Background: Tenofovir disoproxil fumarate (TDF, Viread® ) had been used as a standard treatment option of chronic hepatitis B (CHB). This clinical trial was conducted to evaluate the efficacy and safety of DA-2802 (tenofovir disoproxil orotate) compared to TDF. Methods: The present study was a double blind randomized controlled trial. Patients with CHB were recruited from 25 hospitals in Korea and given DA-2802 at a dose of 319 mg once daily or Viread® at a dose of 300 mg once daily for 48 weeks from March 2017 to January 2019. Change in hepatitis B virus (HBV) DNA level at week 48 after dosing compared to baseline was the primary efficacy endpoint. Secondary efficacy endpoints were proportions of subjects with undetectable HBV DNA, those with normal alanine aminotransferase (ALT) levels, and those with loss of hepatitis B envelop antigen (HBeAg), those with loss of hepatitis B surface antigen (HBsAg). Adverse events (AEs) were also investigated. Results: A total of 122 patients (DA-2802 group: n = 61, Viread® group: n = 61) were used as full analysis set for efficacy analysis. Mean age, proportion of males, laboratory results and virologic characteristics were not different between the two groups. The change in HBV DNA level at week 48 from baseline was −5.13 ± 1.40 in the DA-2802 group and −4.97 ± 1.40 log 10 copies/mL in the Viread® group. The analysis of primary endpoint using the nonparametric analysis of covariance showed statistically significant results (P < 0.001), which confirmed non-inferiority of DA-2802 to Viread® by a prespecified noninferiority margin of 1. The proportion of undetectable HBV DNA was 78.7% in the DA-2802 group and 75.4% in the Viread® group (P = 0.698). The proportion of subjects who had normal ALT levels was 75.4% in the DA-2802 group and 73.3% in the Viread® group (P = 0.795). The proportion of those with HBeAg loss was 8.1% in the DA-2802 group and 10.8% in the Viread® group (P = 1.000). No subject showed HBsAg loss. The frequency of AEs during treatment was similar between the two groups. Most AEs were mild to moderate in severity. Conclusion DA-2802 is considered an effective and safe treatment for patients with CHB.

OBJECTIVE: To evaluate the value of airway computed tomography (CT) in patients with obstructive sleep apnea (OSA) as a predictor of cerebrocardiovascular disease (CCVD) clinically, by quantitatively analyzing carotid arterial calcification (CarAC). MATERIALS AND METHODS: This study included 287 patients aged 40–80 years, who had undergone both polysomnography (PSG) and airway CT between March 2011 and October 2015. The carotid arterial calcium score (CarACS) was quantified using the modified Agatston method on each upper airway CT. The OSA severity was categorized as normal, mild, moderate, and severe using the PSG results. Clinical characteristics, comorbid diseases, and lipid profiles of all patients were analyzed, and the prevalence of CCVDs was investigated during the follow up period (52.2 ± 16.0 months). RESULTS: CCVD occurred in 27 patients (9.3%) at the end of follow-up, and the CCVD-present groups showed a significantly older mean age (57.5 years vs. 54.2 years), higher prevalence of hypertension (59% vs. 34%) and CarAC (51.9% vs. 20.8%), whereas sex, other comorbid diseases, and severity of OSA were not significantly different from the CCVD-absent group. A univariate analysis showed that age, hypertension, incidence of CarAC, and CarACS were risk factors for the occurrence of CCVD events. In a multivariate analysis, the incidence of CarAC was the only independent risk factor for CCVD. CONCLUSION: CarAC is an independent risk factor for CCVD, whereas the severity of OSA is not a contributory risk factor in patients with OSA. Therefore, additional analysis of CarACS based on airway CT scans may be useful for predicting CCVD.
Calcium ; Carotid Arteries ; Fluorouracil ; Follow-Up Studies ; Humans ; Hypertension ; Incidence ; Methods ; Multivariate Analysis ; Polysomnography ; Prevalence ; Risk Factors ; Sleep Apnea, Obstructive ; Tomography, X-Ray Computed

