The Effect of Tegoprazan on the Treatment of Endoscopic Resection-Induced Artificial Ulcers: A Multicenter, Randomized, Active-Controlled Study.

Background/Aims: : Tegoprazan is a novel potassium-competitive acid blocker that has beneficial effects on acid-related disorders such as gastroesophageal reflux and peptic ulcer diseases. This study aimed to validate the effect of tegoprazan on endoscopic submucosal dissection (ESD)-induced artificial ulcers. Methods: : Patients from 16 centers in Korea who underwent ESD for gastric neoplasia were enrolled. After ESD, pantoprazole was administered intravenously for 48 hours. The patients were randomly allocated to either the tegoprazan or esomeprazole group. Tegoprazan 50 mg or esomeprazole 40 mg were administered for 4 weeks, after which gastroscopic evaluation was performed. If the artificial ulcer had not healed, the same dose of tegoprazan or esomeprazole was administered for an additional 4 weeks, and a gastroscopic evaluation was performed. Results: : One hundred sixty patients were enrolled in this study. The healing rates of artificial ulcers at 4 weeks were 30.3% (23/76) and 22.1% (15/68) in the tegoprazan and esomeprazole groups, respectively (p=0.006). At 8 weeks after ESD, the cumulative ulcer healing rates were 73.7% (56/76) and 77.9% (53/68) in the tegoprazan and esomeprazole groups, respectively (p=0.210). Delayed bleeding occurred in two patients in the tegoprazan group (2.6%) and in one patient in the esomeprazole group (1.5%). Other adverse events were negligible in both groups. Conclusions: : Tegoprazan showed similar effects on post-ESD artificial ulcer healing in comparison with esomeprazole.

Helicobacter pylori Infection Status and Gastric Tumor Incidence According to the Year of Birth.

Background/Aims: : The prevalence of Helicobacter pylori-naive status is increasing. Nonetheless, biennial gastroscopy is recommended for all Koreans aged 40 to 75 years. This study aimed to determine whether gastric cancer screening guidelines could be changed according to H. pylori infection status and year of birth. Methods: : Koreans who underwent serum assays and gastroscopy for gastric cancer screening between 2010 and 2016 were included if screening tests were followed up for ≥3 times. H. pylori infection was confirmed when invasive tests or 13C-urea breath tests were positive. In the case of negative test findings, eradication history, serologically detected atrophy, and intestinal metaplasia/atrophy were checked for past infection. If all were absent, H. pylori-naive status was confirmed. Results: : Two-thousand and two (256 H. pylori-naive, 743 past-infected, and 1,003 infected) Koreans underwent screening tests for 95.5±28.4 months. The mean year of birth in the naive group (1969±7) differed from those of the past-infected (1957±10, p<0.001) and infected (1958±10, p<0.001) groups. H. pylori-naive status was correlated with recent year of birth (r=0.368, p<0.001). No gastric tumors were observed among the naive participants (p=0.007), whereas 23 adenomas, 18 adenocarcinomas, and two neuroendocrine tumors were detected in 1.9% (14/743) of past-infected and 2.5% (25/1,003) of infected participants, including four infected participants with metachronous tumors. Conclusions: : The prevalence of H. pylori-naive status is increasing in young Koreans, and gastric tumors are rare in this population. Hence, biennial gastroscopy could be waived after the confirmation of naive status.

2022 Seoul Consensus on Clinical Practice Guidelines for Functional Constipation.

Chronic constipation is one of the most common digestive diseases encountered in clinical practice. Constipation manifests as a variety of symptoms, such as infrequent bowel movements, hard stools, feeling of incomplete evacuation, straining at defecation, a sense of anorectal blockage during defecation, and use of digital maneuvers to assist defecation. During the diagnosis of chronic constipation, the Bristol Stool Form Scale, colonoscopy, and a digital rectal examination are useful for objective symptom evaluation and differential diagnosis of secondary constipation. Physiological tests for functional constipation have complementary roles and are recommended for patients who have failed to respond to treatment with available laxatives and those who are strongly suspected of having a defecatory disorder. As new evidence on the diagnosis and management of functional constipation emerged, the need to revise the previous guideline was suggested. Therefore, these evidence-based guidelines have proposed recommendations developed using a systematic review and meta-analysis of the treatment options available for functional constipation. The benefits and cautions of new pharmacological agents (such as lubiprostone and linaclotide) and conventional laxatives have been described through a meta-analysis. The guidelines consist of 34 recommendations, including 3 concerning the definition and epidemiology of functional constipation, 9 regarding diagnoses, and 22 regarding managements. Clinicians (including primary physicians, general health professionals, medical students, residents, and other healthcare professionals) and patients can refer to these guidelines to make informed decisions regarding the management of functional constipation.

