BACKGROUND: A prolonged-release formulation of oxycodone/naloxone has been shown to be effective in European populations for the management of chronic moderate to severe pain. However, no clinical data exist for its use in Korean patients. The objective of this study was to assess efficacy and safety of prolonged-release oxycodone/naloxone in Korean patients for management of chronic moderate-to-severe pain. METHODS: In this multicenter, single-arm, open-label, phase IV study, Korean adults with moderate-to-severe spinal disorder-related pain that was not satisfactorily controlled with weak opioids and nonsteroidal anti-inflammatory drugs received prolonged-release oral oxycodone/naloxone at a starting dose of 10/5 mg/day (maximum 80/40 mg/day) for 8 weeks. Changes in pain intensity and quality of life (QoL) were measured using a numeric rating scale (NRS, 0–10) and the Korean-language EuroQol-five dimensions questionnaire, respectively. RESULTS: Among 209 patients assessed for efficacy, the mean NRS pain score was reduced by 25.9% between baseline and week 8 of treatment (p < 0.0001). There was also a significant improvement in QoL from baseline to week 8 (p < 0.0001). The incidence of adverse drug reactions was 27.7%, the most common being nausea, constipation, and dizziness; 77.9% of these adverse drug reactions had resolved or were resolving at the end of the study. CONCLUSIONS: Prolonged-release oxycodone/naloxone provided significant and clinically relevant reductions in pain intensity and improved QoL in Korean patients with chronic spinal disorders. (ClinicalTrials.gov identifier: NCT01811238)
Adult ; Analgesia ; Analgesics, Opioid ; Chronic Pain* ; Constipation ; Dizziness ; Drug-Related Side Effects and Adverse Reactions ; Humans ; Incidence ; Nausea ; Quality of Life ; Spine

BACKGROUND/AIMS: Gastro-esophageal reflux disease (GERD) is a chronic condition, with 50-80% of patients experiencing recurrence within one year following completion of initial treatment. The present study aimed to estimate recurrence rate and treatment response in GERD patients treated with proton pump inhibitor. METHODS: A total of 207 symptomatic GERD patients, which were confirmed by endoscopy from July 2008 till January 2009, were enrolled. They were divided into non-erosive reflux disease (NERD) group and erosive reflux disease (ERD) group by endoscopic findings. Patients were treated with lansoprazole 15 mg (NERD group) or 30 mg (ERD group) once daily for 8 weeks. The presence of symptoms was assessed in each patient at baseline and post-treatment using a questionnaire. Subsequent symptomatic recurrence on the cessation of therapy in each improved patients was checked by telephone survey or outpatient interview. RESULTS: Ninety-four patients and 113 patients were first diagnosed with NERD and ERD, respectively. The mean post-treatment follow-up period was 24.4+/-8.5 weeks. Recurrence rate was 40.0% (NERD, 43.8%; ERD, 37.1% (p=0.224)). Recurrence time was 10.1+/-5.8 weeks (NERD 9.6 weeks; ERD, 10.6 weeks (p=0.444)). Regarding the symptom improvement after 8 week therapy with lansoprazole, 89.4% (NERD, 85.1%; ERD, 92.9% (p=0.056)) of total patients were symptomatically improved. CONCLUSIONS: Forty percentage of GERD patients recurred within 6 months following the completion of 8 week therapy with lansoprazole. Recurrence rate, recurrence time, and rate of symptom improvement were not significantly different between NERD group treated with half dose and ERD group treated with full dose lansoprazole.
2-Pyridinylmethylsulfinylbenzimidazoles/therapeutic use ; Adult ; Aged ; Anti-Ulcer Agents/therapeutic use ; Female ; Follow-Up Studies ; Gastroesophageal Reflux/*drug therapy ; Gastroscopy ; Humans ; Interviews as Topic ; Male ; Middle Aged ; Proton Pump Inhibitors/therapeutic use ; Questionnaires ; Recurrence

