[A single nocturnal dose of ranitidine in short-term therapy of duodenal ulcer. A controlled double-blind multicenter study].
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Biomedical subjects
Publications and source records attributed to A Pera.
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Somatostatin was compared with intensive antacid and thrombin in a randomised controlled study on 15 patients with severe haemorrhages of the upper digestive tract deriving from peptic ulcers and identified endoscopically in order to assess the efficacy of the two drugs. The results in both groups were similar but somatostatin appeared more effective than antacids and thrombin in terms of blood transfusions required and the average time it took to stop the bleeding. The insignificance of these results is in contrast with the data from similar studies using other drugs (anti-H2) and reported by others. This shows the need for controlled polycentric studies conducted on large groups of homogeneous patients.
We developed and evaluated a new procedure for imaging gastric ulcer disease with technetium 99m-labeled sucralfate. The new method employs direct in vivo labeling of sucralfate instead of in vitro labeling using human serum albumin, as previously reported in the literature. Tests using hydrochloric acid and a rabbit ulcer model showed the efficacy of the direct in vivo labeling technique and the ability of the tagged material to bind to ulcers, respectively. In 26 studies using humans with sucralfate labeled directly in vivo, 15 gave true-negative results and 11 gave true-positive results. Of 14 studies using humans with in vitro labeled sucralfate, three gave true-negative results, three gave true-positive results, and the results of eight were either false-negative or could not be interpreted because of high levels of activity remaining in the stomach. We suggest that the direct in vivo labeling method significantly improves the sucralfate gastric ulcer imaging technique.
The diagnostic accuracy of abdominal ultrasonography in Crohn's disease has been assessed in a prospective, randomized, simple-blind controlled study. A group of 181 out-patients (89 with accertained Crohn's disease and 92 controls) was studied. Considering "target sign" and/or "probable signs" of Crohn's disease, ultrasonographic sensitivity in diagnosing Crohn's disease was 84% and specificity 83%. Abdominal ultrasonography is indicated in the differential diagnosis of inflammatory bowel diseases, in the screening and follow-up of patients with Crohn's disease and in cases with contraindications to X-Ray examinations.
Candida overgrowth in gastric juice of peptic ulcer subjects under therapy with H2-receptor (H2-R) antagonists has been detected in 21.4 and 53.8% of cases after short- and long-term treatment respectively, and in 8% of controls. Both types of H2-R antagonists, ranitidine and cimetidine, were equally associated with production of yeasts. The location of ulcers, whether gastric or duodenal, seems to have no influence on fungal growth. Females were more susceptible than males to develop Candida in gastric juice. In the short-term course with H2-R blockers fungal colonization of gastric juice was associated with delay of the rate of ulcer healing. Fungal detection in gastric juice was not associated with mucosal invasion by Candida since in none of the patients who had a biopsy for gastric ulcer was Candida detected by histology.
We have studied fasting levels and the response to a standard test breakfast of blood glucose and several gut hormones in 24 patients with ulcerative colitis, in 14 patients with Crohn's disease, and in 14 healthy control subjects. Patients with ulcerative colitis had significantly elevated fasting human pancreatic polypeptide (HPP) concentrations, and both basal and postprandial levels of gastrin, gastric inhibitory polypeptide (GIP), and motilin were greater than normal. In contrast, patients with Crohn's disease had normal gastrin levels but had increased fasting and postprandial levels of GIP and motilin and, in addition, of enteroglucagon, compared with controls. These patients also had greater than normal HPP concentrations 30 min after the breakfast. Normal levels of insulin, pancreatic glucagon, neurotensin, and vasoactive intestinal polypeptide were found in both groups of patients. Much remains to be known about the pathophysiology of these two debilitating diseases, and the abnormal release of gut hormones may be of importance.
To investigate the possible role of gut and pancreatic hormones in the adaptive responses to gut resection, plasma concentrations of the circulating hormones were measured, in response to a test breakfast, in patients with either small or large intestinal resection and in healthy control subjects. In 18 patients with partial ileal resection a significant threefold rise was found in basal and postprandial levels of pancreatic polypeptide, a fourfold increase in motilin, and more than a twofold increase in gastrin and enteroglucagon levels compared with healthy controls. In contrast, nine patients with colonic resection had a threefold rise in levels of pancreatic polypeptide only. One or more of these peptides may have a role in stimulating the adaptive changes found after gut resection.
171 duodenal ulcer patients were treated for four weeks with either ranitidine or placebo under double-blind conditions. 40 patients (monocentre study) received ranitidine (40 mg), or placebo t.d.s. with meals and 80 mg at bedtime. 131 patients (multicentre study) received ranitidine (150 mg), or placebo b.d. In the monocentre study endoscopy after 4 weeks of treatment showed complete healing in 83.3% of the ranitidine patients and 30.4% of those on placebo (P less than 0.01%). In the multicentre study the healing percentages were 79.4% and 30.4%, respectively (P less than 0.001). In both trials pain and antacid consumption decreased in patients taking ranitidine more than in patients on placebo. After 4 weeks in the double blind studies 13 of the 15 patients with unhealed ulcer in the monocentre study and 51 of 54 patients in the multicentre study received open treatment with ranitidine for another 4 week period. The overall healing percentages by the 8th week of treatment with ranitidine were 94.4% and 93.6% respectively. No serious side effects, or haematological changes were observed during the treatment with ranitidine.