Twice-daily intake of bismuth-based quadruple therapy for first-line Helicobacter pylori eradication: A retrospective study on 10-day, 14-day, and half-dose antibiotic therapy.

BACKGROUND/AIMS: In areas with >15% clarithromycin resistance, bismuth-based quadruple therapy is recommended for first-line Helicobacter pylori eradication. This study aimed to determine the efficacy of the twice-daily intake of bismuth-based quadruple therapy among 10-day, 14-day, and half-dose antibiotic regimens. METHODS: From May 2021 to March 2023, H. pylori-infected Korean adults were administered tetracycline (1 g), metronidazole (750 mg), bismuth potassium citrate (300 mg), and lansoprazole (30 mg) twice daily, after breakfast and dinner, for 10 days. The regimen was administered for 14 days if the body weight was ≥70 kg or if the patient had reinfection. Half doses of antibiotics were administered for 14 days if there was a risk of drug interactions or if the patient was aged ≥75 years. The 13 C-urea breath test was performed after 6 weeks. RESULTS: Among the 1258 infected Koreans, 85.1% (412/484) in the 10-day, 84.3% (498/591) in the 14-day, and 86.3% (158/183) in the half-dose antibiotic groups followed the instructions. In the per-protocol (PP) analysis, eradication rates were higher in the 10-day (90.5%, p = 0.019) and 14-day (90.2%, p = 0.023) groups than in the half-dose group (83.5%). In the intention-to-treat (ITT) analysis, eradication rates were higher in the 10-day group (80.6%) than in the half-dose group (73.2%, p = 0.039). In the half-dose group, the eradication rate was lower in patients aged ≥75 years (PP: 74.6%, ITT: 66.2%) than in those with a risk of drug interactions (PP: 89.7% [p = 0.017], ITT: 82.4% [p = 0.019]). CONCLUSIONS: Twice-daily intake of bismuth-based quadruple therapy for 10-14 days showed an eradication rate of >90% in the PP analysis. A 10-day regimen could be administered to eradication-naive patients with a body weight below 70 kg. A half-dose antibiotic regimen might be recommended to patients with a risk of drug interactions but not to those aged ≥75 years simply due to old age.

Randomised clinical trial: comparison of tegoprazan and lansoprazole as maintenance therapy for healed mild erosive oesophagitis.

BACKGROUND: Tegoprazan is a novel potassium-competitive acid blocker used to treat acid-related disorders. AIM: To compare tegoprazan 25 mg with lansoprazole 15 mg as maintenance therapy in healed erosive oesophagitis (EE) METHODS: In this phase 3, double-blind, multi-centre study, patients with endoscopically confirmed healed EE were randomised 1:1 to receive tegoprazan 25 mg or lansoprazole 15 mg once daily for up to 24 weeks. The primary efficacy endpoint was the endoscopic remission rate after 24 weeks. The secondary efficacy endpoint was the endoscopic remission rate after 12 weeks. Safety endpoints included adverse events, clinical laboratory results and serum gastrin and pepsinogen I/II levels. RESULTS: We randomised patients to tegoprazan 25 mg (n = 174) or lansoprazole 15 mg (n = 177). Most had mild EE (Los Angeles (LA) grade A: 57.3%, LA grade B: 37.3%). The endoscopic remission rate after 24 weeks was 90.6% with tegoprazan and 89.5% with lansoprazole. Tegoprazan was not inferior to lansoprazole for maintaining endoscopic remission at 24 weeks and 12 weeks. In subgroup analysis, tegoprazan 25 mg showed no significant difference in maintenance rate according to LA grade (p = 0.47). The maintenance effect of tegoprazan was consistent in CYP2C19 extensive metabolisers (p = 0.76). Increases in serum gastrin were not higher in tegoprazan-treated than lansoprazole-treated patients. CONCLUSIONS: Tegoprazan 25 mg was non-inferior to lansoprazole 15 mg in maintenance of healing of mild EE. In this study, tegoprazan had a similar safety profile to lansoprazole.

