• Title/Summary/Keyword: Adverse Event

Search Result 297, Processing Time 0.021 seconds

Early Clinical Experience in Aortic Valve Replacement Using On-X$^{circledR}$Prosthetic Heart Valve (On-X$^{circledR}$ 기계판막을 이용한 대동맥판 치환술의 조기 임상 경험)

  • 안병희;전준경;류상완;최용선;김병표;홍성범;박종춘;김상형
    • Journal of Chest Surgery
    • /
    • v.36 no.9
    • /
    • pp.651-658
    • /
    • 2003
  • Since the first implanted in September 1997, the use of On-X prosthetic heart valve has been increasing around in the world. This study was designed to assess the feasibility, safety, and the postoperative hemodynamics with this new valve in clinical setting. Material and Method: The current study was carried out on 52 patients undergoing aortic valve replacement with this prosthesis between April 1999 to August 2002 at Chonnam National University Hospital to evaluate the surgical results. 52% of the patients were male and the average age at implant was 50$\pm$13 years. The study followed the guidelines of the AATS/STS. Preoperatively, 32(61.5%) patients were in NYHA functional class III or IV and 2 patients had previous aortic valve surgery. Concomitant cardiac surgery was performed in 71.1%. The implanted valve sizes were 19 mm in 13 patients, 21 mm in 26, 23 mm in 10 and 25 mm in 3, respectively. Mean follow-up was 16.6$\pm$10.5 months (1∼39 months). Echocardiographic assessment was performed pre- and immediate postoperatively, as well as 3, 6, 12 months after surgery, evaluating pressure loss and regression of left ventricular hypertrophy. Result: Mean cardiopulmonary bypass time was 191$\pm$94.7 minutes with an aortic cross-clamp time of 142$\pm$51.7 minutes. There was no early and late mortality, Freedom from adverse events at 1 year in the study were as follows: thromboembolism, 95.6$\pm$6%; bleeding events, 90.2$\pm$4%; paravalvular leakage 92.3$\pm$4%; and overall valve-related morbidity at 1 year was 76.6$\pm$3%. There were no cases of valve thrombosis, prosthetic valve endocarditis and structural or non-structural failure. Left ventricular function at 12 months after surgery (EF=62.7$\pm$9.8%) revealed a statistically significant improvement compared to preoperative investigation (EF=55.8$\pm$15.9%, p=0.006). Left ventricular mass index was 247.3$\pm$122.3 g/$m^2$ on preoperative echocardiographic study, but regressed to 155.5$\pm$58.2 g/$m^2$ at postoperative 1 year (p=0.002). Over the follow-up period a further decrease of peak transvalvular gradients was observed in all patients: 62.5$\pm$38.0 mmHg on preoperative assessment, 18.2$\pm$6.8 mmHg at immediate postoperative period (p < 0.0001), 7.6$\pm$5.09 mmHg (p<0.0001) at 6 month, 18.0$\pm$10.8 mmHg (p<0.0001) at 1 year. Conclusion: The On-X prosthetic heart valve performs satisfactorily in the first 1 year period. Clinical outcome by examining NYHA functional classification revealed especially good results. Effective regression of left ventricular hypertrophy and statistically significant decrease of transvalvular gradient were observed over the first year, but longer-term follow-up of this patient group is needed to establish the expected rates for late valve-related events as well as the long-term clinical efficacy of this valve.

Mid-Term Results of Mitral Valve Repair Using a Partial Flexible Band and a Completely Rigid Ring in Patients with Degenerative Mitral Regurgitation (퇴행성 승모판막역류 환자에서 Partial Flexible Band와 Complete Rigid Ring을 이용한 승모판막 성형술의 중기 결과 비교)

