Comparison between Ranitidine and Omeprazole for Protection against Gastroduodenal Damage Caused by Naproxen

Acute gastroduodenal injury is commonly associated with the use of nonsteroidal anti-inflammatory drugs. The mechanism of injury is not well understood. The objectives of this study were to evaluate the protective effect of two drugs that give different degrees of acid inhibition against naproxen-induced gastroduodenal injury. Fifteen volunteers aged 22–28 years underwent pre- and post-treatment gastroduodenoscopies during three treatment periods (that is, six examinations), and mucosal injury was graded on a Lanza scale ranging from 0 to 4. The subjects placebo, 150 mg ranitidine twice daily, or 40 mg omeprazole in a double-blind, random-order design for 7 days. Plain naproxen, 500 mg twice daily, was given on days 3–7. The mean injury score for the stomach during placebo treatment was 1.53, and ranitidine gave 44% and omeprazole 40% reduction compared with placebo, which did not reach statistical significance. About 70% of the stomach injury was located in the antrum. The mean injury score during placebo for the duodenum was 1.93, and ranitidine gave 80% and omeprazole 90% reduction (p = 0.004). In conclusion, a correlation between different degrees of acid suppression and a protective effect on the gastroduodenal mucosa could not be shown. The study suggests that acid plays a major role in acute naproxen-induced injury to the duodenal mucosa, and a moderate acid reduction is adequate for protection. In the stomach acid seems to play a minor role in the mucosal injury, but physicochemical contact with naproxen in the antrum and a cyclooxygenase inhibition are of greater importance.     

Fibrin-Film Stenting in a Porcine Coronary Injury Model: Efficacy and Safety Compared With Uncoated Stents

Objectives. This study was designed to test the efficacy and safety of a fibrin-film–covered stent compared with that of a bare metal stent in the porcine coronary injury model.Background. Biodegradable stents are a potential method of achieving total lesion coverage and delivering local, lesion-specific drug therapy.Methods. Two coronary arteries in each pig were randomly assigned to deployment of either a fibrin-film or a bare tantalum wire-coil stent. An oversized balloon injury, 1.15 to 1.30 times the reference vessel diameter, was induced in each coronary segment before stenting to simulate angioplasty injury. Thirty pigs were studied: group 1 for 28 days (15 pigs); group 2 for 90 days (5 pigs); group 3 for 6 months (5 pigs); group 4 for 1 year (5 pigs).Results. Two pigs died of occlusion of the bare stent and one of occlusion of the fibrin stent (p > 0.99). There were no significant differences between the fibrin-stented and bare-stented coronary segments with regard to arterial injury. In group 1 (28 days, 14 pigs), the mean neointimal thicknesses in the fibrin-stented and bare-stented groups were 0.57 ± 0.31 and 0.57 ± 0.27 mm, respectively (p = 0.89). In groups 2 to 4 (90 days, four pigs; 6 months, four pigs; 1 year, five pigs), the mean neointimal thicknesses for fibrin- and bare-stented coronary segments at the times studied were 0.48 ± 0.26 versus 0.50 ± 0.22 mm at 90 days; 0.35 ± 0.04 versus 0.35 ± 0.16 mm at 6 months; and 0.33 ± 0.14 versus 0.30 ± 0.14 mm at 1 year (p = 0.98).Conclusions. Fibrin-film stents appear to be an excellent candidate for local drug delivery because they can completely and safely cover the stented coronary segment while degrading slowly over 1 to 3 months. This result is important when compared with the poor results of previous studies of synthetic polymer stents.     

Medium-or High-Dose Omeprazole Plus Amoxicillin Eradicates Helicobacter pylori in Gastric Ulcer Disease

