Safety and efficacy in children of an SQ-standardized grass allergen tablet for sublingual immunotherapy.

BACKGROUND: Immunotherapy with the SQ-standardized grass tablet Grazax is efficacious and well-tolerated in adult patients with rhinoconjunctivitis. Allergic asthma and rhinoconjunctivitis are closely linked, and a strategy combining treatment of the upper and lower airways is recommended. OBJECTIVE: To investigate the efficacy of treatment with the grass tablet on grass pollen-induced rhinoconjunctivitis and asthma as well as the immunologic response and the safety profile in children. METHODS: A total of 253 children age 5 to 16 years, with grass pollen-induced rhinoconjunctivitis with/without asthma, were randomized 1:1 to active treatment or placebo. Treatment was initiated 8 to 23 weeks before the start of the grass pollen season 2007 and continued throughout the entire season. Symptomatic medication was provided as relief medication to both groups in a stepwise fashion. Primary endpoints were rhinoconjunctivitis symptom and medication scores. RESULTS: The rhinoconjunctivitis symptom and medication scores and the asthma symptom score were all statistically significantly different between the 2 treatment groups. The differences in medians relative to placebo were 24%, 34%, and 64% in favor of active treatment. The immunologic response was similar to that observed in adults. The most common adverse reaction was oral pruritus, reported by 40 subjects (32%) in the active and 3 (2%) in the placebo group. Six subjects withdrew because of adverse events. No serious adverse events were assessed as treatment-related. CONCLUSION: Immunotherapy with the grass tablet reduced grass pollen-induced rhinoconjunctivitis and asthma symptoms in a pediatric population and introduced an immunomodulatory response, consistent with treatment of the underlying allergic disease. The treatment was well tolerated.

A comprehensive classification of craniofacial fractures: postmortem and clinical studies with two- and three-dimensional computed tomography.

A comprehensive classification of midfacial/craniofacial fractures, based on two- and three-dimensional computed tomography (2D and 3D-CT) is presented. We performed a postmortem analysis of 24 patients who had died from trauma with signs of craniofacial fractures, based on 2D and 3D-CT studies with pathoanatomical findings. In addition, CT findings for 100 patients with craniofacial injuries requiring an emergency CT were correlated with surgical findings and follow-up results. On the basis of the analysis of a total of 377 fractures a classification system is proposed. The system is based on the use of the AO/ASIF (Arbeitsgemeinschaft für Osteosynthesefragen/Association for the Study of Internal Fixation) scheme, defining three types (A, B, C), three groups within each type (e.g. A1, A2, A3) and three subgroups within each group (e.g. A1.1, A1.2, A1.3) with increasing severity from A1.1 (lowest) to C3.3 (highest). The craniofacial region is divided into three units: the lower midface (I), the upper midface (II) and the craniobasal-facial unit (III). Lateral and central fractures are also distinguished. Type A fractures are non-displaced fractures, type B are displaced fractures and type C are complex/defect fractures. Groups A1, B1 and C1 comprise fractures of an isolated unit; groups A2, B2 and C2, combined fractures without involvement of the skull base; and groups A3, B3 and C3 are those combined fractures with involvement of the skull base. A correlation between the severity of the fracture and (i). the number of posttraumatic functional limitations (Spearman rank test, correlation coefficient r=0.42), (ii). the need for bone grafting or dural plastic (r=0.39) and (iii). facial asymmetry (r=0.37), was observed. The proposed classification system allows standardised documentation of midfacial and craniofacial fractures, including those not precisely defined by the Le Fort classification scheme.