Clinical safety of enamel matrix derivative (EMDOGAIN®) in the treatment of periodontal defects

Abstract The aim of the present clinical trial was to test tolerability during 2 treatments with EMDOGAIN® in a large number of patients. An open, controlled study design in 10 Swedish specialist clinics was chosen, with a test group of 107 patients treated with EMDOGAIN® in connection with periodontal surgery at 2 surgical test sites per patient. The procedures were performed 2 to 6 weeks apart on one-rooted teeth with at least 4 mm deep intraosseous lesions. A control group of 33 patients underwent flap surgery without EMDOGAIN® at I comparable site. In total 214 test and 33 control surgeries were performed. Serum samples were obtained from test patients for analysis of total and specific antibody levels. 10 of the patients had samples taken before and after the first surgery. 56 other samples were taken after one treatment with EMDOGAIN®, and 63 after 2 treatments. None of the samples, not even from allergy-prone patients after 2 treatments, indicated deviations from established baseline ranges. This indicates that the immunogenic potential of EMDOGAIN® is extremely low when applied in conjunction with periodontal surgery. Comparison between the test and control groups demonstrated the same type and frequency of post-surgical experiences, i.e., reactions caused by the surgical procedure itself. Clinical probing and radiographic evaluation was performed at baseline and 8 months postsurgery. About half of the patients (44 test and 21 control) were also evaluated after 3 years. There was a significant difference between the test and control results at 8 months post surgery. and this difference had increased further at the 3 year follow-up. The 2.5–3 mm increase in attachment and bone level after treatment with EMDOGAIN® was of the same magnitude as seen in the studies with split-mouth design aiming for lest of effectiveness of EMDOGAIN®.     

Cerebral function of the guinea pig neonate after chronic intrauterine exposure to khat (Catha edulis Forsk.)

Cerebral function in normoxia and its reactions to standard periods of hypoxia of increasing severity were studied in 30 newborn guinea pigs less than 3 days old. Intrauterine growth retardation was induced either by uterine artery ligation at midgestation or by feeding the female in late gestation with khat leaves, an amphetamine-like stimulant chewed by men and women in several countries in eastern Africa and Arabia. After spontaneous delivery, the neonates were anesthetized and ventilated. Cardiovascular, metabolic, and neurophysiologic (somatosensory evoked potentials) parameters were monitored. Under normoxia, the khat-exposed group showed prolonged latency of the primary response of the somatosensory evoked potentials and a reduced amount of secondary components. Under hypoxia, this group also has a greater reduction of amplitude of the somatosensory evoked potentials. It is concluded that khat exposure during fetal life has an impact on the cerebral function during the neonatal period (at least up to 3 days of age) which is not solely explained by the concomitantly produced growth retardation.     

Benign intracranial hypertension and recombinant growth hormone therapy in Australia and New Zealand

Benign intracranial hypertension (BIH) is reported in three children from Australia and one from New Zealand, who were being treated with recombinant human growth hormone (rhGH). Three males and one female, aged between 10.5 and 14.2 y, developed intracranial hypertension within 2 weeks to 3 months of starting treatment. A national database, OZGROW, has been prospectively collecting data on all 3332 children treated with rhGH in Australia and New Zealand from January 1986 to 1996. The incidence of BIH in children treated with growth hormone (GH) is small, 1.2 per 1000 cases overall, but appears to be greater with biochemical GHD (<10IUml ^-1), i.e. 6.5/1000 (3 in 465 cases), relative risk 18.4, 95% confidence interval 1.9-176.1, than in all other children on the database. The incidence in patients with Turner's syndrome was 2.3/1000 (1 in 428 cases). No cases in patients with partial GHD (10–20 IUml ^-1) or chronic renal failure were identified. Possible causative mechanisms are discussed. The authors'practice is now to start GH replacement at less than the usual recommended dose of 14IUm-² week^-1 in those children considered to be at high risk of developing BIH. Ophthalmological evaluation is recommended for children before and during the first few months following commencement of rhGH therapy and is mandatory in the event of peripheral or facial oedema, persistent headaches, vomiting or visual symptoms. The absence of papilledema does not exclude the diagnosis.     

Brain type creatine kinase in relation to oxygen desaturation in the blood of children with congenital heart disease

The concentration of brain type creatine kinase (CK-BB) was measured in blood from the internal jugular vein in 32 children (less than 1 year old) with congenital heart disease. In transposition of the great arteries the CK-BB levels were significantly higher than in children without cyanosis (10.1 +/- 4.1 vs. 3.0 +/- 0.5 ng/ml). A negative correlation was found for CK-BB concentration and arterial oxygen saturation (r = -0.41, p less than 0.02 for all children and r = -0.62, p less than 0.05 for those with tetralogy of Fallot). It is suggested that the increased CK-BB levels in the blood of cyanotic children reflect chronic cerebral hypoxia, which may explain other reports of reduced psycho-intellectual function in patients with cyanotic heart disease.     

