[Quality assurance or research?].
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Denmark↗
Biomedical subjects
F Madsen
Publications and source records attributed to F Madsen.
[New treatment of emphysema--research or quality assurance?].
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Clinical Trials as Topic↗
The effect of specimen geometry on the mechanical behaviour of trabecular bone specimens.
The effect of specimen geometry on the mechanical behaviour of trabecular bone specimens was studied by non-destructive uniaxial compression to 0.4% strain using cylindrical specimens with different sizes and length-to-diameter ratios, and by comparing cubic and cylindrical specimens with the same cross-sectional area. Both the length and the cross-sectional area of the specimen had a highly significant influence on the mechanical behaviour (p less than 0.0001). Within the actual range of length (2.75-11.0 mm) the normalized stiffness (Young's modulus) was related nearly linearly to the specimen length. This dependency on specimen length is suggested to be caused mainly by structural disintegrity of the trabecular specimens near the surface. The normalized stiffness (Young's modulus) was also positively correlated to the cross-sectional area. This dependency on cross-sectional area is probably due to friction-induced stress inhomogeneity at the platen-specimen interface. A cube with side length 6.5 mm or a cylindrical specimen with 7.5 mm diameter and 6.5 mm length are suggested as standard specimens for comparative studies on trabecular bone mechanics.
Adult↗
Bronchial allergen challenge: dose versus concentration.
This study was designed to investigate if two equivalent doses of allergen administered by different dosing regimes--two breaths and 10 breaths of each concentration--would result in the same magnitude of the early and late asthmatic response. Fifteen patients with extrinsic allergic asthma were challenged twice with either two or 10 breaths of twofold increasing allergen concentrations. The challenge was continued until a 20% decrease in FEV1 had been achieved. A non-cumulative PC20FEV1 allergen was derived, and the cumulative dose of allergen given was similarly derived. In order to assess the reproducibility of the challenge, seven patients were challenged twice with two-breath regime. The mean value of allergen PC20 obtained by the two-breath regime was 4.1 fold (95% CI: 2.3-7.1 fold) greater than those obtained by the 10-breath regime (P less than 0.05), whereas the difference was 1.4 fold (95% CI: -3.3-0.5 fold) for the cumulative dose (P greater than 0.05). A statistically significant larger magnitude of the early asthmatic response, as determined by the maximum per cent fall in FEV1, and late asthmatic response determined by the maximum per cent fall in peak expiratory flow domiciliary recorded during the following 24 hr after challenge, was observed in favour of the 10-breath regime compared to the two-breath regime (mean difference 6%, 95% CI: 0.6-11%). The reproducibility of the provocation test was acceptable (+/- 1.8 two-fold concentration difference). These results confirm the 'equivalent dose hypothesis', and demonstrates that dosage rather than concentration appears to determine the early and late asthmatic response after bronchial allergen challenge.
Adolescent↗
Aeroallergen analyses and their clinical relevance. II. Sampling by high-volume airsampler with immunochemical quantification versus Burkard pollen trap sampling with morphologic quantification.
A comparison was made between the amount of airborne pollen collected by Burkard airsampler and the allergenic activity of particles trapped on glass fibre filters in an Accu-Vol high-volume airsampler. The comparison was made throughout the pollen seasons 1986 to 1989. Both airsamplers were operated 24 h a day. They were placed less than 5 m apart, and estimation of the pollen amount was made on a day-to-day basis during the pollen seasons, and on a weekly basis outside the seasons. The occurrence of the 3 clinically most important allergenic types of pollen, birch, grass, and mugwort, was analysed, and close correlations between the 2 sampling techniques were found (rs 0.5-0.8, p < 0.001). The detected range of counted pollens/m3 was: birch 0-1075, grass 0-156, and mugwort 0-44. By immunochemical analysis we found the corresponding amounts to be 0-80, 0-8, and 0-1 SQ-U/m3, respectively. Pollen counts and immunochemical estimation were compared with the symptom score recordings of allergic persons for birch season 1989 and for grass seasons 1986, 1988, and 1989. A close correlation was found for both sampling techniques for the grass seasons in 1986 and 1989 (rs 0.51-0.61, p < 0.001-0.0001), but a less significant correlation was found for the 1988 grass season, and for birch in 1989 (rs 0.24-0.34, p < 0.001-0.05).
