1.A Randomized, Double-Blind, Active-Control, Noninferiority, Multicenter, Phase 4 Study to Evaluate the Efficacy and Safety of Esomeprazole/Sodium Bicarbonate 20/800 mg in Patients with Nonerosive Gastroesophageal Reflux Disease
Su Hyun PARK ; Kang Nyeong LEE ; Oh Young LEE ; Myung Gyu CHOI ; Jie-Hyun KIM ; In-Kyung SUNG ; Jae Young JANG ; Kyung Sik PARK ; Hoon Jai CHUN ; Eun Young KIM ; Jun Kyu LEE ; Jin Seok JANG ; Gwang Ha KIM ; Su Jin HONG ; Yong Chan LEE ; Suck-Chei CHOI ; Hyun Soo KIM ; Tae Oh KIM ; Gwang Ho BAIK ; Yong Cheol JEON
Gut and Liver 2023;17(2):226-233
Background/Aims:
Efficacy of proton pump inhibitors is limited in patients with nonerosive reflux disease (NERD). The aim of this study was to comparatively evaluate the efficacy and safety of esomeprazole with sodium bicarbonate and esomeprazole alone.
Methods:
This was a multicenter, randomized, double-blind, active-controlled, noninferiority comparative study. A total of 379 patients with NERD were randomly allocated to receive either EsoduoⓇ/sup> (esomeprazole 20 mg with sodium bicarbonate 800 mg) or NexiumⓇ/sup> (esomeprazole 20 mg) once daily for 4 weeks from January 2019 to December 2019. The patients had a history of heartburn for at least 2 days in the week before randomization as well as in the last 3 months and no esophageal mucosal breaks on endoscopy. The primary endpoint was a complete cure of heartburn at week 4. The secondary and exploratory endpoints as well as the safety profiles were compared in the groups at weeks 2 and 4.
Results:
A total of 355 patients completed the study (180 in the EsoduoⓇ/sup> group and 175 in the NexiumⓇ/sup> group). The proportions of patients without heartburn in the entire 4th week of treatment were not different between the two groups (33.33% in the EsoduoⓇ/sup> group and 35% in the NexiumⓇ/sup> group, p=0.737). There were no significant differences in most of the secondary and exploratory endpoints as well as the safety profiles.
Conclusions
EsoduoⓇ/sup> is as effective and safe as NexiumⓇ/sup> for managing typical symptoms in patients with NERD (ClinicalTrial.gov identifier: NCT03928470).
2.The Clinical Profile of Patients with Psoriasis in Korea: A Nationwide Cross-Sectional Study (EPI-PSODE).
Hae Jun SONG ; Chul Jong PARK ; Tae Yoon KIM ; Yong Beom CHOE ; Seok Jong LEE ; Nack In KIM ; Jae We CHO ; Jie Hyun JEON ; Min Soo JANG ; Jai Il YOUN ; Myung Hwa KIM ; Joonsoo PARK ; Ki Ho KIM ; Byung Soo KIM ; Sang Woong YOUN ; Joo Heung LEE ; Min Geol LEE ; Sung Ku AHN ; Young Ho WON ; Seok Kweon YUN ; Bong Seok SHIN ; Seong Jun SEO ; Ji Yeoun LEE ; Kwang Joong KIM ; Young Suck RO ; Youngdoe KIM ; Dae Young YU ; Jee Ho CHOI
Annals of Dermatology 2017;29(4):462-470
BACKGROUND: Psoriasis is an immune-mediated, chronic inflammatory disease affecting multiple aspects of patients' lives. Its epidemiology varies regionally; however, nationwide epidemiologic data on psoriasis depicting profile of Korean patients has not been available to date. OBJECTIVE: To understand nationwide epidemiologic characteristics and clinical features of adult patients with psoriasis visited university hospitals in Korea. METHODS: This multicenter, non-interventional, cross-sectional study recruited 1,278 adult patients with psoriasis across 25 centers in Korea in 2013. Various clinical data including PASI, BSA, DLQI, SF-36 and PASE were collected. RESULTS: A total of 1,260 patients completed the study (male:female=1.47:1). The mean age was 47.0 years with a distribution mostly in the 50s (24.9%). Early onset (<40 years) of psoriasis accounted for 53.9% of patients. The mean disease duration was 109.2 months; mean body mass index was 23.9 kg/m²; and 12.7% of patients had a family history of psoriasis. Plaque and guttate types of psoriasis accounted for 85.8% and 8.4%, respectively. Patients with PASI ≥10 accounted for 24.9%; patients with body surface area ≥10 were 45.9%. Patients with DLQI ≥6 accounted for 78.8%. Between PASI <10 and PASI ≥10 groups, significant difference was noted in age at diagnosis, disease duration, blood pressure, waist circumference of female, and treatment experiences with phototherapy, systemic agents, and biologics. CONCLUSION: This was the first nationwide epidemiologic study of patients with psoriasis in Korea and provides an overview of the epidemiologic characteristics and clinical profiles of this patient population.
