ABSTRACT
Food allergens are frequent causes of anaphylaxis. In particular in children and adolescents they are the most frequent elicitors of severe allergic reactions, and in adults food allergens rank third behind insect venom and drugs. Since July 2006 severe allergic reactions from Germany, Austria, and Switzerland are collected in the anaphylaxis registry. Currently 78 hospitals and private practises are connected. From July 2006 until February 2009 1,156 severe allergic reactions were registered. Among children and adolescents (n = 187, age range from 3 months to 17 years) food allergens were the most frequent triggers, comprising 58% of cases. In the adult group (n = 968, 18 - 85 years) food allergens were in the third position (16.3%) behind insect venom and drugs. In children legumes (31%) and in particular peanuts were frequently responsible food allergens, followed by tree nuts (25%) with hazelnut being the most frequent elicitor. In adults fruits (13.4%) most often induced severe food-dependent anaphylaxis, but also animal products (12.2%); among these most frequently crustaceans and molluscs. Cofactors were often suspected in food-dependent anaphylaxis, namely in 39% of the adult group and in 14% of the pediatric group. In adults drugs (22%) and physical activity (10%) were reported to be the most frequent cofactors, in children physical activity was suspected in 8.7% and drugs in 2.6%. Concomitant diseases like atopic dermatitis, allergic asthma, or allergic rhinoconjunctivitis were reported in 78% of children and adolescents and in 67% of the adults. In conclusion, food-induced anaphylaxis, its cofactors and concomitant diseases are age-dependent. The data offers to identify risk factors of anaphylaxis.
ABSTRACT
PURPOSE OF THE STUDY: The availability of licensed medication for children and adolescents depends on the frequency of clinical trials within this age group. In Germany legislation the framework for clinical trials was changed essentially in 2004 by the 12th amendment on the German Drug Code (AMG). This paper studies the changes in applications to the IRBs for clinical trials in adults and minors before and after implementation of the 12th amendment. METHODS: In total four IRB were included in the study. All IRB were located in one German state, all were located at universities or medical schools. Two of the universities have a clinical research unit (CRU) funded by the German Ministry of Research, one of these CRUs has additionally a unit specialised on conducting trials with minors (PadNET). All data were assessed by the applications to the IRB between 2002 and 2006 and analysed by the number of applications, inclusion criteria (with minors or without) and the funding status (investigator initiated trials=IIT or funded by industry). RESULTS: The total number of applications was stable over the observation period (2002: 1192; 2006: 1231). The number of applications according German Drug Code showed no essential changes (2002: 484; 2006: 504). The number of applications for trials which included minors was low and remained on this low level (2002: 41; 2006: 28). Immediately before and after implementation of the amendment the number of applications increased or, respectively, decreased. IIT with minors constituted a higher proportion of all clinical trials with minors, but in total the number of IIT with minors was low. DISCUSSION: The 12th amendment to the German Drug Code had only slight effects on the number of clinical trials in general and especially on the number of clinical trials with minors. Overall, clinical trial with minors make only a small proportion of all applications for clinical trials to the IRB in Germany. The EU regulation on medical products for children may cause an increasing number of clinical trials with minors in the future.
