M. Petrillo

Circulating trypsin-like immunoreactivity in chronic pancreatitis

The present study has been designed to work out the factors regulating the fasting serum levels of trypsin-like immunoreactivity in chronic pancreatitis. One hundred patients with chronic pancreatitis have been included and studied during a painless phase of the disease. No relationships have been observed between serum trypsin-like immunoreactivity and the presence of pancreatic calcifications. Serum immunoreactive trypsin levels showed a gradual decline parallel to the progressive impairment of bicarbonate and enzyme (trypsin and chymotrypsin) outputs in duodenal aspirates during pancreatic secretory studies. Therefore, serum trypsin-like immunoreactivity levels are thought to reflect the functional capacity of the exocrine pancreas. Reduced levels of trypsin-like immunoreactivity were detected in almost all patients with diabetes and steatorrhea. However, the finding of low levels also in a minority of chronic pancreatitis patients with normal endoscopic retrograde cholangiopancreatography or pancreatic secretory tests points to other factors which, in addition to the atrophy of the pancreatic parenchyma, may influence the circulating levels of trypsin-like immunoreactivity in chronic pancreatitis.

Comparative trial of methylprednisolone and budesonide enemas in active distal ulcerative colitis

Objective To compare the clinical effects of budesonide enema 2mg/100ml and methylprednisolone hemisuccinate (MP) enema 20mg/100ml once daily in active distal ulcerative colitis. Design Patients with mild or moderate distal ulcerative colitis (n = 88), which did not extend beyond the splenic flexure, were enrolled in a multicentre randomized investigator blind study comprising a blind treatment period of 4 weeks followed by a 4-week open phase with the same budesonide dose in patients with partial remission. Patients were assessed at 2, 4 and 8 weeks. Results At 4 weeks, 39% of patients on budesonide and 36% on MP were considered to be in clinical remission; budesonide was more effective in patients with moderate disease at entry (36 versus 29%). On sigmoidoscopy, no differences in the porportion of patients with no or only mild signs of mucosal inflammation were observed between budesonide and MP (43 versus 46%, respectively). No significant differences were observed in the histology scores. Of the 37 patients receiving budesonide for a further 4 weeks, 65% achieved symptomatic remission and 47% showed mucosal healing or substantial improvement on endoscopy at 8 weeks. Plasma cortisol levels fell significantly (P < 0.01) after 4 weeks in patients on MP, while only a slight change was observed in those on budesonide. After 8 weeks, plasma cortisol levels were unchanged in patients continuing on budesonide whereas in those switched from MP to budesonide, they approached the baseline value. No drug-related adverse experiences were observed. Conclusions Budesonide enema seems to be as effective as MP enema in the topical treatment of distal ulcerative colitis but unlike conventional steroids, it causes minimal or no adrenal supression.

Efficacy and tolerability of polyethylene glycol‐electrolyte lavage solution with and without simethicone in the preparation of patients with inflammatory bowel disease for colonoscopy

This placebo‐controlled study assessed the efficacy and tolerability of polyethylene glycol‐electrolyte lavage solution (PEG‐ELS), with and without simethicone, in the preparation of patients with inflammatory bowel disease for colonoscopy. PEG‐ELS 4 L plus placebo, or PEG‐ELS 4 L plus simethicone 120 mg, was administered according to a randomized double‐blind protocol to 115 patients with ulcerative colitis or Crohns disease. The parameters assessed were: presence of bubbles, degree of haziness, degree of bowel cleansing and patient acceptance. In the 105 patients completing the study, the efficacy of colonic lavage was found to be essentially comparable for the two preparations, although the addition of simethicone showed a significant reduction in the formation of bubbles. Significantly better results were reported by patients treated with the drug combination regarding reduction of general malaise (P= 0.01) and sleep disturbance (P= 0.01).

