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.Insulin Secretion and Insulin Resistance Trajectories over 1 Year after Kidney Transplantation: A Multicenter Prospective Cohort Study
Jun Bae BANG ; Chang-Kwon OH ; Yu Seun KIM ; Sung Hoon KIM ; Hee Chul YU ; Chan-Duck KIM ; Man Ki JU ; Byung Jun SO ; Sang Ho LEE ; Sang Youb HAN ; Cheol Woong JUNG ; Joong Kyung KIM ; Su Hyung LEE ; Ja Young JEON
Endocrinology and Metabolism 2020;35(4):820-829
Background:
We investigated the changing patterns of insulin secretion and resistance and risk factors contributing to the development of post-transplant diabetes mellitus (PTDM) in kidney recipients under tacrolimus-based immunosuppression regimen during 1 year after transplantation.
Methods:
This was a multicenter prospective cohort study. Of the 168 subjects enrolled in this study, we analyzed a total 87 kidney transplant recipients without diabetes which was assessed by oral glucose tolerance test before transplantation. We evaluated the incidence of PTDM and followed up the index of insulin secretion (insulinogenic index [IGI]) and resistance (homeostatic model assessment for insulin resistance [HOMA-IR]) at 3, 6, 9 months, and 1 year after transplantation by oral glucose tolerance test and diabetes treatment. We also assessed the risk factors for incident PTDM.
Results:
PTDM developed in 23 of 87 subjects (26.4%) during 1 year after transplantation. More than half of total PTDM (56.5%) occurred in the first 3 months after transplantation. During 1 year after transplantation, insulin resistance (HOMA-IR) was increased in both PTDM and no PTDM group. In no PTDM group, the increase in insulin secretory function to overcome insulin resistance was also observed. However, PTDM group showed no increase in insulin secretion function (IGI). Old age, status of prediabetes and episode of acute rejection were significantly associated with the development of PTDM.
Conclusion
In tacrolimus-based immunosuppressive drugs regimen, impaired insulin secretory function for reduced insulin sensitivity contributed to the development of PTDM than insulin resistance during 1 year after transplantation.
3.Impact of body mass index on survival in patients undergoing peritoneal dialysis: Analysis of data from the Insan Memorial End-Stage Renal Disease Registry of Korea (1985–2014)
Seun Deuk HWANG ; Jin Ho LEE ; Jong Hyun JHEE ; Joon Ho SONG ; Joong Kyung KIM ; Seoung Woo LEE
Kidney Research and Clinical Practice 2019;38(2):239-249
BACKGROUND: Significant increases in the prevalence of obesity have been observed among patients with peritoneal dialysis (PD). The impact of body mass index (BMI) on survival remains unknown in Korean PD patients. METHODS: Among data of 80,674 patients on PD acquired from the Insan Memorial ESRD Registry database for the years 1985 to 2014, 6,071 cases were analyzed. Subjects were classified by baseline BMI; < 21.19 kg/m² (quartile 1, n = 1,518), 21.19 to 23.18 kg/m² (quartile 2, reference; n = 1,453), 23.19 to 25.71 kg/m² (quartile 3, n = 1,583), and > 25.71 kg/m² (quartile 4, n = 1,517). RESULTS: Mean age was 65.8 years, and baseline BMI was 23.57 kg/m². Numbers of male and diabetic patients were 3,492 (57.5%) and 2,192 (36.1%), respectively. Among 6,071 cases, 2,229 (36.7%) all-cause deaths occurred. As a whole, Kaplan–Meier survival curves according to BMI quartiles was significantly different (P = 0.001). All-cause mortality was significantly higher in quartile 4 than in the reference (hazard ratio [HR] = 1.154, 95% confidence interval [CI], 1.025–1.300; P = 0.018). There was no statistical difference in all-cause mortality among BMI quartiles in diabetic patients on PD. In non-diabetic patients, all-cause mortality of quartiles 1 and 3 was not different from the reference, but the HR was 1.176 times higher in quartile 4 (95% CI, 1.024–1.350; P = 0.022). CONCLUSION: Baseline BMI > 25.71 kg/m² seems to be an important risk factor for all-cause mortality in Korean PD patients.
