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Shin W.G.,Kangdong Sacred Heart Hospital | Kim S.J.,Chuncheon Sacred Heart Hospital | Choi M.H.,Hangang Sacred Heart Hospital | Kim K.O.,Hallym University | And 8 more authors.
Gastrointestinal Endoscopy | Year: 2012

Background: There has been no consensus regarding the optimal treatment durations and drug regimens in patients with endoscopic submucosal dissection (ESD)induced ulcers. Objective: To assess the efficacy of proton pump inhibitor (PPI) and rebamipide combination therapy compared with PPI monotherapy for ESD-induced ulcer healing. Design: Randomized, prospective, controlled study; clinical trial. Setting: Five hospitals in a University Medical Center group in Korea. Patients: This study involved 290 adults (309 lesions) who underwent ESD for gastric adenoma or early gastric cancer. Intervention: PPI and rebamipide combination therapy. Main Outcome Measurements: The ulcer healing rate at 4 weeks after ESD. Results: The ulcer healing rates at 4 weeks after ESD in the PPI and rebamipide combination therapy group were significantly higher than those in the PPI alone group, both in the full analysis (94.9% vs 89.9%; P <.0001) and in the per-protocol analysis (94.5% vs 91.2%; P =.020). This combination therapy was an independent predictive factor for a high ulcer healing rate (adjusted odds ratio [OR] 5.572; 95% confidence interval [CI], 2.615-11.876; P =.014). Additionally, the combination therapy group exhibited a higher quality of ulcer healing than the PPI monotherapy group (reviewer 1: P =.027; OR 1.949; 95% CI, 1.077-3.527; reviewer 2: P =.027; OR 1.933; 95% CI, 1.074-3.481). Limitations: Open-label study. Conclusion: PPI and rebamipide combination therapy had a superior 4-week ESD-induced ulcer healing rate and quality of ulcer healing compared with PPI monotherapy. (Clinical trial registration number: NCT01167101.) © 2012 American Society for Gastrointestinal Endoscopy.

Lee W.K.,Hallym University | Lee S.H.,Hallym University | Cho S.T.,Kangnam Sacred Heart Hospital | Lee Y.S.,Hangang Sacred Heart Hospital | And 5 more authors.
Journal of Sexual Medicine | Year: 2013

Introduction: There is partial evidence to support the use of phophodiesterase-5 inhibitor (PDE5-I) for the treatment of premature ejaculation (PE). Aim: We compared on-demand dosing of dapoxetine alone and combined with mirodenafil in subjects with lifelong PE and without erectile dysfunction (ED). Methods: Our prospective, randomized, double-blind, placebo-controlled, multicenter trial enrolled 118 subjects with lifelong PE without ED. PE was diagnosed using Diagnostic andStatisticalManual ofMentalDisorders, fourth edition, text revision. Patients were divided into two groups: dapoxetine 30mg plus placebo (group A, n=56) and dapoxetine 30mg plus mirodenafil 50mg (group B, n=62). Main Outcome Measures: During 12 weeks, intravaginal ejaculatory latency time (IELT) and the time from foreplay to beginning intercourse (FTIT) with a stopwatch, and Premature Ejaculation Profile (PEP) were measured. Overall sexual act time (OSAT; sum of FTIT and IELT) was calculated. Any treatment-emergent adverse events (TEAEs) were also recorded. Results: Over 12 weeks, IELT, OSAT, and PEP index score significantly improved in group B compared with group A (increased geometric mean IELT in group A and B=3.6 and 6.1 minutes, P=0.026; increased geometric mean OSAT in group A and B=5.5 and 9.9 minutes, P=0.012; increased median PEP index score in group A and B=1.0 and 1.3, P=0.046). However, there was no significant difference between two groups with respect to improvement of FTIT (P=0.147). TEAEs did not differ between groups (all P>0.05), and there was no serious adverse event in any subjects. Conclusions: Low dose of dapoxetine combined with mirodenafil showed better results in terms of IELT, OSAT, and PEP index score, and similar TEAEs, compared with that of dapoxetine only. Our results support the suggestion that the PDE5-Is have a potential role in the treatment of PE without ED. © 2013 International Society for Sexual Medicine.

Jeong J.,Seoul National University | Hyun Bae S.,Kangnam Sacred Heart Hospital | Hyun Bae S.,Seoul National University | Seo J.-M.,Seoul National University | And 2 more authors.
Journal of Neural Engineering | Year: 2016