Adult
;
Biological Products
;
Blood Pressure
;
Body Mass Index
;
Body Surface Area
;
Cross-Sectional Studies*
;
Diagnosis
;
Epidemiologic Studies
;
Epidemiology
;
Female
;
Hospitals, University
;
Humans
;
Korea*
;
Phototherapy
;
Psoriasis*
;
Waist Circumference
3.Functional Outcomes of Multiple Sural Nerve Grafts for Facial Nerve Defects after Tumor-Ablative Surgery.
Myung Chul LEE ; Dae Hee KIM ; Yeo Reum JEON ; Dong Kyun RAH ; Dae Hyun LEW ; Eun Chang CHOI ; Won Jai LEE
Archives of Plastic Surgery 2015;42(4):461-468
BACKGROUND: Functional restoration of the facial expression is necessary after facial nerve resection to treat head and neck tumors. This study was conducted to evaluate the functional outcomes of patients who underwent facial nerve cable grafting immediately after tumor resection. METHODS: Patients who underwent cable grafting from April 2007 to August 2011 were reviewed, in which a harvested branch of the sural nerve was grafted onto each facial nerve division. Twelve patients underwent facial nerve cable grafting after radical parotidectomy, total parotidectomy, or schwannoma resection, and the functional facial expression of each patient was evaluated using the Facial Nerve Grading Scale 2.0. The results were analyzed according to patient age, follow-up duration, and the use of postoperative radiation therapy. RESULTS: Among the 12 patients who were evaluated, the mean follow-up duration was 21.8 months, the mean age at the time of surgery was 42.8 years, and the mean facial expression score was 14.6 points, indicating moderate dysfunction. Facial expression scores were not influenced by age at the time of surgery, follow-up duration, or the use of postoperative radiation therapy. CONCLUSIONS: The results of this study indicate that facial nerve cable grafting using the sural nerve can restore facial expression. Although patients were provided with appropriate treatment, the survival rate for salivary gland cancer was poor. We conclude that immediate facial nerve reconstruction is a worthwhile procedure that improves quality of life by allowing the recovery of facial expression, even in patients who are older or may require radiation therapy.
Facial Expression
;
Facial Nerve*
;
Follow-Up Studies
;
Head
;
Humans
;
Neck
;
Neurilemmoma
;
Quality of Life
;
Radiotherapy
;
Salivary Gland Neoplasms
;
Sural Nerve*
;
Survival Rate
;
Transplants*
4.Proximal Variation of the Long Thoracic Nerve would be Vulnerable to Injury during an Axillary Dissection.
