Biodegradable rods of polyglycolide or lactide-glycolide copolymer were used in the internal fixation of a variety of fractures and osteotomies in 516 patients. A clinically manifest foreign-body reaction occurred in 41 patients (7.9%), producing a fluctuant swelling at the implantation site after an average of 12 weeks. Spontaneous sinus formation or surgical drainage yielded a sterile exudate containing liquid remnants of the degrading implants. After prompt drainage this discharge subsided within three weeks. Histological examination showed a typical nonspecific foreign-body reaction with abundant giant cells both in patients with the reaction and in some patients with an uneventful clinical course. The factors determining the nature of the reaction were probably related to the local capacity of the tissues to clear the polymeric debris. The reactions did not influence the clinical or radiographic results, but recognition of the incidence and the features of the reaction is necessary in view of the increasing use of such implants.
The effects of prolonged treatment with intranasally applied budesonide was studied in twenty-four patients with perennial allergic or non-allergic rhinitis. Patients on continuous treatment were followed up for 55 years. At entry and follow-up visits, rhinoscopic findings, nasal symptom scores, blood chemistry, haematoiogy. urine analysis and determination of plasma cortisol levels, before and after stimulation with ACTH (Synacthen®, Ciba-Geigy AG. Basel. Switzerland), were registered. Biopsies of the nasal mucosa were taken before entry into the study, after I year of treatment, and after varying time intervals ranging from 2 5 to 5 5 years during the treatment. The biopsy specimens were examined blindly by an independent pathologist. The analyses revealed no histopathological changes in the nasal mucosa. All nasal symptom parameters assessed by the patients were significantly reduced from the baseline during the entire follow-up period. No clinically significant changes in the haematological and blood chemistry parameters were observed. Plasma cortisol analyses before and after challenge with ACTH revealed no influence on the hypothalamic pituitary adrenal (HPA) axis. The present study suggests that intranasal budesonide in the dose of 200-400 /ig/day is also a safe treatment for prolonged treatment of perennial rhinitis.
A long-term safety study of intranasally administered budesonide, a topical glucocorticoid, has been performed. 104 patients with perennial rhinitis, allergic or non-allergic, participated in a multicentre study in seven ENT-clinics utilising an identical protocol. A budesonide dosage of 400 micrograms/day was used as starting dose, but the patients were at liberty to reduce the daily dose to 200 micrograms. The patients were observed at intervals up to 12 months. At the entry and follow-up visits the following parameters were recorded: rhinoscopic findings, nasal symptom scores, blood chemistry, hematology, urinalysis and determination of plasma cortisol levels before and after stimulation with ACTH (Synacthen). Nasal biopsies taken from 50 of the patients at the beginning and completion of the study were examined in a blinded way by an independent pathologist. The analysis revealed no histopathological changes of the nasal mucosa. At rhinoscopy no signs of atrophy or candida were reported. Lividity of the nasal mucosa was significantly reduced during the trial, which was also the case for nasal congestion and secretion. All nasal symptom parameters assessed by the patients were significantly reduced from baseline during the follow-up period. No clinically significant changes in the hematological and blood chemistry parameters were observed. Plasma cortisol analysis before and after challenge with ACTH revealed no influence on the hypothalamic pituitary adrenal axis. No tachyphylaxis was observed; on the contrary, there was a clear tendency for reduction of the daily dose of budesonide necessary to keep the patients symptom-free.(ABSTRACT TRUNCATED AT 250 WORDS)
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