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Biomedical subjects

L Aabakken

Publications and source records attributed to L Aabakken.

At least 73 records · Page 4Linked to original sources
PubMed1992

Naproxen-associated gastroduodenal toxicity: enteric coated granules versus plain tablets.

Two naproxen formulations were compared with regard to gastroduodenal endoscopic findings. Using a dose of 500 mg bid for one week, plain tablets were compared to enteric coated granules in a gelatine capsule in a randomized, cross over, double-blind, double dummy study in 16 healthy, male volunteers. Endoscopic evaluation revealed no difference between the two formulations. Since previous studies with enteric coated naproxen tablets indicated a favourable side effect profile compared to plain tablets, the present data indicates that enteric coated formulations are not all alike, and should be studied individually.

Adult↗
PubMed1992

NSAID-associated gastrointestinal damage: methodological considerations and a review of the experience with enteric coated naproxen.

Various methods are available for investigating gastrointestinal adverse effects of NSAIDs. Upper endoscopy is regarded a gold standard for controlled studies, but the grading and categorization of the visual impression of mucosal changes is complicated. Faecal blood loss represents another aspect of the toxicity, but quantitative measurements require the cumbersome procedure of 51Cr-labelling of red blood cells. For monitoring distal gut effects, permeability tests can be applied, and combination of tracer substances may further enhance the method. Measurements of electrical potential differences over the gastric mucosa are also available to monitor functional aspects of the gastric mucosal integrity. Controlled endoscopic trials have indicated an advantage of enteric coated naproxen tablets over plain tablets. Distal transfer of the toxicity by small bowel release of the active substance, has not been confirmed by permeability tests.

Endoscopy, Gastrointestinal↗
PubMed1992

Gastrointestinal bleeding associated with the use of non-steroidal, anti-inflammatory drugs--symptomatology and clinical course.

The symptoms associated with admission for gastrointestinal haemorrhage were studied in relation to the intake of non-steroidal, anti-inflammatory drugs (NSAIDs) within fourteen days prior to admission. In a prospective, two-year study we included only those with bleeding due to gastroduodenal ulcers or haemorrhagic erosive gastritis. In 94 patients with a median age of 74 years, NSAID use was stated in 54, but the symptoms in these subjects (degree of epigastric pain, nausea or heartburn) were no different from those without previous NSAID use. Correspondingly, no difference was seen as to the clinical course of the bleeding.

Adult↗
PubMed1991

[Psychomotor physical therapy--patients' starting point and their evaluation of the therapeutic results].

Psychomotor physiotherapy is a technique which aims, through relief of muscular tension and inhibited breathing, to give the patient a better understanding of the connection between mental and somatic reactions, establish improved coping patterns. In a three-year, prospective registration of 152 patients referred to psychomotor physiotherapy the expectations of the patients were evaluated, along with the presented symptoms. After 6-12 months of treatment 75% experienced a relief of symptoms, and 50% a change in symptom profile. At follow-up of 109 patients after 2 1/2 years we found a significant improvement in symptoms as well as in parameters for everyday coping, and a marked reduction in use of drugs. There was a correlation between an academic education and response to treatment.

Adult↗
PubMed1991

The SADE system: an endoscopic database manager.

The development of the SADE database manager was commenced in 1985 since no commercially available systems were suited for the needs of a large endoscopy unit. Over a period of five years, this database was programmed, revised and enhanced through the joint efforts of gastroenterologists and programmers, the SADE system being implemented for daily use on 1 January 1989. The patient administration and medical record modules are fully implemented and functional, while the statistical module has only recently been finished. The present features of the system are described, and the limitations discussed. Instant report generation and direct access to previous medical data are the most immediate benefits of the system. The initial intention to have structured anamnestic data had to be modified to suit the need for flexibility and ease of free text input by the users.

Computer Systems↗
PubMed1991

SADE database for endoscopic procedures: aspects of clinical use.

