Pain and quality of life for patients with venous leg ulcers: proof of concept of the efficacy of Biatain®-Ibu, a new pain reducing wound dressing

Wound pain is a serious problem for elderly patients suffering from chronic leg ulcers, and it may lead to reduced wound healing rates and reduced quality of life. Biatain-Ibu Non-adhesive (Coloplast A/S), a new pain-reducing moist wound healing dressing containing ibuprofen was tested for pain reduction, safety, and efficacy on 10+2 patients in a single-blinded crossover study against Biatain Non-adhesive (Coloplast A/S). Pain was measured with a Numeric Box Scale before, during, and after dressing change. Quality of life was measured using the World Health Organization-5 Well-Being Index. Dressing moist wound healing properties such as absorption capacity and leakage were tested together with assessment of wound exudate and blood plasma content of ibuprofen. Use of the Biatain-Ibu foam dressing correlated with a decrease in pain intensity scores from 7 in the run-in period to approximately 2.5 in the Biatain-Ibu treatment phase. Quality of life measures were improved which together with the reduced pain could contribute to faster wound healing. The moist wound healing properties of Biatain-Ibu were similar to that of the Biatain Non-adhesive and ulcer size was reduced by 24% during the treatment period. Neither side effects nor systemic plasma concentrations of ibuprofen were observed. These data indicate that Biatain-Ibu could reduce persistent and temporary wound pain, increase Quality of life, was found safe to use, and had excellent moist wound healing properties.     

The natural course of DSM-IV somatoform disorders and syndromes among adolescents and young adults: a prospective-longitudinal community study.

OBJECTIVE: Although somatoform disorders are assumed to be chronic clinical conditions, epidemiological knowledge on their natural course based on representative samples is not available. METHOD: Data come from a prospective epidemiologic study of adolescents and young adults in Munich, Germany. Respondents' diagnoses (N = 2548) at baseline and follow-up on average 42 months later are considered. The follow-up incidence, stability as well as selected baseline risk factors (sociodemographics, psychopathology, trauma exposure) for the incidence and stability of somatoform disorders and syndromes are prospectively examined. Diagnostic information was assessed by using the standardized Munich-Composite International Diagnostic Interview (M-CIDI). RESULTS: Over the follow-up period, incidence rate for any of the covered somatoform diagnoses was 25.7%. Stability for the overall group of any somatoform disorder/syndrome was 48%. Female gender, lower social class, the experience of any substance use, anxiety and affective disorder as well as the experience of traumatic sexual and physical threat events predicted new onsets of somatoform conditions, while stability was predicted by being female, prior existing substance use, affective and eating disorders as well as the experience of a serious accident. CONCLUSIONS: At least for a substantial proportion of individuals, the overall picture of somatization seems to be relatively stable, but with fluctuation in the symptom picture over time. Being female, the experience of substance use as well as anxiety disorder seem to constitute risk factors for the onset of new somatoform conditions as well as for a stable course over time.     

Enzyme-linked immunosorbent assay for quantitation of cereal proteins toxic in coeliac disease

Coeliac disease is revealed by polypeptides in the prolamin fraction of wheat, barley, rye and oats. Recovery depends on adherence to a strict cereal-free diet. A few methods for quantitation of the wheat prolamin, gliadin, have been described. In order to assess the suitability of food products for inclusion in the coeliac diet an assay should measure the total amount of potentially toxic cereal proteins. An inhibition ELISA was developed, by use of a purified, polyclonal prolamin-antibody, reacting with gliadin and gliadin-like polypeptides. The antibody did not react with maize, millet, rice or soya prolamins. The assay had a detection limit of 1 ng antigen with a very high degree of accuracy. The interassay coefficient of variation including the day-to-day variation, was close to 30%, which is acceptable for the clinical applications of the assay. The flour of buckwheat was analyzed for antigen content. An amount of 39.5 micrograms gliadin-like polypeptides/g flour was measured, which corresponds to 0.06% of the gliadin content in wheat flour.     

Interobserver variation in the evaluation of neurological signs: observer dependent factors.

Introduction - Interobserver variation among four observers in evaluation of eight selected neurological signs was investigated. Material & methods - Two hundred and two consecutive unselected inpatients were examined by two senior neurologists and two trainees, all without knowledge of the neurological case history. The signs examined were: anisocoria, jerky eye movements, facial palsy, elbow extension force, finger-nose test, Barré sign, knee jerk, and extensor plantar reflex. Observed agreement rates and kappa coefficients were calculated in order to compare the interobserver variability among neurologists and trainees, and to evaluate differences in the interobserver variability between signs. Results - Observed agreement rates varied from 0.80 to 0.95 for neurologists and from 0.65 to 0.98 for trainees. For neurologists kappa coefficients ranged from 0.40 to 0.67 and for trainees from 0.22 to 0.81. The neurologists had higher kappa values than the trainees in 5 signs, but this difference was only statistically significant for jerky eye movements. For the individual signs the observed agreement rates were between 0.50 and 0.93 for all four examiners combined, and overall kappa values varied from 0.32 to 0.71 with highest agreement for facial palsy and lowest for knee jerk. Conclusion - The magnitude of the interobserver and intersign variation indicates that the interpretation of the neurological signs tested, without knowledge of the case history, should be done with some caution.     

