A noncomparative study of cefprozil at two dose levels in the treatment of acute uncomplicated bacterial sinusitis.

The efficacy and safety of cefprozil at two dose levels were evaluated in 110 patients with acute uncomplicated bacterial sinusitis in an uncontrolled, noncomparative, Phase II trial. Ninety patients received 250 mg of cefprozil (low-dose group) and 20 patients received 500 mg of cefprozil (high-dose group) every 12 hours for ten days. Evaluable patients had symptoms consistent with acute sinusitis, pathogens isolated at pretreatment susceptible to cefprozil, and a radiograph positive for sinusitis within 48 hours before treatment. A satisfactory clinical response was achieved in 34 of 39 evaluable patients (87%) in the low-dose group and in all 16 evaluable patients (100%) in the high-dose group. Pathogens were eradicated in 35 of 39 patients (90%) in the low-dose group and in 15 of 16 patients (94%) in the high-dose group. A total of 140 of 155 pathogens (90%) isolated pretreatment were susceptible to cefprozil. Six patients (7%) in the low-dose group and one patient (5%) in the high-dose group reported at least one adverse clinical event.

Cefpodoxime proxetil concentrations in head and neck tissues.

Three to six hours prior to surgery in the head and neck a single dose of 200 mg cefpodoxime proxetil was administered orally to 30 patients. During surgery serum and tissue samples (concha, mocosa, cartilage, bone, parotis and tonsil) were taken and the concentrations of cefpodoxime were determined by bioassay. The serum concentrations ranged from 0.72 mg/l (determined after 6 h 22 min) to 3.34 mg/l (3 h 15 min). The tissue concentrations were between 0.15 mg/l (determined in bone after 5 h 18 min) and 1.94 mg/l (concha 4 h 13 min). Analogously to recent in vitro data the concentrations reached in head and neck tissue were higher than the MIC90 values for most pathogens of upper respiratory tract infections.

[Nimodipine (Bay e 9736) a new therapy concept in diseases of the inner ear?]. / Nimodipin (Bay e 9736) ein neues Therapiekonzept bei Innenohrerkrankungen?

In an open study 30 patients with the symptom of tinnitus were treated for 12 weeks with nimodipin (Bay e 9736) 3 X 30 mg/die. 12 patients showed sudden deafness with a history of one day up to more than 20 years. In six cases we observed complete remission, in two cases remission up to 70-80%, in two cases slight improvement. Four patients showed no side reaction to the treatment of nimodipin. Ten patients suffered from so-called degenerative inner ear deafness. 3 (n = 10) showed complete remission, one nearly 90% improvement, another patient showed 60% improvement, one slight improvement, in 4 patients tinnitus persisted. Vertigo-Morbus Menière: 4 out of 30 patients were included with the diagnosis of Morbus Menière with tinnitus. 3 (n = 4) showed complete remission of tinnitus, normal hearing level and no more symptoms of vertigo after 12 or less weeks of treatment with nimodipin. In one case with an history over more than 20 years only the vertigo could be cured. Traumatic inner ear deafness is not apt to be treated with an agent such as nimodipin.

[Ultrastructure of cilia in Kartagener syndrome]. / Zur Feinstruktur der Zilien bei Kartagener-Syndrom.

The lack of mucociliary transport causes chronic inflammations in the upper and lower respiratory tract and in the middle ear mucosa. The mucosa of 4 female patients with Kartagener's syndrome was studied by means of TEM (transmission electron microscopy) and SEM (scanning electron microscopy) and compared with the fine structure of normal cilia which were also found in these areas. All specimens studied showed, to a different extent, alterations in the fine structure of the axonemata, especially the absence or malformed ATP-ase dynein arms, the lack of spokes and/or the misarrangement of microtubuli within the cilia. The importance of this congenital anomaly - "immotile cilia" - is discussed with the trias of Kartagener's syndrome.

[Electron microscopy findings in allergic reactions of the nasal mucosa]. / Elektronenmikroskopische Befunde bei allergischen Reaktionen der Nasenschleimhaut.