Myocardial metabolism during aortic valve replacement. II. Bolus infusion of cold blood for cardioplegia

Myocardial energy metabolism during hypothermic potassium cardioplegia with blood as the cardioplegia vehicle, given in one or two bolus doses, was studied in eight patients undergoing aortic valve replacement. Myocardial biopsies were taken from the left ventricle 10 min after aortic cross-clamping (a.c.) and immediately before declamping (d.c.) and were analyzed for ATP, creatine phosphate (CP), creatine (C) and lactate. The interindividual range of myocardial temperature was 11-19 degrees C at 10 min a.c. and 11-25 degrees C immediately before d.c. The myocardial ATP concentration fell (17.2 +/- 5.7-12.8 +/- 2.8 mmol X kg-1 dry muscle), the lactate concentration rose (64.7 +/- 35.8-136 +/- 33.8 mmol X kg-1 d.m.) and the total creatine pool (CP + C) was unchanged. Hypothermic blood cardioplegia conferred fairly good initial protection of the myocardium, but the reduction in ATP and the great lactate accumulation towards the end of cardioplegia, especially in patients with myocardial temperature reaching 19-25 degrees C, indicates that such protection is adequate only if the myocardial temperature is maintained between 11 and 18 degrees C.     

Growth hormone stimulates granulation tissue formation and insulin-like growth factor-I gene expression in wound chambers in the rat.

It has been reported that GH stimulates fibroblast growth and wound healing. In the present study we measured the effect of locally applied GH on insulin-like growth factor (IGF-I) mRNA concentrations and granulation tissue formation in wound cylinders, implanted s.c. Four stainless-steel wiremesh cylinders were implanted s.c. in the back of male rats (280 g). Each cylinder was then injected every day with either 0.014 or 0.14 U human GH, or vehicle only. Ingrown granulation tissue and wound fluid was obtained on day 17 after implantation. The wet weight of granulation tissue was determined and concentrations of IGF-I mRNA in the tissue were measured by solution hybridization/RNAase protection assay. Similar assays were used to measure the levels of IGF-I receptor mRNA and GH receptor mRNA, while the IGF-I concentration in wound fluid and serum was determined by radioimmunoassay (RIA) after acid-ethanol extraction. The concentrations of IGF-I mRNA in ingrown granulation tissue as well as the wet weight of this tissue were significantly higher in the GH-treated cylinders. There was no significant effect of GH on IGF-I receptor mRNA and GH receptor mRNA levels. Consistent with the results of previous studies, wound fluid IGF-I levels were lower than serum IGF-I levels, but no significant difference was found between the GH-treated cylinders and the control cylinders. The results of the present study show that GH stimulates granulation tissue formation and increases the concentration of IGF-I mRNA in the ingrown granulation tissue.     

Ethical Reasoning Among Registered Nurses Experienced in Dementia Care

Abstract. Registered nurses regarded as “experienced and good” in dementia care were interviewed about the feeding of a severely demented patient who showed refusal-like feeding behaviour. Not one of the twenty nurses could see herself using force against her patients. Most interviewees justified their decisions to feed a severely demented patient and answered questions about whether they would change their minds if there were certain circumstances in terms of words that could be interpreted as referring to the ethical principle of beneficence. The nurses stressed the difficulty to understand the meaning of severely demented patients' feeding behaviour and decide when force-feeding occurs. When asked to rank ethical principles of importance for the decision, however, the most common answer was that they would give priority to the ethical principle of autonomy. The nurses did not see the ethical principles as separate entities, that could be applied one by one, but tried to integrate them into a whole. The findings of this study were interpreted as indicating that principled ethics is not an adequate model to describe experienced nurses' ethical reasoning.     

Total pancreatectomy in the MEN-1 syndrome

A family with the multiple endocrine neoplasia Type 1 (MEN-1) syndrome, followed over three generations, is presented. In the first generation, one family member died after a history indicating Zollinger-Ellison syndrome. In the second generation endocrine pancreatic tumours were diagnosed or suspected in three out of five members. In the third generation, five out of seven members were investigated and four of these had positive tests at hormonal screening. Of particular diagnostic value in this family was the determination of peripheral serum levels of proinsulin and C-peptide, which were used as tumour markers both for diagnosis and in the postoperative follow-up. Two members in the third generation have been successfully managed by total pancreatectomy. A MEN-1 patient with malignant pancreatic tumours should be considered for total pancreatectomy if the pancreatic disease has caused high morbidity and mortality within the family. This is especially pertinent if the patient has multiple malignant tumours.