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Biomedical subjects

M Petrillo

Publications and source records attributed to M Petrillo.

At least 19 recordsLinked to original sources

Aspirin for secondary prevention after acute myocardial infarction in the elderly: prescribed use and outcomes.

OBJECTIVES: To determine how often aspirin was prescribed as a discharge medication to eligible patients 65 years of age and older who were hospitalized with an acute myocardial infarction; to identify patient characteristics associated with the decision to use aspirin; and to evaluate the association between prescription of aspirin at discharge and 6-month survival. DESIGN: Observational study. SETTING: All 352 nongovernment, acute care hospitals in Alabama, Connecticut, Iowa, and Wisconsin. PATIENTS: 5490 consecutive Medicare beneficiaries who survived an acute myocardial infarction, were hospitalized between June 1992 and February 1993, and did not have a contraindication to aspirin. MEASUREMENTS: Medical charts were reviewed to obtain information on the prescription of aspirin at discharge, contraindications, patient demographic characteristics, and clinical factors. RESULTS: 4149 patients (76%) were prescribed aspirin at hospital discharge. In a multivariable analysis, an increased prescribed use of aspirin at discharge was correlated with several indicators of better overall health status (better left ventricular ejection fraction, absence of diabetes, shorter length of hospital stay, higher albumin level, and discharge to the patient's home). The prescribed use of aspirin at discharge was also associated with several specific patterns of care, including the use of cardiac procedures, beta-blocker therapy at discharge, and aspirin during the hospitalization. The prescribed use of aspirin at discharge was associated with a lower mortality rate 6 months after discharge compared with no prescribed aspirin (odds ratio, 0.77; 95% CI, 0.61 to 0.98), even after adjustment for baseline differences in demographic, clinical, and treatment characteristics between the two groups. CONCLUSIONS: Aspirin was not prescribed at discharge to 24% of elderly patients who were hospitalized with an acute myocardial infarction and did not have a contraindication to aspirin. Several patient characteristics were associated with a higher risk for not being prescribed aspirin. Increasing the prescription of aspirin for these patients may provide an excellent opportunity to improve their care.

Aged

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. AIM: The aim of this randomized, single-blind, study was to compare 10 g sucralfate with 100 mg hydrocortisone enemas in the treatment of 40 patients (26 male and 14 female; mean age 36.5 years, range 18-65 years) with active ulcerative proctitis, twice daily for 4 weeks. METHODS: A clinical, sigmoidoscopic and histological assessment was performed before and 4 weeks after the start of the therapy. RESULTS: Both treatments showed significant within-treatment improvement in clinical, endoscopic and histological grades (Wilcoxon's matched pair test, P < 0.05). Between-treatment comparisons, using the Mann-Whitney test, showed that hydrocortisone is more effective than sucralfate in improving the clinical score (P < 0.05). CONCLUSIONS: Sucralfate enema treatment, which was significantly less effective than hydrocortisone enemas in this study, has very limited use in the treatment of active ulcerative proctitis.

Administration, Topical

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.

Acetaminophen

Prevention with sucralfate gel of NSAID-induced gastroduodenal damage in arthritic patients.

OBJECTIVES: To evaluate the efficacy of a new formulation of sucralfate as gel (Gastrogel) in the short-term prevention of gastroduodenal lesions in arthritic patients receiving nonsteroidal anti-inflammatory drugs. METHODS: One hundred seven patients with arthritis (M/F 18/89, mean age 55.2 +/- 9.7 yr) enrolled in two centers were considered eligible for the study if initial endoscopy showed the absence of any relevant mucosal damage. Patients were randomly allocated to receive diclofenac 200 mg/day or naproxen 1 g/day plus either sucralfate gel 1 g b.i.d. (N = 53) or identical placebo (N = 54) for 14 days in a randomized double-blind study. Repeated assessment of GI symptoms and endoscopy were performed at the end of the study period. RESULTS: At final endoscopy the incidence of erosion and the mean endoscopic score for both stomach and duodenum were significantly lower in the sucralfate gel group compared with placebo group (p < 0.05). Both heartburn and epigastric pain were significantly less frequent in patients receiving sucralfate gel than placebo (51 vs 30% and 49 vs 28% for heartburn and epigastric pain, respectively, p < 0.05). No differences were observed in the incidence or in the mean score for nausea. An unexplained difference in the incidence of ulcers was found between the two centers, but in both a similar reduction in the incidence of ulcers was observed between patients receiving sucralfate gel compared with those receiving placebo. The overall difference (8% in sucralfate-treated patients, 28% in patients receiving placebo) of gastroduodenal ulcers was statistically significant (p < 0.05). CONCLUSIONS: Sucralfate gel reduces both the incidence of acute gastroduodenal mucosal lesions and symptoms in patients with arthritis receiving short-term nonsteroidal anti-inflammatory drugs.

