A multicenter trial of specific local nasal immunotherapy.

OBJECTIVE: To assess the efficacy and safety of specific local nasal immunotherapy (LNIT) in powder form in patients with allergic rhinitis, using subjective and objective parameters. STUDY DESIGN: A double-blind randomized multicenter trial of 102 patients with allergic rhinitis who were treated with specific LNIT for 8 consecutive months. METHODS: After identifying allergens with the skin prick test and sensitization threshold dose with the specific nasal provocation test, 102 patients were selected, of whom 55 were allergic to mites and 47 were allergic to Graminaceae or Parietaria pollen. The specific treatments were self-administered using an insufflator in two phases (phase 1: increasing doses; phase: 2, maintenance dose). Patients were evaluated before and after 32 weeks of treatment by subjective analysis of their self-reported symptoms and by objective analysis of nasal provocation test, nasal resistance by anterior rhinomanometry, and mucociliary clearance time. RESULTS: Clinical efficacy of LNIT for allergy to mites and pollens was confirmed by the differences in the symptoms score between the active group and the placebo group. The nasal provocation test results confirmed that this difference was statistically significant. The rhinomanometric analysis gave positive results for the treated group mainly in LNIT for mites. No differences in mucociliary clearance time were found. CONCLUSIONS: Specific LNIT is effective for allergic rhinitis and appears to offer considerable advantages over other hyposensitization methods. It can be done at home, patient compliance is good, and the treatment is safe.

[The definition of a reference protocol for the clinical study of vertigo drugs]. / Definizione di un protocollo quadro per lo studio clinico di farmaci antivertiginosi.

The aim of this paper is to define the problems that arise in the clinical evaluation of drugs for the treatment of vertigo. Among these are the objective criteria used in defining vertigo and those used in evaluating efficacy of the drugs. The resulting protocol for a clinical study of vestibular drugs is a document that clarifies the debated points in the field, and above all furnishes guidelines for establishing uniformity in clinical studies. This, therefore, may become the reference protocol in Italy for clinical evaluations of drugs for the treatment of vertigo.

Occult metastases in cancer of the larynx and their relationship to clinical and histological aspects of the primary tumor: a four-year multicentric research.

The authors have tried to verify whether some clinical or pathological features of laryngeal cancer may favor the occurrence of occult metastases in the lymph nodes of the neck in N0 cases. The purpose of the investigation was to define the possible existence of tumors, where elective neck dissection, in the absence of palpable nodes, could be done without, thus contributing to settlement of a long debated problem. Different parameters, both clinical and pathological, have been considered. The result of a cross comparison of such parameters in 237 cases of cancer of the larynx without palpable nodes, submitted to surgery on the primary and elective neck dissection, indicates that, although the frequency of occult metastases is significantly related to the site and size of the tumor, its grading, and the degree and type of stromal reaction, the favorable concurrence of all said parameters occurs in 2% of cases only. However, if only clinical parameters, viz. site and size of tumor, are taken into account, a favorable concurrence occurs in 18% of cases with an incidence of occult metastases lower than 2%. These cases are almost exclusively represented by T1N0 supraglottic and T2N0 glottic tumors. We can conclude by saying that clinical and pathological preoperative findings may offer a useful clue in evaluating the risk of occult metastases, and hence advising, or not, an elective neck dissection in N0 cases. Nevertheless, in the vast majority of cases, an elective functional neck dissection still offers the best guarantee of oncologic safety while avoiding unnecessary mutilation.

Surgery of the mixed laryngocele.

The authors first of all consider the classification of laryngoceles, their pathways of spreading, their statistical incidence, etiopathogenesis and their main clinical aspects. Next, they report on the most important surgical techniques proposed to date by the various experts for the three anatomical variants of laryngocele. As regards more particularly the mixed type, which seems to be the most frequent, the authors raise some objections to the classical methods. In fact, the latter do not always allow a satisfactory result to be achieved, and in this connection reference is also made to negative experiences reported by some authors. They go on to suggest, for mixed laryngocele, a new technique of combined exheresis by way of the external lateral approach and laryngofissure. The authors illustrate in detail the method proposed and report the case of a patient suffering from a voluminous bilateral laryngocele of mixed type, on whom they operated by applying the new technique, with very satisfactory results.