1.Efficacy and Safety of Rebamipide versus Its New Formulation, AD-203, in Patients with Erosive Gastritis: A Randomized, DoubleBlind, Active Control, Noninferiority, Multicenter, Phase 3 Study
Gwang Ha KIM ; Hang Lak LEE ; Moon Kyung JOO ; Hong Jun PARK ; Sung Woo JUNG ; Ok-Jae LEE ; Hyungkil KIM ; Hoon Jai CHUN ; Soo Teik LEE ; Ji Won KIM ; Han Ho JEON ; Il-Kwun CHUNG ; Hyun-Soo KIM ; Dong Ho LEE ; Kyoung-Oh KIM ; Yun Jeong LIM ; Seun-Ja PARK ; Soo-Jeong CHO ; Byung-Wook KIM ; Kwang Hyun KO ; Seong Woo JEON ; Jae Gyu KIM ; In-Kyung SUNG ; Tae Nyeun KIM ; Jae Kyu SUNG ; Jong-Jae PARK
Gut and Liver 2021;15(6):841-850
Background/Aims:
The mucoprotective drug rebamipide is used to treat gastritis and peptic ulcers. We compared the efficacy of Mucosta Ⓡ (rebamipide 100 mg) and its new formulation, AD-203 (rebamipide 150 mg), in treating erosive gastritis.
Methods:
This double-blind, active control, noninferiority, multicenter, phase 3 clinical trial randomly assigned 475 patients with endoscopically proven erosive gastritis to two groups: AD-203 twice daily or Mucosta Ⓡ thrice daily for 2 weeks. The intention-to-treat (ITT) analysis included 454 patients (AD-203, n=229; Mucosta Ⓡ , n=225), and the per-protocol (PP) analysis included 439 patients (AD-203, n=224; Mucosta Ⓡ , n=215). The posttreatment assessments included the primary (erosion improvement rate) and secondary endpoints (erosion and edema cure rates; improvement rates of redness, hemorrhage, and gastrointestinal symptoms). Drug-related adverse events were evaluated.
Results:
According to the ITT analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucosta Ⓡ -treated patients were 39.7% and 43.8%, respectively. According to the PP analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucosta Ⓡ -treated patients were 39.3% and 43.7%, respectively. The one-sided 97.5% lower limit for the improvement rate difference between the study groups was −4.01% (95% confidence interval [CI], –13.09% to 5.06%) in the ITT analysis and −4.44% (95% CI, –13.65% to 4.78%) in the PP analysis. The groups did not significantly differ in the secondary endpoints in either analysis. Twenty-four AD-203-treated and 20 Mucosta Ⓡ -treated patients reported adverse events but no serious adverse drug reactions; both groups presented similar adverse event rates.
Conclusions
The new formulation of rebamipide 150 mg (AD-203) twice daily was not inferior to rebamipide 100 mg (Mucosta Ⓡ ) thrice daily. Both formulations showed a similar efficacy in treating erosive gastritis.
2.The clinical and economic burden of community-onset complicated skin and skin structure infections in Korea
Yong Kyun CHO ; Heung Jeong WOO ; Shin Woo KIM ; In-Gyu BAE ; Young Goo SONG ; Hee Jin CHEONG ; Hyuck LEE ; Sang Hoon HAN ; Hee Jung CHOI ; Chisook MOON ; Seong Yeol RYU ; Jian HUR ; Ja Cob LEE ; Yu Mi JO ; Young Joo KIM
The Korean Journal of Internal Medicine 2020;35(6):1497-1506
Background/Aims:
To investigate epidemiologic characteristics, clinical and economic burdens, and factors associated with mortality in complicated skin and skin structure infection (cSSSI) patients in Korea.
Methods:
A retrospective, observational, nationwide study was conducted between April to July 2012 at 14 tertiary-hospitals in Korea. Eligible patients were hospitalized adults with community acquired cSSSI, who underwent surgical intervention and completed treatment between November 2009 and October 2011. Data on demography, clinical characteristics, outcomes and medical resource utilization were collected through medical record review. Direct medical costs were calculated by multiplying quantities of resources utilized by each unit price in Korea.
