ISSN:
1398-9995
Quelle:
Blackwell Publishing Journal Backfiles 1879-2005
Thema:
Medizin
Notizen:
Background: Sublingual immunotherapy (SLIT) appears to be acceptably safe in clinical trials, but post-marketing data are needed to provide essential information. This study specificall_y evaluated the safety of commercial SLIT in adult patients in a post-marketing phase. Methods: A total of 198 patients (83 male, 115 female, mean age 24.4 years) receiving SLIT for respiratory all_ergy were followed up for 3 years by a specific questionnaire for side-effects. SLIT (LAIS, Lofarma SpA, Milan, Italy), a monomeric all_ergoid in tablets, was administered, in association with drug therapy, pre- or pre-coseasonall_y for pollen and continuously for mites. The average duration was 12–36 months, and the total of doses was about 32 800. Side-effects were grouped as ocular, gastrointestinal, rhinitis, asthma, urticaria, edema of tongue/lips, and anaphylaxis. The severity was graded as low (no need for treatment or dose adjusting, no interference with activities), moderate (interference with activities/need for drugs/SLIT discontinuation), and severe (life-threatening/hospitalization/emergency care). Results: Seventeen events corresponding to 7.5% of patients and 0.52 per 1000 doses were reported. Seven episodes of rhinitis (two in two patients), three of oral itching, and one of abdominal pain were self-limiting. Two cases of urticaria and two of abdominal pain/nausea were controlled by a temporary dose-adjustment, and one case of urticaria and conjunctivitis required oral antihistamines. Medical intervention was needed in six patients only during a 3-year period. Conclusions: The results of this study, performed in a real situation of clinical practice, confirm the satisfactory safety profile of SLIT.
Materialart:
Digitale Medien
URL:
http://dx.doi.org/10.1034/j.1398-9995.2001.00181.x
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