  • Kim, Kyung-Hwan;Ahn, Hyuk;Hwang, Ho-Young;Choi, Jin-Ho;Kim, Ki-Bong
    • Journal of Chest Surgery
    • /
    • v.43 no.5
    • /
    • pp.475-481
    • /
    • 2010
  • Background: We evaluated mid-term results of mitral annuloplasty using a flexible band and a completely rigid ring for mitral valve repair in patients with degenerative mitral regurgitation (MR). Material and Method: From January 2004 to September 2008, 71 patients (M:F=36:35, $55{\pm}13$ years) underwent mitral valve repair with mitral annuloplasty for degenerative MR. Ring annuloplasty was done using a Cosgrove-Edwards flexible band (Group I, n=43) or a Carpentier-Edwards classic ring (Group II, n=28). There were no differences in preoperative characteristics of the participants. Average duration of follow-up was 36 months (range: 2~69 mos). Result: There was no in-hospital mortality. Postoperative morbidity, which included atrial fibrillation (n=7) and low cardiac output syndrome (n=5) in groups I and II were similar. There was one late death in group II. The proportion exhibiting freedom from recurrent mitral regurgitation ($\geq$moderate) at 4 years in Groups I and II were, respectively, 94.5 and 91.8%, (p=0.695). Left ventricular ejection fraction decreased in the early postoperative period ($7{\pm}2$ days) and recovered by last follow-up ($25{\pm}16$ mos; p=0.002). The pattern was similar in groups I and II (p=0.905). Re-operation was performed in 3 patients (1 in Group I and 2 in Group II, p=0.316). Four-year event-free survival (free of adverse valve-related events) was 95.2% for Group I and 92.6% for Group II; this difference was not significant, p=0.646). Conclusion: The type of technique used in mitral annuloplasty to repair the mitral valve repair after degenerative MR did not affect mid-term clinical and functional results.

Efficacy and Safety of Red Ginseng on Women's Health Related Quality of Life and Sexual Function (여성의 건강관련 삶의 질과 성기능에 대한 홍삼의 효과 및 안전성 연구)

  • Kim, Dong-II;Choi, Min-Sun;Alm, Hong-Yeop
    • Journal of Ginseng Research
    • /
    • v.33 no.2
    • /
    • pp.115-126
    • /
    • 2009
  • To evaluate the efficacy and safety of red ginseng on women's health-related quality of life (QOL) and sexual function. A randomized, double-blind, placebo-controlled, crossover clinical study was performed. The main efficacy was measured using the Female Sexual Function Index (FSFl) and the 36-Item Short-Form Health Survey (SF-36). Twenty-four healthy, married women aged 30-45 years with FSFl scores below 25 were randomly divided into two groups: the red-ginseng group (N=12) and the placebo group (N=12). During the first six-week period (Study 1), each group was given red ginseng or placebo twice a day. Before the start of the second six-week period (Study 2), a crossover design was chosen with a two-week break (washout period). Interchanging the two groups after the washout period, red ginseng and placebo were given to each group. The outcomes were measured before and after each six-week period. Overall, 23 participants completed the study. In Study 1, the changes relative to the baseline in the FSFl total score were 22.50% and 22.99% for red ginseng and placebo, respectively. In Study 2, the relative changes were 8.14% for red ginseng and 6.29% for placebo. The results showed a greater improving trend in Study 1 with respect to all of the participants' sexual functions, but no significant difference was found between the groups (P=0.9567). After taking red ginseng, all the participants exhibited an improving trend in the desire domain of FSFl, but no significant difference was shown. In the measurement of SF-36, no significant difference was likewise shown. After taking red ginseng, though, all the participants exhibited an improving trend in the physical functioning (PF) domain of SF-36, with no significant difference. Moreover, there was no significant adverse event related to red ginseng. The QOL and sexual function of the study participants in the red-ginseng group were mostly improved, but no statistically significant effect of red ginseng was shown. It is supposed that this result was partly due to the affirmative impression of red ginseng in Korea. Thus, it is anticipated that a long-term clinical trial will show a significant effect of red ginseng on the QOL and sexual function.

Efficacy and Safety of Topical Application of Epidermal Growth Factor (EGF) for Korean Acne Patient (한국인 여드름 환자에서 표피성장인자가 함유된 외용제의 피부 적용에 대한 유효성 및 안전성 평가)