Air Pollutants↗
High-dose inhaled steroids in the management of asthma. A comparison of the effects of budesonide and beclomethasone dipropionate on pulmonary function, symptoms, bronchial responsiveness and the adrenal function.
The efficacy of budesonide (800 micrograms b.d.) and beclomethasone dipropionate (750 micrograms b.d.) in controlling the symptoms of asthma, pulmonary function, bronchial responsiveness to histamine, and adrenal function, was assessed in a double-blind, double-dummy cross-over study of 36 adult chronic asthmatic patients. The patients, the majority of whom were assessed to be affected to a severe degree, were insufficiently controlled in their current regimen of inhaled steroids and/or inhaled and oral bronchodilators. A 2 weeks baseline period preceded 6 weeks of treatment with each of the study drugs. Both treatment groups showed improvements from baseline in clinical assessment of lung function carried out after the first 6 weeks of treatment. No significant differences were seen throughout the entire 12 weeks study, when comparing the effects of the treatments on FEV1, FVC, PEF or the histamine PC20. Asthma severity, symptom score and inhaled bronchodilator use showed the same results after both treatments. It is concluded that inhalations of budesonide and beclomethasone dipropionate in high doses are equally potent in the treatment of severe asthma. There is no significant influence on the adrenal function and no significant side effects during a period equal to that of the present study.
Administration, Inhalation↗
Airway calibre as a confounder in interpreting bronchial responsiveness in asthma.
BACKGROUND: The relation between airway responsiveness to constrictor agents and forced expiratory volume in one second (FEV1) is important when interpreting change in airway responsiveness after an intervention. The aim of the study was to analyse the relation between FEV1 as a percentage of predicted values (% predicted) and airway responsiveness between and within asthmatic subjects. METHODS: Results of non-specific bronchial challenge tests were pooled from two randomised crossover studies comparing the effect of a non-sedative antihistamine with placebo in 35 patients with moderate asthma. The design of the two studies was similar: the provocative concentration of either histamine (first study) or methacholine (second study) resulting in a 20% decrease in ventilatory capacity (PC20) was repeated at two week intervals while patients were treated with the antihistamine or placebo. The dose of inhaled corticosteroid was gradually reduced during the study. Data were analysed with PC20 as the dependent variable in a general linear model so that the influence on PC20 of inhaled corticosteroid dose, antihistamine, and choice of bronchoconstricting agent could be separated from the influence of FEV1% predicted. RESULTS: The correlation coefficient between mean PC20 and mean prechallenge FEV1 for each patient was 0.45. In the general linear model two thirds (65%) of the variation in PC20 was due to variation between subjects. One third of the within subject variation in PC20 could be explained by variation in prechallenge FEV1% predicted (a change in FEV1 of 27% predicted was associated with one doubling or halving of PC20). Treatment with the antihistamine had no influence on PC20, except when histamine was used as the bronchoconstricting agent. The dose of inhaled corticosteroid had a small but significant effect. CONCLUSIONS: The variation in a patient's PC20 over time (several months) is related to changes in FEV1% predicted. Variation in FEV1% predicted explains less of the variation in bronchial responsiveness between subjects where a patient specific factor, which is probably related to the pathogenesis of bronchial asthma, seems to dominate.
Adrenal Cortex Hormones↗
Immunological and physical properties of allergen solutions. Effects of nebulization.
