A comparison of skin graft success in the head & neck with and without the use of a pressure dressing.

BACKGROUND: The success of skin grafting is dependent on the interplay between many factors including nutrient uptake and vascular in-growth. To allow this, it is important that the graft is immobile and traditionally a 'pressure dressing' has been placed over the graft to improve outcome and graft 'take'. We present the findings of our comparative study of full-thickness skin grafts performed in the head, neck and face region over a period of 24 months. We felt that there was an unacceptably high infection rate and graft failure using pressure dressings. METHODS: Data was collected retrospectively from the case notes on 70 patients who had undergone full-thickness skin grafting to the head, neck and face over a 2 year period. Thirty-five patients underwent grafting with pressure dressing and 35 without. The group with the pressure dressing had the same 'bolster' specification-type dressing and those without had their graft 'quilted' in and chloramphenicol ointment applied topically. Success was determined by the percentage 'take' of the grafts and absence of infection i.e. purulence. RESULTS: Infection in those with a pressure dressing stood at 26 % in contrast to those without, at 9 %. Without a pressure dressing we observed no total graft failures, compared to 6 % in those with a pressure dressing. CONCLUSIONS: The results confirmed the perception that there was a higher infection and graft failure rate where a pressure dressing was applied; however, this was not a statistically significant difference and a randomised control trial with a larger sample size would be required to validate the results.

Bisphosphonate osteonecrosis: a protocol for surgical management.

We present a protocol for the management of a subgroup of patients with bisphosphonate osteonecrosis who presented with painful, exposed, necrotic, alveolar bone. It is simple and can easily be adapted to suit anatomical variations of the oral cavity. Current guidelines based on consensus for the management of bisphosphonate-induced osteonecrosis fail to provide mucosal coverage, which is a primary requirement in managing the condition. We have evaluated the results of a group of 15 patients and analysed their postoperative progress for 24 months.

Trainees' perceptions of UK maxillofacial training.

Training is a central component of the work of many units around the UK. Many changes to the way that junior doctors are trained have taken place over the past few years and maxillofacial surgery, of all the surgical specialities, has perhaps undergone the most far-reaching. A postal survey of 93 maxillofacial specialist registrars (SpRs) in all regions of the UK was carried out, of whom 81 (87%) responded. The aim was to seek their views on subjects directly related to the quality of, and access to, training. Information was gathered on age of trainees, entitlement to annual and study leave, certification for Advanced Trauma Life Support (ATLS) and office and research facilities.

Screening for syphilis in patients with carcinoma of the tongue.

The oral signs of syphilis have been comprehensively described and can be identified at each stage of the infection. Despite the historical recognition that inadequately treated or untreated syphilitic leukoplakia may undergo malignant transformation, many surgical units no longer routinely screen patients presenting with malignant or premalignant lesions. In this study, five of the 63 patients (8%) who presented with neoplasms of the tongue reacted to syphilis antibodies. These results indicate that syphilis is still prevalent in this group of patients and suggest that serological investigations may be warranted in the initial assessment of all patients with oral cancer.

An unusual cause of trismus.

This paper reports a case of limited mandibular movement caused by the rare condition of bilateral coronoid hyperplasia. Dental surgeons should be aware of the possibility of this condition when encountering patients with movement problems in the mandible.

An unusual cause of maxillary tuberosity enlargement.

Myelomatous involvement of the maxilla is rare. A case is presented where bilateral enlargement of the maxillary tuberosities lead to a diagnosis of plasma cell myeloma (multiple myeloma) in an edentulous 54-year-old female.

A pilot study of the use of eminectomy in the treatment of closed lock.

There are many treatments described for closed lock of the temporomandibular joint. Eminectomy has been described in the treatment of recurrent dislocation of the jaw. The use of a 'true' eminectomy alone, as the treatment of closed lock has not been previously described. Eighteen patients, three male and 15 female, with a mean age of 28 years, underwent 22 eminectomy procedures. The mean follow-up period was 7 months, assessment was both subjective, using a retrospective Visual Analogue Scale (VAS), and objective with measurement of the Inter Incisal Distance (IID). Overall the subjective improvement in symptoms was high with a score of 85.5 on a 100 mm VAS. The mean improvement in Inter Incisal Distance, was 17.9 mm a statistically significant result using a paired t test (p < 0.001).

