Randomised clinical trial: the efficacy and safety of propionyl-L-carnitine therapy in patients with ulcerative colitis receiving stable oral treatment.

BACKGROUND: Ulcerative colitis (UC) is characterised by impaired fatty-acid oxidation; l-carnitine has a key role in fatty-acid metabolism and short-chain fatty acids such as butyrate and propionate are important energy source for intestinal epithelial cells. AIM: To evaluate efficacy and safety of colon-release propionyl-L-carnitine (PLC) in patients with mild-to-moderate UC receiving stable oral aminosalicylate or thiopurine therapy. METHODS: In a multicentre, phase II, double-blind, parallel-group trial, patients were randomised to receive PLC 1 g/day, PLC 2 g/day or placebo. Main inclusion criteria were as follows: age 18-75; disease activity index (DAI) score 3-10 inclusive, be under oral stable treatment with aminosalicylate or thiopurine. The primary endpoint was clinical/endoscopic response, defined as a decrease in DAI score ≥ 3 points or remission, defined as a DAI score ≤ 2 with no individual sub-score > 1. RESULTS: Of 121 patients who were randomised, 57 of 79 (72%) patients receiving PLC (combined 1 g and 2 g cohort) had a clinical/endoscopic response vs. 20 of 40 (50%) receiving placebo (P = 0.02). Specifically, in PLC 1 g/day group, 30 of 40 (75%) patients had clinical/endoscopic response (P = 0.02 vs. placebo) and 27 of 39 (69%) in the PLC 2 g/day group (P = 0.08 vs. placebo). Rates of remission were 22/40 (55%), 19/39 (49%), 14/40 (35%) in the PLC 1 g, PLC 2 g, and placebo groups, respectively. PLC had a similar safety profile to placebo; the most common adverse events were gastrointestinal. CONCLUSION: Propionyl-L-carnitine 1 g/day should be investigated further as a co-treatment for mild-to-moderate ulcerative colitis (NCT-01026857).

Neutralisation of cytotoxic vacuolating activity by serum antibodies of Helicobacter pylori-infected patients.

The study involved 196 H. pylori strains and 196 serum samples taken from the same patients. H. pylori strains were investigated for the production of vacuolating cytotoxin. Antibodies to the vacuolating cytotoxin produced by H. pylori were detected in the sera samples by neutralisation assay (on Intestine 407 cells) and ELISA. Of the 196 H. pylori strains tested, 80 (40.8%) were found to express vacuolating cytotoxic activity. The titres of cytotoxic nonconcentrated broth culture filtrates ranged from 1:2 to 1:128. The vacuolating assay was positive in 37.1% strains isolated from children, and in 50% strains isolated from adults. Cytotoxin-positive H. pylori strains were found more frequently in duodenal ulcer (71%) than in chronic gastritis (35.2%) patients, and this difference was statistically significant p < 0.05. Neutralising antibodies to vacuolating cytotoxin were present in 51% and 49% of the serum samples tested by neutralisation and ELISA, respectively. Duodenal ulcer patients had antibodies to vacuolating cytotoxin more frequently (p < 0.05) than chronic gastritis patients. Antibodies to cytotoxin were detected in the serum samples from patients infected by cytotoxic (100%) and noncytotoxic (18%) H. pylori strains.

Neutralisation of vacuolating activity of cytotoxin by serum antibodies of Helicobacter pylori infected patients.

The study involved 196 H. pylori strains and 196 serum samples taken from the same patients. H. pylori strains were investigated for the production of vacuolating cytotoxin. Antibodies to the vacuolating cytotoxin produced by H. pylori were detected in the sera samples by neutralisation assay (on Intestine 407 cells) and ELISA. Of the 196 H. pylori strains tested, 80 (40.8%) were found to express vacuolating cytotoxic activity. The titres of vacuolating cytotoxic were ranged from 1:2 to 1:128. The vacuolating assay was positive in 37.1% strains isolated from children, and in 50% strains isolated from adults. Cytotoxin-positive H. pylori strains were found more frequently in duodenal ulcer (71%) than in chronic gastritis (35.2%) patients, and this difference was statistically significant p<0.05. Neutralising antibodies to vacuolating cytotoxin were present in 51% and 49% of the serum samples tested by neutralisation and ELISA, respectively. Duodenal ulcer patients had antibodies to vacuolating cytotoxin more frequently (p<0.05) than chronic gastritis patients. Antibodies to cytotoxin were detected in 100% of the serum samples from patients infected by cytotoxic H. pylori strains. This suggests that the presence of anticytotoxic antibodies in the serum samples may be regarded as a sensitive indicator of infection by cytotoxic H. pylori strains.