Lyophilised birch pollen allergen extracts, reconstituted with different diluents (H2O, saline, Albumin diluent (AD] were investigated to determine whether the allergen activity and quality of the extracts deteriorated by nebulization with different nebulizers (Pari, Wright, and Sandoz). Allergen activity was measured by IgG4 RAST inhibition technique and allergen quality was analysed by crossed immunoelectrophoresis (CIE). The distribution of particle sizes of aerosols of different allergen solutions was determined by a TSI Aerodynamic Particle Sizer. A significant difference (P less than 0.05) in allergen activity was found between the AD and H2O diluents before and after using a Sandoz nebulizer and a Wright nebulizer equipped with a small chamber. This suggested greater allergen activity in AD-diluted solutions, and the pattern was repeated with the other two nebulizers, but was not statistically significant. The samples diluted with saline showed no significant differences in quality after nebulization except for the impacted aerosol in which one of the precipitates was slightly diminished. In the AD-diluted sample one of the precipitates disappeared from the impacted aerosol and from the nebulization chamber after 2 min nebulization. To elucidate whether the extract proteins had been bound by albumin, samples were submitted to CIE with rabbit anti-human albumin in an intermediate gel. By this procedure one precipitate was transformed to a precipitate in the intermediate gel, indicating that one or more proteins in the extracts may associate with albumin. No significant difference in output was observed between the nebulizers. The particle size distribution curves for each diluent (saline, AD) were identical for the Wright nebulizer with 99% of the dry particles distributed within 0.5-2.0 microns.(ABSTRACT TRUNCATED AT 250 WORDS)
Allergens↗
Reproducibility of leukotriene D4 inhalation challenge in asthmatics. Effect of a novel leukotriene D4/E4-antagonist (SR 2640) on leukotriene D4-induced bronchoconstriction.
We have studied the reproducibility of a bronchial leukotriene (LT) provocation test in asthmatics, and the effect of prior treatment with an oral leukotriene D4/E4 antagonist (SR 2640) on LTD4-induced bronchoconstriction in nine asthmatics in a double-blind placebo-controlled randomized cross-over trial. The reproducibility of the bronchial leukotriene provocation test was high. For a specific patient, the replication variance is 0.2303, and the standard deviation is thus 0.4799, corresponding to 48%, i.e. one halving of the dose or half doubling of the dose. SR 2640 antagonised LTD4 induced bronchoconstriction causing a mean shift of 48% to the right of the dose-response curve as compared with placebo (95% confidence interval being 11-137%). This study demonstrates that bronchial LTD4 provocation test is a safe and reproducible method in asthmatics, and that the method can be used to detect LT-antagonism; furthermore that SR 2640 is a weak LTD4-antagonist in asthmatics.
Adult↗
Injuries in high-skilled and low-skilled soccer: a prospective study.
Fifty-five male soccer players organized in three teams, one high and two lower ranking, were followed prospectively during 1 year to register the rate, type and severity of injuries in highly skilled and low-skilled players. The injury rate of the low-skilled players was significantly higher than that of the better players. The reason for this is that low-skilled players play in more competitions. and this is where injuries tend to occur. When we stratified on game/practice, the low-skilled players' excess risk disappeared and no difference was found in the severity of injuries. Different ways of collecting data in epidemiological studies of soccer are discussed and it is concluded that the most precise and accurate collection of data can only be obtained by direct supervision and examination of soccer players in the field.
Adult↗
Instability of the hindfoot after lesion of the lateral ankle ligaments: investigations of the anterior drawer and adduction maneuvers in autopsy specimens.
The mobility patterns in the tibiotalocalcaneal joint complex with a solitary lesion of the anterior talofibular ligament (ATL) and a combined lesion of the ATL and calcaneofibular ligament (CFL) were studied in 22 human lower-extremity autopsy specimens mounted in a kinesiologic testing device. A solitary lesion of the ATL increased the anteroposterior (AP) laxity in the ankle joint in the entire range of flexion, with a maximum median of 3.1 mm in neutral flexion. Further cutting of the CFL increased AP laxity most obviously in dorsiflexion. A solitary lesion of the ATL resulted in a minor instability in adduction, whereas further lesion to the CFL increased adduction in the entire range of flexion, with a maximum median of 14.2 degrees in dorsiflexion. The anterior drawer maneuver can reveal a combined lesion of the ATL and CFL if performed with the tibiotalocalcaneal joint complex in dorsiflexion. Significant clinical instability in adduction will only take place when a combined lesion of the ATL and CFL is present.
