SUMMARY Antisecretory effect of single oral therapeutic doses of pirenzepine (25 mg and 50 mg) and cimetidine (200 mg and 400 mg) was studied in 12 patients with duodenal ulcer. Gastric secretion was studied in basal condition and after stimulation with pentagastrin. Basal, maximum and peak acid output, basal and maximum acidity, and basal and maximum volume were calculated after computerised correction for pyloric loss and duodenal reflux. Both drugs showed dose-related inhibition of all facets of gastric secretion. Cimetidine (200 mg) had a greater inhibitory effect on gastric basal secretion, but a similar effect on pentagastrin stimulated secretion as with pirenzepine (50 mg). Cimetidine (400 mg) showed about twice the inhibitory activity of pirenzepine (50 mg) both on basal and stimulated secretion.The inhibitory effect of pirenzepine on gastric secretion in man has been shown both in basal conditions and on secretion stimulated by pentagastrin.14 As almost all previous studies on pirenzepine were performed with uncorrected data on gastric secretion the extent of the inhibition reported by different authors varies from 14%2 to 97%' for basal output and from 22 %5 to 56%' for the output stimulated by pentagastrin. The difference in these results is attributed to the difference in: (1) dosage used; (2) routes of administration; (3) techniques of study of the gastric secretion; and (4) the sample on which the study has been carried out.In order to obtain univocal data on the inhibitory capacity of pirenzepine on gastric secretion, we studied the effects of single doses of pirenzepine on basal and pentagastrin stimulated gastric secretion, calculated with computerised correction for pyloric loss and duodenal reflux, and compared these with single doses of cimetidine, the histamine H2 receptor antagonist already used in other studies as the substance for reference purposes.6 7 The study was carried out double blind and drugs administered orally, in the dosage suggested for therapy -that is, 25-50 mg pirenzepine and 200-400 mg cimetidine.
Methods
PATIENTSTwelve patients were studied, 11 men and one woman; of these, 11 were suffering from duodenal ulcers and one from erosive duodenitis, all ascertained by endoscopy. The minimum secretory values accepted for entry to the trial were: BAO >2*5 mmol/h, MAO >18 mmol/h. The mean age was 38 years (range 21-60 years) with an eight year mean duration of the illness (range one to 30 years). Nine patients were smokers (19 cigarettes a day on average) and 11 patients drank alcohol (five occasional, five moderate, and one heavy). Five patients had already used cimetidine in the past and none had used pirenzepine.In each patient gastric secretion was studied three times, at intervals of not less than 48 hours. The first secretion study provided control values and the subsequent ones carried out in the same manner as the first, but were started 60 minutes after the administration of the drugs. This interval was chosen on the basis of the pharmacokinetics of the two drugs,8 9 ...
Aims and Background Rarely are conclusions from clinical trials summarized in international consensus conferences and promptly transferred to patient care. The adjuvant therapy for colorectal cancer used in daily clinical practice in Italy is described and compared with the recommendations of the 1990 NIH Consensus Conference. Patients and Methods We audited prescriptions of adjuvant systemic therapies for Italian colorectal cancer patients in 82 centers during a fixed one-week period. Results Among 434 patients receiving adjuvant chemotherapy there were 139 (42.5%) colon cancer patients with N- and 169 (51.7%) with N+ regional nodal involvement. Treatment at academic centers, a young age, T4 and a low total number of lymph nodes removed at surgery were the factors potentially justifying the decision for adjuvant chemotherapy in stage II colon cancer patients. The most common chemotherapy used was a bolus of 5-fluorouracil/folinic acid for 6 months (75.8%). Adjuvant radiotherapy was not administered to 37 (38.5%) of 96 patients with stage II and III rectal cancer. Conclusions The study shows that a substantial proportion of patients on adjuvant treatment at a certain time point in a large enough sample of Italian centers are stage II (potential over-treatment) and that an under-treatment of stage II and III rectal cancer patients (lack of radiotherapy) occurs too often in daily clinical practice in this country.
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