Prevention of delayed emesis with metoclopramide and dexamethasone in patients receiving moderately emetogenic cytotoxic treatment.

Forty-three untreated cancer patients receiving moderately emetogenic polychemotherapy entered a phase II trial in order to evaluate the effectiveness of the combination of metoclopramide (40 mg every 6 hrs) and dexamethasone (8 mg every 12 hrs) in the prevention of delayed emesis (days 2-3). For the control of acute emesis all patients received on day 1 ondansetron 8 mg for 3 times. Results of antiemetic treatment were as follows: complete/major protection from acute emesis (day 1) was observed in 72%/88% of patients. Worst day analysis of delayed emesis (days 2 and 3) showed that complete/major protection was obtained in 93%/95% of cases, respectively. Delayed nausea was not as well controlled: complete/major protection was observed in 44%/79% of patients. Extrapyramidal reactions occurred in 3 patients and moderate epigastric pain was reported by 3 patients. Since control of acute emesis could be one of the most important factors influencing delayed emesis, the absence of acute symptoms in 72% of our patients may be partially responsible for the excellent control of delayed emesis. The combination of metoclopramide and dexamethasone is a feasible and effective treatment for delayed emesis in outpatients receiving moderately emetogenic chemotherapy.

[Sulglicotide in non-ulcerous dyspepsia]. / Sulglicotide nella dispepsia non ulcerosa.

In an open study, the clinical efficacy of sulglycotide was tested in patients with non-ulcerous dyspepsia (NUD). Outpatients with dyspeptic symptoms of at least 3-months' standing were entered into the study; diagnosis was based on history, clinical findings and endoscopy. Forty-four patients could be evaluated after 8 weeks' treatment with sulglycotide (200 mg t.i.d. orally). Treatment results were checked endoscopically and on the basis of changes in subjective symptoms (heartburn, epigastric pain, nausea, vomiting, postprandial sense of fullness, eructations, regurgitation, all of which were quantified on an analogic scale from 0 = absent to 3 = intense). Treatment with sulglycotide led to marked and significant improvement of clinical symptoms of NUD (p less than 0.05 vs. baseline) and of macroscopic endoscopic findings recorded at entry. It is concluded that sulglycotide is a valid therapeutic choice for patients suffering from NUD.

[Sulglicotide in the treatment of dyspeptic patients with duodenogastric reflux]. / Sulglicotide nel trattamento di pazienti dispeptici affetti da reflusso duodenogastrico.

The therapeutic efficacy of sulglicotide was tested in an open study of dyspeptic patients suffering from proven duodenogastric reflux. Twenty outpatients with non-ulcer dyspepsia and alkaline reflux demonstrated by measurement of enterogastric flux were enrolled in the study. All patients could be evaluated at the end of 8 weeks' treatment with 200 mg sulglicotide t.i.d. This treatment did not cause any change for the better of alkaline reflux but did induce marked improvement of subjective symptoms (p less than 0.05 vs baseline), giving the impression that in spite of the continued presence of the damaging agent the drug had reduced the mucosal lesion by increasing gastro-protective capacity.

A multicenter double-blind study of sulglycotide versus sucralfate in nonulcer dyspepsia.

Nonulcer dyspepsia remains to this date a clinical disease entity that is diagnosed and treated empirically by considering such patients potential ulcer carriers and treating them accordingly with H2 antagonists. The purpose of this study was to assess the therapeutic effectiveness of sulglycotide in patients with nonulcer dyspepsia in a random double-blind trial vs sucralfate. One hundred and eighty-seven consecutive patients with nonulcer dyspepsia were treated with sulglycotide (oral, 200 mg t.i.d. for 6 weeks, n = 93) or with sucralfate (oral, 1 g t.i.d. for the same length of time, n = 94). Drug effectiveness was evaluated in terms of apparent clinical symptom modifications, fiberoptic endoscopy findings and histological aspects of biopsy specimens. Both treatments resulted in prompt abatement of the clinical complaints of nonulcer dyspepsia and the improvement of macroscopic gastritis at endoscopy. These results confirm the usefulness of cytoprotective drugs in nonulcer dyspepsia characterized by gastroduodenal inflammation.

Effects of sulglycotide on endogenous prostaglandin synthesis in human antral mucosa.

The effect of sulglycotide, a polysulphated glycopeptide isolated from pig duodenum, on PGE2, 6-ketoPGF1 alpha and TxB2 production from isolated biopsy specimens of human antral mucosa was investigated in vitro, in comparison with carbenoxolone. In addition to a tendency toward increased PGE2 production just short of statistical significance, both sulglycotide and carbenoxolone significantly increased 6-ketoPGF1 alpha accumulation in the incubation medium. TxB2 levels were not significantly modified by the two drugs. Therefore, changes in the prostanoid production by human antral mucosa could, at least partially account for the cytoprotective effects of sulglycotide in man.

Effect of sulglycotide treatment on cell kinetics alterations induced by aspirin in humans.

The effect on gastric epithelial cell proliferation of small doses of aspirin was evaluated in 9 healthy volunteers, with or without administration of sulglycotide, a sulfated glycopeptide with cytoprotective properties. Cell kinetics study was performed by incubation of gastric biopsies with bromodeoxyuridine (BrdU) and immunohistochemistry. A decrease of BrdU-labeling index and a shortening of the height of gastric columns were observed after treatment with aspirin and placebo. No variations were observed after treatment with aspirin and sulglycotide. A decrease of the epithelial cell renewal could be one of the damaging effects of aspirin on the gastric mucosa. The treatment with sulglycotide seems to be effective to prevent this alteration.

[Sulglicotide in the prevention of gastric disease induced by NSAID. Double-blind controlled study versus placebo]. / Sulglicotide nella prevenzione della gastropatia da FANS. Studio controllato in doppio cieco vs placebo.

Non-steroidal anti-inflammatory drugs, essential for the treatment of rheumatic diseases, are frequently associated with significant adverse effects on the integrity of the gastrointestinal mucosa. Sulglicotide (S), a natural product, has been found to possess gastromucosal protective properties. Aim of the present study was to evaluate whether (S) 200 mg t.i.d prevented or reduced the severity of gastric and/or duodenal mucosal injury induced by Diclofenac. A total of 30 patients with either rheumatoid arthritis (RA) or osteoarthritis (OA) who required NSAID therapy for at least 8 weeks were enrolled into a double-blind randomized placebo-controlled study. The main criteria for entry into the trial was the absence of gastrointestinal symptoms, and gastric/duodenal lesions assessed by endoscopy. At the end of the treatment endoscopy and relative symptoms were assessed. Six out of 15 patients, in both groups of treatment developed mucosal injury, but only in the placebo group the gastric damage was important (ulcer and petechiae) while in the group (S) we observed only hyperemia of the gastric mucosa. These preliminary data indicate the usefulness of Sulglicotide in preventing or reducing mucosal injury from NSAID treatment.