Anti-Inflammatory Agents, Non-Steroidal

Aspirin in the treatment of acute myocardial infarction in elderly Medicare beneficiaries. Patterns of use and outcomes.

BACKGROUND: Although aspirin is an effective, inexpensive, and safe treatment of acute myocardial infarction, the frequency of use of aspirin in actual medical practice is not known. Elderly patients, a group with low rates of utilization of effective therapies such as thrombolytic therapy, also may be at risk of not receiving aspirin for acute myocardial infarction. To address this issue, we sought to determine the current pattern of aspirin use and to assess its effectiveness in a large, population-based sample of elderly patients hospitalized with acute myocardial infarction. METHODS AND RESULTS: As part of the Cooperative Cardiovascular Project Pilot, a Health Care Financing Administration initiative to improve quality of care for Medicare beneficiaries, we abstracted hospital medical records of Medicare beneficiaries who were hospitalized in Alabama, Connecticut, Iowa, or Wisconsin from June 1992 through February 1993. Among the 10,018 patients > or = 65 years old who had no absolute contraindications to aspirin, 6140 patients (61%) received aspirin within the first 2 days of hospitalization. Patients who were older, had more comorbidity, presented without chest pain, and had high-risk characteristics such as heart failure and shock were less likely to receive aspirin. The use of aspirin was significantly associated with a lower mortality (OR, 0.78; 95% CI, 0.70 to 0.89) after adjustment for potential confounders. CONCLUSIONS: About one third of elderly patients with acute myocardial infarction who had no contraindications to aspirin therapy did not receive it within the first 2 days of hospitalization. The elderly patients with the highest risk of death were the least likely to receive aspirin. After adjustment for differences between the treatment groups, the use of aspirin was associated with 22% lower odds of 30-day mortality. The increased use of aspirin for patients with acute myocardial infarction is an excellent opportunity to improve the delivery of care to elderly patients.

Aged

Mutual influence between vesicourethral and anorectal function in spinal cord injury patients.

There is clinical evidence of a relationship between urethrovesical and anorectal dysfunction in spinal cord injured patients. This study was performed to assess how rectal distension could influence the results of urodynamic investigations. Ten patients with spinal cord injury were submitted to repeated urodynamic evaluations under different rectal conditions after performing complete anorectal testing. Distension of the rectal ampulla may interfere with vesicourethral function in spinal cord injured patients: in those with complete spinal cord lesions rectal distension causes a reduction in bladder compliance, earlier and higher amplitude of the first hyperreflexic contraction, and an increase in detrusor-external urethral sphincter dyssynergia. We suggest that urodynamic evaluation of spinal cord injured patients should not normally be performed if the patient has a full rectum.

Anal Canal

The watermelon stomach: clinical, endoscopic, endosonographic, and therapeutic aspects in three cases.

BACKGROUND AND STUDY AIMS: To date, the endosonographic (EUS) appearance of watermelon stomach is unknown, and few reports have described the effectiveness of Nd:YAG lasers in the treatment of this condition. This study reports on the first EUS description of watermelon stomach, as well as the clinical, endoscopic, and EUS response to Nd:YAG laser therapy. PATIENTS AND METHODS: Three patients with watermelon stomach, diagnosed by endoscopy and histology, were studied with EUS before and after Nd:YAG laser treatment. RESULTS: On EUS, a thickened antral wall with a spongy appearance in the second and third layer in the areas of vascular structures was seen in all three cases, whereas the muscularis propria was well preserved. This appearance vanished after complete laser ablation of the lesions. CONCLUSIONS: EUS may be useful in the diagnosis of watermelon stomach, as well as in evaluating the completeness of laser ablation treatment for the condition.

Aged

Coated oral 5-aminosalicylic acid (Claversal) is equivalent to sulfasalazine for remission maintenance in ulcerative colitis. A double-blind study.

In a double-blind, single-center, 1-year prospective trial, we compared a pH-dependent Eudragit L-coated formulation of oral 5-aminosalicylic acid (5-ASA) (Claversal), 0.5 g b.i.d., and sulfasalazine (SASP), 1 g b.i.d., in the prophylactic treatment of quiescent ulcerative colitis. Forty-four patients received 5-ASA and 44 received SASP. Clinical, sigmoidoscopic, and histologic findings were assessed at 6 and 12 months. The two groups were comparable in all pretrial characteristics. No significant difference was observed in the relapse rate in the two groups either after 6 months [5-ASA 20.5%, SASP 27.5%, p = 0.32, 95% confidence interval (CI) 0.28 +/- 0.13] or after 12 months (5-ASA 38.4%, SASP 51%, p = 0.18, 95% CI 0.38 +/- 0.1). We conclude that (a) 5-ASA was as effective as SASP in maintaining remission of ulcerative colitis; (b) the relapse rate was, however, higher than expected in both groups; (c) the incidence of side effects was similar with both treatments.