PURPOSE: To investigate the relationship between carotid arterial calcium score (CarACS) and silent cerebrovascular lesions in patients with obstructive sleep apnea (OSA). MATERIALS AND METHODS: This study involved retrospective evaluation of 60 OSA patients who underwent both upper airway CT and brain MRI. Using polysomnography, several indicators, including apnea index (AI), were used to evaluate the relationship between OSA and silent cerebrovascular lesions. The CarACS was quantified on CT imaging using the modified Agatston method. Silent cerebrovascular lesions were evaluated on brain MRI by grading periventricular hyperintensity (PVH). Various clinical characteristics, including age, were analyzed in each patient. RESULTS: The number of patients per PVH grade 0, 1, 2, 3, and 4 was 26 (43.3%), 14 (23.3%), 14 (23.3%), 4 (6.7%), and 2 (3.3%), respectively. The mean age, hypertension, smoking status, AI, and CarACS were significantly different among PVH groups (Ps < 0.05). In univariate analysis, the presence of carotid arterial calcification (β = 0.483, p < 0.01), CarACS (β = 0.482, p < 0.01), and age (β = 0.360, p < 0.01) showed a significant association with PVH grade. The mean AI and lowest O₂ saturation had statistically weak associations with PVH grade (β = 0.267, p < 0.01; β = −0.219, p < 0.14, respectively). In multivariate analysis, CarACS was the only factor affecting PVH grade (p < 0.04). CONCLUSION CarACS is associated with the severity of silent cerebrovascular lesions. Therefore, additional analysis of CarACS in OSA patients may provide more information on their cerebrovascular status.

BACKGROUND: Next-generation sequencing (NGS) can detect many more microorganisms of a microbiome than traditional methods. This study aimed to analyze the vaginal microbiomes of Korean women by using NGS that included bacteria and other microorganisms. The NGS results were compared with the results of other assays, and NGS was evaluated for its feasibility for predicting vaginitis. METHODS: In total, 89 vaginal swab specimens were collected. Microscopic examinations of Gram staining and microbiological cultures were conducted on 67 specimens. NGS was performed with GS junior system on all of the vaginal specimens for the 16S rRNA, internal transcribed spacer (ITS), and Tvk genes to detect bacteria, fungi, and Trichomonas vaginalis. In addition, DNA probe assays of the Candida spp., Gardnerella vaginalis, and Trichomonas vaginalis were performed. Various predictors of diversity that were obtained from the NGS data were analyzed to predict vaginitis. RESULTS: ITS sequences were obtained in most of the specimens (56.2%). The compositions of the intermediate and vaginitis Nugent score groups were similar to each other but differed from the composition of the normal score group. The fraction of the Lactobacillus spp. showed the highest area under the curve value (0.8559) in ROC curve analysis. The NGS and DNA probe assay results showed good agreement (range, 86.2-89.7%). CONCLUSIONS: Fungi as well as bacteria should be considered for the investigation of vaginal microbiome. The intermediate and vaginitis Nugent score groups were indistinguishable in NGS. NGS is a promising diagnostic tool of the vaginal microbiome and vaginitis, although some problems need to be resolved.
Area Under Curve ; Bacteria/*genetics/isolation & purification ; Bacterial Proteins/genetics ; Candida/*genetics/isolation & purification ; Female ; Fungal Proteins/genetics ; Gardnerella vaginalis/genetics/isolation & purification ; High-Throughput Nucleotide Sequencing ; Humans ; *Microbiota ; RNA, Ribosomal, 16S/chemistry/genetics/metabolism ; ROC Curve ; Sequence Analysis, DNA ; Trichomonas vaginalis/genetics/isolation & purification ; Vagina/*microbiology ; Vaginitis/*diagnosis/microbiology

PURPOSE: Surgical site infection (SSI) after open abdominal surgery is still a frequently reported nosocomial infection. To reduce the incidence of SSI, triclosan-coated sutures with antiseptic activity (Vicryl Plus) were developed. The aim of this study was to analyze the effect of Vicryl Plus on SSI after gastric cancer surgery via midline laparotomy. METHODS: A total of 916 patients who underwent gastric cancer surgery at Samsung Medical Center between December 2009 and September 2011 were prospectively collected. We examined the occurrence of SSI (primary endpoint), assessments of wound healing (secondary endpoint). They were evaluated postoperatively on days 3, 7, and 30. RESULTS: Of the 916 patients, 122 were excluded postoperatively by screening (out of the study protocol, adverse events, etc.). The remaining 794 patients were enrolled and monitored postoperatively. The cumulative SSI incidence was 11 cases (1.39%; 95% confidence interval [CI], 0.77-2.50) on day 30. Seromas were most frequently detected in wound healing assessments, with a cumulative incidence of 147 cases (18.51%; 95% CI, 15.98-21.39) on day 30. CONCLUSION: The use of triclosan-coated sutures (Vicryl Plus) for abdominal wall closure can reduce the number of SSIs in gastric cancer surgery.
Abdominal Wall ; Cross Infection ; Humans ; Incidence ; Laparotomy* ; Mass Screening ; Polyglactin 910 ; Prospective Studies ; Seroma ; Stomach Neoplasms* ; Surgical Wound Infection ; Sutures* ; Wound Healing

