Profile of patients treated with omalizumab in routine clinical practice in Spain.

BACKGROUND: Omalizumab is indicated in patients with severe allergic asthma not controlled by high-dose inhaled glucocorticoids and long-acting beta-agonists. Few data are available on the profile of patients treated with this drug in routine clinical practice in Spain. OBJECTIVE: To describe the profile of patients with severe allergic asthma treated with omalizumab and the course of the disease after a period of treatment. METHODS: Retrospective, multicentre study, recording the data on patients of either sex and ≥12 years with uncontrolled severe allergic asthma, previously treated with omalizumab. Data were evaluated in relation to pulmonary function, symptoms, quality of life, and concomitant anti-asthma treatment before the prescription of omalizumab and at the time of the study visit. RESULTS: 214 patients were evaluable (mean age=48.2±17.7 years; mean age at the time of diagnosis=26.6±16.5 years). 90.7% had experienced exacerbations the year before receiving omalizumab, and the mean total IgE level was 273±205.4IU/ml. The mean monthly dose was 380.5±185.4mg. Compared with the baseline situation, differences were observed after treatment with omalizumab in mean FEV1 (62.7±15.9% vs. 70.8±18.7%), in the proportion of patients requiring oral corticosteroids (47.7% vs. 14.0%), and in the ACQ and AQLQ scores. 32.7% of the patients received doses not recommended by the Summary of Product Characteristics (SPC). CONCLUSIONS: Profile of asthmatic patients treated with omalizumab predominantly corresponds to uncontrolled severe asthma cases, in accordance with SPC's indications. The results of the study suggest a favourable clinical course similar to that observed in other studies.

Reduced expression of galectin-1 and galectin-9 by leucocytes in asthma patients.

Accumulating evidence shows that galectins play roles in the initiation and resolution phases of inflammatory responses by promoting anti- or proinflammatory effects. This study investigated the presence of three members of the galectin family (galectin-1, -3 and -9) in induced sputum samples of asthma patients, as well as their possible implication in the immunopathogenesis of human asthma. Levels of interleukin (IL)-5, IL-13, and galectins were determined in leucocytes isolated from induced sputum samples by reverse transcription-polymerase chain reaction (RT-PCR) immunofluorescence and flow cytometry. High levels of IL-5 and IL-13 mRNA were detected in sputum cells from asthma patients. In parallel, immunoregulatory proteins galectin-1 and galectin-9 showed a reduced expression on macrophages from sputum samples compared with cells from healthy donors. In-vitro immunoassays showed that galectin-1 and galectin-9, but not galectin-3, are able to induce the production of IL-10 by peripheral blood mononuclear cells from healthy donors. These findings indicate that macrophages from sputum samples of asthma patients express low levels of galectin-1 and galectin-9, favouring the exacerbated immune response observed in this disease.

Recent trends in COPD prevalence in Spain: a repeated cross-sectional survey 1997-2007.

We aimed to describe changes in the prevalence of chronic obstructive pulmonary disease (COPD) in Spain by means of a repeated cross-sectional design comparing two population-based studies conducted 10 yrs apart. We compared participants from IBERPOC (Estudio epidemiológico de EPOC en España) (n = 4,030), conducted in 1997, with those of EPI-SCAN (Epidemiologic Study of COPD in Spain) (n = 3,802), conducted in 2007. Poorly reversible airflow obstruction compatible with COPD was defined according to the old European Respiratory Society definitions. COPD prevalence in the population between 40 to 69 yrs of age dropped from 9.1% (95% CI 8.1-10.2%) in 1997 to 4.5% (95% CI 2.4-6.6%), a 50.4% decline. The distribution of COPD prevalence by severity also changed from 38.3% mild, 39.7% moderate and 22.0% severe in 1997, to 85.6% mild, 13.0% moderate and 1.4% severe in 2007, and in the 40-69 yr EPI-SCAN sub-sample to 84.3% mild, 15.0% moderate and 0.7% severe. Overall, underdiagnosis was reduced from 78% to 73% (not a significant difference) and undertreatment from 81% to 54% (p<0.05) within this 10-yr frame. The finding of a substantial reduction in the prevalence of COPD in Spain is unexpected, as were the observed changes in the severity distribution, and highlights the difficulties in comparisons between repeated cross-sectional surveys of spirometry in the population.

A haplotype of cyclooxygenase-2 gene is associated with idiopathic pulmonary fibrosis.

