An Open-Label, Multicentre, Observational, Post-Marketing Study to Monitor the Safety and Effectiveness of Umeclidinium/Vilanterol in Korean Patients / 결핵및호흡기질환

Background@#Umeclidinium/vilanterol (UMEC/VI; ANORO ELLIPTA, GSK) is a commonly used dual bronchodilator. This study evaluated the safety and effectiveness of UMEC/VI in Korean patients with chronic obstructive pulmonary disease (COPD) over a 6-year period. @*Methods@#This was an open-label, multicentre, observational, post-marketing surveillance study. A total of 3,375 patients were enrolled consecutively in 52 hospitals, by 53 physicians, between July 2014 and July 2020. Patients who were administered UMEC/VI (fixed-dose 62.5 μg/25 μg) at least once and were monitored for safety and effectiveness were included in the analysis. Incidence and severity of adverse events (AEs) reported after administrating at least one dose of UMEC/VI were monitored, including unexpected adverse events (UAEs) and adverse drug reactions (ADRs). Effectiveness of UMEC/VI after 24 weeks of administration was also assessed using physician’s evaluation (effective, ineffectiveo change, worsening, indeterminable) and lung function improvement. @*Results@#Of 3,375 patients, 3,086 were included in the safety assessment group (mean age±standard deviation: 69.76±8.80 years; 85.9% male [n=2,652]; 73.1% aged ≥65 years [n=2,255]). The overall incidence of AEs was 28.8% (n=890), of which 2.2% (n=67) were ADRs. Serious AEs and UAEs were reported in 181 (5.9%) and 665 (21.6%) patients, respectively, and two patients (<0.1%) reported unexpected severe ADR. Of the 903/3,086 patients analysed for effectiveness, most (82.8%, n=748) showed overall disease improvement after UMEC/VI treatment. @*Conclusion@#This study confirmed UMEC/VI administered to Korean patients according to the prescribing information was well-tolerated and can be considered an effective option for COPD treatment.

A Korean Post-Marketing Surveillance Study of Dolutegravir Single-Agent Tablets in Patients with HIV-1

Background@#The integrase strand transfer inhibitor dolutegravir has been indicated in Korea since 2014 for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in combination with other antiretroviral agents. This regulatory post-marketing surveillance (PMS) study evaluated the real-life safety and effectiveness of dolutegravir in patients with HIV-1 in clinical practice in Korea. @*Materials and Methods@#This open-label PMS study examined data from consecutive patients (aged ≥12 years) with HIV-1 infection receiving dolutegravir according to locally approved prescribing information; treatment-naïve and treatment-experienced patients were permitted. Data regarding patient demographics, medical history, clinical characteristics, medications (HIV-related and concomitant), and comorbidities were extracted from patient records over a 1-year treatment period. Outcomes included the safety of dolutegravir (primary endpoint) and real-life effectiveness according to the Physician Global Assessment (PGA) and the proportion of patients with plasma HIV-1 RNA count <50 copies/mL at 48 weeks. @*Results@#Of 147 patients treated with dolutegravir at 18 centers in Korea (August 2014 – August 2020), 139 were eligible for the safety analyses and 75 for effectiveness analyses.Patients (mean age 47 years) were mostly male (92.8%) and received dolutegravir in combination with nucleoside reverse transcriptase inhibitor (70.5%) or protease inhibitors (21.6%). Adverse events (AEs) (n = 179 in total) were mostly mild in severity, with the most common being nasopharyngitis (5.0%), dyspepsia (5.0%), pruritus (4.3%), and rash (4.3%).Of 16 adverse drug reactions (ADRs), the most frequent were rash, diarrhea, headache, insomnia, and somnolence (1.4% each). Of 2 serious ADRs, only 1 (gastroenteritis) was unexpected, and both resolved. The risk of experiencing an AE while receiving dolutegravir appeared to be especially increased in patients receiving concomitant medications for other conditions. Dolutegravir effectively suppressed HIV-1 (93.3% of patients had plasma HIV-1 RNA <50 copies/mL), and 100% of patients showed symptom improvement based on physician global assessment. @*Conclusion@#Results of this PMS study showed that dolutegravir administered as highly active antiretroviral therapy was well tolerated and effective in patients with HIV-1 infection.

Effect of Ultra-Soft and Soft Toothbrushes on the Removal of Plaque and Tooth Abrasion / 치위생과학회지

To improve the oral health status of Korean people, it is necessary to encourage proper oral hygiene management habits, such as toothbrushing, through appropriate health promotion techniques. Therefore, the purpose of this study was to evaluate the removal of plaque and tooth abrasion using ultra-soft (filament 0.11~0.12 mm) and soft toothbrushes for toothbrushing. The plaque removal was performed using a dentiform and Arti-spray, and the Patient Hygiene Performance (PHP) index was calculated as the sum total score divided by the total number of surfaces. In the abrasivity experiment, according to the number of brushings, a micro Vickers hardness tester was used, and a sample in the range of 280~380 Vickers hardness number was selected. The number of toothbrushing stroke were 1,800 (2 months), 5,400 (6 months), 10,800 (12 months), and 21,600 (24 months). The tooth abrasion was measured using a scanning electron microscope. Statistical analysis was performed using IBM SPSS Statistics 22.0 and a p-value < 0.05 was considered significant. According to the results, there was no statistically significant difference in the degree of plaque removal between ultra-soft and soft toothbrushes. The difference in tooth abrasion between before and after toothbrushing was found to be greater with the soft toothbrushes than with the ultra-soft toothbrushes. Therefore, the ultra-soft toothbrush not only lowers tooth damage by reducing tooth abrasion, but also shows a similar ability to remove plaque as soft toothbrushes.