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.

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Ⓡ (esomeprazole 20 mg with sodium bicarbonate 800 mg) or NexiumⓇ (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Ⓡ group and 175 in the NexiumⓇ 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Ⓡ group and 35% in the NexiumⓇ 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Ⓡ is as effective and safe as NexiumⓇ for managing typical symptoms in patients with NERD (ClinicalTrial.gov identifier: NCT03928470).

Randomized controlled trial to evaluate the efficacy and safety of fexuprazan compared with esomeprazole in erosive esophagitis.

BACKGROUND: Fexuprazan, a novel potassium-competitive acid blocker, reversibly suppresses the K+/H+-ATPase enzyme in proton pumps within gastric parietal cells. Fexuprazan's suppression of gastric acid was maintained in healthy individuals for 24 h in a dose-dependent manner. AIM: To compare fexuprazan to esomeprazole and establish its efficacy and safety in patients with erosive esophagitis (EE). METHODS: Korean adult patients with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg or esomeprazole 40 mg once daily for eight weeks. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy at week 8. The secondary endpoints included the healing rate of EE at week 4, symptom response, and quality of life assessment. Safety profiles and serum gastrin levels were compared between the groups. RESULTS: Of the 263 randomized, 218 completed the study per protocol (fexuprazan 40 mg, n = 107; esomeprazole 40 mg, n = 111). Fexuprazan was non-inferior to esomeprazole regarding the healing rate at week 8 [99.1% (106/107) vs 99.1% (110/111)]. There were no between-group differences in the EE healing rate at week 4 [90.3% (93/103) vs 88.5% (92/104)], symptom responses, and quality of life assessments. Additionally, serum gastrin levels at weeks 4 and 8 and drug-related side effects did not significantly differ between the groups. CONCLUSION: Fexuprazan 40 mg is non-inferior to esomeprazole 40 mg in EE healing at week 8. We suggest that fexuprazan is an alternative promising treatment option to PPIs for patients with EE.

Useful Serum Pepsinogen Levels for Detecting Ongoing Helicobacter pylori Infection in Asymptomatic Subjects: A Cross-Sectional Study Based on 13C-urea Breath Test Findings.

BACKGROUND /AIMS: The serum pepsinogen (PG) assay is used to screen subjects at high risk for gastric cancer. Currently, there are few studies on the PG levels for the detection of Helicobacter pylori infection. This study aimed to determine the PG assay findings for detecting ongoing infection. METHODS: Asymptomatic subjects who underwent a 13C-urea breath test (13C-UBT) on the day of gastroscopy and serum assay for cancer screening were included. Subjects with a recent intake of acid suppressants or antibiotics, gastrectomy, or renal failure were excluded. H. pylori infection was defined as a positive 13C-UBT result. RESULTS: Among the 500 included subjects, 167 (33.4%) had current infection. The serum PG II levels of > 12.95 ng/mL (area under the curve [AUC] = 0.930, sensitivity 86.5%, specificity 90.7%) and PG I/II ratios of < 4.35 (AUC = 0.875, sensitivity 86.8%, specificity 79.6%) were related to infection. The PG I/II ratios were inversely correlated with age (r = -0.160, p = 0.039). The cutoff values of PG I/II ratios were lower in older subjects aged ≥ 50 years (< 4.05; AUC = 0.875, sensitivity 80.7%, specificity 88.2%) than in younger subjects aged < 50 years (< 4.35; AUC = 0.873, sensitivity 77.4%, specificity 88.9%). CONCLUSIONS: Serum PG II levels > 12.95 ng/mL and PG I/II ratios < 4.35 suggest ongoing infection in asymptomatic subjects; therefore, H. pylori confirmation tests (i.e., 13C-UBT) should be considered under these conditions. Stricter criteria are required in older subjects aged ≥ 50 years (PG I/II ratio < 4.05) to detect ongoing infection than younger subjects.

Incidence of Infection among Subjects with Helicobacter pylori Seroconversion.