Results:
Of 473 patients enrolled, 449 patients (except 24 patients with no record on surgical intervention) were eligible for analysis. Microbiological testing was performed on 66.1% of patients and 8.2% had multiple pathogens. Among culture confirmed pathogens (n = 297 patients, 340 episodes), 76.2% were gram-positive (Staphylococcus aureus; 41.2%) and 23.8% were gram-negative. The median duration of hospital stay was 16 days. Among treated patients, 3.3% experienced recurrence and 4.2% died in-hospital. The mean direct medical costs amounted to $4,195/ person, with the greatest expenses for hospitalization and antibiotics. The in-hospital mortality and total medical costs were higher in combined antibiotics therapy than monotherapy (p < 0.05). Charlson’s comorbidity index ≥ 3, standardized early warning scoring ≥ 4, sub-fascia infections and combined initial therapy, were all found to be associated with higher mortality.
Conclusions
Korean patients with community-onset cSSSI suffer from considerable clinical and economic burden. Efforts should be made to reduce this burden through appropriate initial treatment.
3.Mixed Adenoneuroendocrine Carcinoma of the Small Bowel in a Patient with Crohn's Disease: A Case Report
Kwang Min KIM ; Kyung Eun BAE ; Jae Hyung KIM ; Myeong Ja JEONG ; Soung Hee KIM ; Ji Young KIM ; Soo Hyun KIM ; Jihae LEE ; Mi Jin KANG ; Tae Gyu KIM
Journal of the Korean Radiological Society 2019;80(4):793-797
Mixed adenoneuroendocrine carcinoma (MANEC) is a rare tumor of the gastrointestinal tract that has both exocrine and neuroendocrine components. There are only 5 case reports about this combined tumor in the small bowel, arose in a background of long-standing Crohn's disease. Here, we report a case of small bowel MANEC in a 54-year-old male with Crohn's disease, who presented a heterogeneous enhancing, asymmetric small bowel wall thickening with small bowel obstruction and had a difficulty in differential diagnosis before surgery.
4.Extraskeletal Ewing's Sarcoma of the Thoracic Nerve Root: A Case Report
Jung Won KIM ; Jihae LEE ; Jae Hyung KIM ; Myeong Ja JEONG ; Soung Hee KIM ; Ji Young KIM ; Soo Hyun KIM ; Mi Jin KANG ; Tae gyu KIM ; Kyung Eun BAE ; Jun Jae SHIN ; Hyun Jung KIM ; Jung Yeon KIM
Journal of the Korean Radiological Society 2019;80(3):568-573
Extraskeletal Ewing's sarcoma (EES) is a rare malignant soft tissue tumor which is morphologically indistinguishable from skeletal ES. EES usually occurs in young adults and children and there has been only one case reported in a patient aged over 70 years old. We report a case of an EES arising from the first thoracic spinal nerve root in a 73-year-old female, which was misdiagnosed as benign nerve sheath tumor in preoperative imaging evaluation.
