Submandibular gland excision is an operationfrequently performed by many different surgical specialists It is often associated with a variety of postoperative complications, the commonest being neurological deficits related to damage to the marginal mandibular, lingual or hypoglossal nerves. Other patients develop further problems at a later date due to the development ofcalculifrom gravel retained in the duct remnant. This study aims to discuss how these complications can be avoided.
The efficient management of the continuously increasing number of chemical substances used in today’s society is assuming greater importance than ever before. Toxicity testing plays a key role in the regulatory decisions of agencies and governments that aim to protect the public and the environment from the potentially harmful or adverse effects of these multitudinous chemicals. Therefore, there is a critical need for reliable toxicity-testing methods to identify, assess and interpret the hazardous properties of any substance. Traditionally, toxicity-testing approaches have been based on studies in experimental animals. However, in the last 20 years, there has been increasing concern regarding the sustainability of these methodologies. This has created a real need for the development of new approach methodologies (NAMs) that satisfy the regulatory requirements and are acceptable and affordable to society. Numerous initiatives have been launched worldwide in attempts to address this critical need. However, although the science to support this is now available, the legislation and the pace of NAMs acceptance is lagging behind. This review will consider some of the various initiatives in Europe to identify NAMs to replace or refine the current toxicity-testing methods for pharmaceuticals. This paper also presents a novel systematic approach to support the desired toxicity-testing methodologies that the 21st century deserves.
A total of 535 children aged 4-11 years with perennial rhinitis were recruited to two double-blind studies performed at 56 centres in eight European countries, Israel, and South Africa. One study compared the efficacy and tolerability of fluticasone propionate aqueous nasal spray (FPANS), at either 100 micrograms once daily (od) or 100 micrograms twice daily (bd), with beclomethasone dipropionate (BDPANS) 200 micrograms bd for 12 weeks in 120 children aged 6-11 years. The second study compared FPANS 100 micrograms od with FPANS 200 micrograms od and placebo for 4 weeks in 415 children aged 4-11 years. Efficacy was determined by means of patient assessments of nasal symptoms of perennial rhinitis and by investigator assessments of symptoms and nasal condition. The symptoms of nasal blockage, on waking and during the day, sneezing, rhinorrhoea, and nasal itching were assessed by the investigator at clinic visits and by the completion of a patient daily diary card. Safety was assessed by collection of adverse event information, routine haematology and biochemistry testing, and monitoring plasma cortisol levels. FPANS demonstrated good control of symptoms at each dose regimen, which was equivalent or superior to BDPANS and superior to placebo. There was no difference between the dose regimens of FPANS. FPANS was as well tolerated as placebo and BDPANS. It is concluded that FPANS 100 micrograms od is an effective and well-tolerated treatment for perennial rhinitis in children aged 4-11 years.
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