90 patients with active duodenal ulcer were admitted to a double-blind trial to compare the effects of pirenzepine (150 mg/daily), cimetidine (1 g/daily) and placebo on the healing of duodenal ulcer. 5 patients did not complete the trial. In 21 of 29 patients (72%) receiving pirenzepine and in 21 of 28 (75%) of those receiving cimetidine, the ulcers had healed after 4 weeks of treatment compared with 10 of 28 (36%) patients receiving placebo (p < 0.01). Symptomatic improvement and reduction of antacid consumption were significantly more marked in the pirenzepine- and cimetidine-treated groups than in the placebo group. Tolerability of drugs was good. The results show that pirenzepine is as effective as cimetidine for the treatment of duodenal ulcer.
Genome heterogeneity may be related to the wide variability of clinical and pathological features in hepatitis C virus (HCV)-related chronic liver disease. This paper addresses the possible association between HCV subtypes and clinical and histological features of chronically infected patients. Sixty-eight consecutive liver biopsies of chronic hepatitis constituted the basis of the study. HCV genotyping was performed on frozen tissue. Grading of necroinflammatory activity and staging of fibrosis were histologically assessed. Serologic HCV-RNA and liver function were assessed at the same time. All information was compared with clinical data including age, sex, HCV serology, and probable data and route of infection. Two cases were excluded as inadequate tissue was available. Five cases were negative to HCV-RNA in both serum and tissue. In 61 cases HCV RNA was present at the same time in serum and liver tissue. Forty-four patients were men (72%) and 17 (28%) were women. Two peaks of age were observed: 1 in the 4th decade of life, the 2nd in the 7th. The 2 groups had different HCV genotypes. Patients with genotypes lb (mean age 50.7 years), 2c (mean age 61.3 years), and a subgroup of coinfections (mean age 60 years) were older than patients with genotypes la (mean age 35.5 years), 3 (mean age 36 years), and a subgroup of coinfections (mean age 33 years). Patients with genotypes lb, 2, or 2c and a subgroup of coinfections more frequently had a history of blood transfusion and or surgical intervention dating up to 49 years previously. Patients with HCV la, 3, and a subgroup of coinfections frequently admitted a period of intravenous drug abuse. Patients with advanced liver disease, i.e., severe fibrosis and cirrhosis, showed the same 2 peaks of incidence: in the 4th and 7th decades of life, the first group mainly comprising patients with HCV types la and 3, the second, patients with HCV types lb and 2c. Both these groups shared a clinical history of a long-standing infection. Two profiles of patients emerged. The largest group was composed of elderly patients, infected by HCV genotypes lb or 2c, with a history of blood transfusion and/or surgery, presenting an advanced stage of liver disease (namely, severe fibrosis or cirrhosis). The second group was composed of younger patients, mainly in the 4th decade of life, infected by HCV types 3 or la, often presenting with chronic hepatitis in the stage of severe fibrosis or cirrhosis. The latter could be the profile of HCV infection in the near future
A multicenter study that involved 15 Italian institutions was carried out to compare the efficacy and safety of famotidine 40 mg at bedtime, famotidine 20 mg b.i.d., famotidine 40 mg b.i.d., and ranitidine 150 mg b.i.d. in promoting the healing of acute duodenal ulcer. Two hundred and twenty-four patients with endoscopically proven duodenal ulcer were randomly allocated into four treatment groups. Efficacy results for the four groups were similar at weeks 2, 4, and 8 of therapy. At week 8, the percentage of patients healed in each group was as follows: 92% in the famotidine 40-mg bedtime group, 97% with 20 mg b.i.d., 93% with 40 mg b.i.d., and 90% with ranitidine 150 mg b.i.d. Day pain and night pain were markedly reduced in all four groups, antacid consumption fell considerably, and therapy was generally well tolerated. The adverse experiences evaluated by the investigator as possibly, probably, or definitely related to test medication were rare and moderate.
One hundred patients were entered into a double-blind, double-dummy comparison of tripotassium dicitrate bismuthate (TDB) versus ranitidine, to evaluate short-term healing rates, and successfully healed patients were then entered into a follow-up phase to observe relapse rates. At 4 weeks 84% of patients treated with TDB and 68% of those treated with ranitidine had healed. At 8 weeks these figures had risen to 96% and 90%, respectively (p = NS). After a year's follow-up study 84% of patients healed initially with ranitidine had relapsed, whereas in the case of patients healed initially with TDB the relapse rate was 67% (p less than 0.05). The results confirm that in the short term, TDB is as effective as ranitidine, whereas the significantly better protection against relapse offered by TDB compared with ranitidine underlines the importance of restoring mucosal defence, an approach that to date has been somewhat overlooked.