Randomised clinical trial: a comparative study of 10-day sequential therapy with 7-day standard triple therapy for Helicobacter pylori infection in naïve patients.

BACKGROUND: The eradication rates following standard triple therapy for Helicobacter pylori infection are declining worldwide. Recent studies have shown that sequential therapy for H. pylori infection yields high cure rates. AIM: To compare the efficacy and tolerability of a sequential regimen as first-line treatment of H. pylori infection with a standard triple regimen. METHODS: A total of 348 naïve H. pylori-infected patients from six hospitals in Korea were assigned randomly to standard triple or sequential therapy groups. Standard triple therapy consisted of 20 mg of rabeprazole, 1 g of amoxicillin and 500 mg of clarithromycin, twice daily for 7 days. Sequential therapy consisted of a 5-day dual therapy (20 mg of rabeprazole and 1 g of amoxicillin, twice daily) followed by a 5-day triple therapy (20 mg of rabeprazole, 500 mg of clarithromycin, and 500 mg of metronidazole, twice daily). RESULTS: The intention-to-treat (ITT) and per-protocol (PP) eradication rates were 62.2% (95% CI 54.8-69.6%) and 76.0% (95% CI 68.5-83.5%) in the standard triple group, and 77.8% (95% CI 71.4-84.2%) and 87.9% (95% CI 82.3-93.5%) in the sequential group, respectively. The eradication rate was significantly higher in the sequential group compared with the standard triple group in both the ITT and PP populations (P = 0.002 and P = 0.013 respectively), whereas the incidence of adverse events was similar. CONCLUSIONS: Ten-day sequential therapy is more effective and equally tolerated for eradication of H. pylori infection compared with standard triple therapy. Sequential therapy may have a role as first-line treatment for H. pylori infection.

Factors predictive of perforation during endoscopic submucosal dissection for the treatment of colorectal tumors.

BACKGROUND AND AIM: Although perforation of the colon is known as one of the main complications of endoscopic submucosal dissection (ESD) for colorectal tumor management, factors predictive of perforation have not been fully evaluated. This study aimed to determine the factors associated with perforation during colorectal ESD. METHODS: Patients with colorectal tumors undergoing ESD were enrolled and their records were reviewed retrospectively. Age, sex, co-morbidity, medication history, procedure time, resection method, tumor size, location, gross morphology, the presence of fibrosis, and histologic findings were included as possible risk factors. In the cases where perforation had occurred, factors associated with the duration of hospitalization were analyzed. RESULTS: One hundred eight lesions in 108 patients were eligible for inclusion in the study (68 patients were male; mean patient age was 63.01 ± 10.71 years). Mean tumor size was 27.59 ± 10.10 mm (range: 8 - 53 mm). Laterally spreading tumor was the most common type (75 %), followed by the protruding type (25 %). Procedure time was 61.95 ± 41.90 minutes (range: 5 - 198 minutes). Complete en bloc resection was achieved for 85 lesions (78.7 %). Perforation occurred in 22 patients (20.4 %). Multivariate analysis confirmed that tumor size [odds ratio (OR): 1.084; 95 % confidence interval (CI): 1.015 - 1.158; P = 0.017] and the presence of fibrosis (OR: 4.551; 95 %CI: 1.092 - 18.960; P = 0.037) were independent risk factors for perforation. All cases of perforation were managed with nonsurgical treatment. Younger age and abdominal pain appeared to be related to prolonged hospitalization. CONCLUSION: Tumor size and fibrosis are important factors related to complications during colorectal ESD. Younger age and development of abdominal pain can predict the hospital course in patients with perforation after ESD.

Effects of polyhemoglobin-antioxidant enzyme complex on ischemia-reperfusion in kidney.

INTRODUCTION: The kidney suffers ischemia-reperfusion (I/R) injury during transplantation. The purpose of the present study was to investigate the therapeutic effect of artificials cells on renal I/R injury through biochemical assays and histological examination. METHODS: We prepared artificial cells using cross-linked hemoglobin (Hb), superoxide dismutase (SOD), and catalase. Normal male Sprague-Dawley rats were divided into 6 groups: the sham-operated control group, the group treated with polyHb,and the group treated with polyHb-SOD-catalase (PSC) (per groups were subjected to ischemia for 1 hour or 2 hours). After reperfusion for 4 hours, kidney and blood samples were obtained. RESULTS: The levels of SOD and catalase in the PSC group were 15 and 50 times higher than those of the control group, respectively. In the polyHb group, the levels of blood urea nitrogen (BUN), serum creatinine, renal hydrogen peroxide, and renal malondialdehyde were increased. However, their levels were significantly decreased by PSC administration. Renal SOD activity did not show any significant changes in the polyHb group, but renal catalase activity was decreased by polyHb treatment in comparison with the control group. The activities of renal SOD and catalase were increased using PSC treatment. In the histological findings, the PSC group showed no evidence of acute tubular necrosis in proximal convoluted tubules; their microvilli and cytoplasmic microorganelles were relatively well preserved. CONCLUSIONS: These results show that PSC effectively reduces renal damage via diminished oxygen free radical-mediated injury after I/R.

Effect of artificial cells on hepatic function after ischemia-reperfusion injury in liver.

BACKGROUND: The liver suffers from ischemia/reperfusion injury during transplantation. Reactive oxygen species generated by xanthine oxidase during reperfusion of the ischemic liver may be partially responsible for the hepatic injury. Oxygen free radicals are removed by antioxidant enzymes such as superoxide dismutase (SOD), catalase, and glutathione peroxidase. Using glutaraldehyde and lysine we constructed crosslinked hemoglobin, containing SOD and catalase, and assessed its ability to protect against ischemia/reperfusion injury during transplantation. METHODS: In contrast to the sham-operated control groups, blood was exchanged using crosslinked hemoglobin (polyHb) a PolyHb-SOD-catalase (PSC) group. After ischemia/reperfusion injury, several parameters of hepatic damage and oxygen free radicals were measured as well as microscopic examination. RESULTS: Alanine aminotransferase, aspartate aminotransferase, superoxide production, hydrogen peroxide, and malondialdehyde levels were higher among the PolyHb group than sham-operated controls. The PolyHb group revealed a few apoptotic bodies, some acute inflammatory infiltrates in the sinusoids, nuclear fragmentations, cell shrinkage, and chromatin clumping with formation of apoptotic bodies in the apoptotic cells under microscopic examination. Alanine aminotransferase, aspartate aminotransferase, superoxide production, and hydrogen peroxide levels were lower in the PSC than the PolyHb group. Hepatic structures were well preserved in the PSC group. CONCLUSIONS: Reactive oxygen species contribute to hepatic dysfunction with morphologic changes. PSC is effective to reduce hepatic damage by lowering oxygen free radical-mediated injury after ischemia/reperfusion in the liver.