BACKGROUND/AIMS: Eosinophilic esophagitis (EE) is a chronic inflammatory disorder characterized by abnormal dense eosinophilic infiltration of esophageal mucosa and results in dysphasia and food impaction. EE is being increasingly recognized in adults. The prevalence is largely unknown. This study was performed to evaluate the detection rate of EE diagnosed based on pathologic criteria and to define the clinical characteristics of EE in Korea. METHODS: We reviewed biopsy specimen of the 1,609 patients who underwent esophageal biopsy from January 2006 till August 2008. The presence of more than 20 eosinophils per high power field in biopsy specimens was considered cases of EE. Clinical information and endoscopic findings were obtained. RESULTS: 7 (0.4%) patients were diagnosed as EE based on pathologic criteria retrospectively. Clinical symptoms were epigastric pain (43%), regurgitation (29%), dyspepsia (14%), and no symptom (14%). Endoscopic findings were whitish exudates or granules (57%), esophageal polyp (29%), and hyperemic change (14%). Two patients received treatment. One patient with bronchial asthma improved after treatment with inhaled corticosteroid, and one patient improved after 8 week proton pump inhibitor therapy. CONCLUSIONS: Eosinophilic esophagitis was found in 0.4% of the total esophageal biopsied cases. Our results suggest that Korean patients with eosinophilic esophagitis showed symptoms mimicking gastroesophageal reflux disease and atypical endoscopic findings. Therefore, regardless of the gross appearance of the mucosa, meticulous diagnostic approaches are needed for patients with swallowing difficulty and lack of response to proton pump inhibitor.
Adult ; Aged ; Biopsy ; Dyspepsia/etiology ; Eosinophilia/epidemiology/*pathology ; Esophagitis/epidemiology/*pathology ; Female ; Humans ; Incidence ; Incidental Findings ; Male ; Middle Aged ; Regurgitation, Gastric/etiology ; Retrospective Studies

BACKGROUND: This study was prospectively performed to evaluate the clinical spectrum and risk factors of gastroesophageal reflux disease (GERD) in health check-up subjects. METHODS: A prospective survey was performed for 752 subjects, aged 18-79 years, who visited the health promotion center. The subjects were asked to complete a questionnaire, and the risk of GERD was calculated by logistic regression analysis with regard to several variables, including smoking, alcohol, exercise, body mass index, fasting glucose, cholesterol, triglyceride and anti-H. pylori immunoglobulin G (IgG). Non-erosive reflux disease (NERD) was defined as the presence of heartburn and/or acid regurgitation for at least once per week. RESULTS: 752 subjects were classified into three groups: 65 erosive reflux disease (ERD) subjects (8.6%), 66 NERD subjects (8.8%) and 621 control group subjects (82.6%). For the 65 ERD subjects, typical reflux symptoms were found in 19 (29.2%), less frequent reflux or atypical symptoms were found in 38 (58.5%) and no symptoms were found in 8 (12.3%). A Los Angeles grade A score was noted in 48 subjects (73.8%), a B score was noted in 11 (17.0%), and a C score was noted in 6 (9.2%). There was no correlation between the grade of reflux esophagitis and the severity of symptoms. The positive rate of H. pylori IgG in the ERD was 36.4%, and this was significantly lower than the rates for the NERD (60%) and control groups (65.3%); this resulted in the odds ratio of ERD in the absence of H. pylori infection to be 5.079 (95% CI: 1.907-13.530). CONCLUSIONS: The prevalence rate of GERD in health check-up subjects was 17.4%. There was no correlation between the grade of ERD and the severity of the reflux symptoms. The relative risk of GERD in Koreans was significantly low in the H. pylori IgG positive subjects.
Body Mass Index ; Cholesterol ; Esophagitis, Peptic ; Fasting ; Gastroesophageal Reflux* ; Glucose ; Health Promotion ; Heartburn ; Immunoglobulin G ; Logistic Models ; Odds Ratio ; Prevalence ; Prospective Studies ; Risk Factors* ; Smoke ; Smoking ; Triglycerides ; Surveys and Questionnaires