[Frequency of Helicobacter pylori infection depending on morphological changes in gastric mucosa in patients over 65 years of age]. / Czestosc zakazenia Helicobacter pylori w zaleznosci od zmian morfologicznych blony sluzowej zoladka u ludzi po 65 roku zycia.

In older patients involution processes are observed. Frequency of H. pylori infection has been related of histopathological changes of gastric mucosa in patients over 65 yrs old. In 73% of analyzed patients gastritis atrophica has been documented.

Relationship between antibody to cytotoxin and Helicobacter pylori infection.

Broth culture supernatants from 14 (34%) out of the 41 H. pylori strains tested, induced vacuolization in Intestine 407 cells in titers ranging from 1:2 to 1:64. 20% of H. pylori strains isolated from children and 42% of strains isolated from adults expressed vacuolating activity. Serum antibody to cytotoxin produced by H. pylori was detected with a neutralization assay. Anticytotoxic antibodies were present in all sera from patients infected with cytotoxic H. pylori strains. The toxin-neutralizing activity of sera from individuals infected with H. pylori suggests that the cytotoxin is produced in vivo.

Multicenter evaluation of dual-therapy (omeprazol and amoxycillin) for Helicobacter pylori-associated duodenal and gastric ulcer (two years of the observation).

Treatment with the proton pump inhibitor (omeprazole) and single antibiotic (amoxycillin), two synergistic compounds, can cure Helicobacter pylori (H. pylori) infection, but this therapy is not as effective as had been expected. However, some studies show promising results. The aim of our study was to evaluate the effect of two weeks dual-therapy with omeprazole (O) and amoxycillin (A) on gastric (GU) and duodenal ulcer (DU) patients: ulcer healing, eradication of the H. pylori and recurrence rate of the ulcer. We studied 216 patients (aged 18-70) endoscopically proven GU (58 patients) and DU (158 patients). Rapid urease test from the two antrum biopses and two antral and two corporeal biopses using Giemsa stain method for confirmation of the H. pylori infection were used. The patients were treated with omeprazole 20 mg BID and amoxycillin 1.0 g BID for 2 weeks and investigated every 4 months during 2 years. Clearance effect of Hp infection was achieved in 65.1% GU and 66.4% DU patients. Eradication ("check point" after 4 months) in 43% DU and 56.6% GU patients was confirmed. Reinfection rate was found in 16% during 2 years. We conclude--dual-therapy (O and A) is not sufficiently effective to be recommended as an anti-H. pylori treatment. H. pylori eradication prevents recurrence of peptic ulcer and is an important issue in attempts to achieve permanent ulcer healing.

Helicobacter pylori infection in Eastern Europe: seroprevalence in the Polish population of Lower Silesia.

The Helicobacter pylori status of the population of Eastern European countries has not been explored despite the high incidence of peptic ulcer disease and gastric cancer observed in these countries. A seroprevalence study has been performed in Wroclaw, a city of Lower Silesia, Poland, to provide insight into this question. Sera were collected to obtain 50 subjects per 5 yr increment of age. A second generation ELISA kit with a high sensitivity and specificity was used. The results plotted by year of birth show a very high prevalence of H. pylori infection in all adults groups born before 1970 (80-100% positive). In the younger age groups, a dramatic decrease was observed. Because it is now known that most H. pylori infections are acquired in childhood (cohort effect), it can be predicted that the infection rate in the adult population will be much lower in the future compared with that presently observed, and it can be expected that evolution in H. pylori prevalence will have an impact on the rate of gastroduodenal diseases in Poland. Because of the high prevalence, it was not possible to identify risk factors for infection in this population.

