A randomized comparison of intranasal and injectable octreotide administration in patients with acromegaly.

Fifteen acromegalic patients received four single doses of octreotide in random order (500 micrograms, 1000 micrograms, and 2000 micrograms applied intranasally and 100 micrograms given sc). Serum octreotide and GH data were subjected to pharmacokinetic analyses, and local nasal effects were evaluated by acoustic rhinometry. Average areas (+/- SEM) under the serum octreotide curves were: 2000 micrograms: 4597 +/- 536; 1000 micrograms: 1923 +/- 439; 500 micrograms: 957 +/- 168; and 100 micrograms sc: 896 +/- 81 micrograms.L-1.min (n = 13). The calculated relative availability was 27% +/- 0.03; 22% +/- 0.05; 22% +/- 0.03, respectively, for the three nasal doses. The rate of absorption after intranasally administered octreotide was greater than after sc application: t1/2 ka: 7.1 +/- 1.6; 7.9 +/- 1.6; 11.3 +/- 1.9, respectively, vs. 24.1 +/- 2.5 min, whereas the rates of disappearance were similar. GH suppression started immediately after application and reached minimum levels 1-2 h later. The average intervals during which serum GH was below 50% of preadministration values were: 2000 micrograms: 544 +/- 47; 1000 micrograms: 423 +/- 56; 500 micrograms: 289 +/- 52 vs. 351 +/- 34 min after sc injection of 100 micrograms. With 2000 micrograms intranasally all but one of the 15 patients attained constant suppression of serum GH below 5 micrograms/L for 273 to 680 min. Pharmacokinetic analysis demonstrated that 100 micrograms sc and 1000 micrograms intranasally induced the same GH suppressive effect and that 2000 micrograms intranasally approximately doubled the duration of action. Acoustic rhinometry was performed after nasal application of the largest dose of 2000 micrograms and after carrier (n = 9). A highly significant tumescence of the nasal mucosa was maximal after 10 min and gradually receded over the next 2 h. However, this was felt by the patients to be acceptable. The effect was caused by octreotide per se and was probably due to vasodilation.

Preliminary results with Sandostatin nasal powder in acromegalic patients.

This report details the first half of a double-blind, crossover sequence (Latin square) study of local and hormonal effects of nasally insufflated Sandostatin compared with those of subcutaneously injected Sandostatin. Nine of the planned 16 patients have been studied. They received a single application of 0.5, 1.0, and 2.0 mg Sandostatin as nasal powder and 0.1 mg by subcutaneous (SC) injection. The results indicate that absorption from the nasal epithelium occurs after approximately 10 minutes and comprises approximately 20% of the dose administered. This indicates that peak serum Sandostatin values occur very rapidly, ie, 10 minutes after application. After approximately 2 hours, the serum disappearance rates are similar to those obtained after SC injection. The suppressive effect on serum growth hormone (GH) levels is equal with the two forms of application and suggests that future clinical treatment with an intranasal application of 0.5 mg thrice daily is feasible. No side effects were noted apart from an immediate swelling of nasal mucosa, which receded gradually over the following 2 hours. This was either unnoticed or considered insignificant by the patients and will probably be deemed harmless by the rhinologist in eventual long-term clinical trials.

Otological manifestations of Wegener's granulomatosis.

The otological manifestations of Wegener's granulomatosis were studied in 13 patients; diagnosis was confirmed histologically in 10, and in 1 patient periarteritis nodosa presented similar appearances. One patient had destruction of the external ear, and several had refractory otitis externa, usually associated with otitis media: 3 patients had serous otitis media, 4 had purulent otitis media of a fairly mild course, while 6 had otitis media of a fulminant and long-lasting course, accompanied in 5 cases by cranial nerve palsy and in 2 by widespread destruction. Most patients had major sensory hearing loss. Two had short-lasting anacusis during exacerbation of the pulmonary lesions. Often, otological manifestations were the initial signs of the disease. It is important to bear this diagnosis in mind in cases of long-lasting and atypical inflammations and in the presence of peculiar constellations of symptoms from several different organ systems.

Preincisional infiltration with bupivacaine in tonsillectomy.