The fundamental morphologic aspects of acute and chronic allergic reactions, as well as endonasal polyps in allergic patients and disturbances of the autonomic nervous system were studied by means of electron microscopy. Characteristic changes are described which differ according to the stage of the allergic reactions; they are discussed in relation to the altered function of the allergic nasal mucosa.

[Tissue reaction with platinum-iridium insulated electrodes (author's transl)]. / Untersuchungen zur Gewebeverträglichkeit lackisolierter Platin-Iridium-Elektroden.

Pt-Ir-electrodes were coated with different insulations. Some of the insulations proved to be highly cytotoxic. Pt-Ir (9:1) electrodes coated with "PYRE-M.L." were easy to handle and did not show any cytotoxic effects. A change of electric impedance was found when the voltage was raised and platinum had changed the surface of the cathode.

[X-ray tomography in fractures of the temporal bone and injuries of the ossicula (author's transl)]. / Röntgen-Schichtaufnahmen bei Schläfenbeinfrakturen und Verletzungen der Gehörknöchelchen.

Since a high percentage of cross-fractures of the temporal bone cannot be verified in standard projections, tomography is indicated under clinical aspects. With this technique even small fractures concerning the meatus acusticus internus, the labyrinth, and the proximal part of the canalis facialis can be diagnosed. Experimental data concerning longitudinal fractures with facial palsy show the course of the fracture but not the exact point of the lesion. Additional information will be given to verify luxations or displacement of the ossicula.

[Scintigraphy and tomography in inflammations and non-malignant tumors in head and neck (author's transl)]. / Szintigraphie und Tomographie bei Entzündungen und gutartigen Tumoren im Kopf-Hals-Bereich.

Scintigraphy is a non-invasive technically simple tool for diagnostic in the head and neck. Using nuclides with a short life time the irradiation of the skeleton is less than 1 rd. Scintigraphy in addition to X-ray examination is useful in diagnosis and surveillance of different osteoplastic tumors (like osteoma, osteoplastoma, cementoma, meningioma) and in systemic diseases of the bones (fibrotic dysplasia, Morbus Paget). Concerning inflammatory diseases osteomyelitis is the main indication for scintigraphy, but it is as well usefull in the diagnosis of complications of inflammatory diseases of the sinuses, like mucocelia or non resorbed antibiotics which provoked an inflammatory reaction of the mucosa. There is no indication for scintigraphy regarding its low specificity in common acute or chronic sinusitis.

[Bone scintigraphy in the diagnosis and follow up care of malignant head and neck neoplasms]. / Die Skelettszintigraphie in der Diagnostik und Nachsorge von malignen Geschwülsten im Kopf-Hals-Bereich.

In diagnosis and localisation of malignant tumors with destruction of the bone, scintigraphy has its special importance in diagnosis as an addition to X-ray tomography. When carcinoma are localized in the middle or dorsal part of the base of the skull scintigraphy may help to calculate the chance for an operation. The exact knowledge of the dimension of the tumor is a valuable help in radiotherapy. In primary diagnosis of destructions of the base of the skull scintigraphy might give an earlier information than X-ray. Malignant tumors of the ear however are sufficiently detected by means of X-rays alone. The main field of scintigraphy is the observation of irradiated and operated malignoma. We recommend 6 or 12 months controls in combination with a clinical observation and with tomographic controls. Scintigraphy became a most valuable tool in the search and diagnosis of metastases in primary malignoma of the mammae, the lungs or the kidneys. In case of metastases in the skull scintigraphy is most helpful to detect them often earlier than by means of X-rays.

[Rhinobasale mucormycosis (author's transl)]. / Rhinobasale Mukormykose.

A case of mucormycosis in a 82-year old woman is reported. In spite of an early diagnosis, a surgical intervention and the antimycotic treatment with Miconazol-Sodium (Daktar [R]) and Amphothericin B "Squibb" (R) could only prolonge the bad prognosis of this infection. The pathogenesis, the typical, in most cases letal fungal infection and its therapy is discussed.