BACKGROUND: Cyclooxygenase-2, a key regulatory enzyme in the synthesis of the antifibrotic agent prostaglandin E2, is downregulated in lung tissue from patients with idiopathic pulmonary fibrosis. OBJECTIVE: To investigate the association between COX2.3050 (G --> C), COX2.8473 (C --> T) and COX2.926 (G --> C) single nucleotide polymorphisms (SNP) and the susceptibility to idiopathic pulmonary fibrosis and the progression of the disease. DESIGN: Genetic polymorphisms were analyzed in 121 out of 225 available control subjects and in all of 174 patients with idiopathic pulmonary fibrosis by real time polymerase chain reaction. Logistic regression analysis of covariance and chi-squares test were used for statistical analysis. RESULTS: While analysis of disease development did not find any significant association with single SNP genotype, a haplotype analysis revealed a strong association between the disease development and one haplotype [GC] at loci COX2.3050 and COX2.8473, and suggested a recessive genetic effect of this haplotype. Further analysis concluded that subjects having two copies of [GC] haplotype, or equivalently (GG/CC) genotype at the two SNPs, had an increased risk after adjusting for age and sex. Due to the interaction, this elevated risk increased slowly with age, and the estimated odds ratio (OR) decreased with age from OR = 1.4 at age 30 to OR = 1 at age 74 and OR = 0.96 at age SO. The OR was significantly greater than 1 up to age 66, and not significant for age older than 66. Therefore, the recessive effect of [GC] haplotype increased the risk of IPF of subjects younger than 66 years, but its effect diminished for seniors older than 66. One hundred and forty-nine patients with idiopathic pulmonary fibrosis were followed up for 33.7 +/- 2.1 months. Further analysis of disease progressions, defined by the changes in pulmonary function tests, did not reveal any association with either SNP genotypes or haplotypes. CONCLUSIONS: The carriage of double homozygote (GG/CC) at the SNP loci of COX2.3050 and COX2.8473 polymorphisms may increase the susceptibility to idiopathic pulmonary fibrosis, by approximately 1.4 folds at age 30 and by a smaller fold greater than 1 up to age 66 years, but not the progression of the disease. These findings may help to improve our understanding of idiopathic pulmonary fibrosis pathogenesis and may lead to the development of new therapeutic strategies.

Chronic obstructive pulmonary disease (COPD) in Spain and the different aspects of its social impact: a multidisciplinary opinion document.

Chronic obstructive pulmonary disease (COPD) is one of the most prevalent diseases in the World, and one of the most important causes of mortality and morbidity. In adults 40 years and older, it affects more than 10% of the population and has enormous personal, family and social burden. Tobacco smoking is its main cause, but not the only one, and there is probably a genetic predisposition that increases the risk in some patients. The paradigm of this disease is changing in Spain, with an increase of women that has occurred in recent years. Many of the physio pathological mechanisms of this condition are well known, but the psychological alterations to which it leads, the impact of COPD on relatives and caregivers, the limitation of daily life observed in these patients, and the economic and societal burden that they represent for the health system, are not so well-known. A major problem is the high under-diagnosis, mainly due to difficulties for obtaining, in a systematic way, spirometries in hospitals and health-care centers. For this reason, the Fundación de Ciencias de la Salud and the Spanish National Network Center for Research in Respiratory Diseases (CIBERES) have brought together experts in COPD, patients and their organizations, clinical psychologists, experts in health economics, nurses and journalists to obtain their opinion about COPD in Spain. They also discussed the scientific bibliometrics on COPD that is being carried out from the CIBERES and speculated on the future of this condition. The format of the meeting consisted in the discussion of a series of questions that were addressed by different speakers and discussed until a consensus conclusion was reached.

Prevalence of COPD in Spain: impact of undiagnosed COPD on quality of life and daily life activities.

AIMS: This study aimed to determine the prevalence of chronic obstructive pulmonary disease (COPD) in Spain and identify the level of undiagnosed disease and its impact on health-related quality of life (HRQL) and activities of daily living (ADL). METHODS: A population-based sample of 4274 adults aged 40-80 years was surveyed. They were invited to answer a questionnaire and undergo prebrochodilator and postbronchodilator spirometry. COPD was defined as a postbronchodilator FEV(1)/FVC (forced expiratory volume in 1 s/forced vital capacity) ratio of <0.70. RESULTS: For 3802 participants with good-quality postbronchodilator spirometry, the overall prevalence of COPD was 10.2% (95% CI 9.2% to 11.1%) and was higher in men (15.1%) than in women (5.6%). The prevalence of COPD stage II or higher was 4.4% (95%CI; 3.8%-5.1%). The prevalence of COPD increased with age and with cigarette smoking and was higher in those with a low educational level. A previous diagnosis of COPD was reported by only 27% of those with COPD. Diagnosed patients had more severe disease, higher cumulative tobacco consumption and more severely impaired HRQL compared with undiagnosed subjects. However, even patients with undiagnosed COPD stage I+ already showed impairment in HRQL and in some aspects of ADL compared with participants without COPD. CONCLUSIONS: The prevalence of COPD in individuals between 40 and 80 years of age in Spain is 10.2% and increases with age, tobacco consumption and lower educational levels. The rate of diagnosised COPD is very high and undiagnosed individuals with COPD already have a significant impairment in HRQL and ADL.