OBJECTIVE: To investigate the value of preincisional peritonsillar infiltration of bupivacaine hydrochloride before tonsillectomy under general anesthesia. DESIGN: Double-blind trial with two groups comparing 0.25% bupivacaine with placebo (normal saline). The patients were followed up for 10 days after surgery. SETTING: Department of Otolaryngology, University Hospital of Aarhus (Denmark). PATIENTS: Men and women 18 to 40 years of age referred to our department for bilateral tonsillectomy, but with no sign of acute infection or suspected malignant neoplasm. Twenty-six patients entered the study; five were excluded for failure to complete the postoperative data; and two, one from each group, had postoperative bleeding. Data from 19 patients were analyzed, nine in the bupivacaine group and 10 in the placebo group. INTERVENTION: One group had 5 mL of 0.25% bupivacaine hydrochloride (Marcaine) infiltrated around each tonsil, the other an identical placebo (normal saline) infiltration. OUTCOME MEASURES: A visual analogue scale was used as the primary efficacy measure. The daily intake of analgesics and a possible weight loss were registered. RESULTS: A notably lower score on the visual analogue scale was found in the bupivacaine group. CONCLUSIONS: Preoperative blocking of nociceptive impulses reduces prolonged postoperative pain, but no reduction in the intake of analgesics was found. Medication was insufficient for the first postoperative days.

Wegener's granulomatosis. Long-term results of treatment.

Seventeen patients with Wegener's granulomatosis are presented. The very complex clinical features are outlined. A recently suggested new classification (ELK-classification) is applied. Fourteen patients were treated with cytotoxic agents and steroids, 12 of these receiving 6-mercaptopurine. Of the ten patients still alive, eight are in remission with treatment withdrawn in three cases. The duration of the treatment is discussed. The results are largely satisfactory, but the course of the disease is still capricious. Progression to a higher step in the ELK-classification has been observed in several cases and a number of serious sequelae to the disease are recorded. The initial symptoms of Wegener's granulomatosis are varied and uncharacteristic, and it is important to bear this disease in mind when patients with a long course of apparently trivial infections or peculiar constellations of symptoms from several organs are encountered. Repeated biopsies from the respiratory tract are important in order to establish the diagnosis, but treatment should not be delayed in cases where only a tentative diagnosis can be made on the basis of a reasonably typical clinical picture, even with a negative histological response.

Endoscopic examination of the nasopharynx.

Endoscopic examination of the nasopharynx is a simple and rapid procedure. The inspection can be made through the nose. This method is recommended for screening. If abnormalities of the nasopharynx are disclosed and are to be studied in detail, and particularly if such abnormalities are to be documented photographically, it is necessary to inspect them through the oropharynx while the soft palate is drawn forward. It is possible under direct vision to take representative biopsy specimens, and it is easy to take photographs for the purpose of documentation, comparison and education. This procedure can to a great extent replace diagnostic excision of tissue from the nasopharynx under general anaesthesia. Especially with a view to early diagnosis of malignant disease of the masopharynx, it is important to extend the use of this method, which can be performed with little discomfort to the patient.

Disodium cromoglycate nasal spray in the treatment of perennial rhinitis.

In a double-blind crossover trial, 24 patients with perennial rhinitis have been treated with 2% disodium cromoglycate (DSCG) nasal spray. 15 patients preferred DSCG to placebo, 9 patients showed no preference. Analysis of the diary cards showed a significant preference of DSCG in the group which received placebo first for the symptoms blocking, secretion and sneezing (p less than 0.1), while no preference between the treatment periods occured in the group receiving DSCG first. A significantly higher IgG concentration in serum was found in 15 patients with preference for DSCG than with remainder (p less than 0.05). No other changes in immunoglobulin concentration in nasal secretion or serum were found, which could be related to the effect of DSCG. DSCG nasal spray is considered a valuable supplement in the treatment of perennial rhinitis.

Morphology of tracheal scar after resection with CO2-laser and high-frequency cutting loop. A study in normal pigs.

In 6 pigs a bronchoscopical resection of the tracheal mucosa was performed using CO2-laser on one side, and an electric high-frequency cutting loop (ECL) on the other. The pigs were sacrificed 3 months later. On macroscopic examination the tracheal mucosa appeared almost normal on the laser-resected side, while severe deformation was seen after ECL treatment. Microscopically the respiratory epithelium had regenerated irrespective of the instrument used. After laser resection the subepithelial tissue had a normal width and consisted of collagen fibrils with few vessels and sparse fragmented elastic tissue. The cartilage showed necrosis and pericellular fibrosis. The scar tissue after ECL was a broad cellular and richly vascularized connective tissue. The content of elastic fibres was markedly greater than after laser resection. The cartilage showed small irregular necroses lined by pyknotic nuclei. In neither case had the gland regenerated. Both CO2-laser and ECL caused severe (but not identical) damage to the tissue, clearly visible after 3 months. However, the deformation caused by ECL was not seen at the laser-resected sites, which makes the laser technique seem preferable--where economy permits.

Legal aspects in nasal fractures.