5.Comparison of Breast Conserving Surgery Followed by Radiation Therapy with Mastectomy Alone for Pathologic N1 Breast Cancer Patients in the Era of Anthracycline Plus Taxane-Based Chemotherapy: A Multicenter Retrospective Study (KROG 1418)
Gyu Sang YOO ; Won PARK ; Jeong Il YU ; Doo Ho CHOI ; Yeon Joo KIM ; Kyung Hwan SHIN ; Chan Woo WEE ; Kyubo KIM ; Kyung Ran PARK ; Yong Bae KIM ; Sung Ja AHN ; Jong Hoon LEE ; Jin Hee KIM ; Mison CHUN ; Hyung Sik LEE ; Jung Soo KIM ; Jihye CHA
Cancer Research and Treatment 2019;51(3):1041-1051
PURPOSE: We compared the oncologic outcomes of breast-conserving surgery plus radiation therapy (BCS+RT) and modified radical mastectomy (MRM) under anthracycline plus taxane-based (AT) regimens and investigated the role of adjuvant radiation therapy (RT) in patients with pathologic N1 (pN1) breast cancer treated by mastectomy. MATERIALS AND METHODS: We retrospectively reviewed the medical records of 2,011 patients with pN1 breast cancer who underwent BCS+RT or MRM alone at 12 institutions between January 2006 and December 2010. Two-to-one propensity score matching was performed for balances in variables between the groups. RESULTS: The median follow-up duration for the total cohort was 69 months (range, 1 to 114 months). After propensity score matching, 1,074 patients (676 in the BCS+RT group and 398 in the MRM-alone group) were analyzed finally. The overall survival, disease-free survival, locoregional failure-free survival, and regional failure-free survival (RFFS) curves of the BCS+RT group vs. MRM-alone group were not significantly different. The subgroup analysis revealed that in the group with both lymphovascular invasion (LVI) and histologic grade (HG) III, the BCS+RT showed significantly superior RFFS (p=0.008). Lymphedema (p=0.007) and radiation pneumonitis (p=0.031) occurred more frequently in the BCS+RT group than in the MRM-alone group, significantly. CONCLUSION: There are no differences in oncologic outcomes between BCS+RT and MRM-alone groups under the AT chemotherapy regimens for pN1 breast cancer. However, BCS+RT group showed superior RFFS to MRM-alone group in the patients with LVI and HG III. Adjuvant RT might be considerable for pN1 breast cancer patients with LVI and HG III.
Anthracyclines
;
Breast Neoplasms
;
Breast
;
Cohort Studies
;
Disease-Free Survival
;
Drug Therapy
;
Follow-Up Studies
;
Humans
;
Lymphedema
;
Mastectomy
;
Mastectomy, Modified Radical
;
Mastectomy, Segmental
;
Medical Records
;
Propensity Score
;
Radiation Pneumonitis
;
Retrospective Studies
6.Significance of Increased Rapid Treatment from HIV Diagnosis to the First Antiretroviral Therapy in the Recent 20 Years and Its Implications: the Korea HIV/AIDS Cohort Study
Yoon Jung KIM ; Shin Woo KIM ; Ki Tae KWON ; Hyun Ha CHANG ; Sang Il KIM ; Youn Jeong KIM ; Min Ja KIM ; Jun Yong CHOI ; Hyo Youl KIM ; June Myung KIM ; Bo Youl CHOI ; Bo Young PARK ; Yun Su CHOI ; Mee Kyung KEE ; Myeong Su YOO ; Jung Gyu LEE
Journal of Korean Medical Science 2019;34(38):e239-
From December 2006 to December 2016, 1,429 patients enrolled in the Korea human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) Cohort Study were investigated. Based on the year of diagnosis, the time interval between HIV diagnosis and initiation of antiretroviral therapy (ART) was analyzed by dividing it into 2 years. The more recent the diagnosis, the more likely rapid treatment was initiated (P < 0.001) and the proportion of patients starting ART on the same day of HIV diagnosis was increased in 2016 (6.5%) compared to that in 2006 (1.7%). No significant difference in the median values of CD4+ cell counts according to the diagnosis year was observed. In the past 20 years, the time from the HIV diagnosis to the initiation of ART was significantly reduced. Rapid treatment was being implemented at the HIV diagnosis, regardless of CD4+ cell count. Considering the perspective “treatment is prevention,” access to more rapid treatment is necessary at the time of HIV diagnosis.
CD4 Lymphocyte Count
;
Cohort Studies
;
Diagnosis
;
HIV Infections
;
HIV
;
Humans
;
Korea
7.Isolated Myxoma in the External Auditory Canal: A Case Report
Ah Reum PARK ; Tae Gyu KIM ; Hyun Jung KIM ; Woo Ho CHO ; Jae Hyung KIM ; Myeong Ja JEONG ; Soung Hee KIM ; Ji Young KIM ; Soo Hyun KIM ; Mi Jin KANG ; Ji Hae LEE ; Kyung Eun BAE
Journal of the Korean Radiological Society 2018;79(2):101-105
Myxoma is a benign mesenchymal neoplasm found in the heart, bone, and other soft tissues. However, myxoma of the external auditory canal is extremely rare. Since myxoma of the external auditory canal can be manifested as a part of the Carney complex, an autosomal dominant multiple familial neoplastic disorder, correct diagnosis and thorough investigation is important. We report a case of a 59-year-old man who presented to hospital with a complaint of growing mass within the right external auditory canal during one month. The surgical excision was done, and the histopathological examination revealed myxoma. In this article, we report the magnetic resonance imaging and computed tomography findings of the myxoma of the external auditory canal and correlate with the histopathological finding.