An unexpected death associated with an acute dentoalveolar abscess--report of a case.

A case which was reported in the national press, is described where a fatality occurred as a result of an acute dentoalveolar abscess, and the subsequent development of septicaemia with Disseminated Intravascular Coagulation (DIC). A review of the English literature shows that there are no reported cases of death associated with acute dentoalveolar infection and DIC.

Adenocarcinoma: the use of computed tomography and magnetic resonance imaging for investigation of a tumour in the infratemporal fossa.

A case of a salivary gland adenocarcinoma involving the right infratemporal fossa is presented. The diagnostic and clinical management of the case was aided by the use of both CT and MRI.

Drug development and registration in Japan: threshold of transition.

The responsibility for the regulation of pharmaceuticals is situated within the Pharmaceutical Affairs Bureau (PAB) of the Japanese Ministry of Health and Welfare. The scientific evaluation of the application is undertaken by a series of committees consisting of independent senior members of the medical and scientific community whereas all communication between them and the pharmaceutical company is conducted through PAB offices (Koseisho). As in the U.S., the Japanese drug application covers product quality, safety, and efficacy, but the actual data requirements differ between the two countries. Some of these differences have a basis in Japanese regulations whereas others emulate from demands set by senior members of the medical fraternity who carry great sway in Japan. These cause concern to international pharmaceutical companies since they may require studies to be duplicated with consequent delays. Moves toward the achievement of global harmonization of regulatory requirements with the associated benefits of reducing the numbers of animals sacrificed in the total development program and of important new medications reaching patients earlier are discussed.

Sialolithiasis of minor salivary glands.

Sialolithiasis of minor salivary glands is generally considered to be extremely rare. Reports of seven cases are presented. A review of the literature suggests that the condition is not as uncommon as previously considered, and that definitive histopathological diagnosis of lip swellings should be obtained due to the incidence of labial pleomorphic adenoma and the possibility of the clinical misdiagnosis with sialolithiasis.

European registration: today, tomorrow, and beyond.

Within the European Community (EC) countries the national pharmaceutical regulatory systems work with varying degrees of efficiency and scientific sophistication. At the Community level the objective of mutual recognition has failed to be realized. To achieve for one registration application within the EC, timely and simultaneous marketing approvals throughout the member states will require changes to the present regulatory procedures or the single market concept for pharmaceuticals will not be realized. To have the greatest chances for success we should move cautiously, identifying and correcting deficiencies in the present procedures, which are known from experience, rather than abandoning such hard won knowledge for a new system with all its attendant potential unknowns and uncertainty. The free movement of drugs within the Internal European market will be a reality. The question remaining is at what price will it be achieved? It is vital to the European economy and consumer, as well as to the innovative pharmaceutical industry, that Europe does not exchange its present competitive edge in the time to develop and register new drugs for a costly drug lag. The experiment must equally succeed as a torch showing the way forward not only for an enlarging European Community, but also to the ever increasing interest in global harmonization of drug regulation.

The evolving horizon of drug registration--Europe and beyond.

The thalidomide tragedy gave rise to national drug regulation without thought to international harmonization. Thus from the early days of the European Community (EC), there has been a barrier to the free movement of medicinal products. Previous attempts have failed to resolve the problem and the European Commission is currently involved in attempting to establish Community drug legislation which will remove these barriers and create a single internal market. The Commission advocates two procedures (a centralized and a decentralized) largely under the control of the Committee for Proprietary Medicinal Products (CPMP) within the framework of a new European Agency for the Evaluation of Medicinal Products. The present authority of the Commission to make decisions binding on all 12 Member States will be utilized by the CPMP. While the present draft legislation should create significant improvement towards the goal of a single market, it contains some areas of potential concern. That this major venture should be a success is not only critical to the EC economy, its research-based pharmaceutical industry and the health care of its citizens but also to the achievement of global harmonization for pharmaceutical marketing authorization for which there is much evidence of enthusiasm and desire.

