• Title/Summary/Keyword: Adverse events

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The evaluation for Clinical usefulness and Safety of Sirolimus-eluting stent and Paclitaxel-Eluting Stents In Patients With Acute Myocardial Infarction (급성심근경색증 환자의 일차적 관동맥 스텐트 삽입술 시 삽입된 Sirolimus-eluting stent 와 Paclitaxel-eluting stent의 임상적 안정성 및 유용성 평가)

  • Min, Gye-Sik;Han, Man-Seok
    • Journal of the Korean Society of Radiology
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    • v.6 no.1
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    • pp.5-10
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    • 2012
  • There is a still unsettled issue about the comparison of long-term clinical effects between sirolimus-(SES) and paclitaxel-eluting stents (PES) for the patients with acute myocardial infarction (AMI). Therefore, we performed a retrospective analysis to evaluate the 4-year clinical outcome of SES as compared with PES after percutaneous coronary intervention (PCI) in patients with AMI. From January 2004 to August 2006, all consecutive patients with acute ST-segment elevation myocardial infarction (STEMI) underwent primary PCI and acute NSTEMI underwent PCI by implantation either SES or PES were enrolled. The occurrence of death, cardiac death, recurrent infarction, target vessel revascularization (TVR) and stent thrombosis were analyzed. The composite of major adverse cardiac events (MACE; death, recurrent infarction and TVR) were also analyzed. During the study period, total 668 AMI patients had visited. Of them, total 522 patients (299 with SES and 223 with PES) were enrolled. During 4-year clinical follow-up, there were similar occurrences of death ($18.3{\pm}3.0%$ vs. $14.6{\pm}2.2%$, p=0.26), cardiac death ($11.2{\pm}2.6%$ vs. $6.8{\pm}1.52%$, p=0.39), re-infarction ($6.4{\pm}1.8%$ vs. $3.3{\pm}1.1%$, p=0.31), and stent thrombosis ($5.4{\pm}1.7%$ vs. $3.2{\pm}1.1%$, p=0.53) between the two groups, consecutively. The occurrences of TVR ($10.0{\pm}3.0%$ vs. $4.0{\pm}1.2%$, p=0.008) and MACE ($29.4{\pm}3.5%$ vs. $19.4{\pm}2.5%$, p=0.003) were significantly higher in patients treated with PES than SES. In AMI patients treated with either SES or PES implantation, SES had a significantly lower risk of TVR and MACE during 4-year clinical follow-up. Rates of death, cardiac death or recurrent infarction, and stent thrombosis were similar.

Antiemetic Effect of Dolasetron Mesylate in the Prevention of Acute and Delayed Nausea and Vomiting due to Moderately Emetogenic Chemotherapy (악성종양환자에서 중등도 이상의 오심, 구토를 유발하는 항암화학요법 시급성 및 지연성 오심, 구토의 예방에 대한 Dolasetron의 효과)

  • Kim, D.S.;Sung, H.Y.;Choi, K.M.;Paik, J.Y.;Roh, S.Y.;Moon, H.;Kim, C.C.;Hong, Y.S.
    • Journal of Hospice and Palliative Care
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    • v.7 no.2
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    • pp.248-257
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    • 2004
  • Purpose: To evaluate the efficacy of dolasetron mesylate in controlling nausea and vomiting in the first 24 hours and to extend these comparisons over the next 4 days in patients receiving moderately emetogenic chemotherapy. Methods: This was a single center, open-labeled study with single arm. Dolasetron (1.8 mg/kg) was given intravenously (I.V.) prechemotherapy with 10 mg of dexamethasone IV, followed 24 hours later by oral dolasetron (200 mg once daily) for the subsequent 4 days. The frequency of vomiting, severity of nausea and the presence of rescue antiemetics were assessed daily. Results: Of 30 patients enrolled, 28 were eligible and evaluable for the efficacy. Four out of 28 patients had complete control of nausea and vomiting without any rescue antiemetics through 5 days. The complete control got better as time went by with the rates of 17.9/46.4/42.9/53.6/60.7% on days 1 to 5. Vomiting was better controlled than nausea in both cisplatin-containing and non-containing chemotherapy. The adverse events were mild to moderate degrees of headache, diarrhea and fever, but were recovered spontaneously. Conclusion: Dolasetron was effective and safe for the control of nausea and vomiting in the patients with moderately emetogenic chemotherapeutic agents.