Body Mass Index
;
Diabetes Mellitus
;
Humans
;
Kidney Failure, Chronic
;
Korea
;
Male
;
Mortality
;
Obesity
;
Peritoneal Dialysis
;
Prevalence
;
Risk Factors
4.Comparison of Metal Artifact Reduction for Orthopedic Implants versus Standard Filtered Back Projection: Value of Postoperative CT after Hip Replacement
Jiwon RIM ; Jung Ah CHOI ; Seun Ah LEE ; Eun Kyung KHIL
Journal of the Korean Radiological Society 2018;78(1):22-29
PURPOSE:
To evaluate Metal Artifact Reduction for Orthopedic Implants (O-MAR, Philips Healthcare) technique compared with standard filtered back projection (SFBP) technique on post-operative hip CT regarding image noise reduction and detection of post-operative complications.
MATERIALS AND METHODS:
Fifty-six hip CT scans after hip replacement with SFBP technique and O-MAR application were retrospectively reviewed. Region of interests (ROIs) were drawn at levels wherein acetabular cup and femoral head were largest at anterior and posterior acetabula, gluteus maximus muscle, subcutaneous fat adjacent to gluteus maximus muscle, and in area adjacent to prosthesis stem wherein lesser trochanter is largest. Hounsfield units (HU) were measured to evaluate artifact quantitatively; mean and standard deviations (SDs) calculated and compared. Periprosthetic complications were evaluated, and visibility rated between two reconstruction techniques; 1-SFBP better, 2–SFBP same as O-MAR, 3–O-MAR better.
RESULTS:
Average HU was significantly lower in O-MAR at posterior acetabulum, gluteus maximus muscle, and subcutaneous fat (p < 0.05). SD for HU was significantly lower in O-MAR at all ROIs (p < 0.05). Mean visibility of periprosthetic complications was 2.0, so equivalent.
CONCLUSION
Reconstruction with O-MAR technique in post-operative hip CT scans after hip replacement yielded statistically significant decrease in image noise. However, visibility of periprosthetic complications was not impacted by reconstruction technique.
5.Correction: Minimal Resection of Jejuna Dieulafoy's Lesion Using an Intraoperative Fluoroscopic Localization of the Metallic Coils Used in Angiography.
Kwang Il SEO ; Won MOON ; Cheon Woo LEE ; Seun Ja PARK ; Moo In PARK ; Sung Eun KIM ; Jae Hyun KIM ; Ki Young YOON ; Hee Kyung CHANG
The Korean Journal of Gastroenterology 2017;69(5):332-332
This correction is being published to correct the 6th author's English name in the article.
6.A Promising Method for Tumor Localization during Total Laparoscopic Distal Gastrectomy: Preoperative Endoscopic Clipping based on Negative Biopsy and Selective Intraoperative Radiography Findings.