1992. Is there the will for there to be a way?

The European Community must become a fully integrated market by 1992. The differing national requirements for pharmaceutical product registration constituted a barrier, unresolved by the creation of a nonmandatory process of mutual recognition of pharmaceutical licences. Interested parties have been asked to recommend measures to abolish the remaining barriers. The principle sought is that a single authorisation shall afford simultaneous approvals in all member states. Considerable debate has taken place but there is no clear concensus. Recommendations include mandatory mutual recognition, a central FDAlike European Agency and a combination of both. A tripartite solution is recommended. This is a sharing of responsibility between the National Agencies and a central European body. A small European Secretariat would coordinate activities and, using expert consultants, hear and resolve appeals. The National Agencies would share the licence application assessments and the CPMP would be responsible for, among other things, the education standards of Agency personnel.

The regulation of medicines post 1992.

The European Community (EC) is scheduled to become a fully integrated market by 1992. Currently the present national variations in pharmaceutical marketing authorization constitutes an unresolved barrier. The need is for agreed and clearly specified requirements to afford EC wide marketing authorization within agreed time frames. Great care will be required to avoid such problems as a European drug-lag and mounting cost, to the detriment of patients, government, and the research-based pharmaceutical industry.

Post-marketing surveillance of enalapril: experience in 11,710 hypertensive patients in general practice.

Post-marketing surveillance in general practice represents an important part of the monitoring of adverse events associated with newly introduced drugs. Such a study of the angiotensin-converting enzyme inhibitor enalapril maleate has been undertaken in 11 710 patients with essential hypertension. Serious adverse events occurred in 1.7% of patients, though most of these were not thought to be related to the treatment. The incidence rates of death (0.09%), stroke (0.11%) and myocardial infarction (0.15%) were compatible with rates predicted from age, sex and blood pressure considerations. Other events reported were hypotension (0.3%), angioneurotic oedema (0.03%), rash (0.5%), taste disturbance (0.2%) and cough (1.0%). The degree of blood pressure reduction attained was similar to that previously reported from pre-marketing development studies, as was the overall nature and frequency of both serious and non-serious adverse events. The most frequently reported event during enalapril therapy was of an improvement in well-being (19.8%).

Effects of sulindac on renal function and prostaglandin synthesis in patients with moderate chronic renal insufficiency.

The renal effects of therapeutic doses of sulindac were studied in nine patients with stable renal insufficiency, mean creatinine clearance 37.0 +/- 2.2 ml min-1 1.73 m-2 (range 24.7-54.6 ml min-1 1.73 m-2). Nine days' treatment with sulindac produced a small, but significant, reduction in the mean creatinine clearance (37.0 +/- 2.2 to 34.7 +/- 2.2 ml min-1 1.73 m-2; P less than 0.02) and 99mTc diethylenetriaminepenta-acetate (DTPA) clearance (35.5 +/- 3.4 to 31.4 +/- 3.6 ml min-1 1.73 m-2; P less than 0.02) without altering body weight, effective renal plasma flow [131I]hippuran clearance), plasma renin activity (PRA), 24 h urinary volume or electrolyte excretion. After discontinuation of sulindac, creatinine clearance returned to pretreatment values. In five female patients, pretreatment urinary excretion of the 6-ketoprostaglandin F1 alpha (6-keto-PGF1 alpha), a stable breakdown product of prostacyclin (PGI2), was significantly reduced (P less than 0.02) when compared with four healthy controls, whereas prostaglandin E2 (PGE2) was unchanged. Administration of sulindac did not significantly alter the excretion rate of PGE2 or 6-ketoPGF1 alpha in this group of patients. In chronic renal disease with moderate renal impairment, reduced renal prostacyclin synthesis may be an important predisposing factor to the renal toxicity associated with the use of non-steroidal anti-inflammatory drugs (NSAID). Short term use of sulindac in therapeutic doses does not appear to influence the excretion of prostaglandins and produces only a minor reversible change in renal function; used cautiously it may have advantages over other NSAID in these patients.

Pharmacokinetics of enalapril in normal subjects and patients with renal impairment.

The pharmacokinetics of enalaprilat were studied after administration of single and multiple doses of enalapril maleate to people with normal and impaired renal function. Renal impairment was associated with higher serum concentrations of enalaprilat, longer times to peak concentrations, slower decline of serum concentrations and with reduced urinary elimination. Urinary elimination of enalaprilat was closely related to renal function. In patients with severe renal impairment (GFR values below 30 ml min-1 1.73 m-2) significantly smaller doses of enalapril maleate will be required than in patients with normal or less severely impaired renal function.