A criminal act is involved in a high percentage of cases of nasal fracture, and exact medical information describing the damages found is mandatory for the criminal court. It is necessary, that the medical information are obtained from the ENT-department, where the patient is treated, as the information obtained from the casualty department has a too low degree of truth in the establishment of the diagnosis. The statement should include information on the treatment given, as linear fractures in good position requiring no treatment may be classified legally as an offence against the person rather than as a bodily harm. X-ray examination of the nose in cases of nasal fracture gives a much too high number of false positive and false negative results to have any legal value, and, having no medical value as well, they should not be taken unless for scientific purposes.

Congenital choanal atresia treated by laser surgery.

Nine patients with choanal atresia have been operated upon with the carbon dioxide laser. Five of the patients had been operated upon before by various methods, and four of the cases were unilateral and untreated before. The operation was performed under general anaesthesia using the operating microscope. The pharyngeal mucosa was protected by a saline-soaked packing in the nasal pharynx. No stent was used in the postoperative period. Normal air passage was obtained in six patients, and one patient, who had co-existing adhesions through the whole nasal cavity after previous treatment by dilation, achieved a limited air passage after one laser treatment, and further attempts were postponed until he grew older. One patient did not want another try after one failure. One patient has been operated recently, and the result is uncertain. Laser-treatment of choanal atresia seems to make other methods of operation obsolete for the following reasons: The operation is easy and quick and of slight discomfort to the patient. The time of hospitalization is short, and the operation can be repeated, if a good result is not achieved in the first try. And most important is the fact, that no stent is needed.

Nasal mucoliliary clearance in patients with septal deviation.

We studied nasal mucociliary clearance by means of the saccharin-sky-blue technique in patients with septal deformities of the nose before and after plastic operation. The results were compared with clearance measurements in healthy persons. Prior to operation nasal clearance was statistically significantly slower (p less than 0.05) in the patient group, and mucociliostasis occurred in 21% of all measurements compared with only 3% in the group of healthy persons. 3 months after septoplasty nasal clearance was found normal in all but 3 persons who had an active nasal infection at the time of postoperative investigation. In our opinion the saccharin-sky-blue test serves as a valuable technique in the evaluation of nasal mucociliary function prior and subsequent to operation of patients with septal deformities of the nose.

Hereditary hemorrhagic telangiectasia treated by laser surgery.

Hereditary hemorrhagic telangiectasia (Osler's disease) is a rare, inherited abnormality of the subepithelial vessels causing severe nose bleed as the most predominant symptom. The most efficient treatment has, until now, been dermoplasty of the nasal septum and cavity. There have been a few reports on treatment with CO2-, argon- or Nd-YAG-lasers, which have been encouraging. Ten patients with Osler's disease were treated for severe epistaxis. Three were treated with CO2-laser, two of these under general anaesthesia. Seven patients were treated with the argon laser under local anaesthesia. A variety of other sites were treated at the same time for functional or cosmetic reasons (mouth, face, fingers, rectum). Good results were obtained in eight cases. In three of the cases the observation period was more than two years. A second treatment has been necessary in three cases. Two other patients were treated recently, and it is too early to judge the results. The argon-laser is more convenient for this purpose than the CO2-laser. The method is quick and reliable and there is no need for hospitalization. The treatment can be repeated without permanent damage to the function of the nose.

Treatment of seasonal allergic rhinitis--a double blind, group comparative study of terfenadine and dexchlorpheniramine.

In order to evaluate the efficacy of and adverse reactions to terfenadine compared to dexchlorpheniramine, a double blind, group comparative study was carried out in 42 patients suffering from grass-pollen induced allergic rhinitis. The treatment was either terfenadine tablets 60 mg twice daily or dexchlorpheniramine tablets 6 mg twice daily. Nasal and eye symptoms as well as tiredness were rated daily on a scale from 0 (absent) to 3 (severe). Terfenadine and dexchlorpheniramine performed almost equally well in keeping symptoms at a mild level with a superiority of dexchlorpheniramine in the control of runny nose. Dexchlorpheniramine was associated with a significant increase in the score for tiredness in contrast to terfenadine which caused no significant change. Two patients in the group treated with dexchlorpheniramine stopped treatment because of tiredness. Other adverse reactions were few, mild and transient.

Bilateral inferior turbinoplasty in chronic nasal obstruction.

