH-OROS and parental satisfaction for treatment of children with ADHD Method : The 569 participants were clinically diagnosed for ADHD using DSM-IV criteria. We switched current medication to MPH-OROS or introduced MPH-OROS for treatment of ADHD. We assessed the clinical global impression severity of illness (CGI-S), the clinical global impression severity of improvement(CGI-I). And the parents of participants measured the Korean version of Conners rating scale at baseline, the 1 st week and the 3rd week after MPH-OROS trial. At the 3rd week, the parents measured the parent satisfaction questionnaire. Results : $13\%$ of participants dropped out because of several causes including side effects. The change of CGI-S was significantly decreased. Using CGI-I, the improvement was $72.3\%$ at the 1st week and $87.4\%$ at the 3rd week. The total score of the Korean version of Conners parent rating scale was significantly decreased. The participants complaining one or more of side effects were 119$(20.7\%)$, and the most common side effect was anorexia. The $94\%$ of parents replied that they were overall satisfied with MPH-OROS trial. Also the advantages of MPH-OROS of parental report were the long duration of the drug, the improvement of schoolwork and attitude, the improvement of home behavior and homework and the improvement of overactivity. Conclusion : MPH-OROS is effective and well-tolerated in actual clinical use for ADHD.

• The korean journal of orthodontics
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• v.34 no.5 s.106
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• pp.371-379
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• 2004

The purpose of this study was to investigate the changes and types of statistical methods used in the Korean Journal of Orthodontics (KJO) and the American Journal of Orthodontics and Dentofacial Orthopedics (AJODO) from )999 to 2003. The frequency of use, transitions, assumption check of statistical methods and types of advanced statistical methods were examined from each journal. The study consisted of 247 articles published in the KJO and randomly chosen 50 articles per year which were original articles and used statistical methods T-test, analysis of variance(ANOVA), correlation analysis, nonparametric analysis. regression analysis chi-square test. factor analysis, were the order of statistical methods most frequently used in the KJO, while t-test. ANOVA, nonparametric analysis, correlation analysis, regression analysis, chi-square test. factor analysis. were the order of statistical methods used in the AJODO The changes of statistical methods observed in the KJO were not significant $(X^2=17.4\;p=0.5881)$ but the changes observed in the AJODO was seen to be significant $(x^2=42.4,\;p=0.0397)$ Some of the studies examined had overlooked the assumptions of the statistical methods employed. Data investigation such as outlier should be performed before analysis and alternative statistical approaches are applied for a small sample size. Types of advanced statistical methods were factor analysis and discriminant analysis in the KJO and Intention-To-Treat (ITT) analysis in clinical trials through multi-center, survival analysis and Generalized Estimating Equations (GEE) in the AJODO. Appropriate analysis approaches and interpretations should be applied for the correlated and repeated measurements of the orthodontic data set.

• Tuberculosis and Respiratory Diseases
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• v.55 no.1
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• pp.69-87
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• 2003

Background : LB20304(gemifloxacin) is a new fluoroquinolone antibacterial agent with excellent activity against both Gram-negative and Gram-positive organisms. In vitro studies using clinical isolates have shown gemifloxacin to be highly active against penicillin-resistant strains of S. pneumoniae and in contrast to other reference quinolones, gemifloxacin retained good activity against clinical isolates of S. pneumoniae that were resistant to other members of the quinolone class. Therefore, gemifloxacin is thought to be effective in treating acute bacterial exacerbation of chronic bronchitis(AECB). The objective of this study was to evaluate the efficacy and safety of oral gemifloxacin at doses of 160mg or 320mg once daily for 7 days for the treatment of AECB in Korean adult population. Methods : This was a randomized, multicenter, double-blind, parallel group Phase II study to assess the clinical and antibacterial efficacy and safety of oral gemifloxacin for the treatment of AECB. Treatment Group A (67 patients) took oral gemifloxacin 160mg once daily for seven days and treatment Group B (70 patients) took oral gemifloxacin 320mg once daily for seven days. Results : The demographic profiles of the two treatment groups were similar. The clinical response at follow-up was 84.2% in the gemifloxacin 160-mg group, and 88.7% in the gemifloxacin-320 mg group, showing no statistically significant difference between two treatment groups(p=0.49). The clinical response at the end of therapy was 96.5% in the 160-mg group, and 96.4% in the 320-mg group. The bacteriological response at the end of therapy and follow-up were 81.8% and 78.9%, respectively, in the 160-mg group, and 86.4% and 84.2%, respectively, in the 320-mg group, showing no statistically significant difference between two treatment groups(p=0.68 and 0.68, respectively). S. pneumoniae(12 isolates) and H. influenzae(10 isolates) were the most prevalent pathogens. The MICs were lower for gemifloxacin than other quinolones against these key pathogens, and for S. pneumoniae, the MICs for gemifloxacin were considerably lower(${\leq}0.03$ ug/mL) than those for other quinolones, beta-lactams and macrolides. In the period on-therapy plus 30 days post-therapy, a total of 18 patients(26.9%) in the gemifloxacin 160mg group and 22 patients(31.4%) in the 320mg group reported at least one adverse event(AE). The most frequently reported AE was abdominal pain(3/67 patients, 4.5%) in the gemifloxacin 160mg group and increased level of hepatic enzyme(5/70 patients, 7.1%) in the 320mg group. The overall AE profiles for the two treatment groups were similar. Two out of 67 patients(3.0%) in the gemifloxacin 160mg group and 1/70 patients(1.4%) in the 320mg group reported at least one serious AE, however, none of which was considered by the investigator to be of suspected or probable relationship to study medication. Conclusion : The results of this study showed that gemifloxacin at doses of 160mg or 320mg once daily for 7 days in the treatment of acute exacerbations of chronic bronchitis(AECB) in adult Koreans was a very effective and safe treatment both clinically and bacteriologically.