Joo Weon CHUNG ; Kyung Won SEO ; Kyoungwon JUNG ; Moo In PARK ; Sung Eun KIM ; Seun Ja PARK ; Sang Ho LEE ; Yeon Myung SHIN
Journal of Gastric Cancer 2017;17(3):220-227
PURPOSE: Precise localization of tumors and creation of sufficient proximal resection margins are complicated processes during total laparoscopic distal gastrectomy (TLDG) for clinical T1/T2 gastric cancers. Various solutions to this problem have also yielded many disadvantages. In this study, we reviewed a preoperative endoscopic clipping method based on the results of negative biopsy and selective intraoperative radiography. MATERIALS AND METHODS: A retrospective review of 345 consecutive patients who underwent TLDG and preoperative endoscopic clipping for tumor localization was conducted. During preoperative endoscopy, the endoscopists performed negative biopsies just 1–2 cm selectively above the tumor's upper limit. After confirming the biopsy results, endoscopic metal clips were applied just proximal to the negative biopsy site the day before surgery. Selective intraoperative tumor localization using portable abdominal radiography was performed only when we could not ensure a precise resection line. RESULTS: Negative biopsy was performed in 244 patients. Larger tumor size (P=0.008) and more distally located tumors (P=0.052) were observed more frequently in the negative biopsy group than in the non-negative biopsy group. The non-negative biopsy group had significantly higher frequencies of differentiated tumor types than the negative biopsy group (P=0.003). Of the 244 patients who underwent negative biopsies, 6 had cancer cells in their biopsy specimens. We performed intraoperative radiography in 12 patients whose tumors had difficult-to-determine proximal margins. No tumors were found in the proximal resection margins of any patients. CONCLUSIONS: Our tumor localization method is a promising and accurate method for securing a sufficient resection margin during TLDG.
Biopsy*
;
Endoscopy
;
Gastrectomy*
;
Humans
;
Laparoscopy
;
Methods*
;
Radiography*
;
Radiography, Abdominal
;
Retrospective Studies
;
Stomach Neoplasms
7.Minimal Resection of Jejuna Dieulafoy's Lesion Using an Intraoperative Fluoroscopic Localization of the Metallic Coils Used in Angiography.
Kwang Il SEO ; Won MOON ; Cheon Woo LEE ; Seun Ja PARK ; Moo In PARK ; Seung Eun KIM ; Jae Hyun KIM ; Ki Young YOON ; Hee Kyung CHANG
The Korean Journal of Gastroenterology 2017;69(2):135-138
Dieulafoy's lesions of the Jejunum are extremely rare. Therefore, localization of lesions is very difficult due to their small size and tendency of occasional bleeding. However, it is important to mention the location of the Dieulafoy's lesions to prevent excessive intestinal resections or, even worse, resection of the normal intestine. We report a case of preoperative localization of a Dieulafoy's lesion embolized by a metallic coil that allows a surgeon to accurately identify the bleeding, permitting a minimally invasive surgical treatment. A 25-year-old man presented with massive hematochezia. There was no definite bleeding focus on the upper gastrointestinal endoscopy and colonoscopy. An angiography found a persistent extravasation of the contrast media at the end of straight artery of the mid-jejunal branch, around the terminal ileum, embolized with metallic coils immediately. The combination of embolized metallic coils and intraoperative fluoroscopy allowed accurate identification and minimal laparotomy. Consequently, a highly selective and minimal resection of the jejunum containing the dieulafoy lesion was possible without any postoperative complications.
Adult
;
Angiography*
;
Arteries
;
Colonoscopy
;
Contrast Media
;
Endoscopy, Gastrointestinal
;
Fluoroscopy
;
Gastrointestinal Hemorrhage
;
Hemorrhage
;
Humans
;
Ileum
;
Intestines
;
Jejunum
;
Laparotomy
;
Postoperative Complications
8.Retinoic Acid-induced Differentiation of Rat Mesenchymal Stem Cells into beta-Cell Lineage.
Jae Hyung KIM ; Kyung Sik KIM ; Sang Woo LEE ; Hyun Woo KIM ; Dong Jin JOO ; Yu Seun KIM ; Hwal SUH
The Journal of the Korean Society for Transplantation 2015;29(3):118-129
BACKGROUNDS: Type I diabetes mellitus (T1DM), an autoimmune disease, is associated with insulin deficiency due to the death of beta-cells. Bone marrow-derived mesenchymal stem cells (BM-MSCs) are capable of tissue repair and thus are a promising source of beta-cell surrogates. METHODS: In this study, the therapeutic potential of BM-MSCs as beta-cell replacements was analyzed both in vitro and in vivo. First, we used retinoic acid (RA) to induce rat BM-MSCs to differentiate into cells of endodermal/pancreatic lineage. Then, differentiated rat BM-MSCs were syngeneically injected under the renal capsule of rats. RESULTS: Analysis of gene expression revealed that rat BM-MSCs showed signs of early pancreatic development, and differentiated cells were qualitatively and quantitatively confirmed to produce insulin in vitro. In vivo study was performed for short-term (3 weeks) and long-term (8 weeks) period of time. Rats that were injected with differentiated MSCs exhibited a reduction in blood glucose levels throughout 8 weeks, and grafted cells survived in vivo for at least 3 weeks. CONCLUSIONS: These findings show that RA can induce differentiation of MSCs into the beta-cell lineage and demonstrate the potential of BM-MSCs to serve as therapeutic tools for T1DM.
