Postmarketing study for assessment of tolerability of a grass allergen immunotherapy tablet (GRAZAX) in patients with rhinitis or rhinoconjunctivitis.

BACKGROUND AND OBJECTIVE: Many patients with grass pollen allergy in Spain have concomitant sensitization to other allergens such as profilin. Since this type of sensitization is more common in Mediterranean countries than in countries where most patients were enrolled in clinical trials on GRAZAX (Phleum pratense 75,000 SQ-T/2, 800 BAU, ALK), the aim of this study was to analyze tolerability to GRAZAX under clinical practice conditions in patients with grass pollen allergy. METHODS: A total of 155 patients were enrolled consecutively in a prospective, open-label, observational study. Adverse reactions were recorded during the first month of treatment at 3 different timepoints: after the first dose, when patients were kept under observation for 30 minutes, and on days 15 and 30 after starting treatment RESULTS: With the first dose, 117 adverse reactions were recorded in 63 patients (40.7%). The commonest reactions (>10% patients) were oral pruritus (25.2%) and throat irritation (24.5%). Ear pruritus was recorded in 7.7%. All reactions but 1 occurred within 30 minutes of administration and all were mild-to-moderate. At the end of treatment, the percentage of patients with adverse reactions had decreased significantly (21.3%). Most adverse reactions (95.2%) were mild-to-moderate and only 3 (1.4%) were severe. No serious adverse reactions were recorded. CONCLUSION: GRAZAX seems to be well tolerated, and most reactions were mild-to-moderate. Many of these reactions occur with the first dose. Therefore, according to the Summary of Product Characteristics, the first dose has to be administered under medical supervision.

Literature on integrated HIV care: a review.

With a significant proportion of HIV-infected patients now presenting with co-occurring substance abuse disorders and mental disorders, interest in integrated HIV care is growing. However, no review of integrated HIV care has been conducted. Using relevant key word searches of the Medline and Psychlit databases, the authors identified about 450 publications. The few evaluations of integrated models tended to focus on measurements of engagement and retention in medical care, and their findings indicated an association between integrated HIV care and increased service utilization. No random assignment controlled studies were identified, except in the peripheral area of integrated care (without HIV primary care) for persons with co-occurring substance abuse disorders and mental disorders. The majority of reviewed articles described integrated models operating in the field and various aspects of implementation and sustainability. Overall, they supported use of a wide range of primary and ancillary services delivered by a multidisciplinary team that employs a 'biopsychosocial' approach. Despite the lack of scientific knowledge regarding the effects of integrated HIV care, those wanting to optimize treatment for patients with multiple interacting disorders can gain useful and practical knowledge from this literature.

Genital candidiasis: topical management with clotrimazole.

Clotrimazole was administered in the form of 100 mg tablets to patients with vaginal candidiasis, and in the form of a 1% solution to patients with cutaneous candidiasis of the genital and perigenital areas. The clinical and mycological response observed and the excellent tolerance and lack of side effects indicate that clotrimazole may be proposed as a treatment for candidiasis.

Clotrimazole troches: a new therapeutic approach to oral candidiasis.

To ascertain the topical effectiveness of clotrimazole in oral candidiasis, a troche form was administered to 12 patients suffering from longstanding infection. One-half of the patients took one 10 mg troche and the other half of the patients one 50 mg troche, ten times a day. The troches were not chewed, but were retained in the mouth until completely dissolved. The impressive clinical and mycological response to this treatment as well as the lack of toxicity strongly indicate that further trials are warranted.