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Effects of Coculture on Development of Biopsied Mouse Embryos as a Preclinical Model for Preimplantation Genetic Diagnosis of Human Embryos (생쥐 모델을 이용한 배아의 할구 생검법과 할구가 생검된 배아의 배양시 공배양 효과에 관한 연구: 인간에서의 착상 전 유전진단 기술 개발을 위한 동물실험 모델의 개발)

  • Kim, S.H.;Ryu, B.Y.;Jee, B.C.;Choi, S.M.;Kim, H.S.;Pang, M.G.;Oh, S.K.;Suh, C.S.;Choi, Y.M.;Kim, J.G.;Moon, S.Y.;Lee, J.Y.;Chae, H.D.;Kim, C.H.
    • Clinical and Experimental Reproductive Medicine
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    • v.26 no.1
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    • pp.9-20
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    • 1999
  • The genetic defects in human gametes and embryos can cause adverse effects on overall reproductive events. Biopsy of embryos for preimplantation genetic diagnosis (PGD) offers a new possibility of having children free of the genetic disease. In addition, advanced embryo culture method may enhance the effectiveness of embryo biopsy for the practical application of PGD. This experimental study was undertaken to evaluate the effects of coculture on the development in vitro of biopsied mouse embryos as a preclinical model for PGD of human embryos. Embryos were obtained after in vitro fertilization (IVF) from F1 hybrid mice (C57BLfemale/CBAmale). Using micromanipulation, 1, 2, 3 or 4 blastomeres of 8-cell stage embryos were aspirated through a hole made in the zona pellucida by zona drilling (ZD) with acidic Tyrode's solution (ATS). After biopsy of blastomeres, embryos were cultured in vitro for 110 hours in Ham's F-10 supplemented with 0.4% BSA or cocultured on the monolayer of Vero cells in the same medium. The frequence of blastocyst formation were recorded, and the embryos beyond blastocyst stage were stained with 10% Giemsa to count the total number of nuclei in each embryo. There was no significant difference in the blastocyst formation between the zona intact control group and the zona drilling (ZD) only, or biopsied groups. The hatching rate of all the treatment groups except 4/8 group was significantly higher than that of control group. In all the treatment groups, there was a significant reduction in the mean cell number of embryos beyond blastocyst stage ($50.2{\pm}14.0$ in control group vs. $41.2{\pm}7.9$ in ZD, $39.3{\pm}8.8$ in 7/8, $29.7{\pm}6.4$ in 6/8, $25.1{\pm}5.7$ in 5/8, and $22.1{\pm}4.3$ in 4/8 groups, p<0.05). When the same treatments were followed by coculture with Vero cells, a similar pattern was seen in the blastocyst formation and the hatching rate. However, in all the treatment groups, there was a significant increase in the mean cell number of embryos beyond blastocyst stage with coculture, compared with the parallel groups without coculture. In the cleavage rate of biopsied blastomeres cultured for 110 hours after IVF, there was no significant difference between coculture and non-coculture groups (87.2% vs. 78.7%). However, the mean cell number of embryos developed from the biopsied blastomeres was significantly higher in coculture group ($11.5{\pm}4.7\;vs.\;5.9{\pm}1.9$, p<0.05). In conclusion, biopsy of mouse embryos after ZD with ATS is a safe and highly efficient method for PGD, and coculture with Vero cells showed a positive effect on the development in vitro of biopsied mouse embryos and blastomeres as a preclinical model for PGD of human embryos.