[Neutrophil elastase activity in patients with ulcerative colitis]. / Aktywnosc elastazy granulocytów obojetnochlonnych u chorych na wrzodziejace zapalenie jelita grubego.

In order to find an objective marker of disease intensity, neutrophil elastase activity was determined in patients with ulcerative colitis. The study included 41 patients with ulcerative colitis who were divided into two groups depending on tge stage of the disease on the basis of the activity index according to Maier et al. The obtained results of studies were compared a group of 18 healthy persons. The values of neutrophil elastase activity in the patients and in the control group were subjected to statistical analysis. It was found that neutrophil elastase activity in the patients with high degree of disease intensity was lower than that in the patients with low degree of disease intensity and in healthy subjects. The obtained differences were statistically significant. From the results of the study the conclusion was drawn that the neutrophil elastase activity may be an indicator of ulcerative colitis activity.

[Incidence of Helicobacter pylori infections in patients with duodenogastric reflux]. / Czestosc wystepowania infekcji Helicobacter pylori u pacjentów z odplywem wstecznym dwunastniczo-zoladkowym.

The purpose of the work was a comparison of the incidence of Helicobacter pylori (HP) infections in persons with dyspeptic symptoms of non-ulcer dyspepsia (NUD) character in relation to the presence or absence of duodenogastric reflux (DGR). The study included 80 patients aged from 17 to 80 years, 21 males and 59 females. In all studied patients endoscopy of upper digestive tract segment was performed with biopsy specimen taking for microbiological investigations. From each patient two biopsy specimens were taken from the prepyloric part and the fundus. The specimens were subjected to a microbiological analysis using the rapid urease test, culturing, and direct preparation. The presence of duodenogastric reflux was evaluated during endoscopy. In persons with diagnosed NUD and duodenogastric reflux, lower incidence of HP infections was found than in patients with the same diagnosis but without the reflux.

Proctologic diseases in geriatric persons.

The aim of present study was the estimation of the frequency and kind of disease of the lower part of the digestive tract in aged patients, based on rectoscopic examination. There were undertaken rectoscopy and examination per rectum of 193 patients over 65 years (mean age 70.4 years from whom only 13 patients had not suffered from any sensations on the part of digestive tract and among 239 patients ranging up to 65 (mean age value 39.6 years from whom majority suffered from various sensations on part of digestive tract and were treated in Clinic of Gastrology and Angiology or Clinic Endoscopy Department. It was stated that the most frequent disease in the elder group of patients were: proctitis (or sigmoiditis) with accompanying spastic conditions of large bowel 14 per cent and hemorrhoids 46.4 per cent. Rectal polyps and sigmoidic polyps occurred in 8.1 per cent of the whole examined group, in the elder group they ranged to 10.4 per cent and in the younger one they ranged to 6.6 per cent. Cancers in rectum and sigmoid were present in 4.1 per cent of the whole examined group, in the elder group in 5.6 per cent and 2 per cent in the younger one.

[Procollagen Type III-N-terminal peptide as an indicator of hepatic fibrogenesis]. / Peptyd III prokolagenu jako wskaznik fibrogenezy watrobowej.

An assay of procollagen peptide III in blood serum enables non-invasive assessment of fibrogenesis in the liver. An increased level of this peptide has been shown in the chronic aggressive hepatitis and liver cirrhosis.

[Comparison of the value of the glucagon test and galactose tolerance test in the clinical diagnosis of cirrhosis]. / Porównanie wartosci próby glukagonowej i testu tolerancji galaktozy w diagnostyce klinicznej marskosci watroby.

Using the test of glucagon load and the test of galactose tolerance the usefulness was compared of both these carbohydrate tests in the clinical diagnosis of cirrhosis. The studied group comprised 30 patients with cirrhosis divided into two groups depending on the stage of the disease, and 21 women with spastic colitis serving as a control group. Both tests were found to be useful in the diagnosis of cirrhosis. The results of these tests were statistically significantly different from those in the control group which could be demonstrated as different shapes of blood glucose curves. Moreover, range values could be proposed for blood glucose levels characteristic of cirrhosis and criteria could be established using these tests for differentiating compensated against decompensated cirrhosis.