Adolescent↗
Peak inspiratory flow and inspiratory vital capacity of patients with asthma measured with and without a new dry-powder inhaler device (Turbuhaler).
In 101 asthmatic adults with varying degrees of bronchial obstruction, lung function tests including peak inspiratory flow (PIF), inspiratory vital capacity (IVC), peak expiratory flow (PEF), forced vital capacity (FVC), and forced expiratory volume in one second (FEV1) measurements were made. Significant correlations between inspiratory and expiratory volumes were found. In most patients, PIF was less reduced than the expiratory parameters of pulmonary function. When inhalation was performed through the new multi-dose, dry-powder inhalation device, Turbuhaler (PIF-TBH), it was significantly lower than PIF measured without Turbuhaler. In previous studies, PIF-TBH of 30 l.min-1 or more has proven sufficient to produce a therapeutic dose of terbutaline, and to produce significant bronchodilatation. Of 101 asthmatics in the present study, only four had PIF-TBH of less than 30 l.min-1. Although no parameters of spirometry could accurately predict PIF-TBH, there was a tendency for patients with severely impaired ventilatory capacity to produce lower PIF-TBH than patients with normal or near-normal ventilatory capacity. If patients with severely impaired ventilatory capacity are to receive inhalation therapy through Turbuhaler, either PIF or PIF-TBH should be measured, or the effect should be carefully monitored.
Adult↗
A comparison of the effects of nedocromil sodium and beclomethasone dipropionate on pulmonary function, symptoms, and bronchial responsiveness in patients with asthma.
The efficacy of nedocromil sodium (NED) (4 mg twice daily) and beclomethasone dipropionate (BDP) (200 micrograms twice daily) in controlling the symptoms of asthma, the pulmonary function, and bronchial responsiveness to histamine was assessed in a double-blind, double-dummy, crossover study of 39 adult patients with chronic asthma. The patients, most of whom were assessed to be affected to a moderate degree, were insufficiently controlled in their current regimen of inhaled and/or oral bronchodilators. A 2-week baseline period preceded 6 weeks of treatment with each of the study drugs. Both treatment groups demonstrated improvements from baseline in clinical assessment of lung function performed after the first 6 weeks of treatment. No significant differences were observed when the effects of the treatments were compared on FEV1, FVC, and peak expiratory flow. Bronchial reactivity to histamine, measured as the amount of histamine causing a 20% fall in FEV1 (PC20), decreased significantly (p less than 0.05) after 6 weeks of treatment with BDP compared to the effect of NED treatment. Asthma severity, symptom score, and inhaled bronchodilator use demonstrated significantly better results with BDP. After crossover of treatment, the group transferring from NED to BDP continued to improve, whereas the group crossing from BDP to NED tended to demonstrate a major deterioration during the first 3 weeks, after which a stabilization or an increase in FEV1, FVC, and ln PC20 appeared to occur. It is concluded that NED for inhalation is a potent new drug for treatment of both atopic and nonatopic subjects with asthma. With the number of patients and dosages used, the effect on the pulmonary function was not significantly different from that of BDP after the initial 6 weeks of treatment, but BDP had a better effect on asthma severity, overall opinions, symptom score, bronchodilator use, ln PC20, and morning peak expiratory flow.
Adult↗
Beclomethasone dipropionate versus flunisolide as topical steroid treatment in patients with perennial rhinitis.