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Impacts of Diastolic Function on Clinical Outcomes in Young Patients with Acute Myocardial Infarction (젊은 급성 심근경색증 환자에서 좌심실 이완 기능 및 충만압이 관상동맥중재술 후 임상 경과에 미치는 영향)

  • Cho, Eun Young;Jeong, Myung Ho;Yoon, Hyun Ju;Kim, Yong Cheol;Sohn, Seok-Joon;Kim, Min Chul;Sim, Doo Sun;Hong, Young Joon;Kim, Ju Han;Ahn, Youngkeun;Cho, Jae Young;Kim, Kye Hun;Park, Jong Chun
    • The Korean Journal of Medicine
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    • v.93 no.6
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    • pp.538-547
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    • 2018
  • Background/Aims: The impact of left ventricular (LV) diastolic function and filling pressure on clinical outcomes in young patients with acute myocardial infarction (AMI) has been poorly studied. Therefore, the aim of this study was to investigate the impact of LV diastolic function and LV filling pressure on major adverse cardiac events (MACEs) in young patients with AMI. Methods: A total of 200 young patients (males < 45 year, females < 55 year) with AMI were divided into two groups according to the diastolic function; normal (n = 46, $39.5{\pm}5.3$ years) versus abnormal (n = 154, $43.5{\pm}5.1$ years). Results: Despite regional wall motion abnormalities, normal LV diastolic function was not uncommon in young AMI patients (23.0%). During the 40 months of clinical follow-up, MACEs developed in 26 patients (13.0%); 14 re-percutaneous coronary intervention (7.0%), 8 recurrent MI (4.0%), and 4 deaths (2.0%). MACEs did not differ between the normal and abnormal diastolic function group (13.6% vs. 10.9%, p = 0.810), but MACEs were significantly higher in the high LV filling pressure group than the normal LV filling pressure group (36.8% vs. 10.5%, p < 0.001). On multivariate analysis, high LV filling pressure was an independent predictor of MACEs (hazard ratio 3.022, 95% confidence interval 1.200-7.612, p = 0.019). Conclusions: This study suggested that measurement of the LV filling pressure (E/e' ratio) would be useful in the risk stratification of young patients with AMI. However, it would be necessary to monitor this category of patient more carefully.

Safety and Efficacy of Gemcitabine Based Chemotherapy in Elderly Patients with Advanced Pancreatic Cancer - Safety of Gemcitabine in Elderly (진행성 췌장암을 가진 노인환자에서 Gemcitabine 항암화학요법의 안정성과 효과 - 노인에서 Gemcitabine의 안정성 -)

  • You Ie Choi;Dong Uk Kim;Jae Hoon Cheong;Bong Eun Lee;Gwang Ha Kim;Geun Am Song
    • Journal of Digestive Cancer Research
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    • v.1 no.1
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    • pp.36-42
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    • 2013
  • Background/Aims: Gemcitabine is regarded as a reference regimen for advanced pancreatic cancer and shows relatively safe toxicity profiles compared with other cytotoxic agents. However, many oncologists are appeared to be still reluctant to treat elderly pancreatic cancer patients with cytotoxic chemotherapy because of predicted low response rate and potential adverse events. Methods: All patients who were received gemcitabine based chemotherapy between 2007 and 2010 were identified and clinical, laboratory, radiographic data were retrospectively reviewed. Patients were divided into two groups based on their ages: less than 65, and equal or more than 65 years old. Gemcitabine, at a dose of 1,000 mg per square meter of body surface area, was administered by intravenously over 30 minutes weekly for 3 weeks followed by 1 week rest, alone or along with other chemotherapeutic agents including cisplatin, capecitabine and erlotinib. Results: A total of 61 patients were identified and all patients were not eligible to receive operation because of advanced stage at diagnosis. Twenty three patients (37.7%) were equal or more than 65 year of age. Mean age was 56 years old and 71 years old in each group. Laboratory data including CA 19-9 were not significantly different. More gemcitabine monotherapy was delivered (56.5% vs. 26.3%, p=0.029) and less second or third line therapy was adminis- tered (17.4% vs. 50.0%, p=0.014) in elderly group. Cholangitis occurred and stent placement were performed similarly in both groups. Conclusion: Gemcitabine based chemotherapy can be administered safely to elderly pancreatic cancer patients and comparable response rate and progression free survival can be expected as young patients.