The time aspects of daily use of a clinical database system in an endoscopy department were studied. The SADE database system for endoscopic procedures was introduced for daily use at Ullevål Hospital on 1 January 1989. The average weekly programme of the endoscopy unit includes 57 gastroduodenoscopies, 23 colonoscopies and 12 ERCP/EPTs. During three consecutive weeks of the study the mean physician input time was 4 min 17 sec per patient (range 57 sec to 15 min), individual variation depending mainly on the extent of the report. Assistants spent a mean time of 4 min 23 sec for each patient. Thus, a total of 8 min 40 sec was spent for every patient seen. Endoscopic units should analyze their routines and needs before introducing an electronic data base manager.

Database Management Systems↗
PubMed1991

Gastrointestinal bleeding: dyspeptic symptoms and clinical course in relation to use of non-steroidal antiinflammatory drugs.

To study the symptoms of NSAID-associated gastroduodenal bleeding, 94 patients (median age 71 years, range 19-90), were included in a prospective, clinical trial where hematemesis or melena from gastroduodenal ulceration or haemorrhagic/erosive gastritis were the inclusion criteria. NSAID use within one month was studied in relation to subjective symptoms prior to admission and to clinical course of the episode. Significantly fewer of the NSAID users (n = 54) than the non-users (n = 40) had experienced prior peptic ulceration or dyspeptic symptoms. Otherwise, no differences were seen between users and non-users, as regards pre-admission epigastric pain, heartburn or nausea. Also, the clinical course was similar in the two groups. We also found sporadic and regular NSAID use to be similar in this respect. These data do not support the alleged masking of ulcer symptoms by NSAIDs in bleeding ulcers.

Adult↗
PubMed1990

NSAID-associated gastroduodenal damage: does famotidine protection extend into the mid- and distal duodenum?

Eighteen healthy volunteers were included in a cross-over, double-blind study where 500 mg naproxen b.d. was given for 1 week with 20 mg famotidine b.d., 40 mg nocte or placebo. Endoscopic evaluation of the gastroduodenal mucosa was performed before and after each treatment period, with separate evaluation of the mid- and distal duodenum. 51Cr-EDTA-permeability tests were done to study effects on the mid- and distal gut, and, in addition, symptom registration was performed. The mucosal damage was significant in all treatment periods, and a statistically significant reduction was seen with 20 mg famotidine b.d. for erosive lesions in the stomach/duodenal bulb region as well as for the sum of damage score in the mid- and distal duodenum. The reduction was considerable in a few subjects with extensive duodenal damage. The reduction was considerable in a few subjects with extensive duodenal damage. Intestinal permeation increased significantly in all periods, and was not reduced by famotidine. Symptoms were modest and equal in all periods.

Adult↗
PubMed1990

51Cr-ethylenediaminetetraacetic acid absorption test. Effects of naproxen, a non-steroidal, antiinflammatory drug.

Eighty volunteers were studied to determine the effects of 750 or 1000 mg naproxen daily for a week on intestinal permeability, by means of the 51Cr-ethylenediaminetetraacetic acid (EDTA) absorption test. With 750 mg naproxen (n = 42) the median urinary excretion increased from 2.44% to 3.51% (p less than 0.01), and with 1000 mg (n = 38) from 2.26% to 3.39% (p less than 0.01). When the individual pretreatment absorption was included in the analysis, a statistically significant difference was found between the two doses (19% and 68% median increase as a percentage of base line, respectively (p = 0.04)). Similar results were found in 27 subjects who were given both doses of naproxen. Intraduodenal instillation of the test dose in 18 subjects showed that gastric absorption was negligible, and no correlation was found with upper endoscopy findings, changes in orocoecal transit time, or reported symptoms.

Adult↗
PubMed1990

Gastroduodenal lesions induced by naproxen. An endoscopic evaluation of regional differences and natural course.

