An open, randomized, parallel-group study was conducted to investigate whether asthmatic patients, considered adequately treated with a corticosteroid and/or short-acting beta 2-agonist via pressurized metered-dose inhaler (pMDI), could be transferred to a corresponding nominal dose of budesonide and/or terbutaline via Turbuhaler, an inspiratory flow-driven multidose dry powder inhaler (Astra Draco; Lund, Sweden), without a decrease in the effect of treatment. One thousand four patients (555 women; mean age, 44 years; mean peak expiratory flow [PEF], 102% predicted normal value) were randomized and treated with either pMDI (current therapy) or Turbuhaler for 52 weeks. The variables studied were asthma-related events, morning PEF, and inhaler-induced clinical symptoms. Asthma-related events were defined in two ways: (1) sum of health-care contacts plus doublings or additions of steroids, and (2) number of 2 consecutive days with PEF less than 80% of baseline. Baseline was obtained from a 2-week run-in period while receiving previous therapy. No statistically significant difference was found in asthma-related events according to definition 1. According to definition 2, there was a statistically significant difference between the groups in favor of Turbuhaler (p = 0.008). The mean number of events was 1.7 with Turbuhaler and 2.2 with pMDI. The mean number of weeks per patient with a PEF less than 90% of baseline was 4.5 with Turbuhaler compared with 6.0 with pMDI (p = 0.002). The sum of inhaler-induced symptoms after 1 year of use was statistically significantly lower with Turbuhaler (0.40) than with pMDI (0.75) (p = 0.0001). In conclusion, budesonide and terbutaline in Turbuhaler offered a superior alternative to corticosteroids and bronchodilators delivered by pMDIs in the maintenance treatment of asthma.
An open-label randomized study was undertaken to compare a 2-dose regimen (Months 0 and 6) of hepatitis B surface antigen (HBsAg) vaccine formulated with a novel adjuvant (HBsAg/AS04) with a standard 3-dose regimen (Months 0, 1 and 6) of licensed recombinant HBsAg vaccine in terms of immunogenicity and reactogenicity when administered to healthy subjects aged between 15 and 40 y. At 1 and 6 months after the full vaccination course there was a 100% seroprotection rate (anti-HBs > or = 10 mIU/ml) with the HBsAg/AS04 vaccine, compared with a 99% response rate with the licensed vaccine. The corresponding geometric mean titres were significantly higher for the novel vaccine compared to the standard vaccine: 15,468 and 2,745 mIU/ml at Months 7 and 12 vs. 6,274 and 1,883 mIU/ml, respectively. There was a higher prevalence of local symptoms with the adjuvant vaccine (90% of doses) than with the standard vaccine (48% of doses). However, these symptoms (pain, swelling and redness) were predominantly of mild-to-moderate intensity and resolved rapidly without treatment. A 2-dose regimen of the new HBsAg/AS04 adjuvant vaccine therefore compared favourably to the standard regimen in healthy young adults. It is anticipated that the simplified vaccination schedule may improve compliance and reduce costs.
A study was made of clinical effectiveness and mechanism of action of the inhibitor of the specific 3',5'-cAMP phosphodiesterase papaverine in a therapeutic complex of measures designed to treat RA patients involving an immunodepressive preparation free from any cytopenic effect prospidin as a basic mediator. It has been shown that the papaverine antiarthritic action is associated with its positive effects on the unspecific component of the immune-complex inflammation, viz. processes of lipid peroxidation, activity of the antioxidant system of defence as well as on the vascular tone and microcirculation. All this improves tissue metabolism, and in this way enhances efficiency of RA basic therapy.
PURPOSE: To study the long-term results of implantation of the 3M diffractive multifocal intraocular lens (IOL). SETTING: Eye Department, ASA, Arendal, Norway. METHODS: The study comprised 97 eyes in 72 patients. Follow-up was 8 years. Distance and near visual acuities, refractive results, contrast sensitivity, IOL centration, and neodymium:YAG (Nd:YAG) capsulotomies to treat posterior capsule opacification were evaluated. RESULTS: All patients without ocular pathology achieved a best corrected visual acuity (BCVA) of 0.5 or better (i.e., 98.7% had a BCVA of 1.0 or better). Without correction, 73.8% of eyes had a Jaeger acuity of J3 or better and with distance correction, 92.1%. Emmetropia or within +/-0.25 diopter (D) of it was achieved in 58.8% of eyes. An astigmatic shift of 0.827 D cylinder correction was induced. This shift was mainly against the rule (0.717 D). Contrast sensitivity was reduced with spatial frequencies of 6 to 18 cycles per degree. No need for spectacles was reported by 54.2% of patients and by 68.0% of those with bilateral implantation. For near tasks, 63.9% of patients never used spectacles. The IOLs were well centered or minimally decentered in 99.0% of eyes. Posterior capsule opacification was treated by Nd:YAG laser capsulotomy in 55.7% of eyes, with a mean time between surgery and treatment of 34.0 months +/- 23.2 (SD). CONCLUSION: This long-term study proved the 3M diffractive IOL to be safe and effective despite some reduction in contrast sensitivity at higher spatial frequencies. More than half the patients never wore spectacles; 2 of 3 patients with IOLs in both eyes never wore spectacles. Proper patient selection is crucial.