Effect of simethicone on lactulose-induced H2 production and gastrointestinal symptoms.

The results of studies of the effect of simethicone on abdominal gas-related symptoms have been contradictory. In a randomized, double-blind cross-over study, 10 healthy volunteers were given 30 g lactulose and 600 mg simethicone or placebo. End-expiratory breath samples were collected and analyzed for H2 and gastrointestinal symptoms registered. There were no differences in biochemical parameters or symptom score between simethicone and placebo. In contrast to previous studies, we used a sufficiently large dose of lactulose to produce gastrointestinal symptoms, a higher dose of simethicone and placebo tablets containing the same additives as the simethicone tablets. There was no demonstrable effect of simethicone on symptoms or intestinal gas production caused by carbohydrate malabsorption.     

The health insurance status of US Latino women: A profile from the 1982-1984 HHANES.

OBJECTIVES: This research studied the correlates of health insurance status among three major subpopulations (Mexican, Puerto Rican, and Cuban) of adult (ages of 20 to 64) Latino women. METHODS: Data from the Hispanic Health and Nutrition Examination Survey (HHANES), 1982-1984, were examined to determine the percentages of health insurance coverage among the sample populations and to assess the relationship between access to coverage and selected sociodemographic employment/income, ancestry, and acculturation variables. RESULTS: Variations in health insurance coverage existed by Latina subpopulation. While Puerto Rican women had the highest percentage of any health insurance coverage, Mexican-origin women (particularly those 50 to 64 years old) had the lowest. For all three Latina groups, health insurance coverage was greater among those who reported a family income above the poverty level than among those whose income fell below the poverty level; employment location, acculturation variables, and ancestry were also related to coverage. CONCLUSIONS: Eligibility requirements, particularly for Mexican-and Cuban-origin women, need to be streamlined, and innovative health insurance programs need to be developed to increase access of Latinas to health insurance.     

Development of Activity Assays for High-Volume Evaluation of Human Immunodeficiency Virus (HIV) Protease Inhibitors in Rat Serum: Results with Ditekiren

We showed previously that a commercially available synthetic tetradecapeptide, Asp-Arg-Val-Tyr-Ile-His-Pro-Phe-His-Leu-Leu-Val-Tyr-Ser, produces authentic angiotensin I (Ang I) upon incubation with the HIV-1 protease (S. K. Sharma et al., Anal. Biochem. 198:363, 1991). Therefore, we developed an Ang-I based activity assay for HIV protease inhibitors based on the technology developed earlier (M. J. Ruwart et al., Pharm. Res. 7:407, 1990; S. K. Sharma et al., Anal. Biochem. 186:24, 1990) for tracking renin inhibitors in rat sera. Ditekiren was either extracted from sera with ethyl acetate or assayed after the interfering substances in sera were precipitated with acetonitrile. Purified recombinant HIV-1 protease was added to extracted rat serum and the enzymatic reaction was initiated in the presence of the tetradecapeptide substrate. The inhibition of Ang I production was measured by a commercially available RIA kit. The cleanup methodology also enabled a commercially available Proteinase Scintillation Proximity Assay (SPA, Amersham) to quantify ditekiren in rat serum through the addition of recombinant HIV-1 protease and cleavage of substrate from SPA beads. Results were confirmed by HPLC or by the renin assay for ditekiren, which inhibits both aspartyl proteases. These technologies should prove useful for assessing serum levels of HIV protease inhibitors in rat.     

Intraoperative frozen section examination of axillary sentinel lymph nodes in breast cancer

The study presents the results from intraoperative frozen section assessment of axillary sentinel lymph nodes (SLNs) in breast cancer. Routine histological frozen sections from one level were used, two sections stained with haematoxylin and eosin. Immunohistochemistry for cytokeratins was applied to the permanent SLN paraffin sections only. Axillary dissection was performed on all SLN-positive cases regardless of the size of the metastatic deposits. With a detection rate of 83%, 272 patients entered the study over a period of 46 months. A total of 61 cases were SLN positive by frozen section analysis. The paraffin sections gave an additional 23 SLN-positive cases. The false-negative rate for frozen sections was then 27% (23/84). Micrometastases were found in 28 of 84 cases, and macrometastases in 56. The false-negative rate of frozen sections for micrometastases was 71% (20/28), and for macrometastases 5% (3/56). A total of 73% (61/84) of the patients underwent axillary surgery as a one-step procedure.     

Body awareness group therapy for patients with personality disorders. 2. Evaluation of the Body Awareness Rating Scale

The Body Awareness Rating Scale (BARS) was developed to evaluate the treatment process of the Body Awareness Group Therapy. The BARS subscales proved to have high interrater reliability. A factor analysis revealed two factors which seemed to measure one awareness and one movement dimension. The BARS was sensitive to change. As hypothesized, the BARS improvement enlarged with increasing duration of treatment. At discharge the good BARS outcome patients had improved significantly more than the poor BARS outcome ones, both concerning symptoms and global psychopathology.