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Biomedical subjects

Eugenio Mira

Publications and source records attributed to Eugenio Mira.

8 recordsLinked to original sources

Intratympanic gentamicin in monolateral Meniere's disease: our experience.

The aim of this study was to verify the efficacy of a modified Odkvist titration protocol of intratympanic gentamicin application in the control of vertigo attacks and the effects on the auditory and vestibular function in a group of 71 patients affected by monolateral MD resistant to medical therapy. All the patients underwent an intratympanic administration of a 1-ml solution containing 26.6 mg of gentamicin sulfate. The treatment protocol provided one to three injections for a total amount of gentamicin varying from 26.6 to 80 mg. Five days after the first gentamicin administration, cochlear and vestibular function tests were performed. The worsening of the PTA greater than 15 dB, the appearance of clinical signs of vestibulotoxicity such as imbalance or persistent spontaneous nystagmus beating away from the injected ear or of a "curative vertigo" were the criteria taken into consideration to stop the treatment. In the absence of any sign, a second and third injection were performed. The presence of an unchanged frequency of the attacks at least 3 months after the previous cycle was the parameter considered to perform a second or third cycle. Seventeen (24%) patients were submitted to a second cycle of therapy and two (3%) to a third cycle. After a mean follow-up period of 20.3 months (range: 3 to 48) all 71 patients experienced good control of the vertigo attacks: grade A in 46 cases and grade B in 25 cases according to the AAO-HNS CoHE criteria. The pure tone average (PTA) hearing threshold (500-3,000 Hz) worsened in 19 patients, improved in 5 and was unchanged in 47. On the basis of the experience acquired during the treatment, we progressively decreased the number of injections from 3/cycle to a 1-2/cycle of therapy. Moreover, in the later phase of the study re-injections were administered 1 or 2 weeks after the previous application and avoided in the presence of signs of depression of the vestibular and/or cochlear function. A residual caloric excitability was found in 30% of the cases. Vertigo control doesn't seem to be linked to the achievement of vestibular inexcitability. The marker of successful gentamicin treatment at short-term is the appearance of signs of curative vertigo and/or vestibular imbalance, and at long-term the disappearance of vertigo attacks.

Adult↗

13-cis retinoic acid in head and neck cancer chemoprevention: results of a randomized trial from the Italian Head and Neck Chemoprevention Study Group.

Patients with squamous cell carcinoma of the head and neck (HNSCC) after being treated radically remain at high risk for both recurrent and second primary tumours. 13-cis retinoic acid (13-cRA) was demonstrated to reverse pre-malignant lesions of the oral cavity and to reduce the incidence of second primary tumours in patients treated radically for HNSCC. Synergism between retinoids and interferon in tumoural cell lines have been demonstrated. Based on these data, the Italian Head and Neck Chemoprevention Study Group started a randomized chemoprevention study in patients radically treated for stage III and IV HNSCC. From February 1992 to January 1996, 267 patients were randomized: 126 were allocated to the control group, 126 were randomized to receive 13-cRA at a dose of 0.5 mg/kg per day per os and 15 patients have been assigned to the group of 13-cRA plus interferon alpha2a (IFN-alpha2a) at a dose of 3,000,000 UI 3 times a week (randomization in this arm interrupted due to administrative financial problems). The mean follow-up was 39 months. The 5-year actuarial survival was 58.9% for patients of the 13-cRA group and 57.2% for those of the control group (P=0.94). Among evaluable patients, disease progression was observed in 45 of 123 patients (36.6%) of the 13-cRA group and in 42 of 124 (33.9%) of the control group. The 5-year actuarial relapse-free survival was 48.9% for the 13-cRA group and 55.6% for the control group (P=0.62). Adverse effects, mostly of grade I were reported in 69.4% of treated patients (haematologic disorders, mucositis, conjunctivitis, cutaneous toxicity, hypertriglyceridemia and hypercholesterolemia). Only 5 patients (4.1%) reported grade III-IV toxicity. Low-dose of 13-cRA given for 1 year is ineffective as chemoprevention in patients with radically treated HNSCC.

Adult↗

Clinical, genetic and immunologic analysis of a family affected by ozena.

Primary atrophic rhinitis is a chronic inflammation of the nasal mucosa characterized by atrophy of the mucous and bony tissue of the turbinates and by a thick, dense secretion, which quickly forms a characteristically fetid-smelling, greenish crust. We report the results of the clinical, genetic and immunologic investigations performed on eight subjects (three with ozena and five asymptomatic), members of the same familial group. The presence of the disease in the family fits well with dominant inheritance. All the culture specimens from the patients affected by ozena were positive for Klebsiella ozaenae, and one of them was also positive for Pseudomonas aeruginosa. All the three patients with ozena and two of the five apparently unaffected family members were positive for antinuclear antibodies. Immunoblotting showed a reactivity to a 50-kD protein, which was not identified by the common, recognized nuclear autoantigens. This was present in one of the three patients and three of the five other family members. Positivity for IgG-class anticardiolipins was correlated with disease manifestation in that it was found in two of the three patients and only in one of the five asymptomatic family members. The hypothesis of a genetic factor that could drive the chronicity of the inflammatory pattern of a pre-existing infectious nasal disease is suggested.

Adolescent↗

Double-blind, randomized, multicenter study comparing the effect of betahistine and flunarizine on the dizziness handicap in patients with recurrent vestibular vertigo.