  • Suh, Joon Hyuk;Hyun, Moo Yeol;Jang, Seong Eum;Choi, Sun Young;Kim, Myeung Nam;Kim, Beom Joon
    • Journal of the Society of Cosmetic Scientists of Korea
    • /
    • v.42 no.2
    • /
    • pp.111-118
    • /
    • 2016
  • Acne vulgaris is a chronic inflammatory condition characterized by comedo, papule, cyst, nodule and postinflammatory hyperpigmentation. Meanwhile, it is also induced by adverse event of drugs. Among them, acneiform folliculitis is a side effect of epidermal growth factor receptor (EGFR) inhibitor, which is an anticancer agent, and its incidence may occur in upward of 75 ~ 100% of cases. The main method of acne vulgaris treatment is oral antibiotics, retinoids, topical medication and so on. However, it is limitation that teratogenicity caused by retinoids and antibiotic resistance increased by using antibiotics. In this study, we aimed to evaluate the clinical efficacy and safety of topical recombinant human (rh) EGF in treating facial acne vulgaris. Twenty three Koreans (age: 10 ~ 29 years) with mild to moderate acne vulgar participated in the study and applied topical rhEGF cream (trouble control EGF) with 3 products (trouble control clarifying cleansing foam, trouble control all-clear filling toner, redroll calming moisture) on their face twice daily for four weeks. Several assessment methods were applied: Acne lesion counts score by investigator's global assessment, efficacy and satisfaction score by subjects. Skin sebum output level, hydration level and redness level were also measured at each visit. At the final visit, skin sebum level, transepidermal water loss, skin redness statistically decreased and acne lesions (comedone, papule) were statistically reduced. No severe side effects were observed during the study. In conclusion, topical rhEGF seems to be an effective and safe adjuvant treatment option for mild acne vulgaris.

Clinical Results and Optimal Timing of OPCAB in Patients with Acute Myocardial Infarction (급성 심근경색증 환자에서 시행한 OPCAB의 수술시기와 검색의 정도에 따른 임상성적)

  • Youn Young-Nam;Yang Hong-Suk;Shim Yeon-Hee;Yoo Kyung-Jong
    • Journal of Chest Surgery
    • /
    • v.39 no.7 s.264
    • /
    • pp.534-543
    • /
    • 2006
  • Background: There are a lot of debates regarding the optimal timing of operation of acute myocardial infarction (AMI). Off pump coronary artery bypass grafting (OPCAB) has benefits by avoiding the adverse effects of the cardio-pulmonary bypass, but its efficacy in AMI has not been confirmed yet. The purpose of this study is to evaluate retrospectively early and mid-term results of OPCAB in patients with AMI according to transmurality and timing of operation. Material and Method: Data were collected in 126 AMI patients who underwent OPCAB between January 2002 and July 2005, Mean age of patients were 61.2 years. Male was 92 (73.0%) and female was 34 (27.2%). 106 patients (85.7%) had 3 vessel coronary artery disease or left main disease. Urgent or emergent operations were performed in 25 patients (19.8%). 72 patients (57.1%) had non-transmural myocardial infarction (group 1) and 52 patients (42.9%) had transmural myocardial infarction (group 2). The incidence of cardiogenic shock and insertion of intra-aortic balloon pump (IABP) was higher in group 2. The time between occurrence of AMI and operation was divided in 4 subgroups (<1 day, $1{\sim}3\;days,\;4{\sim}7\;days$, >8 days). OPCAB was performed a mean of $5.3{\pm}7.1$ days after AMI in total, which was $4.2{\pm}5.9$ days in group 1, and $6,6{\pm}8.3$ days in group 2. Result: Mean distal an-astomoses were 3.21 and postoperative IABP was inserted in 3 patients. There was 1 perioperative death in group 1 due to low cardiac output syndrome, but no perioperative new MI occurred in this study. There was no difference in postoperative major complication between two groups and according to the timing of operation. Mean follow-up time was 21.3 months ($4{\sim}42$ months). The 42 months actuarial survival rate was $94.9{\pm}2.4%$, which was $91.4{\pm}4.7%$ in group 1 and $98.0{\pm}2.0%$ in group 2 (p=0.26). The 42 months freedom rate from cardiac death was $97.6{\pm}1.4%$ which was $97.0{\pm}2.0%$ in group 1 and $98.0{\pm}2.0%$ in group 2 (p=0.74). The 42 months freedom rate from cardiac event was $95.4{\pm}2.0%$ which was $94.8{\pm}2.9%$ in group 1 and $95.9{\pm}2.9%$ in group 2 (p=0.89). Conclusion: OPCAB in AMI not only reduces morbidity but also favors hospital outcomes irrespective of timing of operation. The transmurality of myocardial infarction did not affect the surgical and midterm outcomes of OPCAB. Therefore, there may be no need to delay the surgical off-pump revascularization of the patients with AMI if surgical revascularization is indicated.

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
    • /
    • v.39 no.3 s.260
    • /
    • pp.184-193
    • /
    • 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
    • /
    • v.55 no.1
    • /
    • pp.69-87
    • /
    • 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.