BACKGROUND/AIMS: Helicobacter pylori (H. pylori) seroconversion may occur during screening for gastric cancer. Our study aimed to assess the number of seroconverted subjects with H. pylori and their results in follow-up tests. METHODS: Data were consecutively collected on subjects who were H. pylori-seronegative and presented for gastric cancer screening. Subjects who were followed up using the same serology test and pepsinogen (PG) assays on the day of endoscopy were included in the study. RESULTS: During the follow-up of 57.7±21.4 months, 61 (15.0%) of 407 seronegative subjects showed seroconversion. H. pylori infection was detected in six (9.8%) of 61 seroconverted subjects. A diffuse red fundal appearance, with a significant increase in the Kyoto classification scores for gastritis, was observed in the infected subjects (p<0.001). Compared to the false-seropositive subjects, infected subjects showed higher serology titers (p<0.001) and PG II levels (p<0.001) and lower PG I/II ratios (p=0.002), in the follow-up tests. CONCLUSION: Seroconversion occurred in 3.3% of seronegative subjects per year; however, only 9.8% had H. pylori infection. The majority (90.2%) of the seroconverted subjects showed false seropositivity without significant changes in the follow-up test results. The diffuse red fundal appearance could be an indicator of H. pylori infection.

Risk factors associated with prolonged mechanical ventilation after surgical patent ductus arteriosus ligation in preterm infants.

BACKGROUND: One of the main pathophysiologies of a hemodynamically significant patent ductus arteriosus (hsPDA) involves pulmonary over-circulation. However, PDA treatment does not present with uniform effects on pulmonary outcomes. We aimed to evaluate the clinical characteristics - in particular, respiratory parameters - associated with prolonged mechanical ventilation after PDA ligation. METHODS: Preterm infants ≤32 weeks gestation were included in the study. Infants who underwent PDA ligation were grouped depending on whether the infant successfully was extubated ≤14 d after ligation or required prolonged invasive mechanical ventilation >14 d after ligation. The clinical characteristics, including the parameters concerning the respiratory illness severity and hemodynamical significance of PDA shunt, were compared between the two groups. RESULTS: Among 172 preterm infants, 36 (20.9%) infants underwent surgical PDA ligation. Fifteen (41.6%) infants were successfully extubated at ≤14 d after ligation, and 21 (58.3%) infants required prolonged invasive mechanical ventilation for >14 d after ligation. In the univariable analysis, the infants who required prolonged mechanical ventilation was significantly smaller in terms of gestational age (GA) and birth weight and tended to present a greater respiratory illness severity [represented by the use of high-frequency oscillatory ventilation (HFOV) and greater RSS (respiratory severity score)/kg] with a larger PDA size prior to PDA ligation. In the multivariable logistic regression analysis, peak preoperative RSS/kg (p = 0.012, OR = 0.207, 95% CI = 0.060-0.706) was the only significant factor associated with prolonged mechanical ventilation after PDA ligation. CONCLUSION: Preterm infants with the compromised respiratory condition may be prone to prolonged mechanical ventilation after PDA ligation. The respiratory status during the early phase of life should be considered when evaluating the effect of PDA treatment. With an extended view, distinguishing infants with such risk factors may lead to more polished treatment strategies toward hsPDA.

Efficacy of Seven-Day Potassium-Competitive Acid Blocker-Based First-Line Helicobacter Pylori Eradication Therapy Administered with Bismuth.

PURPOSE: To determine the efficacy of a potassium-competitive acid blocker (P-CAB)-based first-line eradication therapy with bismuth compared with that of proton pump inhibitor-based first-line therapy with bismuth. MATERIALS AND METHODS: Eradication-naive H. pylori-infected patients were consecutively enrolled from January to November 2020. Before approval of the P-CAB-based eradication therapy, twice daily administration of a regimen containing lansoprazole 30 mg, amoxicillin 1 g, clarithromycin 500 mg, and bismuth potassium citrate 300 mg was prescribed for 7 days. After approval, lansoprazole was replaced with tegoprazan (50 mg). Clarithromycin resistance was examined in patients who underwent gastroscopic biopsy at our center. Efficacy was assessed via the 13C-urea breath test. RESULTS: Of the 381 eradication-naive patients, eradication was successful in 88.3% (151/171) treated with tegoprazan and 82.8% (140/169) treated with lansoprazole in per-protocol analysis (p=0.151). In intention-to-treat analysis, eradication rates were 78.8% (152/193) in the tegoprazan and 74.5% (140/188) in the lansoprazole group (p=0.323). Clarithromycin resistance was observed in 30 (20.1%) of the 148 patients (74 from each group), and only four of the 16 clarithromycin-resistant patients in the tegoprazan group achieved successful eradication. Clarithromycin resistance [odds ratio (OR)=42.1, 95% confidence intervals (CIs)=12.6-141.0] and poor patient compliance (OR=17.1, 95% CIs=1.6-189.1) were independent risk factors for eradication failure. CONCLUSION: In eradication-naive patients, eradication success rates for 7-day first-line triple therapy regimen exceeded 82% with bismuth administration. In clarithromycin-resistant patients, neither tegoprazan 50 mg nor lansoprazole 30 mg achieved acceptable eradication rates when administered twice daily for 7 days.