BACKGROUND: The mean wheal diameter >/= 3 mm is the usual criterion for positive skin prick test (SPT) reaction to dust mites. The study assessed the accuracy of this SPT criterion with respect to specific IgE values of above 0.35 kUA/l (+ sIgE). METHODS: Specific IgE (ImmunoCAP, Pharmacia AB Diagnostics, Uppsala, Sweden) and standard SPT to Dermatophagoides pteronyssinus (DP) and farinae (DF), Lepidoglyphus destructor (LD) and Tyrophagus putrescentiae (TP) (ALK, Hørsholm, Denmark) were performed in a random sample of 457 subjects, of whom 273 men (mean age 35.3 +/- 11.0 years) and 184 women (mean age 37.9 +/- 9.5 years). Statistical analysis was performed using the chi-square test, regression analysis and discriminant analysis. RESULTS: When the mean wheal diameter of >/= 3 mm was considered positive (+ SPT), the correlation between + SPT and + sIgE was 0.47 for DP (P
The aim of the present study was to evaluate the long-term outcome of a behavioural medicine rehabilitation programme and the outcome of its two main components, compared to a 'treatment-as-usual' control group. The study employed a 4 x 5 repeated-measures design with four groups and five assessment periods during a 3-year follow-up. The group studied consisted of blue-collar and service/care workers on sick leave, identified in a nationwide health insurance scheme in Sweden. After inclusion, the subjects were randomised to one of the four conditions: behaviour-oriented physiotherapy (PT), cognitive behavioural therapy (CBT), behavioural medicine rehabilitation consisting of PT+CBT (BM) and a 'treatment-as-usual' control group (CG). Outcome variables were sick leave, early retirement and health-related quality of life. A cost-effectiveness analysis, comparing the programmes, was made. The results showed, consistently, the full-time behavioural medicine programme being superior to the three other conditions. The strongest effect was found on females. Regarding sick leave, the mean difference in the per-protocol analysis between the BM programme and the control group was 201 days, thus reducing sick leave by about two-thirds of a working year. Rehabilitating women has a substantial impact on costs for production losses, whereas rehabilitating men seem to be effortless with no significant effect on either health or costs. In conclusion, a full-time behavioural medicine programme is a cost-effective method for improving health and increasing return to work in women working in blue-collar or service/care occupations and suffering from back/neck pain.
The purpose of this study was to compare the diagnostic performance of a digital radiography system that uses 6- and 8-bit displays with conventional D-speed film for the detection of simulated periodontal bone lesions. Eleven human hemimandibles were used as specimens. Simulated lesions were created at the buccal cortical plate in the marginal bone area with the use of a round bur 1.4 mm in diameter. Lesions were created in a defined sequence to preclude visual cues as to the depth of the lesions. Lesion size progressed in 0.5 mm increments. At each stage the mandibles were imaged with a Sens-A-Ray system (REGAM Medical Systems AB, Sundsvall, Sweden) and D-speed film. Exposure parameters for each specimen/receptor combination were standardized by either the mean optical density or mean gray value at the approximal crestal bone area. Film images and digital images displayed with 64 and 256 gray levels were presented to six observers for evaluation. Observers were ask to rate their confidence as to the presence or absence of a lesion using a 5-point confidence scale. A total of 96 lesion sites and 96 control sites were presented to the observers. Receiver operating characteristic curves were generated for each system. The area under the curve was used as the index of diagnostic accuracy. The mean receiver operating characteristic areas for 6-bit and 8-bit displays and D-speed film were 0.746 +/- 0.043, 0.717 +/- 0.056 and 0.742 +/- 0.059, respectively. Analysis of variance was used to compare the means. No statistical difference was found between any of the three image displays (p > 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)