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We have used a simple and precise radioimmunoassay to measure trypsin in human plasma. Fasting plasma trypsin concentrations were extremely low in patients with chronic pancreatitis with steatorrhoea (5 +/- 2 ng/ml) when compared to healthy controls (86 +/- 7 ng/ml, p less than 0.001). In patients with chronic pancreatitis but no steatorrhoea basal plasma trypsin levels were similar to those of the normal controls (99 +/- 25 ng/ml). A small but significant postprandial rise in plasma trypsin concentrations was observed in normal subjects (mean increment 15 +/- 4%, p less than 0.005, paired t test) but was absent in patients with chronic pancreatitis with steatorrhoea. In contrast to exocrine deficient chronic pancreatitis, other malabsorptive conditions associated with steatorrhoea (active coeliac disease and acute tropical sprue) demonstrated mean fasting trypsin concentrations similar to controls. Patients with adenocarcinoma of the pancreas had basal trypsin concentrations similar to healthy subjects as did patients with adenocarcinoma of the stomach, colon, rectum, brochus, and breast. In some cases measurement of plasma trypsin may be of help in the differential diagnosis of steatorrhoea.
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Unspecific binding of immunoglobulins to gastrin, somatostain and glucagon cells of the gastrointestinal mucosa or pancreas has been found to occur through a nonantigen-antibody mechanism mediated by the C14 fraction of complement. The phenomenon represents an important drawback in hormone immunohistochemistry, which can be overcome by using complement deprived, highly dilute anti-hormone sera.
Antral somatostatin- and gastrin-producing cells (D and G cells) were studied in a group of patients with chronic renal failure (CRF) in comparison with a control group. Gastric acid secretion and serum gastrin, phosphate, and parathormone (PTH) levels were also evaluated in every patient. The group with CRF showed a mild increase both in G- and in D-cell denisty. In this group serum phosphate and PTH levels were higher than normal, showing hyperparathyroidism in every patient. A direct correlation was found between G-cell density and parathyroid function in patients with CRF. Hyperparathyroidism, therefore, seems to play a role in the mechanism of increased serum gastrin levels in CRF.
The incidence of connective tissue antibodies was assessed in 3,000 adults and in 388 pediatric patients with gastroenterological disorders. Following a previous classification, connective tissue antibodies were distinguished in 5 different types, R1 and R2 reacting with reticulin components, KC with Kupffer cells, AC and Rs with intra- and extracellular mesenchymal antigens. R1 predominated in children and was observed only in patients with malabsorption; the great majority of them had celiac disease and an abnormal small bowel mucosa. Ac was rarely seen in children and occurred in several unrelated gastrointestinal diseases of the adult; its incidence, however, was significantly higher in disorders with idiopathic and secondary malabsorption. R2, KC and Rs were seen only occasionally in unrelated gastroenterological disorders without malabsorption. R1, therefore, seems to be strongly suggestive of a malabsorption syndrome with abnormal small bowel mucosa and AC is a nonspecific reaction occuring predominantly in primary and secondary malabsorption; the other connective tissue antibodies have no clinical significance in gastroenterological disorders.
A double-blind 4-week trial of cimetidine (1 g daily) versus placebo was conducted in 68 adult outpatients with active duodenal ulceration endoscopically confirmed. 3 of the patient admitted to the study (1 on cimetidine and 2 on placebo) did not complete the trial. After 4 weeks of treatment, 25 of 33 patients (76%) receiving cimetidine had healed their ulcers compared with 15 (47%) of 32 patients receiving placebo (p less than 0.02). Antacid consumption was also significantly decreased by cimetidine when compared with placebo. Tolerability of the drug was good.
Cimetidine, a non-thiourea-containing histamine H2-receptor antagonist, has been employed in the treatment of peptic ulcer. We studied 50 patients, partly with double-blind method, and partly in a free trial. Duodenal ulcers were completely healed in 80% of the cases, at the control endoscopy after a 4-week period of treatment with cimetidine (1000 mg/day). Peptic ulcer in general healed in 76% of the cases. Gastric secretion was significantly reduced after cimetidine. An important improvement in subjective symptoms was noted in every patient. No toxic effect was noted.
Antral gastrin-producing cell (G-cells) were counted by an immunofluorescence technique in the antral biopsies obtained at endoscopy from 67 subjects; they included patients with duodenal ulcer, gastritis, and individuals with a normal gastric mucosa. The G-cell count was significantly lower (P less than 0.01) in patients with duodenal ulcer (142 G cells per mm2) in comparison to normal subjects (327 G cells per mm2). No statistically significant correlation was found between the G-cell number and any of the other parameters tested (pentagastrin test, basal serum gastrin and its response to a standard meal).