Bilateral inferior turbinoplasty was performed in cases of chronic nasal obstruction, in which conservative treatment had failed. Forty-five patients without significant septal deviation and with chronic nasal obstruction were objectively evaluated by acoustic rhinometry (AR) before and 3-6 months after turbinoplasty, in order to assess the changes of the dimensions of the nasal cavity obtained. Mucosal turbinate hypertrophy (defined objectively by AR) was present in 76% of the cases. Satisfactory subjective nasal patency was achieved in 93% of patients. Turbinoplasty resulted in an increase of 22% at the minimum cross-sectional area, 37% at the cross-sectional area 3.3 cm from the nostrils, and 47% at the cross-sectional area 4.0 cm from the nostrils. The increase was not related to the subjective result of the operation. Tendency to crusting and to vasomotor symptoms were related to unsatisfactory results. No crusting or bleeding were observed.

Grass pollen-induced hay fever treated with a new steroid fluocortin butylester (FCB).

The clinical effect and the side effects of a new steroid, Fluocortin butylester (FCB) in the topical treatment of hay fever was studied in a double-blind trial. The drug was administered by inhalation of a fine powder through a special inhalator (Rhinolator). The material comprised 31 patients, and the treatment period was three weeks. There was a highly significant difference in favour of FCB compared with placebo as regards the nasal symptoms blockage and discharge. Side effects were few and mild.

Perennial rhinitis treated with a new steroid: fluocortin butylester (FCB).

The effect of fluocortin butylester (FCB) in the topical treatment of perennial rhinitis was investigated in a double-blind study using a cross-over technique. The daily dose was 4 mg. Of the 30 patients who completed the trial, 26 had either allergy or nasal eosinophilia. 20 of the 30 patients preferred FCB to placebo. Moreover, there was a positive, but not statistically significant, therapeutic effect according to the patient score cards (0.1 less than p less than 0.2). In other words, the results are positive, but not definite. It is concluded that possibly the dose ought to be increased to obtain a more reliable effect.

Thyroid carcinoma in Pendred's syndrome.

A case of Pendred's syndrome is reported. One year after subtotal removal of a simple adenomatous colloid goitre, the patient presented with a follicular thyroid carcinoma with invasive growth through the capsule into the surrounding muscular tissue and vascular invasion.

Long-term results after treatment of nasal fractures.

One hundred and six patients with nasal fractures, treated by reduction in 65 per cent, were seen three months and three years after the trauma. The results were compared with a normal group. Sixteen patients (15 per cent) had sustained recent nasal injuries, and another four patients had undergone correction of the nose during the follow-up period. These patients were left out of the statistical analysis, which thus comprises 88 patients. Ninety per cent were satisfied with the result, and 84 per cent reported normal passage of air. Physical examination revealed a considerable number of deformities in all groups, including the normal group. Deviation of the external nose was significantly more common in the patients than in the normals. During the follow-up period, secondary deformity--saddling or hump--developed in some cases. Most deformities were slight and of little importance to the patient. Septal deformities were present in over 50 per cent of all groups, including the normal group. There was no aggravation of septal deformities or increasing nasal stenosis during the follow-up period. Three patients were interested in secondary corrective treatment. It is concluded that closed reduction of nasal fractures affords satisfactory long-term results. The study does not support the view that a large number of cases of nasal fracture should be treated by open reduction.

Resection with laser and high frequency cutting loop in tracheo-bronchial diseases.

A total of 23 patients have been treated endoscopically during the last three and a half years for a variety of diseases in the tracheo-bronchial tree; nine had a tracheal stenosis. Thirteen patients have been treated by resection with a high frequency cutting loop, eleven with a CO2-laser and one with an argon laser. A total of 44 treatments have been performed. Half of the treatments were given because of various malignant diseases. The results of the treatment of this very mixed group of patients were, as a whole, satisfactory with both CO2-laser and cutting loop. A more precise technique can be applied with the CO2-laser than the cutting loop, though the latter is the more efficient and easy to work with. Care must be taken with the loop because of its greater cutting depth. The argon laser has only limited use in the treatment of diseases in the trachea.

Surgical treatment of Zenker's diverticulum.

One-hundred-and-fifty patients with Zenker's diverticulum were reviewed; twelve patients received no treatment; 26 patients were treated endoscopically by dilatation, five of these had a diverticulectomy performed at a later stage. One-hundred-and-ten patients had a diverticulectomy performed (a total of 115 primary operations were performed). Eighteen of the patients operated upon had a recurrence and six underwent re-operation. Local complications occurred in 24 patients. Seven patients had a fistula and two had mediastinitis. Ten patients had recurrent nerve palsy, of which five were permanent. Thirteen patients had other complications, usually infection. One death occurred. Post-operative prophylactic treatment with antibiotics was found to significantly reduce the number of local infectious complications and a correlation was found between the occurrence of local, infectious complications and later recurrence of the pouch.