OBJECTIVE: The aim of this double-blind, randomized, multicenter study was to compare the efficacy of betahistine dihydrochloride (BH) and flunarizine (FL) using the Dizziness Handicap Inventory (DHI), a validated self-assessment questionnaire that has not previously been used in a clinical trial to evaluate antivertigo drugs. MATERIAL AND METHODS: Patients with recurrent vertigo of peripheral vestibular origin and who were severely handicapped by vertigo were randomized to an 8-week course of treatment with oral BH 48 mg daily or oral FL 10 mg daily. The efficacy endpoints were the total DHI score and the physical, functional and emotional subscores. RESULTS: Fifty-two patients completed the study. After 8 weeks of treatment the mean total DHI score and the physical subscore were significantly lower in the BH group compared to the FL group (7.5 and 3.6 points, respectively). The mean total DHI score as well as the three subscores decreased significantly after 4 and 8 weeks in both treatment groups. CONCLUSION: This study showed that at 8 weeks BH is significantly more effective than FL in terms of improving the total DHI score and the physical subscore. It was also established that the DHI is a useful and reliable method for evaluating the efficacy of antivertigo drugs.

Adult↗

Angioneurotic edema of the upper airways and antihypertensive therapy.

Angioneurotic edema is a non-pitting edema which is usually limited to the skin and the mucous membranes of the face and upper aerodigestive tract. The risk of acute upper airway obstruction makes angioneurotic edema a concern for emergency room physicians, internists and otolaryngologists because prompt recognition of the condition and immediate institution of therapy is essential for proper airway management. Angiotensin-converting enzyme (ACE) inhibitors have recently been associated with angioneurotic edema, the probable link being the reduction in angiotensin II and the potentiation of bradykinin, resulting in vasodilatation, increased vascular permeability and angioedema. We report four cases of acquired angioneurotic edema, which were probably related to ACE inhibitor use. These cases are discussed, including a review of the literature, methods of diagnosis, pathophysiology and treatment of angioedema. Care should be taken when antihypertensive ACE inhibitor treatments are started and patients should be warned of the potential risk of angioneurotic edema.

Aged↗

Betahistine dihydrochloride in the treatment of peripheral vestibular vertigo.

The present study compares the efficacy and safety of betahistine dihydrochloride to that of a placebo in recurrent vertigo resulting from Meniere's disease (MD) or in paroxysmal positional vertigo (PPV) of probable vascular origin. The design was double-blind, multicentre and parallel-group randomised. Eleven Italian centres enrolled 144 patients: 75 of the patients were treated with betahistine (41 MD/34 PPV) and 69 with placebos (40 MD/29 PPV). The betahistine dosage was 16 mg twice per day for 3 months. Compared to the placebo, betahistine had a significant effect on the frequency, intensity and duration of vertigo attacks. Associated symptoms and the quality of life also were significantly improved by betahistine. Both the physician's judgement and the patient's opinion on the efficacy and acceptability of the treatment were in agreement as to the superiority of betahistine. The effective and safe profile of betahistine in the treatment of vertigo due to peripheral vestibular disorders was confirmed.

Administration, Oral↗

Efficacy of selective lymph node dissection in clinically negative neck.

OBJECTIVE: The purpose of this study was to evaluate the efficacy of selective neck dissection (SND) for elective treatment of the clinically negative neck in head and neck squamous cell carcinoma (SCC). METHODS: A retrospective review was undertaken on 91 previously untreated patients with T1-4 SCC of oral cavity (23), oropharynx (5), hypopharynx (7), larynx (56), and clinically negative neck (N0), undergoing 126 SND from January 1990 to March 1999 at a single institution. Twenty-five patients received postoperative radiation therapy on the basis of histologic evidence of >2 positive nodes, extracapsular spread (ECS), and/or the presence of advanced primary lesion. RESULTS: On pathologic examination the average number of lymph nodes was 20.5 per neck, occult disease was detected in 14 (11.11%) of 126 necks; of necks with positive nodes, 6 (42.85%) of 14 had ECS. The median follow-up was 36 months. Overall recurrence rate (local, regional, and distant) was 12.8% (11 of 91). Recurrent disease developed in the neck of one patient, outside the dissected field. There was no difference in recurrence rate between pN0 and pN+ patients, as well as between pN+ with or without ECS. Overall survival rate was 84% (77 of 91), with a statistically significant difference between pN0 and pN+ necks. CONCLUSION: SND seems to be a pragmatic approach that is as effective as comprehensive procedures for staging and treating the clinically negative neck.

Adult↗

beta-carotene supplementation in patients radically treated for stage I-II head and neck cancer: results of a randomized trial.

This study was aimed at evaluating the efficacy of beta-carotene in improving survival (S) and in disease-free survival (DFS) and reducing the incidence of second primary tumors (SPT) in patients with a radically treated stage I-II squamous head and neck tumors. Eligible patients were randomly allocated to receive beta-carotene (n=104) or no treatment (n=110). beta-carotene was administered at the dose of 75 mg/day for 3-month cycles within one month intercycle intervals for a 3-year period. The 3-year compliance to the beta-carotene was 68.7%. Only eight patients reported drug-related toxicity (7.8%). The median follow-up of all patients was 59 months. The median follow-up was 61 months (range 1-116 months) in the beta-carotene and 58 months (1-123 months) in the control group. The 10-year DFS was 75.7% for the patients in the beta-carotene and 74.3% for those in the control group (P=0.56). The 10-year S was 85.9% in the beta-carotene group and 80.9% in the control group (P=0.20). beta-carotene supplementation had no significant effect on the incidence of second primary tumors (RR=0.99; 95% C.I. 0.28-3.44). A statistically non-significant 40% reduction in the risk of death among subjects assigned to the beta-carotene compared to the controls was observed (RR=0.60; 95% C.I. 0.26-1.38). No increase in the death from cardiovascular diseases was observed among patients treated with beta-carotene. Our results might support the hypothesis that an adequate beta-carotene treatment could be potentially associated with a decreased risk of death in these patients.

Adult↗