A Case of Endoscopic Hemoclip Management of Dieulafoy-like Lesion on the Hyperplastic Polyp in the Duodenum / 대한소화기내시경학회지

Dieulafoy's lesion (DL) is an uncommon but important cause of massive upper gastrointestinal bleeding that has been reported to be involved in 0.3~6.7% of cases of major gastrointestinal bleeding. The lesion usually occurs in the lesser curvature of the stomach within 6 cm of the gastroesophageal junction. Similar lesions have also been observed in the esophagus, duodenum, small intestine, colon, and rectum. Most DLs encountered in the duodenum occur in the bulb. Recently, with the advances in endoscopic techniques, the successful management of DL has been achieved through the application of a hemoclip or elastic band ligation. In particular, the application of a hemoclip is considered to be a safe and effective treatment for DL located on a relatively narrow and thin walled canal such as the duodenum. We report the successful application of endoscopic hemoclipping for the treatment of a rare Dieulafoy-like lesion on a hyperplastic polyp in the 2nd portion of the duodenum.

A Case of Aggravated Esophageal Candidiasis and Gastric Yeast Bezoar Formation following Gastric Outlet Obstruction due to Duodenal Stenosis / 대한소화기내시경학회지

Esophageal candidiasis is the most common disease among all candida infections of the gastrointestinal tract, and generally develops in immunocompromised patients. The prevalence of esophageal candidiasis has increased in patients undergoing antibiotic therapy, diabetes, adrenal dysfunction, alcohol intoxication, old age, esophageal injury, esophageal stasis, gastric surgery, and acid suppressive therapy. However, the overall prevalence is not higher than that of immunocompromised patients. Gastric candidiasis is uncommon because of the strong acidity of the gastric juices. The most common clinical setting for gastric candidiasis is in patients with neoplastic disease. However, there are some case reports suggesting an increase in the prevalence of gastric candidiasis after gastric ulcer therapy with surgery or acid suppressive agents. Delayed gastric emptying, increased intragastric pH, and reflux of the duodenal contents into the stomach are factors indicative of the pathophysiology of gastric candidiasis after gastric surgery. We encountered a case of aggravated esophageal candidiasis and the formation of a gastric yeast bezoar following a gastric outlet obstruction due to a duodenal stenosis. We herein report this case along with an overview of the relevant literature.

A case of Diphyllobothrium latum infection with a brief review of diphyllobothriasis in the Republic of Korea

A case of Diphyllobothrium latum infection in a 49-year old man is described, and diphyllobothriasis latum in the Republic of Korea is briefly reviewed. An incomplete strobila of a tapeworm, 95 cm in length, without scolex and neck, was spontaneously discharged in the feces of a patient. On the basis of morphologic characteristics of the worm and eggs, the worm was identified as D. latum. The patient was successfully treated with a single dose (15 mg/kg) of praziquantel. The most probable source of infection was salmon flesh according to the past history of the patient. The first case of D. latum infection was documented in 1971, and this is the 43rd recorded case in the Republic of Korea. The 43 cases were briefly reviewed. The patients' main complaints were gastrointestinal troubles, such as mild abdominal pain, indigestion, and diarrhea, and discharge of tapeworm segments in the feces. The suspected infection sources included raw or improperly cooked flesh of fresh or brackish water fish, including the perch, mullet, salmon, and trout.

ST-T Change on Electrocardigraphy in Old Diabetics Without Chest Pain

BACKGROUND: Silent myocardial ischemia is often found in old diabetics. Many diagnostic tools are used for diagnosis of angina. But these tools are difficult to use in primary care. Therefore we have planned to investigate the change of electrocardiography in old diabetics, using resting electrocardiogram which is available for primary care. METHOD: 67 patients with ST-T change group and 262 patients with control group were included in this study. Patients with chest pain or heart problem were excluded. The resting electrocardigraphy is examined by standard 12 lead electrocardiogram. RESULTS: There are differences of diabetes, HDL-cholesterol between ST-T change group and control group. Diabetes and HDL- cholesterol are significant factors that change ST-T wave in the resting electrocardigraphy. CONCLUSION: ST-T change of old diabetics without chest pain is more frequent than non diabetics. That means myocardial ischemia and requires treatment at secondary or third medical center. In conclusion, regular electrocardigraphy monitoring at primary care should be required in old diabetics.