• Title/Summary/Keyword: adverse event

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The Comparison Study of Early and Midterm Clinical Outcome of Off-Pump versus On-Pump Coronary Artery Bypass Grafting in Patients with Severe Left Ventricular Dysfunction (LVEF${\le}35{\%}$) (심한 좌심실 부전을 갖는 환자에서 시행한 Off-Pump CABG와 On-Pump CABG의 중단기 성적비교)

  • Youn Young Nam;Lee Kyo Joon;Bae Mi Kyung;Shim Yeon Hee;Yoo Kyung-Jong
    • Journal of Chest Surgery
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    • v.39 no.3 s.260
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    • pp.184-193
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    • 2006
  • Background: Off-pump coronary artery bypass grafting (OPCAB) has been proven to result in less morbidity. The patients who have left ventricular dysfunction may have benefits by avoiding the adverse effects of the cardiopulmonary bypass. The present study compared early and midterm outcomes of off-pump versus on-pump coronary artery bypass grafting (On pump CABG) in patients with severe left ventricular dysfunction. Material and Method: Ninety hundred forth six patients underwent isolated coronary artery bypass grafting by one surgeon between January 2001 and Febrary 2005.. Data were collected in 100 patients who had left ventricular ejection fraction (L VEF) less than $35\%$ (68 OPCAB; 32 On pump CABG). Mean age of patients were 62.9$\pm$9.0 years in OPCAS group and 63.8$\pm$8.0 years in On pump CABG group. We compared the preoperative risk factors and evaluated early and midterm outcomes. Result: In OPCAB and On pump CABG group, mean number of used grafts per patient were 2.75$\pm$0.72, 2.78$\pm$0.55 and mean number of distal anastomoses were 3.00$\pm$0.79, 3.16$\pm$0.72 respectively. There was one perioperative death in OPCAB group ($1.5\%$). The operation time, ventilation time, ICU stay time, CK-MB on the first postoperative day, and occurrence rate of complications were significantly low in OPCAB group. Mean follow-up time was 26.6$\pm$12.8 months (4${\~}$54 months). Mean LVEF of OPCAB and On pump CABG group improved significantly from $27.1\pm4.5\%$ to $40.7\pm13.0\%$ and $26.9\pm5.4\%$ to $33.3\pm13.7\%$. The 4-year actuarial survival rate of OPCAB and On pump CABG group were $92.2\%,\;88.3\%$ and the 4-year freedom rates from cardiac death were $97.7\%,\;96.4\%$ respectively. There were no significant differences between two groups in 4 year freedom rate from cardiac event and angina. Conclusion: OPCAS improves myocardial function and favors early and mid-term outcomes in patients with severe left ventricular dysfunction compared to On pump CABG group. Therefore, OPCAB is a preferable operative strategy even in patients with severe left ventricular dysfunction.

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.