Gastroduodenal endoscopic findings were studied in 65 healthy volunteers receiving 750 mg or 1000 mg naproxen for 1 or 2 weeks. Separate registration of the mid- and distal duodenum showed that mucosal toxicity can be demonstrated even distally to the duodenal bulb. The lesions were closely correlated to the findings in the stomach and duodenal bulb, though generally somewhat less extensive. Whereas a difference between 750 mg and 1000 mg naproxen was demonstrated in an intraindividual comparison (n = 26; median sum of visual analogue scale score in the stomach/duodenal bulb, 129 mm and 183 mm, respectively; p less than 0.05), no difference was seen in two parallel groups (n = 32 and 33). In the stomach and duodenal bulb, a significant aggravation of mucosal lesions was seen from 1 to 2 weeks in 16 subjects. Healing was complete in 10/12 subjects after 3 weeks, independent of the extent of the initial damage.

Adolescent↗
PubMed1990

Visual analogue scales for endoscopic evaluation of nonsteroidal anti-inflammatory drug-induced mucosal damage in the stomach and duodenum.

The use of visual analogue scales in the evaluation of mucosal lesions may reduce sample size requirements in clinical trials, but they may be complex to use, and adding guide points may reduce their informative value. We found that two investigators with differing levels of endoscopic experience reached comparable conclusions in 4 clinical trials (738 scores), and their scores were highly correlated, with similar dispersion characteristics. With guide texts along the scales, thus avoiding points on the actual scales, no tendency towards accumulation was seen in 1449 scores. These results encourage the use of visual analogue scales in endoscopic studies.

Adolescent↗
PubMed1989

Optimal assessment of gastrointestinal side effects induced by non-steroidal anti-inflammatory drugs. Endoscopic lesions, faecal blood loss, and symptoms not necessarily correlated, as observed after naproxen and oxindanac in healthy volunteers.

Gastrointestinal side effects caused by naproxen and oxindanac (a developmental non-steroidal anti-inflammatory drug) were compared by combined endoscopy and determination of faecal blood loss in 16 healthy male volunteers in a randomized, double-blind, crossover study. Individual daily faecal blood loss was determined by means of 51Cr-labelled erythrocytes. Gastroduodenoscopy was performed before and after administration of naproxen, 750 mg/day, and oxindanac, 600 mg/day, for 1 week each. A washout period of at least 3 weeks was inserted between drug periods. Visual analogue scales (VAS) were used for endoscopic assessment of lesions and subjective complaints. Mean faecal blood loss increased from a base line 0.48 ml/24 h to 1.59 ml/24 h with naproxen (p less than 0.01) and from 0.56 ml/24 h to 1.31 ml/24 h with oxindanac (p less than 0.01). VAS scores for gastroduodenal lesions increased significantly with both drugs. Naproxen caused a significantly greater increase than oxindanac (p less than 0.05). There was no correlation between gastrointestinal blood loss and endoscopic findings. Subjective symptoms were correlated to faecal blood loss with naproxen, but not to endoscopic findings. No such correlations were observed for oxindanac. Naproxen caused a significant prolongation of bleeding time (p less than 0.01), whereas the increase caused by oxindanac was not significant (p = 0.09).

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1989

Non-steroidal anti-inflammatory drug-induced disease in the distal ileum and large bowel.

Non-steroid, anti-inflammatory drug (NSAID)-induced lesions in the gut are common, but so far most focus has been placed on the gastroduodenal mucosa. However, an increasing number of reports describe deleterious effects on the distal gut as well. Findings range from asymptomatic mucosal inflammation to stricture and obstruction, perforations, and major hemorrhages. Induction and exacerbation of inflammatory bowel disease has also been noted for most of the commercially available NSAIDs. Although final proof of a causal relationship is lacking, the indices present strongly suggest such a connection. The mechanism is largely unknown, although inhibition of cyclooxygenase with subsequent depletion of endogenous prostanoid synthesis has been suggested as a mediator. If surgery can be avoided, stopping the NSAID therapy is often sufficient to obtain lasting remission. The main point is knowledge of this facet of NSAID use, so that the pertinent drug history is obtained. Determination of the distal gut effects should probably also be included in the evaluation of present and future NSAIDs.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1989

Comparison of the gastrointestinal side effects of naproxen formulated as plain tablets, enteric-coated tablets, or enteric-coated granules in capsules.