Youn SI ; Sin Sun KIM ; Je Seung LEE ; Hae Myung JEON ; Jai Hak LEE ; Woo Chan PARK
Journal of the Korean Surgical Society 2007;72(6):488-490
Herein, our experience of a rare variation of the long thoracic nerve during an axillary dissection in a female patient with a breast ductal carcinoma in situ (DCIS) is reported. Her long thoracic nerve was duplicated and united at its proximal and distal parts, respectively. She was a 45-year old female, with microcalcification on her left breast, which had been diagnosed as a DCIS by a stereotactic core needle biopsy. Due to the diffuse distribution of lesions, a mastectomy was performed, with immediate reconstruction using a transverse rectus abdominis muscle (TRAM) free flap. After the mastectomy, an axillary dissection was performed for anastomoses of the free flap to the thoracodorsal vessels, at which point the duplicated variation of the proximal part of the long thoracic nerve was found. This variation is very rare, and would be vulnerable to injury during an axillary dissection. Therefore, surgeons should take care to avoid injury to such a nerve during axillary surgery.
Axilla
;
Biopsy, Large-Core Needle
;
Breast
;
Breast Neoplasms
;
Carcinoma, Intraductal, Noninfiltrating
;
Female
;
Free Tissue Flaps
;
Humans
;
Mastectomy
;
Middle Aged
;
Rectus Abdominis
;
Thoracic Nerves*
5.Bladder Rupture during Voiding Cystourethrography.
Ju Hyun LIM ; Sang Bong JEON ; Jung Sun PARK ; Jai Seong CHA ; Myung Ki KIM ; Young Beom JEONG ; Hyung Jin KIM ; Young Gon KIM
Korean Journal of Urology 2007;48(2):230-232
A ruptured bladder, or extravasation from the bladder, is almost always associated with trauma. Spontaneous extravasation, or iatrogenic extravasation, is extremely rare, with only few reported cases. Herein, two cases of bladder rupture, which occurred during voiding cystourethrography (VCUG), one in an 18 month old patient and the other in a 6 week old patient, due to instill dye by high pressure, are presented.
Humans
;
Infant
;
Rupture*
;
Urinary Bladder*
6.A Case of Riedel's Thyroiditis Associated with a Benign Nodule.
Young Sung WON ; Youn SI ; Han Hong LEE ; Youn Soo LEE ; Jeong Soo KIM ; Hae Myung JEON ; Sang Seol JUNG ; Jai Hak LEE ; Woo Chan PARK
Korean Journal of Endocrine Surgery 2006;6(2):98-101
Riedels thyroiditis is a rare variant of thyroiditis that is characterized by replacement of the normal thyroid parenchyma by extensive fibrosis. Typically, the thyroid is diffusely involved and a painless, hard anterior neck mass shows clinical features similar to those of anaplastic thyroid carcinoma, that is, a rapidly enlarging, hard, fixed thyroid mass and symptoms such as dysphagia, dysphonia, and dyspnea. We encountered a case of Riedels thyroiditis in a 41-year-old female patient with a longstanding benign thyroid nodule for 6 years; she subsequently presented with a rapidly growing, hard, fixed, thyroid mass mimicking anaplastic thyroid cancer. The clinical features were indistinguishable from those of anaplastic transformation, but open biopsy excluded anaplastic thyroid cancer. After surgery, the final diagnosis of Riedels thyroiditis was made based on typical microscopic findings and immunohistochemical studies. We have reported this case and reviewed the related literature.
Adult
;
Biopsy
;
Deglutition Disorders
;
Diagnosis
;
Dysphonia
;
Dyspnea
;
Female
;
Fibrosis
;
Humans
;
Neck
;
Thyroid Carcinoma, Anaplastic
;
Thyroid Gland*
;
Thyroid Nodule
;
Thyroiditis*
7.The Clinical Significance of Preoperative MRI for Determination of Surgery in Breast Cancer.
