Effect of patients' functional status on satisfaction with outcomes 12 months after elective spine surgery for lumbar degenerative disease

Background

Comprehensive assessment of quality of care includes patient-reported outcomes, safety of care delivered, and patient satisfaction. The impact of the patient-reported Oswestry Disability Index (ODI) scores at baseline and 12 months on satisfaction with outcomes following spine surgery is not well documented.

Development and characterization of mucoadhesive microspheres for nasal delivery of ketorolac

The objective of the present investigation was to prepare mucoadhesive microspheres of ketorolac for nasal administration by means of a solvent evaporation technique using carbopol (CP), polycarbophil (PL) and chitosan (CS) as mucoadhesive polymers. The prepared microspheres were characterized for morphology, swelling behavior, mucoadhesion, interaction studies, drug encapsulation efficiency, in vitro drug release, release kinetics, and ex vivo nasal cilio toxicity studies. The effects of various process variables on the particle size of the microspheres were investigated. Drug encapsulation efficiency and particle size of the microspheres ranged from 52-78% w/w and 14-46 microm respectively. Interaction studies revealed that there were no drug-polymer interactions. The in vitro release profiles showed prolonged-release of the drug. In vitro release data showed a good fit with the Higuchi model, and indicated Fickian diffusion. No severe damage was found to the integrity of nasal mucosa after ex vivo experiments.     

Endovascular intervention for repositioning the distal catheter of ventriculo-atrial shunt

Displacement of distal ventriculo-atrial (VA) shunt is not uncommon. However, misplacement of the distal catheter of VA shunt in the internal jugular vein is a possibility, especially when conducted without intraoperative monitoring. We describe a patient in whom a VA shunt was performed due to failure of ventriculo-peritoneal shunt and the distal catheter of the shunt was found to be misplaced in the left internal jugular vein. Endovascular intervention via femoral vein was used to retrieve the distal catheter.     

Interaction between the tryptophan hydroxylase gene and the serotonin transporter gene in schizophrenia but not in bipolar or unipolar affective disorders

Increasing focus is being given to identify possible combinations of genes related to specific clinical phenotypes. In our sample of 814 patients comprising 114 with schizophrenia, 416 with bipolar affective disorder and 284 with unipolar affective disorder, we studied interactions between the tryptophan hydroxylase (TPH), the serotonin transporter (5-HTTLPR), and the dopamine receptor (DRD4) genes in relation to five major psychiatric symptomatology scores. There was significant interaction between the TPH and the 5-HTTLPR genes. With an increasing number of short (s) alleles of 5-HTTLPR, the scores for delusions, disorganization and negative symptoms were significantly decreasing among subjects having the TPH genotype AA but increasing among subjects having the TPH genotype AC, yielding the highest scores for the combinations AA x ll and AC x ss. Since high scores on just delusions, disorganization and negative symptoms but low scores on excitement and depression were found among subjects with schizophrenia, we conducted comparisons among the three diagnostic categories and controls as regards the combined TPH x 5-HTTLPR genotype distribution. Schizophrenia subjects had a significantly different distribution of the genotype combination for TPH x 5-HTTLPR as compared to 241 controls or to unipolar or bipolar subjects, and had significantly higher frequencies of AA x ll and of AC x ss. Thus, an interaction between TPH and 5-HTTLPR genes constitutes susceptibility to schizophrenia, thereby yielding apparent relationships between the major psychiatric symptomatology scores and genotype combinations in samples that are obtained by pooling schizophrenia with other diagnostic categories.     

