RESUMO
BACKGROUND & AIMS: Little is known about the efficacy of H(2)-receptor antagonists in preventing recurrence of aspirin-related peptic ulcers. We compared the efficacy of high-dose famotidine with that of pantoprazole in preventing recurrent symptomatic ulcers/erosions. METHODS: We performed a randomized, double-blind, controlled trial of 160 patients with aspirin-related peptic ulcers/erosions, with or without a history of bleeding. Patients were given either famotidine (40 mg, morning and evening) or pantoprazole (20 mg in the morning and placebo in the evening). All patients continued to receive aspirin (80 mg daily). The primary end point was recurrent dyspeptic or bleeding ulcers/erosions within 48 weeks. RESULTS: A total of 130 patients (81.1%) completed the study; 13 of 65 patients in the famotidine group reached the primary end point (20.0%; 95% one-sided confidence interval [CI] for the risk difference, 0.1184-1.0) compared with 0 of 65 patients in the pantoprazole group (P < .0001, 95% one-sided CI for the risk difference, 0.1184-1.0). Gastrointestinal bleeding was significantly more common in the famotidine group than the pantoprazole group (7.7% [5/65] vs 0% [0/65]; 95% one-sided CI for the risk difference, 0.0226-1.0; P = .0289), as was recurrent dyspepsia caused by ulcers/erosions (12.3% [8/65] vs 0% [0/65]; 95% one-sided CI for the risk difference, 0.0560-1.0; P = .0031). No patients had ulcer perforation or obstruction. CONCLUSIONS: In patients with aspirin-related peptic ulcers/erosions, high-dose famotidine therapy is inferior to pantoprazole in preventing recurrent dyspeptic or bleeding ulcers/erosions.
Assuntos
2-Piridinilmetilsulfinilbenzimidazóis/administração & dosagem , Aspirina/efeitos adversos , Famotidina/administração & dosagem , Úlcera Péptica/induzido quimicamente , Úlcera Péptica/prevenção & controle , Idoso , Antibacterianos/uso terapêutico , Anti-Inflamatórios não Esteroides/efeitos adversos , Antiulcerosos/administração & dosagem , Feminino , Seguimentos , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/epidemiologia , Hemorragia Gastrointestinal/prevenção & controle , Infecções por Helicobacter/tratamento farmacológico , Infecções por Helicobacter/epidemiologia , Antagonistas dos Receptores H2 da Histamina/administração & dosagem , Humanos , Masculino , Pessoa de Meia-Idade , Pantoprazol , Úlcera Péptica/epidemiologia , Fatores de Risco , Prevenção Secundária , Resultado do TratamentoRESUMO
INTRODUCTION: The major complication of aspirin and clopidogrel (A+C) co-therapy is upper gastrointestinal bleeding (UGIB). However, data are unavailable for real-life situations. Furthermore, the treatment effect of antisecretory agents is unknown. AIM: This cohort study aimed to determine the occurrence of UGIB. The treatment effect of H2-receptor antagonist (H2RA) and proton pump inhibitor (PPI) was also analyzed. METHOD: The records of 987 consecutive patients on A+C co-therapy between January 2001 and September 2006 were analyzed. The follow-up ended on the dates of a first occurrence of UGIB, stopping A+C co-therapy, a change in the antisecretory class, death, or March 2007. RESULTS: After a follow-up of 5.8 +/- 6.5 months, UGIB occurred in 39 (4.0%) patients. PPI, H2RA and control were prescribed in 213, 287 and 487 patients respectively. After adjustment for age, dose of aspirin, previous UGIB and duration of treatment, the risk was marginally reduced by H2RA (OR = 0.43, 95% CI 0.18-0.91, p = 0.04) and significantly reduced by PPI (OR = 0.04, 95% CI 0.002-0.21, p = 0.002), as compared to control. CONCLUSION: The occurrence of UGIB associated with A+C co-therapy for a median of 5.8 months was 4.0%. Co-prescription with PPI was associated with a lower risk.
Assuntos
Aspirina/uso terapêutico , Hemorragia Gastrointestinal/induzido quimicamente , Isquemia Miocárdica/tratamento farmacológico , Inibidores da Agregação Plaquetária/uso terapêutico , Ticlopidina/análogos & derivados , Idoso , Idoso de 80 Anos ou mais , Clopidogrel , Doença das Coronárias/tratamento farmacológico , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Razão de Chances , Ticlopidina/uso terapêuticoRESUMO
BACKGROUND: There are controversies on the benefits of elective neck dissection (END) for oral tongue carcinoma. METHOD: This is a prospective randomized study of elective selective I, II, III neck dissection versus observation for N0 neck of stage I to II oral tongue carcinoma. There were 35 patients on the observation arm and 36 patients on the END arm. The main outcome assessment parameters are node-related mortality and disease-specific survival rate. RESULTS: There were 11 patients in the observed arm and 2 patients in the END arm who developed nodal recurrence alone without associated local or distant recurrence. All 13 patients were salvaged, and no patient died of nodal recurrence. The 5-year disease-specific survival rate was 87% for the observation arm and was 89% for the END arm; the 2% difference was not significant. CONCLUSION: Observation may be an acceptable alternative to END if strict adherence to a cancer surveillance protocol is followed.