Acrylic Resins

Gastroduodenal tolerability of nabumetone versus naproxen in the treatment of rheumatic patients.

OBJECTIVE: The objective of this endoscopic, double-blind study was to evaluate the gastric tolerability of nabumetone, a novel nonsteroidal anti-inflammatory drug, compared with naproxen in patients with rheumatoid arthritis. METHODS: Patients with definite or classic rheumatoid arthritis as defined by ACR criteria were eligible for entry into the study if an initial endoscopy was normal or showed the presence of only one erosion or one or two submucosal hemorrhages. After a 7-day washout period, the patients were randomized to receive either nabumetone, 1 g, or naproxen, 500 mg, b.i.d. Blinding was achieved by the use of double dummies. Endoscopy was repeated after 4 wk of treatment. The primary efficacy parameters were Ritchie articular index, duration of morning stiffness, and global assessments. RESULTS: Gastric mucosal lesions of different degrees were observed in 9% (2/22) of nabumetone-treated patients and in 40% (12/30) of those who received naproxen (p = 0.01). One duodenal ulcer was found in a patient treated with nabumetone, and this patient had a history of duodenal ulcer. In the naproxen group, six patients were found to have an ulcer. Clinical evaluation of rheumatological symptomatology showed no statistical difference in relieving symptoms between the two drugs in the primary efficacy assessments. However, six nabumetone-treated patients dropped out because of lack of efficacy, compared with one in the naproxen group. Side effects were noted in three patients treated with nabumetone and in 14 treated with naproxen (p = 0.004). CONCLUSION: This study showed that nabumetone, 1 g daily, results in significantly less deterioration of gastric mucosa than naproxen, 500 mg daily, but the efficacy of naproxen, 1 g, appears to be more than that achieved with nabumetone, 1 g.

Anti-Inflammatory Agents, Non-Steroidal

Low Pentasa dosage versus hydrocortisone in the topical treatment of active ulcerative colitis: a randomized, double-blind study.

OBJECTIVES: To compare a low dosage (1 g/day) rectal preparation of 5-aminosalicylic acid in slightly acidic, buffered suspension (Pentasa) with a hydrocortisone 100 mg/day enema (Cortenema). METHODS: Fifty-two patients with mild to moderate distal ulcerative colitis were randomized under double-blind conditions to receive a rectal preparation of either Pentasa (1 g/day) or Cortenema (100 mg/day) for 3 wk. RESULTS: After 3 wk, both types of treatment resulted in statistically significant improvements in clinical and endoscopic activity. No significant difference was observed between the two drugs in any of the parameters considered, although a statistical trend in favor of Pentasa was evident when analysis was limited to clinical activity (p = 0.07). No side effects were reported in either group. CONCLUSIONS: Our experience confirms that short term topical treatment with a low dosage 5-aminosalicylic acid is at least as effective as 100-mg hydrocortisone enemas in treating mild to moderate distal ulcerative colitis and is generally well tolerated.

Administration, Rectal

A role for acetylcholine in spatial memory in turtles.

The present research was undertaken to determine whether acetylcholine plays a role in memory for a maze in turtles. Cholinergic cells have been observed in the basal forebrain of turtles, and the basal forebrain of turtles projects to the dorsal cortex, a region that has been implicated in associative function. In Experiment 1, turtles were trained on an X-maze for water reward and then given lesions of the dorsal cortex or basal forebrain or sham lesions and retested postoperatively on the maze. Both dorsal cortex and basal forebrain lesions impaired performance on the maze. In Experiment 2, turtles were trained on the maze and then given saline, scopolamine, or methylscopolamine on a 1-day retention test. Scopolamine in the higher doses impaired maze performance on the test day, but methylscopolamine did not. The highest dose of scopolamine had no effect on measures of general activity, showing that the effects of the drug were specific to the learned task.

Acetylcholine

A comparison of severe gastric damage as a result of pirprofen and naproxen treatment in rheumatoid arthritis: a controlled endoscopic study.