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Impact of Gender Differences in Elderly Patients with Acute Myocardial Infarction (고령의 급성 심근경색증 환자에서 성별에 따른 영향)

  • Seol, Soo Young;Jeong, Myung Ho;Lee, Seung Hun;Sohn, Seok-Joon;Cho, Jae Yeong;Kim, Min Chul;Sim, Doo Sun;Hong, Young Joon;Park, Hyung Wook;Kim, Ju Han;Ahn, Youngkeun;Cho, Jeong Gwan;Park, Jong Chun
    • The Korean Journal of Medicine
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    • v.94 no.1
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    • pp.96-106
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    • 2019
  • Background/Aims: It is well known that gender differences are associated with clinical outcomes in patients with acute myocardial infarction (AMI). However, it is not clear whether gender differences affect the prognosis of elderly patients with AMI. Methods: We analyzed the incidence of in-hospital complications and mortality in the Korea Acute Myocardial Infarction Registry-National Institutes of Health from November 2011 to June 2015. This study included elderly patients (≥ 75 years) diagnosed with AMI. Results: A total of 2,953 patients were eligible for this study. Among them, 1,529 (51.8%) patients were female, and the mean age of the female group was older than that of the male group (80.7 ± 4.4 vs. 79.6 ± 4.0 years, respectively, p < 0.001). Elderly females utilized emergency medical services less frequently compared with elderly males (11.5 vs. 15.4%, respectively, p < 0.001). Elderly female AMI patients had a similar rate of in-hospital mortality compared with elderly males (7.1 vs. 8.4%, respectively, p = 0.196). The rate of major cardiac adverse events (MACEs) was lower in elderly females than males during a 12-month follow-up (hazard ratio [HR] 1.19, 95% confidence interval [CI] 1.00-1.41, p = 0.045). According to multivariate analysis, the male gender is an independent factor for predicting 1-year MACEs (HR 1.37, 95% CI 1.14-1.65, p < 0.001). Conclusions: No significant differences in peri-procedural complications or in-hospital mortality were observed between male and female elderly patients with AMI. However, elderly female patients had a more favorable prognosis than male patients during a 1-year clinical follow-up.

Prospective Multi-Center Korean Registry of Transcatheter Arterial Chemoembolization with Drug-Eluting Embolics for Nodular Hepatocellular Carcinoma: A Two-Year Outcome Analysis