BACKGROUND: The aim of this study is to evaluate the diagnostic usefulness of endoscopy, 24 hour esophageal pH monitor and Bernstein test for GERD and its relationship with GERD symptom in the presence or absence of reflux esophagitis (RE). METHODS: This study was performed for 168 patients with GERD. Clinical symptoms and the results of endoscopy, 24 hour esophageal pH monitor, esophageal manometry with Bernstein test were analyzed. RESULTS: 168 (42%) of 403 patients who complained symptoms suggestive of GERD were diagnosed as GERD (65% as RE, 35% as nonerosive reflux disease) using diagnostic tools for GERD. The most chief complaint symptoms were heartburn (18.5%), regurgitation (18.5%), noncardiac chest pain (10.7%), cough (10.7%), laryngeal symptoms (11.3%), non specific dyspepsia (24.4%) and others (6%). When comparison of symptoms depending on RE among GERD patients was performed, laryngeal symptoms were significantly more frequent in patients without RE (p=0.001), and dyspepsia in patients with RE (p<0.001), respectively. Regarding diagnostic efficacy of each test depending on symptom, patients with heartburn showed higher positive rate of Bernstein test (p=0.035) and patients with laryngeal symptoms showed higher positive rate of 24 hour esophageal pH monitor (p=0.015), respectively. In addition, there was no correlation among endoscopy, 24 hour esophageal pH monitor and Bernstein test in the diagnosis of GERD by Kappa index. CONCLUSIONS: Typical reflux symptoms of GERD such as heartburn and regurgitation were found in 37% of GERD patients in Korea, lower than in Western countries. The lack of correlation among the diagnostic tools for GERD suggests that these tools are complementary to each other for the diagnosis of GERD.
Chest Pain ; Cough ; Diagnosis ; Dyspepsia ; Endoscopy* ; Esophagitis ; Esophagitis, Peptic ; Gastroesophageal Reflux* ; Heartburn ; Humans ; Hydrogen-Ion Concentration* ; Korea ; Manometry

BACKGROUND AND OBJECTIVES: Recent randomized studies have shown a significant reduction in the rate of recurrent cardiac events with adjunctive pharmacotherapy, using Glycoprotein IIb/IIIa inhibitors (GPI), in patients undergoing percutaneous coronary intervention (PCI) procedures. However, in Korea, there is a paucity of data concerning complications of tirofiban therapy in patients with acute coronary syndrome (ACS). Therefore, this study was performed to evaluate the safety of tirofiban therapy. SUBJECTS AND METHODS: ACS patients who underwent tirofiban administration between May 2002 and October 2003 were reviewed. The rates of bleeding, transfusion, and thrombocytopenia were analyzed, and the rates of complications by ages, gender and PCI compared with medical treatment, renal function and vascular access route. RESULTS: A total of 261 ACS patients (male/female=150/111) underwent tirofiban therapy. The mean ages of the subjects was 64.5 years, the rates of minor bleeding, major bleeding, transfusion and thrombocytopenia were 8.1% (n=21), 2.3% (n=6), 4.6% (n=12) and 1.2% (n=3), respectively. Minor bleeding occurred at similar rates in both sexes (8 vs. 8.1%) and to a greater extent in old age (> or =65) (12.5 vs. 2.6%, p=0.093), but major bleeding occurred to a greater extent in females and old age (5.4 vs. 0% and 4.2 vs. 0%, p=0.25 and 0.093, respectively). The rates of thrombocytopenia and transfusion were greater in old age (2.1 vs. 0% and 8.3 vs. 0%, p=0.052 and 0.087, respectively). In-hospital days were greater in old age (14.7+/-9.5 vs. 11.9+/-4.4 days, p=0.065). The rates of complications were similar in both groups when compared by PCI or medical treatment and vascular access route. The serum creatinine was 3.3 mg/dL in those with major bleeding, which was higher than in the other groups (p=0.000). CONCLUSION: The tirofiban therapy in patients with ACS did not induce an increase in the bleeding rates, in-hospital days and it was safe and well tolerated in old age.
Acute Coronary Syndrome* ; Coronary Disease ; Creatinine ; Drug Therapy ; Female ; Glycoproteins ; Hemorrhage ; Humans ; Korea ; Percutaneous Coronary Intervention ; Thrombocytopenia