Upper GI bleeding in healthy full-term infants: a case-control study

Abstract OBJECTIVE: The aim of this case-control study was to evaluate the frequency and the type of mucosal lesions in newborn babies with upper GI bleeding (UGIB), the diagnostic role and safety of upper GI endoscopy, and the recognition of risk factors associated with the hemorrhagic event. METHODS: A population of 5180 infants born from June, 1988 to May, 1997 was examined. A case was defined as any patient who had UGIB within 4 days of delivery. The diagnosis was made by endoscopic examination in an endoscopy room. The following parameters were determined: amniotic fluid features, funicular blood pH, Apgar index at 5 min, neonatal weight, body length, gestational age, and the presence of other pathologies. Biochemical profiles were also evaluated. Clinical and demographic data of the mothers of the newborn babies were analyzed. Sera of cases and the respective parents were tested for gastrin and pepsinogen. As a control group, 53 full-term healthy infants matched for sex and age were randomly selected from the population of infants born in our pediatric department. RESULTS: Sixty-four of 5180 newborn babies (1.23%) suffered from UGIB within 26.5 ± 20 h of life. In 53 of 64 cases (mean age = 24.2 ± 25.5 h) it was possible to carry out an endoscopic examination. In one case, endoscopy was limited to the esophagus because of the presence of multiple mucosal ulcers and substenosis of the viscus. Esophageal damage was observed in 24/53 patients. The esophageal lesions were isolated in nine cases, and occurred jointly with gastric or duodenal damage in 14 cases and one, respectively. Gastric and duodenal lesions were seen in 43/52 and 1/52 patients, respectively. There were 17 cases of gastric ulcers and one case of duodenal ulcer. Blood clots were observed in 14 gastric ulcer patients; in one case there was evidence of active bleeding at the margins of a gastric ulcer. There was no significant difference with regard to the demographic and clinical characteristics of the cases and controls. Median values of serum gastrin of the cases and controls were similar. Median serum pepsinogen was significantly higher in the case group. CONCLUSIONS: UGIB in the newborn babies is often associated with clinically relevant mucosal lesions of the upper GI tract. The evolution, after treatment with antisecretory drugs, is generally rapid and favorable, with clinical recovery usually obtained within 24–48 h. The higher serum pepsinogen levels may only represent a significant risk factor of mucosal lesions and complications.

A double-blind gastroscopic evaluation of the effects of etodolac and naproxen on the gastrointestinal mucosa of rheumatic patients

Abstract. The aim of this clinical, endoscopical study was to evaluate the therapeutic efficacy and the gastric tolerability of etodolac, a new anti‐inflammatory, non‐steroidal drug, compared with naproxen. The study was conducted on 48 patients suffering from rheumatoid arthritis, 44 of whom completed the trial. After an initial oesophago‐gastroduodenoscopy to exclude the presence of gastric mucosal lesions, patients were randomly allocated to double‐blind treatment with either etodolac 200 mg b.i.d. or naproxen 500 mg b.i.d. for a period of 4 weeks. Endoscopic control followed this treatment period. Both drugs proved effective in relieving clinical symptoms, without a statistically significant difference. Gastric mucosal lesions were observed in 15% of etodolac‐treated patients and in 46% of patients treated with naproxen (P < 0.05) (95% CI 0.01‐0.60). Painful dyspepsia was observed in 15% of patients treated with etodolac vs. 38% of patients on naproxen therapy. This study demonstrates that etodolac is at least as active as naproxen in relieving rheumatic symptoms, and its administration results in a significantly lower degree of gastric damage.

Ranitidine treatment in newborn infants: effects on gastric acidity and serum prolactin levels.

Data about the use of ranitidine in the early postnatal period are lacking. In this study, 30 term newborn infants < 2 days old with bleeding erosions in their upper gastrointestinal tracts were treated with ranitidine by continuous i.v. infusion (0.2 mg/kg/h) for 48 h and thereafter by mouth (5 mg/kg b.i.d.) for 1 month. Mean gastric pH (SD) rose from 4.27 (1.62) to 5.70 (0.95) during i.v. infusion; after oral therapy it was still 5.55 (1.25). Serum ranitidine concentrations were 642.4 (376.5) and 321.5 (368.2) ng/ml after i.v. and oral therapy, respectively, with wide interindividual variations; the correlation between serum ranitidine and gastric pH was found to be weak. No untoward effect was observed either on the cardiorespiratory rate or on creatinine and aminotransferase values. Mean serum prolactin concentration after i.v. therapy was found to be lower, although within the reference range, than in control infants; no significant correlation was observed between serum ranitidine and prolactin concentrations. From these data, a < 0.2 mg/kg/h rate seems to be advisable for continuous ranitidine infusion in neonates, whereas the 5 mg/kg b.i.d. regimen could be considered adequate for oral therapy.