Animals
;
Autoimmune Diseases
;
Blood Glucose
;
Diabetes Mellitus
;
Diabetes Mellitus, Type 1
;
Gene Expression
;
Insulin
;
Insulin-Secreting Cells
;
Mesenchymal Stromal Cells*
;
Rats*
;
Transplants
;
Tretinoin
9.Retraction Notice to "Endoscopic Resection for Rectal Carcinoid Tumors: Comparision of Polypectomy and Endoscopic Submucosal Resection with Band Ligation".
Sang Heon LEE ; Seun Ja PARK ; Hyung Hun KIM ; Kyung Sun OK ; Ji Hyun KIM ; Sam Ryong JEE ; Sang Young SEOL ; Bo Mi KIM
Clinical Endoscopy 2015;48(1):87-87
This retracts the below mentioned article upon the authors' request.
10.Clinical Implications for Graft Function of a New Equation Model for the Ratio of Living Donor Kidney Volume to Recipient Body Surface Area.
Chang Ki LEE ; Young Eun YOON ; Kyung Hwa CHOI ; Seung Choul YANG ; Joong Shik LEE ; Dong Jin JOO ; Kyu Ha HUH ; Yu Seun KIM ; Woong Kyu HAN
Korean Journal of Urology 2013;54(12):870-875
PURPOSE: We propose an equation that predicts graft function after kidney transplantation by using donated kidney volume and recipient body surface area (BSA). MATERIALS AND METHODS: Included were 261 cases of living kidney transplantation between 2007 and 2009. Preoperative computed tomography scans were performed and the donated kidney volume was measured by use of a three-dimensional reconstruction program (Ripidia). The estimated glomerular filtration rate (eGFR) was calculated by using the modification of diet in renal disease formula. Donated kidney volume, preoperative renal function, and demographic factors of both donors and recipients were evaluated as predictors. RESULTS: The mean ages of the donors and recipients were 40.8 and 41.6 years, respectively. The mean donated kidney volume and donated kidney volume/recipient BSA ratio were 153.4 mL and 96.9 mL/m2, respectively. Mean preoperative and postoperative 12-month eGFR of recipients were 7.1 and 59.7 mL/min, respectively, and the mean preoperative eGFR of donors was 92.2 mL/min. Donated kidney volume/recipient BSA ratio, donor age, and recipient gender were the significant predictors of eGFR level (p<0.001) and eGFR<45 mL/min at postoperative 12 months (p=0.005, p<0.001, and p=0.006). From the multiple linear regression equation and predicted probability from logistic regression, we could calculate the equation for the ratio of living donor kidney volume to recipient BSA on graft function. CONCLUSIONS: Graft kidney volume/recipient BSA ratio, donor age, and recipient gender were predictors of graft function 12 months after kidney transplantation. Although we are concerned only with the preoperative, this equation model could help physicians to counsel patients concerning their postoperative prognosis and to avoid insufficient volume donations.
Body Surface Area*
;
Delayed Graft Function
;
Demography
;
Diet
;
Glomerular Filtration Rate
;
Humans
;
Kidney Transplantation
;
Kidney*
;
Linear Models
;
Living Donors*
;
Logistic Models
;
Organ Size
;
Prognosis
;
Tissue Donors
;
Transplantation
;
Transplants*

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