Objective: To compare the efficacy of two omeprazole/amoxicillin regimens concerning Helicobacter pylori eradication, ulcer healing, pain relief, and safety in patients with gastric ulcer disease. Methods: In a prospective, single-blind, single-center study, 70 patients with active, H. Pylori -positive (histology and/or culture) gastric ulcers were randomly treated with either omeprazole 20 mg b.i.d . plus amoxicillin 1 g b.i.d . (group I; n = 35) or with omeprazole 40 mg b.i.d . plus amoxicillin 1 g b.i.d . over 2 wk, followed by full dose ranitidine for another 4 wk. Patients were investigated clinically and endoscopicaily prior to treatment and after 6 wk, including the assessment of H. pylori status by means of urease test, specific culture, and histology. Results: Patients of group I and II had similar demographic and clinical characteristics. Three patients were lost to follow-up. The overall proportion of H. pylori eradication was 88.1% (group I, 91.2%; group II, 84.8%, p = NS). The ulcer healing rate was 79.1% after 6 wk, 92.5% after 10 wk, and 100% after 6 months, without a statistically significant difference between the study groups. Complete pain relief occurred after a median of 2 days (group I) and 1.5 days (group II, p = NS), respectively. Six patients (9.0%) complained of side effects that led to discontinuation of amoxicillin treatment in three patients (4.5%). Conclusions: Omeprazole plus amoxicillin is a highly effective and well-tolerated therapy regimen to eradicate H. pylori from the gastric mucosa of patients with gastric ulcer disease. In addition, the results clearly suggest that medium- and highdose omeprazole schedules are equally effective with regard to bacterial eradication, ulcer healing, pain relief, and safety in gastric ulcers. Thus, medium- and not high-dose omeprazole plus amoxicillin should be the treatment regimen of first choice to eradicate H. pylori in gastric ulcer disease.     

Omeprazole Plus Amoxicillin: Efficacy of Various Treatment Regimens to Eradicate Helicobacter pylori

In five subsequent open clinical studies, 180 patients with Helicobacter pylori (HP)-associated ulcer disease (n = 163) or severe functional dyspepsia (n = 17) requiring therapy were treated with either 40 mg omeprazole plus 4 × 500 mg amoxicillin suspension for 1 wk (group I, n = 35), 2 × 40 mg omeprazole plus 4 × 500 mg amoxicillin for 1 wk (group II, n = 50), 2 × 20 mg omeprazole plus 4 × 500 mg amoxicillin for 2 wk (group III, n = 62), 2 × 20 mg omeprazole (day 1–14) and 4 × 500 mg amoxicillin (day 8–14) (group IV, n = 22) or with 2 × 20 mg omeprazole for 2 wk (group V, n = 11). The HP eradication rates determined with a biopsy urease test, microscopy of a mucosal smear, specific culture, and histology after modified GIEMSA staining in the 5th wk after discontinuation of study medication were 61.3% in group I, 61.7% in group II, 82.8% in group III, 28.6% in group IV, and 0% in group V. Apart from clinical insignificant pharyngeal paresthesias (n = 6), nine patients (5.7%) with combined therapy complained of important side effects (stomatitis: n = 3, diarrhea: n = 3, allergic exanthema: n = 3) that led to termination of amoxicillin treatment in four cases (2.5%). We conclude that omeprazole-enhanced amoxicillin antibiosis is a simple and effective approach to the eradication of HP colonization.     

The Efficacy and Toxicity of Paclitaxel Plus S-1 Compared With Paclitaxel Plus 5-Fu for Advanced Gastric Cancer: A PRISMA Systematic Review and Meta-analysis of Randomized Controlled Trials

The standard treatment for patients with advanced gastric cancer (AGC) is still a matter of debate. The chemotherapy regimen of paclitaxel (PTX) combined with S-1 has been used to treat AGC or metastatic gastric cancer.We conducted a meta-analysis to compare oral S-1 and infusional 5-fluorouracil (5-FU) to determine which agent was more efficacious and less toxic in combination with PTX. A systematic review with a meta-analysis was performed. PubMed, EmBase, the Cochrane Central Register of Controlled Trials, and the China National Knowledge Infrastructure databases were searched to select randomized controlled trials (RCTs) comparing PTX plus S-1 and PTX plus 5-FU in patients with AGC.Three RCTs were eligible and 352 patients were analyzed. PTX plus S-1 increased the disease control rate (risk ratio [RR] = 1.14, 95% confidence interval [CI] = 1.00–1.30, P = 0.04) and reduced the progressive disease rate (RR = 0.62, 95% CI] = 0.39–0.98, P = 0.04) compared with PTX plus 5-FU. There was a significant decrease in nausea (RR = 0.60, 95% CI = 0.43–0.82, P = 0.001) and vomiting (RR = 0.55, 95% CI = 0.33–0.91, P = 0.02) in patients treated with PTX plus S-1.PTX plus S-1 was associated with almost equivalent safety and a lower progressive disease rate compared with PTX plus 5-FU. PTX plus S-1 is a good alternative strategy for patients who cannot tolerate a continuous intravenous infusion.