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OBJECTIVE: To assess the efficacy of lamivudine treatment on hepatitis B e antigen (HBeAg) and/or hepatitis B surface antigen (HBsAg) seroconversion, on other virological and serological markers of response including hepatitis B virus (HBV) DNA and serum aminotransferases, and the safety of lamivudine treatment in hepatitis B patients. PATIENTS: This phase III open-label study evaluated the virological and biochemical response to lamivudine in 70 Portuguese patients with HBeAg positive chronic hepatitis B. Patients were treated with lamivudine 100mg once daily for 12 months. METHODS: Antiviral activity was assessed by measuring alanine aminotransferase (ALT)/aspartate aminotransferase (AST) levels at all protocol visits, and hepatitis B serology and HBV DNA were performed at baseline and at month 12 visits. Evaluation of safety and tolerance was based on clinical adverse events and laboratory analyses. RESULTS: The primary endpoint was virological response at month 12, defined as loss of detectable HBeAg from serum with a reduction of HBV DNA to undetectable levels, and this was observed in 19/69 (27.5%) of patients. Almost half of the patients were HBV DNA negative by this time. Mean ALT values decreased steadily during treatment and by 12 months 61% of patients had values within the normal range. HBeAg seroconversion (HBeAg negative, HBeAb positive) was achieved in 27.9% of patients by 12 months, although all patients remained HBsAg positive. CONCLUSION: Lamivudine was well tolerated and the incidence of adverse events was similar to those reported in previous studies. Lamivudine treatment resulted in virological and biochemical improvements in HBeAg positive chronic hepatitis B patients, with HBeAg seroconversion in one-third of patients.
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Evidence from large cohort studies has established an increased risk of gastric cancer for individuals infected with Helicobacter pylori (HP). In low incidence countries, like the United Kingdom and Sweden, case-control studies suggested that the prevalence of anti-HP antibodies in gastric cancer patients (at the time of cancer diagnosis) is greater than in control populations. We present results from a case-control study of the prevalence of IgG anti-HP antibodies in gastric cancer patients and a control population in a country with a high incidence of gastric cancer. Sera were studied from 80 gastric cancer patients (GC group) admitted consecutively to our department in 1990/91, and from 80 controls (CT group) matched by age and sex. IgG anti-HP was determined by ELISA. Patients' files were reviewed for evidence of previous diagnosis of peptic ulcer, gastric surgery, tumor localization and histopathological classification. Controls were submitted to a questionnaire for past history of peptic ulcer and gastric surgery. Positive results for anti-HP were: gastric cancer patients, 70.0%; control group, 81.5% (NS). However, the median optical densities (OD, a measure of antibody concentration) were significantly lower in the gastric cancer group than in controls: gastric cancer patients, 0.720 +/- 0.424 OD; control group, 0.906 +/- 0.443 OD (P = 0.004). There were no differences concerning past history of peptic ulcer or surgery. The proportion of positives for cancer of the cardia (66.7%) was lower than for the other tumour localizations (70.4%) (NS). Anti-HP positivity was lower in patients with gastric cancer associated with intestinal metaplasia than in controls (P = 0.14).(ABSTRACT TRUNCATED AT 250 WORDS)