Abnormal Semen Quality and Low Serum Testosterone in Men with Inflammatory Bowel Disease Treated for a Long Time with Sulfasalazine

Summary: Our purpose was to study the effects of long‐term salazopyrine treatment on male fertility.

Endoscopic Assessment of the Effects of Dipyrone (Metamizol) in Comparison to Paracetamol and Placebo on the Gastric and Duodenal Mucosa of Healthy Adult Volunteers

The potentially damaging gastric and duodenal effects of dipyrone, a nonnarcotic analgesic agent, were evaluated in three phases in comparison to placebo and paracetamol. Three groups of 12 healthy adult volunteers were treated in a double-blind study, according to a cross-over, randomization sequence, using the double-dummy technique, for two 15-day periods, with dipyrone 3 g/day and placebo (group I), dipyrone 1.5 g/day and placebo (group II), and dipyrone 1.5 g/day and paracetamol 1.5 g/day (group III). An esophagogastroduodenoscopy was performed at the beginning and end of each treatment period. In the first treatment group, grade-3 and 4 mucosal lesions were found after dipyrone administration (3 g/day) in 3 of 12 (25%) subjects (multiple antral erosions, gastric ulcer and duodenal ulcer, 1 case each), whereas grade-2 mucosal lesions (antral erosions) were detected in 1 of 12 cases (8%) after the corresponding placebo treatment. The difference between the two treatments, however, was not statistically significant (p > 0.05). Only in the gastric ulcer case were subjective symptoms reported (feeling of hunger). At the 1.5-g/day dose (groups II and III), dipyrone produced no gastroduodenal lesions, the endoscopic results showing no appreciable difference between dipyrone and either placebo (p = 0.54) or paracetamol (p = 0.99). No subjective symptoms were reported in any of these subjects. Dipyrone, administered for 2 weeks, has effects on the gastric and duodenal mucosa comparable to those of paracetamol and placebo, though noticeable damage is detectable at a dosage of 3 g/day.

Sucralfate and hydrocortisone enemas in the treatment of active ulcerative proctitis—a randomized single-blind comparative study

Background: Sucralfate is a non‐absorbable aluminium salt of sucrose octasulphate which in recent studies has proved to be of possible use in the treatment of active distal ulcerative colitis.

Sulglycotide in the prevention of nonsteroidal anti-inflammatory drug-induced gastroduodenal mucosal injury. A controlled double-blind double-dummy, randomized endoscopic study versus placebo in rheumatic patients

The aim of this double-blind, randomized placebo-controlled trial was to evaluate whether sulglycotide prevents the onset of gastroduodenal mucosal injury in patients with rheumatic disease treated with nonsteroidal anti-inflammatory drugs (NSAIDs). One hundred patients, free from endoscopically detectable lesions of the gastroduodenal mucosa, affected either by rheumatoid arthritis or osteoarthritis, and candidates for NSAID therapy, were randomly allocated either to 200 mg sulglycotide three times daily (n = 50) or to an indistinguishable placebo (n = 50) for 4 weeks, together with standard NSAID administration (50 mg diclofenac three times daily (n = 50); 50 mg indomethacin three times daily (n = 50)). Upper gastrointestinal endoscopy was repeated at the end of the study. It was possible to evaluate 86 patients after treatment (sulglycotide = 42, placebo = 44); diclofenac = 45, indomethacin = 41). Six of 42 patients (14%) in the sulglycotide group and 15 of 44 (34%) in the placebo group had developed gastric or duodenal ulcerative lesions (p = 0.02). These data suggest that sulglycotide prophylaxis may be useful for the prevention of gastric and duodenal ulcer associated with NSAID therapy in rheumatic patients.