8.Breast Cavernous Hemangioma with Increased Size on Ultrasonography: A Case Report
Kwang Min KIM ; Ji Young KIM ; Soung Hee KIM ; Myeong Ja JEONG ; Soo Hyun KIM ; Jae Hyung KIM ; Kyung Eun BAE ; Ji Hae LEE ; Mi Jin KANG ; Tae Gyu KIM
Journal of the Korean Radiological Society 2018;79(6):311-314
Cavernous hemangioma of the breast is a rare benign vascular tumor. It is usually diagnosed as non-palpable mass during imaging examination, incidentally. Common sonographic finding of the breast hemangioma is a superficially located, oval shape, circumscribed margin mass. But the appearance of breast hemangioma is variable and it can be difficult to diagnose in preoperatively. Here, we report a 68-year-old female case with palpable breast mass and increased size on follow up ultrasonography.
9.Retroperitoneal Extraskeletal Osteosarcoma without Calcification Mimicking Pancreas Tumor: CT Imaging of a Case Report
Jung Won KIM ; Kyung Eun BAE ; Kyeong Mee PARK ; Jae Hyung KIM ; Myeong Ja JEONG ; Soung Hee KIM ; Ji Young KIM ; Soo Hyun KIM ; Mi Jin KANG ; Ji Hae LEE ; Tae Gyu KIM
Journal of the Korean Radiological Society 2018;78(5):340-344
Retroperitoneal extraskeletal osteosarcoma is a rare tumor. Typical imaging findings include a soft tissue mass accompanied with internal calcifications. The authors encountered a case involving a 44-year-old woman with a large retroperitoneal extraskeletal osteosarcoma, without calcification, that mimicked a pancreatic tumor. The present report highlights computed tomography features of retroperitoneal extraskeletal osteosarcoma, followed by a brief literature review. It is challenging for radiologists to diagnose retroperitoneal masses. However, in patients who present with large retroperitoneal masses, combined with clinical information including the elevation of serum alkaline phosphatase levels, retroperitoneal extraskeletal osteosarcoma should be considered in the differential diagnosis, even if the mass does not exhibit a gross calcification on the imaging.
10.A Case of Granular Cell Tumor of the Breast in a Male Patient
Gyoung Eun LEE ; Ji Young KIM ; Jae Hyung KIM ; Myeong Ja JEONG ; Soung Hee KIM ; Soo Hyun KIM ; Mi Jin KANG ; Ji Hae LEE ; Kyung Eun BAE ; Tae Gyu KIM
Journal of the Korean Radiological Society 2018;79(5):259-263
A 52-year-old male complained of a painless, firm, and slow-growing mass in his right breast outer portion. The chest CT revealed a 3.3 cm-sized oval shaped, microlobulated, mild enhancing mass. Ultrasound showed a microlobulated marginated heterogeneous hypoechoic mass with internal vascularity and calcifications in the mass. On the ultrasound-guided core needle biopsy, the mass was confirmed as a benign granular cell tumor (GCT). The patient transferred to another hospital and underwent surgical removal of the lesion. GCT of the breast is uncommon and mostly benign neoplasm to originate from Schwann cell. Clinical and radiologic features of GCTs, including CT and ultrasound images, mimic malignancy and make diagnosis of GCT more difficult. The CT images of GCTs are much rarely reported. Physicians and radiologists must be aware of radiologic characteristics of this rare benign tumor for male breast, to avoid misdiagnosis this tumor for breast malignancy and overtreat.

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