ABSTRACT
AIM: To evaluate the efficacy of Dermatophagoides pteronyssinus (DPT) subcutaneous immunotherapy in allergic rhinoconjunctivitis patients. PATIENTS & METHODS: This 17-week double-blind study randomized 136 patients (95 evaluable) to five dose groups of DPT depot extract (0.0625-0.75 skin prick test [SPT] units) or placebo, administered in a six updosing schedule. RESULTS: A dose-response was observed for clinical efficacy (allergen concentration needed to induce a positive nasal provocation test response from baseline to final visit) and safety (adverse reactions). Local and systemic reactions occurred with 14.8 and 6.4% of administered doses, respectively; a single anaphylactic reaction occurred in each of Groups 3, 4 and 5 (0.3% of doses). CONCLUSION: The risk-benefit profile appeared most favorable with a DPT dose of 0.125 SPT units.
Subject(s)
Antigens, Dermatophagoides/administration & dosage , Cell Extracts/administration & dosage , Conjunctivitis, Allergic/therapy , Dermatophagoides pteronyssinus/immunology , Desensitization, Immunologic , Rhinitis, Allergic/therapy , Adult , Animals , Antigens, Dermatophagoides/adverse effects , Antigens, Dermatophagoides/immunology , Cell Extracts/adverse effects , Conjunctivitis, Allergic/immunology , Dose-Response Relationship, Immunologic , Female , Humans , Injections, Subcutaneous , Male , Rhinitis, Allergic/immunology , Treatment Outcome , Young AdultABSTRACT
AIM: A double-blind placebo-controlled study was conducted according to EMA guidelines, to evaluate safety, tolerability and short-term treatment effects of three updosing regimens of Dermatophagoides pteronyssinus subcutaneous allergen immunotherapy. PATIENTS & METHODS: Forty-eight patients were randomized to groups: A (six weekly doses), B (eight weekly doses) or C (eight doses, two clustered doses over 3 weeks). RESULTS: The most frequent adverse events were local reactions. No serious adverse events were found. Severe systemic reactions were reported more frequently in Group C. Decreased cutaneous responses and increased specific IgGs were shown in all active groups, even within the short-term. CONCLUSION: Dermatophagoides pteronyssinus subcutaneous allergen immunotherapy in depot presentation exhibited good safety and tolerability. Group A seemed to show the best profile for further clinical development.
Subject(s)
Antigens, Dermatophagoides/administration & dosage , Conjunctivitis, Allergic/drug therapy , Dermatophagoides pteronyssinus , Desensitization, Immunologic , Rhinitis, Allergic/drug therapy , Adult , Animals , Antigens, Dermatophagoides/immunology , Conjunctivitis, Allergic/immunology , Conjunctivitis, Allergic/pathology , Female , Humans , Immunoglobulin G/immunology , Injections, Subcutaneous , Male , Rhinitis, Allergic/immunology , Rhinitis, Allergic/pathologyABSTRACT
BACKGROUND AND OBJECTIVE: The relationship between Helicobacter pylori infection and functional dyspepsia (FD) is disputed. Although there is a greater prevalence of infection by H. pylori in subjects with non-ulcer dyspepsia than in healthy subjects, results regarding the eradication of infection have been inconclusive so far in terms of disease improvement. In this study, we administered eradicating treatment to a group of patients with both FD and infection by H. pylori to determine the possible beneficial effect of such a treatment. Thus, our objective was to study the effectiveness of eradication therapy for H. pylori in the clinical course of FD. PATIENTS AND METHOD: This was a randomized, double-blind study in 93 consecutive patients diagnosed with FD and infection by H. pylori who received eradicating treatment with omeprazol, amoxicillin and clarythromicin for 7 days (group A, n = 47) vs. placebo, amoxicillin and clarythromicin for 7 days (group B, n = 46). We analyzed the clinical evolution of the disease within the following 9 months. RESULTS: Both groups of treatment were comparable concerning all the variables studied except for the consumption of alcohol, with a greater prevalence in group A, yet no patient consumed more than 40 g per day. The average age of patients was 42 (18-65). Eradication of H. pylori occurred in 65.9% of patients in group A and 4.3% of patients in group B. 40% of all patients included in the study had improved symptoms. In 60.6% of patients whose infection was eradicated, their symptoms improved, as opposed to 25% of patients whose infection was not eradicated (p = 0.001). Among patients whose symptoms improved following eradication, 70% had had an FD duration of less than 3 years and in 30% FD had lasted for more than 3 years (p < 0.05). CONCLUSIONS: The eradication of H. pylori in patients with short-lasting FD may lead to a significant clinical benefit, especially in those whose duration of symptoms is below 3 years.
Subject(s)
Anti-Bacterial Agents/therapeutic use , Dyspepsia/drug therapy , Dyspepsia/microbiology , Gastrointestinal Agents/therapeutic use , Helicobacter Infections/drug therapy , Helicobacter pylori , Adult , Amoxicillin/therapeutic use , Clarithromycin/therapeutic use , Double-Blind Method , Drug Therapy, Combination , Female , Humans , Male , Middle Aged , Omeprazole/therapeutic useABSTRACT
FUNDAMENTO Y OBJETIVO: La relación de la infección por Helicobacter pylori y la dispepsia funcional (DF) constituye un tema controvertido. Si bien existe mayor prevalencia de infección por H. pylori en sujetos con DF que en sujetos sanos, los resultados de la erradicación de la infección no parecen concluyentes, en términos de mejoría de la enfermedad, en los diversos estudios publicados. En el presente trabajo se realiza tratamiento erradicador a un grupo de pacientes con DF e infección por H. pylori para determinar el posible efecto beneficioso de la erradicación. PACIENTES Y MÉTODO: Se realizó un estudio aleatorizado y doble ciego en 93 pacientes consecutivos diagnosticados de DF e infección por H. pylori que recibieron tratamiento erradicador con omeprazol, amoxicilina y claritromicina durante 7 días (grupo A, n = 47), frente a tratamiento con placebo de omeprazol, amoxicilina y claritromicina durante 7 días (grupo B, n = 46); durante los 9 meses posteriores se analizó la evolución clínica de la enfermedad. RESULTADOS: Los dos grupos de tratamiento fueron homogéneos en todas la variables estudiadas excepto en el uso de alcohol con una mayor prevalencia en el grupo A, aunque ningún paciente consumía más de 40 g/día. La edad media de los pacientes incluidos fue de 42 años (18,65 años). La erradicación de H. pylori se produjo en el 65,9 por ciento de pacientes del grupo A y en el 4,3 por ciento de pacientes del Grupo B. El 40 por ciento de todos los pacientes incluidos en el estudio mejoraron sus síntomas. En el grupo A, el 53,2 por ciento de los pacientes mejoraron sus síntomas al final del estudio mientras que sólo lo hizo el 32,6 por ciento de los del grupo B. El 60,6 por ciento de los pacientes con erradicación de la infección mejoraron la sintomatología frente al 25 por ciento de los pacientes en que la erradicación no se produjo (p = 0,001). De los pacientes que mejoraron los síntomas tras la erradicación se observó que el 70 por ciento tenía una duración de la DF inferior a 3 años y el 30 por ciento superior (p < 0,05), fenómeno no observado en los pacientes que mejoraban sus síntomas y no presentaban erradicación de la infección. CONCLUSIONES: En nuestra serie, la erradicación de H. pylori en pacientes con DF mejora el curso evolutivo de la enfermedad, especialmente el grupo de pacientes con una duración de los síntomas inferior a los 3 años (AU)