BACKGROUND: In the general population, the incidence of bundle branch block (BBB) is relatively low, and its effects on long-term prognosis have not been established. Previous studies on the incidence and correlation of BBB to clinical factors have produced conflicting results. However, the incidence of BBB was strongly related to age. This study aimed to describe the incidence of and risk factors for BBB in Korea. METHODS: In this study, 14, 540 adults (male 6, 573/female 7, 967) > or=40 years old received screening tests for general health between April and December 2000. Participants answered questionnaires and underwent examinations, which included blood pressure, electrocardiogram (ECG), total cholesterol and fasting glucose. The data analysis was performed using SPSS 10.0 for windows. RESULTS: The incidences of complete right bundle branch block (CRBBB) were 1.5 and 2.9% in people older than 40 and 65 years, respectively. Approximately 38.0% of individuals with CRBBB were older than 65 years. The incidence of CRBBB was higher in men than women at all age groups was highest in those aged 75-79 years. Males, advancing age (> or=65 years), hypertension and diabetes mellitus (DM) were associated with an increased risk of CRBBB. The incidences of complete left bundle branch block (LBBB) and bifascicular bundle branch block (BBBB) were 0.1 and 0.08% and 0.3 and 0.2% in those older than 40 and 65 years, respectively. Approximately 71.4 and 58.3% of individuals with LBBB and BBBB, respectively, were older than 65 years. Advancing age and cardiac disease were associated with an increased risk of LBBB. Advancing age was associated with an increased risk of BBBB. The most potent risk factor for BBB in this study was advancing age. CONCLUSION: The incidences of BBB were 1.7 and 3.4% in those older than 40 and 65 years respectively. Bundle branch block correlates strongly with age, and is common in the older ages groups. These findings support the theory that bundle branch block is a marker of slowly progressing degenerative diseases.
Adult ; Age Factors ; Bundle-Branch Block/*epidemiology ; Female ; Heart Diseases/complications/epidemiology ; Humans ; Incidence ; Korea/epidemiology ; Male ; Risk Factors ; Sex Factors

BACKGROUND: Since the international guideline of Helicobacter pylori eradication therapy was introduced into Korea, many reports about eradication outcomes have been documented. These data were published mostly from referred university hospital. However, in Korea, majority of patients has been treated with H.pylori eradication regimen in primary care setting. This study was performed to investigate the eradication rate of H. pylori in primary care office of Seoul, Korea. METHODS: Total 173 patients with H.pylori-positive gastroscopy results received eradication regimen-mainly one week PPI based triple therapy-from January 1998 to March 2003. Four weeks after completion of medication, urea breath test, biopsy and CLO test were performed to detect H.pylori. RESULTS: Total eradication rate was 87.9%. The eradication rate of male and female were 90.3% and 84.3%, respectively (p>0.05). The eradication rate of patients older than younger than 60 was 81.5% vs 89.0%, respectively (p>0.05). There was no statistical significance in annual eradication rate. In eradication rate, there was no significant difference among PPI regimen (omeprazole, rabeprazole, pantoprazole). Whether endoscopic diagnosis is gastric ulcer or duodenal ulcer, there was no statistical difference in eradication rate between them. In the same way, there was also no statistical difference between peptic ulcer and H.pylori associated gastritis. CONCLUSION: The current eradication rate of H. pylori in primary care setting of Korea was 87.9%. H.pylori eradication rate in primary care setting was not much different from that in referred hospital in Korea, but it was lower than that reported by controlled trials of 1995 (initial times of introduction of international guide line into Korea). So far, the results have been acceptable, but there still remains to be investigated in PPI-based triple therapy as H.pylori eradication in primary care setting in the future of Korea.
Biopsy ; Breath Tests ; Diagnosis ; Drug Therapy ; Duodenal Ulcer ; Female ; Gastritis ; Gastroscopy ; Helicobacter pylori* ; Helicobacter* ; Humans ; Korea* ; Male ; Peptic Ulcer ; Primary Health Care* ; Rabeprazole ; Seoul ; Stomach Ulcer ; Urea