Converging evidence suggests that monoamine neurotransmitter turnover in human adults is associated with their season of birth

Separate studies on adults, including those in suicidology and another regarding personality in the general population, have indicated associations with their season of birth. We analyse each of these studies by multiple nonlinear regression employing a cosine function for the month of birth, and compare these studies regarding the birth months giving the maxima and minima. The method of suicide in suicide studies shows a significant month-of-birth variation similar to that for the serotonin metabolite 5-HIAA in the separate study on cerebrospinal fluid, with a peak around the birth month September and a nadir around birth in March. When comparing the personality study with the study on cerebrospinal fluid, the trait novelty seeking varies similar to that for the dopamine metabolite HVA or the norepinephrine metabolite MHPG, and the trait reward dependence varies similar to that for HVA. The trait self-transcendence varies similar to the ratio of the dopamine and serotonin metabolites. Dopamine turnover in adults thus shows a peak around the birth months November-December, and a nadir around the birth months May-June, suggesting a possible involvement of the length of photoperiod during their perinatal period. These results provide strong evidence for the influence of season of birth on adult monoamine neurotransmitter turnover, and give further support for the monoaminergic modulation of the temperament and character traits. Received: 14 November 2001 / Accepted: 20 May 2002     

Association of parathyroid tumors in multiple endocrine neoplasia type 1 with loss of alleles on chromosome 11

Familial multiple endocrine neoplasia type 1 (MEN-1) is an autosomal dominant disorder characterized by the combined occurrence of tumors of the parathyroid glands, the pancreas, and the pituitary gland. Pancreatic tumors have previously been shown to be associated with the loss of alleles on chromosome 11; we therefore looked for similar genetic alterations in specimens of parathyroid tumors, which are the most common feature of MEN-1. We obtained parathyroid tumors and peripheral-blood leukocytes from six patients with MEN-1; 18 cloned human DNA sequences from chromosome 11 were then used to identify restriction-fragment-length polymorphisms. A loss of heterozygosity was detected in parathyroid tumors from three of the six patients with MEN-1; this finding demonstrated that allelic deletions on chromosome 11 are involved in the monoclonal development of parathyroid tumors in patients with MEN-1. In addition, studies of three affected families (with 17 affected members and 51 unaffected members) established linkage with the oncogene INT2 (peak lod score, 3.30, at 0 percent recombination); the MEN-1 gene was thus mapped to the pericentromeric region of the long arm of chromosome 11 (11q13). Our location of the MEN-1 gene at 11q13 is close to the location previously reported. We conclude that a single inherited locus on chromosome 11, band q13, causes MEN-1 and that the monoclonal development of parathyroid and pancreatic tumors in patients with MEN-1 involves similar allelic deletions on chromosome 11.     

Variations in CSF monoamine metabolites according to the season of birth

The cerebrospinal fluid (CSF) concentrations of the monoamine metabolites 5-hydroxyindoleacetic acid (5-HIAA), homovanillic acid (HVA) and 3-methoxy-4-hydroxyphenylglycol (MHPG) as well as their ratios and correlations were analyzed in relation to the season of birth. The sample consisted of 241 drug-free patients participating in psychobiological programs and comprising the DSM-III-R diagnoses of mood, anxiety and adjustment disorders. Significant season-of-birth variations were found even after adjusting for sex, age, height, the diagnostic category and the month of lumbar puncture. Those born during February to April had significantly lower values of 5-HIAA. Values of HVA and of the ratios HVA/5-HIAA and HVA/MHPG were significantly higher for those born during October to January. Correlation coefficients also showed season-of-birth variations. These results may provide an important link for the season-of-birth variations reported for several neuropsychiatric disorders.     

Mathematical evaluation of similarity factor using various weighing approaches on aceclofenac marketed formulations by model-independent method

The US Food and Drug Administration's (FDA's) guidance for industry on dissolution testing of immediate-release solid oral dosage forms describes that drug dissolution may be the rate limiting step for drug absorption in the case of low solubility/high permeability drugs (BCS class II drugs). US FDA Guidance describes the model-independent mathematical approach proposed by Moore and Flanner for calculating a similarity factor (f2) of dissolution across a suitable time interval. In the present study, the similarity factor was calculated on dissolution data of two marketed aceclofenac tablets (a BCS class II drug) using various weighing approaches proposed by Gohel et al. The proposed approaches were compared with a conventional approach (W = 1). On the basis of consideration of variability, preference is given in the order of approach 3 > approach 2 > approach 1 as approach 3 considers batch-to-batch as well as within-samples variability and shows best similarity profile. Approach 2 considers batch-to batch variability with higher specificity than approach 1.