OBJECTIVE: The aim of this controlled endoscopic study was to compare the therapeutic efficacy and the gastric tolerance of two nonsteroidal anti-inflammatory drugs, pirprofen versus naproxen. DESIGN: A randomized endoscopic double-blind double-dummy study. SETTING: The gastrointestinal unit of a teaching hospital. SUBJECTS: Forty patients suffering from rheumatoid arthritis were enrolled. After an initial upper gastrointestinal endoscopy to rule out the presence of gastric mucosal lesions, the patients were randomly allocated in a double-blind, double-dummy manner, to receive either pirprofen (400 mg t.i.d.) or naproxen (500 mg b.i.d.) for 4 weeks; endoscopic control followed this treatment period, or was anticipated in the event of painful dyspepsia. INTERVENTIONS: Endoscopy at the beginning of the study and at 4 weeks, or anticipated in the event of painful dyspepsia. MAIN OUTCOME MEASURES: Primary outcome measure of the study was the possibility that pirprofen was less toxic to the gastric mucosa than naproxen, and at least as effective. RESULTS: Both drugs proved effective in relieving clinical symptoms, without a statistically significant difference. Gastric mucosa lesions were observed in 90% of pirprofen-treated patients and in 60% of those on naproxen (P = 0.03). The most severe lesions (grades 3 and 4) were found in 65% of subjects treated with pirprofen, as opposed to 15% of those treated with naproxen (P = 0.001). CONCLUSIONS: This study shows that pirprofen is at least as active as naproxen in relieving rheumatic symptoms, but its administration results in a significantly severe degree of gastric damage.

Adult

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 Crohn's 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). The PEG-ELS solution represents an effective bowel cleansing method which can also be used for patients suffering from inflammatory bowel disease. The addition of simethicone to the traditional formulation is an acceptable development in terms of clinical efficacy and tolerability.

Adult

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.

Adolescent

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.

Administration, Oral

Diazemuls versus diazepam as premedication in upper gastrointestinal endoscopy: a randomised cross-over study.

The efficacy and tolerability of Diazemuls versus conventional diazepam as endoscopic premedication was evaluated in a study with a cross-over design performed in 26 patients undergoing upper gastrointestinal tract endoscopy. No statistically significant differences were found between the two forms of premedication with regard to degree of sedation, patient compliance or recovery of psychomotor function. With respect to short-term amnesic effects, efficacy and tolerability Diazemuls was comparable to the conventional formulation of diazepam. Diazemuls may therefore be proposed as an alternative premedication for endoscopy.

Adult

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

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 oesophagogastroduodenoscopy 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 less than 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.

Anti-Inflammatory Agents, Non-Steroidal

Treatment of refractory peptic ulcer with omeprazole or continued H2 receptor antagonists: a controlled clinical trial.

We tested the hypothesis that the gastric H+/K+ adenosine triphosphatase inhibitor, omeprazole, because of its different mode of action and pronounced inhibitory effect on gastric acid secretion, may be more effective in peptic ulcer that is refractory to histamine H2 receptor antagonist treatment than continuing the same therapy. Altogether 107 patients (duodenal ulcer, n = 88; prepyloric ulcer, n = 14; gastric ulcer, n = 3; mixed sites, n = 2) with refractory peptic ulcer - that is ulcer unhealed after at least two months' treatment with cimetidine 0.8 g or 1 g daily or with ranitidine 0.3 g daily - were randomly allocated to receive either omeprazole 40 mg daily (n = 54) or to continue treatment with the same H2 receptor antagonist and at the same dose (n = 53) for up to eight weeks. The patients in the two treatment groups were well matched demographically. Healing by 'intent to treat' analysis was as follows: at four weeks, omeprazole 46 of 54 (85%), H2 receptor antagonist 18 of 53 (34%) (p less than 0.0001); and at eight weeks, 52 of 54 (96%) and 30 of 53 (57%) respectively (p less than 0.0001). One patient was lost to follow up but of the 22 patients whose ulcers were shown to be unhealed at endoscopy after receiving continued H2 receptor antagonist treatment, 21 healed in four to eight weeks when changed to omeprazole. Daytime epigastric pain cleared at four weeks in 43 of 47 (91%) patients on omeprazole and in 32 of 46 (70%) on H2 receptor antagonists (p=0.01) and relief of all dyspeptic symptoms occurred in 39 of 47 (83%) and 23 of 45 (51%) (p=0.0009) patients respectively. Adverse events occurred in 11 of 54 (20%) patients on omeprazole and in 12 of 35 (34%) on cimetidine but in none on ranitidine. The events were mild and none required treatment withdrawal. The commonest event in patients on omeprazole was loose stools or diarrhoea (n=5). Omeprazole was significantly better than continued H2 receptor antagonist treatment for the short term management of refractory peptic ulcer as judged by healing rate and pain relief, and it was safe.

Cimetidine