Plasmodium vivax reemerged in the Republic of Korea (ROK) in 1993, and is likely to continue to affect public health. The purpose of this study was to measure levels of anti-P. vivax antibodies using indirect fluorescent antibody test (IFAT) in border areas of ROK, to determine the seroprevalence of malaria (2003-2005) and to plan effective control strategies. Blood samples of the inhabitants in Gimpo-si, Paju-si, and Yeoncheon-gun (Gyeonggi-do), and Cheorwon-gun (Gangwon-do) were collected and kept in Korea Centers for Disease Control and Prevention (KCDC). Out of a total of 1,774 serum samples tested, the overall seropositivity was 0.94% (n=17). The seropositivity was the highest in Paju-si (1.9%, 7/372), followed by Gimpo-si (1.4%, 6/425), Yeoncheon-gun (0.67%, 3/451), and Cheorwon-gun (0.19%, 1/526). The annual parasite incidence (API) in these areas gradually decreased from 2003 to 2005 (1.69, 1.09, and 0.80 in 2003, 2004, and 2005, respectively). The highest API was found in Yeoncheon-gun, followed by Cheorwon-gun, Paju-si, and Gimpo-si. The API ranking in these areas did not change over the 3 years. The seropositivity of Gimpo-si showed a strong linear relationship with the API of 2005 (r=0.9983, P=0.036). Seropositivity data obtained using IFAT may be useful for understanding malaria prevalence of relevant years, predicting future transmission of malaria, and for establishing and evaluating malaria control programs in affected areas.
Antibodies, Protozoan/*blood ; Fluorescent Antibody Technique, Indirect ; Humans ; Incidence ; Malaria, Vivax/*epidemiology ; Plasmodium vivax/*immunology ; Republic of Korea/epidemiology ; Seroepidemiologic Studies

BACKGROUND: Obesity is a complex problem that is now considered a chronic metabolic disease. In Korea, phentermine has been widely used for the treatment of obesity in the primary care setting since 2004. However, there have been very few studies on the safety and efficacy of phentermine. To investigate the safety and efficacy of this drug, a postmarketing surveillance study was performed. METHODS: A total of 795 patients with obesity (body mass index > or = 25 kg/m2) were enrolled from 30 primary care centers in Korea from September 2006 to November 2007. Patients were examined to ascertain safety and efficacy at 4-, 8-, and 12-week intervals. The criterion for efficacy was defined as a weight loss > or = 5% of body weight. RESULTS: Of the 795 enrolled patients, 735 (92.5%) were evaluated in safety assessments and 711 (89.4%) was included in efficacy assessments. A total of 266 adverse events (AEs) were reported by 218 patients (30.6%), and no serious AEs were reported. Among 711 patients, 324 patients (45.6%) lost > or = 5% of their body weight. The mean weight loss was 3.8 +/- 4.0 kg. CONCLUSION: AEs are commonly associated with phentermine, even though phentermine is effective for weight loss and relatively well-tolerated.
Body Weight ; Humans ; Korea ; Metabolic Diseases ; Obesity ; Phentermine ; Primary Health Care ; Weight Loss

PURPOSE: According to previous studies, the prevalence of premature ejaculation (PE) in Korea ranges from 11.3% to 33%. However, the actual practice patterns in managing patients with PE is not well known. In this study, we have endeavored to determine how contemporary urologists in Korea manage patients with PE. MATERIALS AND METHODS: The e-mailing list was obtained from the Korean Urological Association Registry of Physicians. A specifically designed questionnaire was e-mailed to the 2,421 urologists in Korea from May 2012 to August 2012. RESULTS: Urologists in Korea diagnosed PE using various criteria: the definition of the International Society for Sexual Medicine (63.4%), Diagnostic and Statistical Manual of Mental Disorders (43.8%), International Statistical Classification of Disease, 10th edition (61.7%), or perceptional self-diagnosis by the patient himself (23.5%). A brief self-administered questionnaire, the Premature Ejaculation Diagnostic Tool, was used by only 42.5% of the urologists. Selective-serotonin reuptake inhibitor (SSRI) therapy was the main treatment modality (91.5%) for PE patients. 40.2% of the urologists used phosphodiesterase type 5 inhibitors, 47.6% behavior therapy, and 53.7% local anesthetics. Further, 286 (54.3%) urologists managed PE patients with a surgical modality such as selective dorsal neurotomy (SDN). CONCLUSIONS: A majority of Korean urologists diagnose PE by a multidimensional approach using various diagnostic tools. Most urologists believe that medical treatment with an SSRI is effective in the management of PE. At the same time, surgical treatment such as SDN also investigated as one of major treatment modality despite the lack of scientific evidence.
Anesthetics, Local ; Behavior Therapy ; Classification ; Diagnostic and Statistical Manual of Mental Disorders ; Electronic Mail ; Humans ; Korea ; Operative Time ; Phosphodiesterase 5 Inhibitors ; Physician's Practice Patterns ; Premature Ejaculation* ; Prevalence ; Surveys and Questionnaires ; Urologic Surgical Procedures