Hyun Jong KANG ; Je Seung LEE ; Hyo Lim KIM ; Byung Joo SONG ; Jeong Soo KIM ; Se Jeong OH ; Hae Myung JEON ; Sang Seol JUNG ; Jai Hak LEE ; Woo Chan PARK
Journal of Breast Cancer 2006;9(4):343-348
PURPOSE: Currently MRI (Magnetic Resonance Imaging) is widely used for the preoperative staging of breast cancer. In this study, we assessed the impact of preoperative breast MRI on the surgical management of breast cancer in women. METHODS: From March 2004 to October 2006, 162 cases were enrolled for preoperative MRI for the staging of breast cancer. The MRI findings and clinicopathological results were investigated and the accuracy of breast MRI was analyzed with respect to the detection of multiplicity, nipple involvement and bilaterality of the breast cancers. RESULTS: For detecting multifocal lesions, the sensitivity and specificity of breast MRI were 100% and 48.5%, respectively, and the results of bresat ultrasound were 100% and 63.4%, respectively. For detecting nipple invasion, the sensitivity and specificity of breast MRI was 80% and 74.6%, and for ultrasound was 33.3% and 86.4%. In 27 cases (16.7%) the type of surgery was changed according to the preoperative MRI findings; however, in only 6 cases were the MRI findings in concordance with the pathological findings of the mastectomy specimen. CONCLUSION: In clinical application of breast MRI for preoperative staging, the decision to undertake surgery for breast cancer based on a MRI findings should be prudent due to its low specificity.
Breast Neoplasms*
;
Breast*
;
Female
;
Humans
;
Magnetic Resonance Imaging*
;
Mastectomy
;
Nipples
;
Sensitivity and Specificity
;
Ultrasonography
8.Metabolic Stone Risk Factors Associated with Papillary Calcification on Unenhanced Spiral Computed Tomography.
Jai Seong CHA ; Sang Bong JEON ; Myung Ki KIM ; Young Beom JEONG ; Young Gon KIM
Korean Journal of Urology 2006;47(5):507-511
PURPOSE: Increasing evidence suggests that Randalls plaque contributes to the pathogenesis of urinary stone formation. The purpose of our study is to compare the incidence of the abnormal metabolic stone risk factors between the calcium stone former with papillary calcification and the calcium stone former without papillary calcification on unenhanced spiral computed tomography (CT). MATERIALS AND METHODS: A series of patients with calcium stones (n=49) underwent unenhanced spiral CT and complete metabolic evaluation after they consumed a random diet for 1 month after stone removal. Of the 49 patients, 38 patients showed papillary calcification on unenhanced spiral CT and 11 patients did not. Their blood was evaluated by using a multichannel analysis sequential multichannel autoanalyzer (SMA)-20 and PTH tests. The 24-hour urinary constituents were assayed for calcium, oxalate, citrate, total volume, phosphorus and sodium. We compared the incidence of abnormal metabolic risk factors between the two groups. Statistical analysis was performed by chi-square tests. RESULTS: The incidences of hyperuricemia were 27.3% in the patients without papillary calcification and 31.6% in the patients with papillary calcification. The incidences of hypernatriuria were 18.2% versus 42.1%, the incidences of hypercalciuria were 36.4% versus 26.3%, the incidences of hyperuricosuria were 18.2% versus 18.4%, the incidences of hyperoxaluria were zero versus 28.9%, and the incidences of hypocitraturia were 45.5% versus 44.7%, respectively. The difference between the two groups was statistically significant only for hyperoxaluria (p=0.043). CONCLUSIONS: Hyperoxaluria is the only metabolic risk factor that more frequently occurred in the patients with papillary calcification. Our date suggest that hyperoxaluria may be an important factor in the pathogenesis of papillary calcification.
Calcium
;
Citric Acid
;
Diet
;
Humans
;
Hypercalciuria
;
Hyperoxaluria
;
Hyperuricemia
;
Incidence
;
Phosphorus
;
Risk Factors*
;
Sodium
;
Tomography, Spiral Computed*
;
Urinary Calculi
9.The Clinical Usefulness of 99mTc-MIBI Scintimammography in Diagnosis of Breast Cancer.