Preventive Intervention Program on the Outcomes of Very Preterm Infants and Caregivers: A Multicenter Randomized Controlled Trial.

Increased survival in the very preterm population results in a higher risk of developing neurodevelopmental and behavioral disabilities among survivors. We examined the outcomes of very preterm infants and parents after a preventive intervention program of four home visits by a specialized nurse, 5 days, 2 weeks, and 1 month after discharge, respectively, and at CA 2 months, followed by up to 12 times of group sessions between CA 3 and 6 months. Our multicenter randomized controlled trial assessed 138 preterm infants (gestational age ≤30 weeks or birth weight ≤1500 g) enrolled from the three participating hospitals. We randomly allocated the preterm babies to either the intervention or the control group. The primary outcome was the neurodevelopmental outcomes of Bayley-III scores at CA 10 and 24 months. At CA 10 months and 24 months, there were no significant differences between the intervention and control groups in the cognitive, motor, and language domains of Bayley-III scores. In addition, there were no significant differences in the mother's depression scale, mother-child attachment, and the modified Infant and Toddler Social and Emotional Assessment.

Efficacy and Safety of Rebamipide versus Its New Formulation, AD-203, in Patients with Erosive Gastritis: A Randomized, Double-Blind, Active Control, Noninferiority, Multicenter, Phase 3 Study.

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.

Comparative study for predictability of type 1 gastric variceal rebleeding after endoscopic variceal ligation: High-frequency intraluminal ultrasound study.

BACKGROUND: The efficacy of endoscopic ultrasonography for the follow-up of gastric varices treated with endoscopic variceal ligation (EVL) has not been established. AIM: To evaluate the diagnostic correlation of esophagogastroduodenoscopy (EGD) and high-frequency intraluminal ultrasound (HFIUS) for type 1 gastric varices (GOV1) after EVL and to identify the predictability for rebleeding of EGD and HFIUS. METHODS: In liver cirrhosis patients with GOV1, we performed endoscopic follow-up using EGD and HFIUS synchronously after EVL for hemorrhage from GOV1. Endoscopic grading and red color signs were analyzed using EGD, and the largest variceal cross-sectional areas were measured using HFIUS. In addition, 1-year follow-up was performed. Variceal rebleeding was defined as the presence of hematemesis, hematochezia, or melena without other evidence of bleeding on endoscopic follow-up. RESULTS: In 26 patients with GOV1, variceal cross-sectional areas on HFIUS of GOV1 was poorly correlated with EGD grading of GOV1 (r = 0.36). In 17 patients who completed the 1-year follow-up, variceal cross-sectional areas on HFIUS was a good predictor of subsequent rebleeding, whereas EGD grading was not a predictor of subsequent rebleeding. CONCLUSION: HFIUS measurement is more predictive of GOV1 rebleeding than EGD grading, so HFIUS measurement may be necessary for endoscopic follow-up after EVL in patients with GOV1.

Clinical characteristics predicting abnormal brain magnetic resonance image findings in hypoxic-ischemic encephalopathy infants.