  • Myungsu Lee;Jin Wook Chung;Kwang-Hun Lee;Jong Yun Won;Ho Jong Chun;Han Chu Lee;Jin Hyoung Kim;In Joon Lee;Saebeom Hur;Hyo-Cheol Kim;Yoon Jun Kim;Gyoung Min Kim;Seung-Moon Joo;Jung Suk Oh
    • Korean Journal of Radiology
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    • v.22 no.10
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    • pp.1658-1670
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    • 2021
  • Objective: To assess the two-year treatment outcomes of chemoembolization with drug-eluting embolics (DEE) for nodular hepatocellular carcinoma (HCC). Materials and Methods: This study was a prospective, multicenter, registry-based, single-arm trial conducted at five university hospitals in Korea. Patients were recruited between May 2011 and April 2013, with a target population of 200. A DC Bead loaded with doxorubicin was used as the DEE agent. Patients were followed up for two years. Per-patient and per-lesion tumor response analysis, per-patient overall survival (OS) and progression-free survival (PFS) analysis, and per-lesion tumor control analysis were performed. Results: The final study population included 152 patients, with 207 target lesions for the per-lesion analysis. At one-month, six-month, one-year, and two-year per-patient assessments, complete response (CR) rates were 40.1%, 43.0%, 33.3%, and 19.6%, respectively. The objective response (OR) rates were 91.4%, 55.4%, 35.1%, and 19.6%, respectively. The cumulative two-year OS rate was 79.7%. The cumulative two-year PFS rate was 22.4% and the median survival was 9.3 months. In multivariable analysis, the Child-Pugh score (p = 0.019) was an independent predictor of OS, and tumor multiplicity (p < 0.001), tumor size (p = 0.020), and Child-Pugh score (p = 0.006) were independent predictors of PFS. In per-lesion analysis, one-month, six-month, one-year and two-year CR rates were 57.5%, 58.5%, 45.2%, and 33.3%, respectively, and the OR rates were 84.1%, 65.2%, 46.6%, and 33.3%, respectively. The cumulative two-year per-lesion tumor control rate was 36.2%, and the median time was 14.1 months. The Child-Pugh score (p < 0.001) was the only independent predictor of tumor control. Serious adverse events were reported in 11 patients (7.2%). Conclusion: DEE chemoembolization for nodular HCCs in the Korean population showed acceptable survival, tumor response, and safety profiles after a two-year follow-up. Good liver function (Child-Pugh score A5) was a key predictor of per-patient OS, PFS, and per-lesion tumor control.

Off-pump Coronary Artery Bypass Surgery Versus Drug Eluting Stent for Multi-vessel Coronary Artery Disease (다혈관 관상동맥질환에서의 심폐바이패스를 사용하지 않은 관상동맥우회술과 약물용출 스텐트시술)

  • Lee, Jae-Hang;Kim, Ki-Bong;Cho, Kwang-Ree;Park, Jin-Shik;Kang, Hyun-Jae;Koo, Bon-Kwon;Kim, Hyo-Soo;Sohn, Dae-Won;Oh, Byung-Hee;Park, Young-Bae
    • Journal of Chest Surgery
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    • v.41 no.2
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    • pp.202-209
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    • 2008
  • Background: The introduction of Drug Eluting Stents (DES) decreased the number of patients referred for coronary artery bypass grafting (CABG). The impact of DES on CABG (Step 1) was studied and compared with the 1-year outcome after CABG with DES (Step 2). Material and Method: Surgical results for patients who underwent off-pump CABG (OPCAB) before the introduction of DES(n=298) were compared with those who underwent OPCAB after the introduction of DES (n=288) (Step 1). Postoperative 30-day and 1-year results were also compared between the patients who underwent percutaneous coronary intervention (PCI) using DES (n=220) and those who underwent OPCAB (n=255) (Step 2). Result: Since the introduction of DES, the ratio of CABG versus PCI decreased. In the CABG group, the number of high risk patients such as elderly patients (age 62 vs. 64, p=0.023), those with chronic renal failure (4% vs. 9%, p=0.021), calcification of the ascending aorta (9% vs. 15%, p=0.043), or frequency of urgent or emergent operations (12% vs. 22%, p=0.002) increased. However, there were no differences in the cardiac death and graft patency rates between the two groups (step 1). During the one-year follow up period, the rate of target vessel revascularization (12.3% vs. 2.4%, p<0.001) and major adverse cardiac events (MACE: death, myocardial infarct, TVR) were higher in the DES than the CABG group (13.6% vs 4.3%) (stage 2). Conclusion: Introduction of DES decreased the number of patients referred for surgery, and increased the comorbidity in patients who underwent CABG. DES increased the rate of target vessel revascularization, and the occurrence of MACE during the 1-year follow-up. However, there was no difference in the incidence of myocardial infarction and cardiac death between the two groups.