The combination of scanning and transmission electron microscopy techniques in pathology of the organ of Corti in guinea pigs.

The pathology of the organ of Corti in guinea pigs is studied by means of SEM and TEM. It was the purpose of this study to examine the surface of an experimentally altered organ of Corti by means of SEM screening method). As it was our main interest to find out the localization of acoustic stimulation regarding the tonotopicity on the surface of the organ of Corti, we always examined the whole cochlear by means of SEM first. In acoustic experiments we used long-time pure-tone stimulation beyond the directly damaging sound pressure level, as well as white noise or shots for experimental damage of hair cells and supporting cells. Specimens of particular interest underwent a special procedure for a supplementary TEM examination. A prolonged and modified technique of embedding the specimens in Epon 812 permitted us to obtain supplementary data from TEM without major artifacts in the fine structure of the cells.

[The acoustic trauma in animal experiment. II. Morphological reaction in the guinea pig cochlea after traumatisation by pure tones and octave band noise (a SEM- and TEM-study) (author's transl)]. / Das akustische Trauma im Tierexperiment. II. Morphologische Veränderungen der Meerschweinchenkochlea nach Sinuston-stimulation und rosa Rauschen. (Raster-und Transmissionselektronenmikroskopie).

Guinea pigs were exposed in groups to pure tones of varying frequences (1000, 3000, 5000 cps) and intensities in the range of 85--130 dB SPL. Other guinea pigs were exposed to octave band noise (180--5600 cps). By means of morphology we examined the immediate and late degenerative changes of the cochleae. The changes in sensory and supporting cells were simular after a short time overstimulation (130 db SPL--15 min) compared to a 5-days-stimulation at the 85 dB SPL level. After an OBN-Stimulation with 105 dB SPL--61 hours, lesions of sensory cells were found spread over several coils of the cochleae, with a predominance of the basal and 2nd coil. After pure tone stimulation the destruction of the organ of Corti was not tonotopically related according to the frequencies which were used in the experiments. The circumscribed destroyed areas in the organ of Corti were found mainly in the tonotopical range of the receptors of 2000--5000 cps--this means the end of the basal coil and the 2nd coil. The probable mere influence of direct mechanical stress is discussed.

[The acoustic trauma in animal experiment: I. Morphological reaction in the guinea pig cochlea after traumatisation by shots (a scanning microscopical study) (author's transl)]. / Das akustische Trauma im Tierexperiment. I. Morphologische Veränderungen der Meerschweinchenchencochlea nach Knalltrauma (Rasterelektronenmikroskopie).

Guinea pigs were exposed to shots of a pistol under standardized experimental conditions. The organs of Corti were examined by SEM after surviving times of 5 min, 1, 5 and 10 days. In correlation to the acoustic trauma we found mainly three different ways of morphological reaction of sensory cells. After 1--3 shots alterations and even losts of stereocilia were observed mainly in the 2nd (and 1st) coil from base. Only the rows III and II of outer hair cells (OHC) were concerned while changes in inner hair cells (IHC) were not observed. 5--10 shots regularly caused more severe alterations in the 1st, 2nd (and 3rd) coils of the organ of Corti. The three rows of outer hair cells degenerated within 2--5 days, while inner hair cells did not show any changes of the surface when the pillar cells remained intact. (20) 40 or even 100 shots most often caused a complete damage of all sensory--and supporting cells. The cell detritus was abolished within 5 days. At this time the damaged organ of Corti was replaced by a flat epithelium on the intact basilar membrane.

[Diagnosis and therapy of the so-called malignant external otitis (author's transl)]. / Zur Diagnostik und Therapie der sog. malignen Otitis externa.