After a 2-week run-in period 23 atopics and non-atopics with perennial rhinitis were treated with intranasally nebulized aqueous flunisolide or aqueous beclomethasone dipropionate in a randomized, double-blind cross-over study, each treatment period being 4 weeks. Before and after each treatment period daily rhinitis symptoms were recorded, and additional determination of nasal airway resistance was performed by posterior rhinomanometry. No statistically significant difference between drugs was observed for any effect parameter recorded, and furthermore no difference in patient preference for either drug was found. It is concluded that both steroids are effective for the improvement of nasal airway in patients with perennial, atopic and non-atopic rhinitis.
Administration, Intranasal↗
Clinical comparison of inhaled budesonide delivered either via pressurized metered dose inhaler or Turbuhaler.
The aim of this open, randomized cross-over study was to compare the efficacy and safety of inhaled budesonide administered either via a pressurized metered dose inhaler with a 750 ml spacer attached, or via a new dry powder inhaler, Turbuhaler, in 28 patients with stable bronchial asthma. During the 2-week run-in period, the patients received their ordinary inhaled steroid treatment. This was followed by two 4-week periods of active treatment with inhaled budesonide given via Turbuhaler or pressurized MDI. The patients were divided into two groups according to their previous, inhaled steroid doses. Group A received 400 micrograms of budesonide b.i.d, and Group B 800 micrograms of budesonide b.i.d. Diary cards were used by the patients at home to report asthma symptoms, beta 2-agonist consumption, and PEF twice daily, as well as the number of coughs experienced in a 5-min period after steroid inhalation. Budesonide Turbuhaler produced a significantly better effect on morning peak flow than budesonide MDI. The number of coughs in the 5 min after steroid inhalation was significantly lower with the Turbuhaler than with the MDI. In all other parameters recorded (e.g. FEV1, evening PEF, histamine PC20 and other diary measurements) there were no statistically significant differences between the two devices. Turbuhaler was significantly more appreciated than MDI in all questions of preference. The study showed that budesonide via Turbuhaler was at least as effective and safe as budesonide via a pressurized MDI at daily doses of 800 and 1,600 micrograms.(ABSTRACT TRUNCATED AT 250 WORDS)
Administration, Inhalation↗
The Pritchard Mark II elbow prosthesis in rheumatoid arthritis.
Twenty-five consecutive rheumatoid elbows treated with the Pritchard Mark II elbow prosthesis were prospectively followed for 3 (2-5) years. There were marked pain relief and increased motion after the operation. Two elbows were revised, one because of deep infection and the other because of loosening. There were no neuropathies or fractures. The major long-term complication was radiographic loosening (6/24), which mainly occurred in elbows with only moderate rheumatoid destructions.
Adult↗
Watson-Jones tenodesis for ankle instability. A mechanical analysis in amputation specimens.
The stabilizing effect of a modified Watson-Jones ankle tenodesis was studied in 10 lower extremity amputation specimens using a kinesiologic testing device. Cutting of the lateral ligaments caused maximal instability in adduction of the entire hindfoot joint complex, as well as of the talocalcaneal joint. The tenodesis restricted adduction and internal rotation when compared with the movement pattern with intact ligaments. Instability in external rotation persisted because the tenodesis did not restore the function of the calcaneofibular ligament. Our study confirms clinical observations that the Watson-Jones ankle tenodesis prevents abnormal inversion of the hindfoot, but does not restore hindfoot kinematics.
Amputation, Surgical↗
A custom-made prosthesis for the treatment of supracondylar femoral fractures after total knee arthroplasty: report of four cases.
Four supracondylar femoral fractures following total knee arthroplasty, two because of intraoperative notching of the anterior femoral cortex and two because of osteoporosis, were revised using a custom-made prosthesis with femoral condyle section. At 1-6 year follow-up (median 3 years) after the revision, all patients had an excellent clinical result, although 2 had a prolonged rehabilitation period because of severe osteoporosis. At roentgenographic examination, no signs of loosening of the prostheses at the cement-bone interface were present.
Aged↗