• Title/Summary/Keyword: Multicenter study

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Mitral Valvuloplasty using New Mitral Strip (Mitracon^{(R)}$) (새로운 Strip (Mitracon^{(R)}$)을 이용한 승모판막 성형술)

  • Kang, Seong-Sik;Kim, Sang-Pil;Song, Meong-Gum
    • 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.

The National Survey of Acute Respiratory Distress Syndrome in Korea (급성호흡곤란증후군의 전국 실태조사 보고)

  • Scientific Subcommittee for National Survey of Acute Respiratory Distress Syndrome in Korean Academy of Tuberculosis and Respiratory Disease
    • Tuberculosis and Respiratory Diseases
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    • v.44 no.1
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    • pp.25-43
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    • 1997
  • Introduction : The outcome and incidence of acute respiratory distress syndrome (ARDS) could be variable related to the varied definitions used for ARDS by researchers. The purpose of the national survey was to define the risk factors of ARDS and investigate the prognostic indicies related to mortality of ARDS in Korea according to the definition of ARDS determined by the American-European Concensus Conference on 1992 year. Methods : A Multicenter registry of 48 University or University-affliated hospital and 18 general hospital s equipped with more than 400 patient's beds conducted over 13 months of patients with acute respiratory distress syndrome using the same registry protocol. Results : 1. In the 12 months of the registry, 167 patients were enrolled at the 24 hospitals. 2. The mean age was 56.5 years (${\pm}17.2$ years) and there was a 1.9:1 ratio of males to females. 3. Sepsis was the most common risk factors (78.1%), followed by aspiration (16.6%), trauma (11.6%), and shock (8.5%). 4 The overall mortality rate was 71.9%. The mean duration was 11 days (${\pm}13.1$ days) from the diagnosis of ARDS to the death. Respiratory insufficiency appeared to be a major cause in 43.7% of the deaths followed by sepsis (36.1%), heart failure (7.6%) and hepatic failure (6.7%). 5. There were no significant differences in mortality based on sex or age. No significant difference in mortality in infectious versus noninfectious causes of ARDS was found. 6. There were significant differences in the pulse rate, platelet numbers, serum albumin and glucose levels, the amounts of 24 hour urine, arterial pH, $Pa0_2$, $PaCO_2$, $Sa0_2$, alveolar-arterial oxygen differences, $PaO_2/FIO_2$, and PEEP/$FI0_2$ between the survivors and the deaths on study days 1 through 6 of the first week after enrollment. 7. The survivors had significantly less organ failure and lower APACHE III scores at the time of diagnosis of ARDS (P<0.05). 8. The numbers of organ failure (odd ratio 1.95, 95% confidence intervals:1.05-3.61, P=0.03) and the score of APACHE III (odd ratio 1.59, 95% confidence interval:1.01-2.50, P=0.04) appeared to be independent risk factors of the mortality in the patients with ARDS. Conclusions : The mortality was 71.9% of total 167 patients in this investigation using the definition of American-European Consensus Conference on 1992 year, and the respiratory insufficiency was the leading cause of the death. In addition, the numbers of organ failure and the score of APACHE III at the time of diagnosis of ARDS appeared to be independent risk factors of the mortality in the patients with ARDS.

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Multicenter Analysis of Gestational Trophoblastic Neoplasia in Turkey

  • Ozalp, Sabit Sinan;Telli, Elcin;Oge, Tufan;Tulunay, Gokhan;Boran, Nurettin;Turan, Taner;Yenen, Mufit;Kurdoglu, Zehra;Ozler, Ali;Yuce, Kunter;Ulker, Volkan;Arvas, Macit;Demirkiran, Fuat;Bese, Tugan;Tokgozoglu, Nedim;Onan, Anil;Sanci, Muzaffer;Gokcu, Mehmet;Tosun, Gokhan;Dikmen, Yilmaz;Ozsaran, Aydin;Terek, Mustafa Cosan;Akman, Levent;Yetimalar, Hakan;Kilic, Derya Sakarya;Gungor, Tayfun;Ozgu, Emre;Yildiz, Yunus;Kokcu, Arif;Kefeli, Mehmet;Kuruoglu, Serkan;Yuksel, Hasan;Guvenal, Tevfik;Hasdemir, Pinar Solmaz;Ozcelik, Bulent;Serin, Serdar;Dolanbay, Mehmet;Arioz, Dagistan Tolga;Tuncer, Nadire;Bozkaya, Hasan;Guven, Suleyman;Kulaksiz, Deniz;Varol, Fusun;Ali, Yanik;Ogurlu, Gonca;Simsek, Tayyup;Toptas, Tayfun;Dogan, Selen;Camuzoglu, Hakan;Api, Murat;Guzin, Kadir;Eray, Caliskan;Doger, Emek
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.8
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    • pp.3625-3628
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    • 2014
  • Background: To evaluate the incidence, diagnosis and management of GTN among 28 centers in Turkey. Materials and Methods: A retrospective study was designed to include GTN patients attending 28 centers in the 10-year period between January 2003 and May 2013. Demographical characteristics of the patients, histopathological diagnosis, the International Federation of Gynecology and Obstetrics (FIGO) anatomical and prognostic scores, use of single-agent and multi-agent chemotherapy, surgical interventions and prognosis were evaluated. Results: From 2003-2013, there were 1,173,235 deliveries and 456 GTN cases at the 28 centers. The incidence was calculated to be 0.38 per 1,000 deliveries. According to the evaluated data of 364 patients, the median age at diagnosis was 31 years (range, 15-59 years). A histopathological diagnosis was present for 45.1% of the patients, and invasive mole, choriocarcinoma and PSTTs were diagnosed in 22.3% (n=81), 18.1% (n=66) and 4.7% (n=17) of the patients, respectively. Regarding final prognosis, 352 (96.7%) of the patients had remission, and 7 (1.9%) had persistence, whereas the disease was mortal for 5 (1.4%) of the patients. Conclusions: Because of the differences between countries, it is important to provide national registration systems and special clinics for the accurate diagnosis and treatment of GTN.

A Randomized, Double-Blind Study to Assess the Efficacy and Safety of Oral LB20304 (Gemifloxacin) at Doses of 160mg or 320mg (Equivalent to 200mg or 400mg of the Mesylate Salt) Once Daily for 7 Days for the Treatment of Acute Exacerbations of Chronic Bronchitis (AECB) in Korean Adult Population (한국인에서 만성기관지염의 급성악화를 치료하기 위한 LB20304(Gemifloxacin) 160mg 또는 320mg 1일 1회 7일간 투여의 유효성과 안전성에 대한 연구)

  • Kim, Young Whan;Shim, Young-Soo;Kim, Won Dong;Shim, Tae Sun;Kang, Hong Mo;Choi, ByoungWhui;Kim, Jae-Yeol;Kwon, O Jung;Kim, Hojoong;Kim, Ju Ock;Jung, Ki-Suck;Hyeon, In Gyou;Mo, Eun Kyung;Lee, Seung-Joon;Nam, Gui Hyun;Lee, Kye Young;Park, Jae Seuk
    • 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.