The malignant external otitis is characterized by the following symptoms: Severe neuralgic pain in the deep ear region is found in the elderly diabe-the cases with a facial palsy due to the infection of the outer ear. In more than 50 percent of the cases with a facial palsy due to the infection the further course was letal (Chandler 1968). A new surgical treatment of the malignant external otitis (Naumann 1977) is presented: After the adequate excision of all infected tissue and cartilage a perforated polyethylen-tube is placed into the infected area along the base of the skull. The combined therapy of a parenteral and local administration of antibiotics helps to improve the bad prognosis of the malignant external otitis.

[Fine structure of nasal mucosa in mucoviscidosis, with special regard to polyposis (author's transl)]. / Feinstruktur der Nasenschleimhaut bei Mukoviszidose, unter besonderer Berücksichtigung der Polyposis.

In mucoviscidosis, even the clinically and histologically often normal appearing nasal mucosa exhibits characteristic changes with the electron microscope. The epithelial cells show intra- and extracellular edema, the cilia membrane damage. The highly viscous mucous blanket and the frequent lamination of the basement membrane of the capillaries can be explained by a disturbance in mucopolysaccharide and glycoprotein metabolism respectively. The functional disorder of the goblet cells and the nasal glands manifests itself with signs of increased activity, but without definite degenerative changes. The course of the pathologic mucous formation on the cells appears morphologically normal so that a disturbance of membrane transport or in the dilution of the secretions must be assumed. The endonasal polyps differ from allergic polyps by the absence of eosinophilic infiltration.

Comparative surface studies of ototoxic effects of various aminoglycoside antibiotics on the organ of Corti in the guinea pig. A scanning electron microscopic study.

It was the purpose of this study to establish criteria for use in comparing the toxic effects of aminoglycosid antibiotics on the organ of Corti by means of scanning electron microscopy. Amikacin, Tobramycin and Gentamicin were administered twice a day subcutaneously for 10 days to healthy guinea pigs. One group of animals was sacrificed 1 day after completion of the treatment; the other group was allowed to survive 22 days. Depending upon the dosage of the administered drug, Amikacin (150 mg per kg body weight daily, corresponding to 10 times an average recommended human dose) caused pronounced outer hair cell damage even 1 day after the treatment was stopped. At this time Gentamicin and Tobramycin (150 mg per kg body weight daily, corresponding to 50 times an average human dose) showed less damage. After 22 days' survival, late toxic effects were found mainly in Gentamicin- and Tobramycin-treated animals. After 3 weeks, nearly total outer hair cell loss was found in the basal coil, while the 2nd and 3rd coils were often less severely damaged. At this time Amikacin-treated animals showed severe damage in all coils. 300 mg per kg body weight Amikacin (i.e. 20 times the average human dose) showed about the same toxic effect on sensory cells of the guinea pig as did 150 mg Gentamicin or Tobramycin per kg body weight. We are conscious of the fact that there are problems in correlating the weight of a drug and its probable toxic effect. In comparative animal experiments we consider it useful to standardize the time of exposure, the amount of drug administered (e.g. related to the human dose) and the survival time.

[Postmortem changes of fine structure in the auditory pathways (organ of Corti and nucleus cochlearis of the guinea pig (author's transl)]. / Feinstrukturelle postmortale Veränderungen der Hörbahnen (Cortisches Organ und Nucleus cochlearis des Meerschweinchens)

Autolytic changes in the guinea pig cochlear nucleus were studied by means of light- and transmission electron microscopy from 5 min. up to 5 h post mortem. Hyperchromasy and shrinking of neurons was observed already after 5 min. in areas, where the neurons have a high number of primary afferent nerve endings (Kane 1973). A second mode of post mortem degeneration was found. It was characterized by a swelling of the cell, which showed a diminished stain-ability. This lytic swelling seemed to be less rapid and probably less harmful in the beginning. The cochleae were examined by scanning electron microscopy. In contrary to known damaging agents (like noise or antibiotics) the outer haircells showed hardly any changes in the surface structures up to 1 hour in the basal coil, while lytic protrusions were observed in outer and inner haircells already after 5 min. in the apical parts. Post mortem changes in the cochlea and in the nucleus cochlearis show two different modes of autolytic degeneration.