We studied the gastrointestinal side effects of three formulations of naproxen in 18 healthy male volunteers. In a Latin-square design crossover study, the subjects received 500 mg naproxen twice daily for 7 days as plain tablets, enteric-coated tablets, or enteric-coated granules in capsules. The 51Cr-EDTA absorption test was performed before and at the end of each drug period, to evaluate changes in the distal gut. The test dose was instilled distally in the duodenum to prevent lesions in the stomach from interfering with the evaluation. Upper endoscopy was performed at the same intervals, scoring changes in the middle and distal duodenum separately from findings in the stomach and duodenal bulb. The nature and severity of adverse effects were recorded for each treatment period. Non-parametric methods were used for statistical evaluation. All drugs induced a significant increase in 51Cr-EDTA absorption, but we did not detect any difference between the three formulations. All formulations were associated with a significant increase in all the endoscopic findings monitored. Enteric-coated tablets induced significantly less lesions than enteric-coated granules in the stomach and duodenal bulb, and an advantage over plain tablets was indicated. No difference was seen in the middle and distal duodenum. The proximal endoscopic scores were not correlated to those found in the middle and distal duodenum. Evaluation of the small and large bowel should probably be included in clinical studies of NSAIDs, but our findings suggest that the importance of transfer of mucosal lesions to the distal gut by enteric coating may have been overemphasized.

Adult↗
PubMed1989

Cr-ethylenediaminetetraacetic acid absorption test. Methodologic aspects.

The 51Cr-ethylenediaminetetraacetic acid (EDTA) absorption test was evaluated in 83 healthy, male volunteers. Base-line 24-h excretion after peroral administration ranged from 0.88% to 7.96%, with a higher median absorption than reported by most authors (2.45%). However, the reproducibility and stability of the method and the reproducibility of the results were satisfactory. Urinary excretion after intraduodenal instillation (n = 18) was comparable to that seen after peroral test dose administration, indicating a limited significance of gastric 51Cr-EDTA absorption under normal conditions. In 16 subjects a single intake of alcohol immediately before the test gave a modest and short-lasting increase in 51Cr-EDTA absorption. No correlation was seen to body mass index, creatinine clearance, urinary volume, or small-bowel transit time, possibly reducing the number of confounding factors in the evaluation of absorption data. A small but significant negative correlation was, however, found to body surface area and age.

Adolescent↗
PubMed1989

Sucralfate for prevention of naproxen-induced mucosal lesions in the proximal and distal gastrointestinal tract.

To study the protective effect of Sucralfate on Naproxen-induced mucosal lesions, 16 healthy, male volunteers were given Naproxen 500 mg b.i.d. together with Sucralfate 2 g b.i.d. or placebo in a double-blind, crossover study. Drug periods were 1 week, with a 3-week wash out in between. Mucosal lesions in stomach and duodenum were assessed by upper endoscopy before and after each drug period, using a visual analogue with separate scoring of mid- and distal duodenal lesions. 51Cr-EDTA absorption tests were performed to demonstrate possible changes in distal gut permeability. In addition, subjective symptoms were registered. Both drug periods induced significant lesions in the stomach and duodenum. Statistically speaking, fewer changes were found in the stomach and duodenal bulb after Sucralfate co-administration, whereas no significant reduction of lesions was seen in the distal duodenum. The 51Cr-EDTA absorption was increased in both periods, indicating deleterious effects to distal parts of the gut, but our results did not demonstrate Sucralfate-mediated protection from these changes. Symptoms were modest, and equal in the two periods. We conclude that Sucralfate may offer protection in the gastric and proximal duodenal mucosa, but no such protective effect was seen distally to the duodenal bulb.

Absorption↗