Comparison of the One-year Follow-up Results after Coronary Bypass Surgery versus Percutaneous Coronary Intervention with Drug-eluting Stents in Patients with Left Main Coronary Artery Disease (좌주간지 병변에 대한 약물방출스텐트시술과 관상동맥우회수술의 1년 추적결과 비교)

  • Choi, Jin-Ho;Lim, Cheong;Park, Kay-Hyun;Chung, Eui-Suk;Chung, Woo-Young;Chae, In-Ho;Choi, Dong-Ju
    • Journal of Chest Surgery
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    • v.41 no.2
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    • pp.210-215
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    • 2008
  • Background: Drug-eluting stents are contributing to the exponential growth of percutaneous coronary intervention, and even in the patients with left main coronary artery disease, owing to the decreased restenosis rate. Our study aimed at comparing the one-year results after coronary artery bypass grafting versus percutaneous coronary intervention with drug-eluting stents in patients with left main coronary artery disease. Material and Method: Those patients who underwent coronary bypass surgery or stenting at our hospital under the diagnosis of left main coronary artery disease were divided in two groups. The variables for comparison were the preoperative disease severity, the length of the hospital stay, the early mortality and the cumulative incidence of mortality, myocardial infarction and repeated revascularization. Result: There were 101 cases in the surgery group and 78 cases in the stent group. Age, gender, the risk factors, the left ventricular ejection fraction and the proportion of acute coronary syndrome showed no significant differences between the two groups. The surgery group showed a more severe condition according to the Euroscore, a greater incidence of urgency, a longer hospital stay and a greater incidence of multi-vessel disease. The early mortality and one-year cumulative mortality were not different between the groups. The Euroscore-matched comparison for the surgery group (41 patients) and the stent group (78 patients) showed no significant differences in the Euroscore, age, gender, risk factors and the proportion of acute coronary syndrome. The surgery group in the Euroscore-matched comparison showed more multi-vessel disease and a longer hospital stay. The surgery group showed lower early mortality and lower one-year cumulative mortality, but this was statistically insignificant (0% vs 2.6%, respectively, p=0.55; 0% vs 6.6%, respectively, p=0.30). The rates of repeated revascularization and major adverse events (death or myocardial infarct) were lower in the CABG group, but this was not statistically significant (13.3% vs 6.3%, respectively, p=0.48; 10.0% vs 0%, respectively, p=0.09). Conclusion: Percutaneous coronary intervention using drug-eluting stents in low-risk patients with left main coronary artery disease resulted in a shortened length of the hospital stay, as compared with that of the CABG group of patients. However, the patients who underwent percutaneous coronary intervention using drug-eluting stents showed a tendency for an increased rate of repeated revascularization and higher one-year cumulative mortality. Further studies with large populations and longer follow-up will be necessary to reaffirm our findings.

A Multicenter, Randomized, Open, Comparative Study for the Efficacy and Safety of Oral Moxifloxacin 400 mg Once a Day and Clarithromycin 500 mg Twice Daily in Korean Patients with Acute Exacerbations of Chronic Bronchitis (한국인의 만성 기관지염의 급성 악화 환자를 대상으로 한 Moxifloxacin 400mg 1 일 1회 요법과 Clarithromycin 500mg 1일 2회 요법의 치료효과 및 안전성 비교)

  • Kim, Seung-Joon;Kim, Seok-Chan;Lee, Sook-Young;Yoon, Hyeong-Kyu;Kim, Tae-Yon;Kim, Young-Kyoon;Song, Jeong-Sup;Park, Sung-Hak;Kim, Ho-Joong;Chung, Man-Pyo;Suh, Gee-Young;Kwon, O-Jung;Lee, Shin -Hyung;Kang, Kyung-Ho;Lee, Eh-Hyung;Hwang, Sung-Chul;Han, Myung-Ho
    • 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.

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