Subject(s)
Humans , Male , Female , Irritable Bowel Syndrome/diagnosis , Irritable Bowel Syndrome/therapy , Disease Management , Odds RatioABSTRACT
Patients with reflux esophagitis (grade II or III, Savary-Miller, intention-to-treat, n=256, age range 19-82 years) were randomly assigned to a double-blind, double-dummy treatment with either pantoprazole 40 mg once daily or ranitidine 150 mg twice daily. After 4 weeks, each patient was clinically and endoscopically assessed. Failure to heal required a further 4 weeks of treatment and a new evaluation thereafter. After 4 weeks, healing of lesions was confirmed in 63% (69 out of 109) of patients receiving pantoprazole and in 22% (25 out of 113) receiving ranitidine (P < 0.001, per protocol population). After 8 weeks, the cumulative healing rates were 88% and 46%, respectively (P < 0.001). Complete freedom from esophagitis-related symptoms (acid eructation, heartburn, pain while swallowing) was greater in the pantoprazole than in ranitidine group after 2 and 4 weeks (74% vs. 47%; 87% vs. 52%, respectively, P < 0.001). After 4 weeks, the healing rate was 76% in Helicobacter pylori (Hp)-positive vs. 45% in Hp-negative patients treated with pantoprazole (P < 0.01). The Hp status did not influence healing rates in patients treated with ranitidine. The most frequent adverse events in the pantoprazole group were diarrhea and somnolence (2-3% of patients), and in the ranitidine group, headache, diarrhea, dizziness, increase of liver enzymes and pruritus (2-4% of patients). In conclusion, pantoprazole was more effective than ranitidine in the healing rate and relief from reflux esophagitis-associated symptoms, and Hp infection was associated with higher healing rate during therapy with pantoprazole but not with ranitidine.
Subject(s)
Benzimidazoles/administration & dosage , Esophagitis, Peptic/drug therapy , Helicobacter Infections/complications , Helicobacter pylori/isolation & purification , Ranitidine/administration & dosage , Sulfoxides/administration & dosage , 2-Pyridinylmethylsulfinylbenzimidazoles , Administration, Oral , Adult , Aged , Aged, 80 and over , Benzimidazoles/adverse effects , Dose-Response Relationship, Drug , Double-Blind Method , Drug Administration Schedule , Esophagitis, Peptic/complications , Esophagitis, Peptic/diagnosis , Female , Follow-Up Studies , Helicobacter Infections/diagnosis , Humans , Male , Middle Aged , Omeprazole/analogs & derivatives , Pantoprazole , Probability , Ranitidine/adverse effects , Risk Assessment , Sulfoxides/adverse effects , Treatment Outcome , Wound Healing/drug effects , Wound Healing/physiologyABSTRACT
No presente estudo randomizado, paralelo, cego para o investigador, comparamos a eficácia do inibidor da encefalinase racecadotril ao Saccharomyces boulardii em 336 pacientes adultos ambulatoriais avaliáveis com diarréia aguda. Foram incluídos 175 pacientes avaliáveis no grupo com racecadotril e 161 pacientes avaliáveis foram incluidos no grupo com Saccharomyces boulardii. A duraçäo mädia da diarréia foi significativamente mais curta após o tratamento com racecadotril em comparaçäo com Saccharomyces boulardii. O tempo de recuperaçäo também foi mais curto com racecadotril em comparaçäo com S. boulardii, independente da gravidade da diarréia. Em casos brandos foi observada uma diferença de 24 horas entrte o tempo de recuperaçäo para racecadotril e S. boulardii e em casos graves a diferença entre os grupos foi de 17 horas. Além disso, a probabilidade de cura com racecadotril após dois dias de tratamento foi duas vezes maior e significante em comparaçäo ao Saccharomyces boulardii. Após três dias de tratamento, mais de dois terços dos pacientes em uso de racecadotril apresentaram recuperaçäo completa ao passo que quase metade dos pacientes com Saccharomyces boulardii näo haviam se recuperado. Em casos mais graves, a probabilidade de cura no dia 2 do tratamento com racecadotril foi três a quatro vezes maior em comparaçäo ao S. boulardii. Tanto racecadotril quanto Saccharomyces boulardii apresentaram um bom perfil de segurança.(au)