BACKGROUND: The aim of this study was to elucidate the specific clinical characteristics associated with abnormal brain magnetic resonance image (MRI) findings in hypoxic ischemic encephalopathy (HIE) infants in order to discern how to predict poorer outcomes more accurately. METHODS: A retrospective data analysis of HIE infants admitted to the neonatal intensive care unit of a tertiary hospital was performed. Baseline perinatal information and physical and neurological findings were compared in HIE infants according to the presence of abnormal brain MRI findings. RESULTS: A total of 69 infants were enrolled in the study. Of these, 48(69.6%) infants received therapeutic hypothermia, and 60(87.0%) infants presented abnormal findings on brain MRI. Decreased muscle tone and lower Apgar scores were more often observed in infants with abnormal MRI results(P<0.05). The presence of hypotonia and 1- and 5-minute Apgar scores equal to or less than the yielded cut-off values (5.5 and 7.5, respectively)were associated with a 7.23-, 9.14-, 9.78-fold increased risk of having abnormal brain MRI results. CONCLUSIONS: As muscle tone and Apgar scores were associated with abnormal brain MRI findings in HIE infants, these clinical characteristics may serve as early indicators of poor neurodevelopmental outcomes and signal the need for special attention and in-depth follow-up by MRI.

Efficacy and Safety of DWJ1252 Compared With Gasmotin in the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Double-blind, Active-controlled Study.

BACKGROUND/AIMS: Prokinetics such as mosapride citrate CR (conventional-release; Gasmotin) are commonly used in functional dyspepsia (FD). This study aims to evaluate the efficacy and safety of once-a-day mosapride citrate SR (DWJ1252), a sustained-release formulation of mosapride citrate, compared with mosapride citrate CR 3 times a day, in patients with FD. METHODS: In this multicenter, randomized, double-blind, active-controlled, non-inferiority study, 119 patients with FD (by the Rome III criteria, 60 for mosapride citrate SR and 59 for mosapride citrate CR) were randomly allocated to mosapride citrate SR once daily or mosapride citrate CR thrice daily for 4 weeks in 16 medical institutions. Primary end point was the change in gastrointestinal symptom (GIS) score from baseline, assessed by GIS questionnaires on 5-point Likert scale after 4-week treatment. Secondary end points and safety profiles were also analyzed. RESULTS: The study included 51 and 49 subjects in the mosapride citrate SR and mosapride citrate CR groups, respectively. GIS scores at week 4 were significantly reduced in both groups (mean ± SD: -10.04 ± 4.45 and -10.86 ± 5.53 in the mosapride citrate SR and mosapride citrate CR groups, respectively; P < 0.001), and the GIS changes from baseline did not differ between the 2 groups (difference, 0.82 point; 95% CI, -1.17, 2.81; P = 0.643). Changes in GIS at weeks 2 and 4 and quality of life at week 4, and the improvement rates of global assessments at weeks 2 and 4, did not differ between the groups. Adverse events were similar in the 2 groups, and there were no serious adverse events. CONCLUSION: In patients with FD, mosapride citrate SR once daily is as effective as mosapride citrate CR thrice daily, with a similar safety profile.

Interleukin 8 may predict surgical necrotizing enterocolitis in infants born less than 1500 g.

Necrotizing enterocolitis (NEC) often leads to gastrointestinal emergency resulting high mortality in very low birth weight infants (VLBWIs) requiring surgery. To date, few studies have explored the role of serum cytokines in the development of feeding intolerance (FI) or NEC outcomes in VLBWIs. Infants born weighing <1500 g or of 32 weeks of gestational age were prospectively enrolled from May 2018 to Dec 2019. We measured several cytokines routinely within 72 h of life, even before NEC-like symptoms developed. NEC or FI group comprised 17 (27.4%) infants, and 6 (9.7%) infants had surgical NEC. The gestational age and birth weight were significantly lower in the NEC or FI group with more prematurity-related complications. The surgical NEC group also demonstrated significantly lower gestational age and birth weight along with more infants experiencing refractory hypotension within a 1 week of life, pulmonary hypertension, and patent ductus arteriosus. IL-10 levels were significantly higher in the NEC or FI group, whereas IL-8 levels were significantly higher in the infants with surgical NEC. Our findings indicated to IL-8 can predict surgical NEC while increased IL-10 can predict NEC development in VLBWIs.

The prognosis of brain magnetic resonance imaging injury pattern for outcomes of hypothermia-treated infants.