Sung Bong YOO ; Woo Chan PARK ; Hyung Sun SON ; Hae Myung JEON ; Jai Hak LEE
Journal of Korean Breast Cancer Society 2004;7(1):32-36
PURPOSE: Imaging studies for the diagnosis of breast cancer such as ultrasonography or mammography, play an essential role; however, it is well known that they have some limitations; the low specificity of ultrasonography and the low sensitivity of mammography, especially in the dense breasts of Korean women. Recently, 99mTc-MIBI scintimammography was introduced for the detection of breast cancer, and showed acceptable results in its diagnostic accuracy. In this study, the clinical usefulness of 99mTc-MIBI scintimammography was evaluated for the determination of a better imaging study for the diagnosis of breast cancer. METHODS: This study included 75 patients with breast masses, and 3 imaging studies were performed; mammography, ultrasonography and 99mTc-MIBI scintimammography and the results compared on the basis of the pathological reports from core needle or excisional biopsies of the patients. RESULTS: From the pathological reports of 75 patients, 45 cases were confirmed as malignant and 30 as benign diseases. Based on the pathological reports, the sensitivities of mammography, ultrasonography and 99mTc-MIBI scintimammiography were 62.2, 88.9, and 86.7%, and the specificites of 3 imaging studies were 90.0, 76.7, and 90.3% respectively. The positive predictive values were 90.3, 85.1, and 92.9% and the negative predictive values were 61.4, 82.1, and 81.8%, respectively. 99mTc-MIBI mammoscintigraphy showed a comparable sensitivity to ultra-sonography, and a similar specificity to mammography, in the diagnosis of breast cancer. CONCLUSION: Clinically, as a primary imaging tool, 99mTc-MIBI mammoscintigraphy showed acceptable results in the diagnosis of breast cancer. Considering the weak points of ultrasonography and mammography, 99mTc-MIBI mammoscintigraphy would be a very useful tool in the diagnosis of breast cancer.
Biopsy
;
Breast Neoplasms*
;
Breast*
;
Diagnosis*
;
Female
;
Humans
;
Mammography
;
Needles
;
Sensitivity and Specificity
;
Ultrasonography
10.A Clinical Analysis of 100 Cases of Gasless Endoscopic Thyroidectomy.
Jeong Soo KIM ; Chung Goo KIM ; Kee Hwan KIM ; Chang Hyuck AHN ; Hae Myung JEON ; Keun Woo LIM ; Eung Kook KIM ; Chung Soo CHUN ; Jai Hak LEE ; Hyun Shik SON ; Jung Min LEE ; Jong Bun KIM ; Hyun Ju JUNG
Journal of the Korean Surgical Society 2002;63(1):18-22
PURPOSE: With recent developments in endoscopic surgery for thyroid tumors, several approaches have been applied to endoscopic neck surgery. Gasless endoscopic thyroidectomy has some advantages over gas insufflating surgery. We evaluated the role of gasless endoscopic thyroidectomies on various thyroid tumors including malignant thyroid tumors. METHODS: We performed thyroidectomies for a total of 195 patients who were admitted to Uijongbu St. Mary's Hospital from November 1999 to February 2002. We compared the clinical data of 100 patients who received gasless endoscopic thyroidectomies with the data of 95 patients who underwent conventional thyroidectomies. Furthermore, we subclassified the 100 patients who received a gasless endoscopic thyroidectomy into two groups, before and after the start of 2001. RESULTS: The analysis of the clinical data showed that an endoscopic thyroidectomy gave superior results with respect to the time of postoperative recovery and cosmetic results. Also, the patients in the second half group showed significantly shorter operation times reduced from 153.4 min. to 128.6 min. and length of hospital stay similarly reduced(3.55 days vs. 5.35 days). CONCLUSION: A gasless endoscopic thyroidectomy is a safe and technically feasible alternative to a conventional thyroi-dectomy in benign and early malignant tumors, and provides good cosmetic results.
Humans
;
Length of Stay
;
Neck
;
Thyroid Gland
;
Thyroidectomy*

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