STUDY DESIGN: A retrospective study of perioperative complications was performed in elderly patients undergoing posterior decompression and fusion for lumbar degenerative conditions. OBJECTIVES: To identify the perioperative complications and to analyze the influence of posterior decompression and fusion on the occurrence of the morbidity. SUMMARY OF BACKGROUND DATA: Because of the better long-term results, the decompression and fusion with instrumentation have been recently recommended for treatment of degenerative lumbar disease in the elderly. However, the perioperative complication rate and their correlating factors have not been adequately defined. MATERIALS AND METHODS: A retrospective review of the medical charts of fifty-one patients aged 65 years or older operated during June 1997 to July 1998 was undertaken. The minimum follow-up required for inclusion was three months. All medical and surgical perioperative complications directly related to the surgical procedure were noted. The association of fusion levels and other factors with the occurrence of perioperative complications were analyzed. RESULTS: Perioperative complications occurred in 17(33.3%) of the 51 patients. Seven patients(13.7%) had at least one major complication, 5(9.8%) had at least one minor complication and 9(17.6%) had insignificant complications. Hematoma and wound infection were the most common surgical complications. Paralytic ileus was the most common medical complication. There was no difference in the rate of perioperative complications between the long and short fusion groups. An age of more than seventy-five years at the time of surgery was associated with a higher risk of complications. There was no statistically significant relationship between the perioperative complications and sex diagnosis, operative time, type of bone grafting, amount of blood transfusion, or preoperative comorbidity of the patients. CONCLUSION: Perioperative complications were quite common in the present series, occurring in 33.3% of the patients. An age over seventy-five years was a risk factor for associated with morbidity. The number of levels fused and the comorbidity did not associated the development of the complications.
Aged* ; Blood Transfusion ; Bone Transplantation ; Comorbidity ; Decompression ; Diagnosis ; Follow-Up Studies ; Hematoma ; Humans ; Intestinal Pseudo-Obstruction ; Operative Time ; Retrospective Studies ; Risk Factors ; Wound Infection

STUDY DESIGN: A retrospective study. OBJECTIVES: To determine the indications of fusing the proximal thoracic curve when treating an idiopathic thoracic scoliosis with segmental instrumentation. SUMMARY OF BACKGROUND DATA: Failure to recognize a significant proximal thoracic curve often results in postoperative shoulder asymmetry due to relative overcorrection of the lower thoracic curve. With segmental instrumentation that enhances the correction of the instrumented curve, the double thoracic curve pattern that needs fusion of both the proximal and the distal thoracic curves needs to be redefined. MATERIALS AND METHODS: Forty thoracic AIS patients with a right lower thoracic curve > 40 and a left proximal thoracic curve > 25 treated by segmental pedicle screw instrumentation were analyzed after a minimum follow up of 2 years. RESULTS: Of the 40 patients, 18 were treated by fusion of both the proximal and the distal curves while 22 were treated by fusion of the distal curve only. The postoperative shoulder height difference(SHD, mm) was 0.9 x preoperative SHD(mm) + 5.3 for the both curve fusion and 0.6 x preoperative SHD(mm) + 12 for the distal curve fusion(linear regression), showing that proximal thoracic curve fusion improved the SHD when the left shoulder was level with or higher than the right. CONCLUSIONS: An idiopathic thoracic scoliosis with a proximal thoracic curve > 25 and level or elevated left shoulder should be considered a double thoracic curve pattern and treated by both the proximal and the distal curve fusion when using a segmental instrumentation.
Adolescent* ; Follow-Up Studies ; Humans ; Retrospective Studies ; Scoliosis* ; Shoulder