Magnetic resonance imaging (MRI) can be a tool that allows the observation of structural injury patterns after cooling. The aim of this study was to determine the early pattern of brain injury in the MRIs of infants with hypoxic ischemic encephalopathy (HIE) after cooling and to search for any clinical factors related to abnormal MRI findings.The study retrospectively recruited 118 infants who were treated with therapeutic hypothermia (TH) between 2013 and 2016.Forty-three patients had normal brain MRI, and 75 had abnormal brain MRI findings. The TH-treated infants with abnormal brain MRI readings showed significantly more clinical seizures and the use of additional antiepileptic drugs (AEDs) than the normal MRI group. As a long-term outcome, more lesions in the basal ganglia and thalamus, posterior limb of internal capsule, or severe white matter lesions were associated with abnormal neurodevelopmental outcomes at 18 to 24 months of age.A higher frequency of clinical seizures and AED use were related to abnormal brain injury on MRI. A significant risk for poor long-term outcomes was found in the abnormal brain MRI group.

Development of the Korean Developmental Screening Test for Infants and Children (K-DST).

BACKGROUND: Most developmental screening tools in Korea are adopted from foreign tests. To ensure efficient screening of infants and children in Korea, a nationwide screening tool with high reliability and validity is needed. PURPOSE: This study aimed to independently develop, standardize, and validate the Korean Developmental Screening Test for Infants and Children (K-DST) for screening infants and children for neurodevelopmental disorders in Korea. METHODS: The standardization and validation conducted in 2012-2014 of 3,284 subjects (4-71 months of age) resulted in the first edition of the K-DST. The restandardization and revalidation performed in 2015-2016 of 3.06 million attendees of the National Health Screening Program for Infants and Children resulted in the revised K-DST. We analyzed inter-item consistency and test-retest reliability for the reliability analysis. Regarding the validation of K-DST, we examined the construct validity, sensitivity and specificity, receiver operating characteristic curve analysis, and a criterion-related validity analysis. RESULTS: We ultimately selected 8 questions in 6 developmental domains. For most age groups and each domain, internal consistency was 0.73-0.93 and test-retest reliability was 0.77-0.88. The revised K-DST had high discriminatory ability with a sensitivity of 0.833 and specificity of 0.979. The test supported construct validity by distinguishing between normal and neurodevelopmentally delayed groups. The language and cognition domain of the revised K-DST was highly correlated with the K-Bayley Scales of Infant Development-II's Mental Age Quotient (r=0.766, 0.739), while the gross and fine motor domains were highly correlated with Motor Age Quotient (r=0.695, 0.668), respectively. The Verbal Intelligence Quotient of Korean Wechsler Preschool and Primary Scales of Intelligence was highly correlated with the K-DST cognition and language domains (r=0.701, 0.770), as was the performance intelligence quotient with the fine motor domain (r=0.700). CONCLUSION: The K-DST is reliable and valid, suggesting its good potential as an effective screening tool for infants and children with neurodevelopmental disorders in Korea.

Respiratory Severity Score with Regard to Birthweight during the Early Days of Life for Predicting Pulmonary Hypertension in Preterm Infants.

OBJECTIVE: The respiratory severity score (RSS) has been demonstrated to be associated with the oxygenation index in intubated newborn infants. We aimed to evaluate the usefulness of RSS with regard to birthweight (BW) in preterm infants for predicting an association with future pulmonary hypertension (PH). METHODS: Preterm infants with <30 weeks' gestation and <1250 g BW were reviewed and grouped into two (PH vs. no PH). Basic perinatal characteristics, comorbidities and parameters reflecting lung condition, including duration of invasive mechanical ventilator care, were compared. Respiratory support parameters (FiO2, RSS and RSS/kg) during the first 5 days of birth (0-120 h) were compared between the groups, and receiver operating characteristics curves were produced to evaluate the association with PH. RESULTS: RSS/kg, of the three respiratory support parameters, demonstrated significantly higher values in the PH group in the early days of life. Particularly, RSS/kg at day 2 of life had the greatest area under the curve [0.762, 95% confidence interval (CI) 0.655-0.869, p < 0.001] and maintained statistical significance [odds ratio (OR) 1.352, 95% CI 1.055-1.732, p = 0.017] in the multivariable analysis for a potential association with PH, along with gestational age (OR 0.996, 95% CI 0.993-0.999, p = 0.015) and preterm premature rupture of membrane >18 h (OR 4.907, 95% CI 1.436-16.765, p = 0.011). CONCLUSION: RSS/kg is a potential marker associated with the development of PH. Future studies could verify its usefulness as a reliable surrogate for predicting respiratory morbidity in clinical settings.