Objective. The aim of this study is to evaluate the long-term reliability of a recently presented liquid crystal polymer (LCP) -based retinal prosthesis in vitro as well as in vivo. Because an all-polymer implant introduces another intrinsic leak type due to gas permeation, for which the traditional helium leak test for metallic packages was not designed to quantify, a new method to investigate its durability is required. Approach. We designed and carried out a series of reliability tests specifically for all-polymer implants by quantitatively investigating moisture ingress through various pathways of the polymer surface, and the polymer-polymer and polymer-metal adhesions. Moisture permeation through the bulk material was estimated by analytic calculation, while water ingress through the adhesively sealed LCP-LCP and LCP-metal interfaces was investigated using the separate parts of an electrode array and a package in an accelerated aging condition. In vivo tests were done in rabbits to examine the long-term biocompatibility and implantation stability by fundus observation and optical coherence tomography (OCT) imaging. Main results. The analytic calculation estimated good barrier properties of the LCP. Samples of the LCP-based electrode array failed after 114 days in 87°C saline as a result of water penetration through the LCP-metal interface. An eye-conformable LCP package survived for 87 days in an accelerated condition at 87°C. The in vivo results confirmed that no adverse effects were observed around the retina 2.5 years after the implantation of the device. Significance. These long-term evaluation results show the potential for the chronic use of LCP-based biomedical implants to provide an alternative to traditional metallic packages. © 2016 IOP Publishing Ltd.

Bae S.H.,Kangnam Sacred Heart Hospital | Hwang J.S.,Seoul National University | Yu H.G.,Seoul National University
Retina | Year: 2012

PURPOSE: To document comparative analysis of macular microstructures before and after silicone oil (SO) removal via spectral-domain optical coherence tomography and to assess the retinal changes associated with visual outcome. METHODS: Forty-six eyes that underwent vitrectomy with SO tamponade were included. Ophthalmic examinations were performed before SO removal and at Months 1, 3, and 6 postoperatively including best-corrected visual acuity and spectral-domain optical coherence tomography. The macular microstructures identified by spectral-domain optical coherence tomography were compared before and after SO removal, and tomographic parameters related to visual outcome were analyzed. RESULTS: Under SO tamponade, spectral-domain optical coherence tomography demonstrated macular tomographic findings: epiretinal membrane in 12 eyes (26.1%), cystoid macular edema in 9 (19.6%), undulated inner retina in 8 (17.4%), and submacular fluid in 4 (8.7%). The mean duration of SO tamponade was significantly longer in eyes with macular changes (6.3 ± 4.6 months) than those without changes (5.2 ± 4.4 months) (P = 0.02). A total of 13 eyes had peeling of epiretinal membrane or internal limiting membrane combined with SO removal. After SO removal, most of microstructural changes were resolved. In the eyes with macular epiretinal membrane or cystoid macular edema, final best-corrected visual acuity was significantly improved compared with baseline (P = 0.017, 0.049), which paralleled the decrease of central foveal thickness. Restoration of photoreceptor layer and external limiting membrane was achieved in 2 (4.9%) and 5 eyes (12.5%), and those with continuous photoreceptor layer or external limiting membrane had the better final best-corrected visual acuity. CONCLUSION: Under SO tamponade, macular microstructural changes were identified by spectral-domain optical coherence tomography and were associated with duration of SO tamponade. Most of the microstructural changes were recovered after SO removal, if needed, combined with macular surgery. Anatomic resolution was accompanied by postoperative visual improvement. © Lippincott Williams & Wilkins.

Gwon H.-C.,Sungkyunkwan University | Hahn J.-Y.,Sungkyunkwan University | Park K.W.,Seoul National University | Song Y.B.,Sungkyunkwan University | And 22 more authors.
Circulation | Year: 2012

BACKGROUND-: The optimal duration of dual antiplatelet therapy (DAPT) after implantation of drug-eluting coronary stents remains undetermined. We aimed to test whether 6-month DAPT would be noninferior to 12-month DAPT after implantation of drug-eluting stents. METHODS AND RESULTS-: We randomly assigned 1443 patients undergoing implantation of drug-eluting stents to receive 6- or 12-month DAPT (in a 1:1 ratio). The primary end point was a target vessel failure, defined as the composite of cardiac death, myocardial infarction, or ischemia-driven target vessel revascularization at 12 months. Rates of target vessel failure at 12 months were 4.8% in the 6-month DAPT group and 4.3% in the 12-month DAPT group (the upper limit of 1-sided 95% confidence interval, 2.4%; P=0.001 for noninferiority with a predefined noninferiority margin of 4.0%). Although stent thrombosis tended to occur more frequently in the 6-month DAPT group than in the 12-month group (0.9% versus 0.1%; hazard ratio, 6.02; 95% confidence interval, 0.72-49.96; P=0.10), the risk of death or myocardial infarction did not differ in the 2 groups (2.4% versus 1.9%; hazard ratio, 1.21; 95% confidence interval, 0.60-2.47; P=0.58). In the prespecified subgroup analysis, target vessel failure occurred more frequently in the 6-month DAPT group than in the 12-month group (hazard ratio, 3.16; 95% confidence interval, 1.42-7.03; P=0.005) among diabetic patients. CONCLUSIONS-: Six-month DAPT did not increase the risk of target vessel failure at 12 months after implantation of drug-eluting stents compared with 12-month DAPT. However, the noninferiority margin was wide, and the study was underpowered for death or myocardial infarction. Our results need to be confirmed in larger trials. CLINICAL TRIAL REGISTRATION-: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00698607. © 2011 American Heart Association, Inc.

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