Lymphangioleiomyomatosis: a study of 72 patients from the Spanish registry.

BACKGROUND: Pulmonary lymphangioleiomyomatosis (LAM) is a rare lung disease that almost exclusively affects young women of childbearing age. The true incidence and prevalence of LAM are unknown. This study was conducted to evaluate the characteristics of lymphangioleiomyomatosis in Spain. METHODS: Over a 2-year period, a questionnaire designed for this study was collected. This questionnaire included sociodemograhic, clinical, radiological and functional data. Information about the study and this questionnaire were both sent by e-mail to all the participants of the interstitial disease registry of 2004. RESULTS: Seventy-two patients, all of whom were women, were included in the registry, with a mean age of 44.56 +/- 11.1 yr. Sixty-three patients (87.5%) presented the sporadic LAM and 9 (12.5%) presented LAM associated with tuberous sclerosis (LAM-TS). LAM diagnosis was confirmed with an open lung biopsy in 57 patients (79.2%) and was performed with thoracic HRCT compatible with LAM diagnosis in the other 15 cases. The most frequent symptom was dyspnoea (90%) followed by cough (44.4%). Almost 40% of patients presented renal angiomyolipomas in the study and the most frequent spirometric pattern was obstructive in more than half of the patients. Most patients with LAM-TS (88.8%) had renal angiomyolipomas compared with 31.7% in the sporadic LAM group. CONCLUSION: The characteristics of the Spanish population affected with LAM are similar to those of other countries. Most patients were symptomatic, had a history of previous pneumothorax and presented abnormal radiological findings and pulmonary function tests.

Nutritional state during COPD exacerbation: clinical and prognostic implications.

AIMS: To estimate the prevalence of malnutrition in chronic obstructive pulmonary disease (COPD) patients hospitalized for exacerbation and to evaluate its clinical and prognostic influence on the exacerbation. SUBJECTS/METHODS: The subjects were 78 consecutive patients with moderate-to-severe COPD who were admitted to hospital with a diagnosis of exacerbation. Nutritional status was assessed by means of body mass index (BMI), bioelectric impedance analysis and levels of plasmatic albumin. Previous spirometry, 6-min walk test, severity of the exacerbation, days of hospitalization and readmission in the following 3 months were also evaluated. RESULTS: Malnutrition [BMI <20 or fat-free mass (FFM) index

[The EPI-SCAN survey to assess the prevalence of chronic obstructive pulmonary disease in Spanish 40-to-80-year-olds: protocol summary]. / Estudio EPI-SCAN: resumen del protocolo de un estudio para estimar la prevalencia de EPOC en personas de 40 a 80 años en España.

BACKGROUND AND OBJECTIVES: Chronic obstructive pulmonary disease (COPD) causes considerable morbidity and mortality in Spain. The 1997 IBERPOC study, applying the old criteria of the European Respiratory Society, reported a COPD prevalence of 9.1% in the adult population of Spain. The Epidemiologic Study of COPD in Spain (EPI-SCAN) aims to determine the current prevalence of COPD in residents of Spain aged 40-80 years and to estimate changes over the past 10 years. Secondary objectives are, among others, to describe the current prevalence of smoking and changes in COPD prevalence relative to previous studies; to describe treatments received by patients, quality of life, and the BODE index (body mass index, obstruction of airflow, dyspnea, and exercise tolerance); and to measure inflammatory markers in blood and exhaled-breath condensate. PATIENTS AND METHODS: EPI-SCAN is a population-based, cross-sectional epidemiologic study targeting the general population of Spain aged between 40 and 80 years. Participating centers were located in Barcelona, Burgos, Cordoba, Huesca, Madrid, Oviedo, Seville, Valencia, Vic, and Vigo. All subjects filled in an extensive questionnaire to collect social, demographic, and clinical information. Slow and forced spirometry tests before and after a bronchodilator test were also undertaken. Additionally, selected subjects performed a 6-minute walk test and answered generic and specific quality-of-life questionnaires, as well as an activities-of-daily-living questionnaire. Exhaled-breath condensate and blood samples were also collected from these subjects for measurement of inflammatory and other biomarkers.

Angiotensinogen gene G-6A polymorphism influences idiopathic pulmonary fibrosis disease progression.

Angiotensin II is a growth factor that plays a key role in the physiopathology of idiopathic pulmonary fibrosis (IPF). A nucleotide substitution of an adenine instead of a guanine (G-6A) in the proximal promoter region of angiotensinogen (AGT), the precursor of angiotensin II, has been associated with an increased gene transcription rate. In order to investigate whether the G-6A polymorphism of the AGT gene is associated with IPF development, severity and progression, the present study utilised a case-control study design and genotyped G-6A in 219 patients with IPF and 224 control subjects. The distribution of G-6A genotypes and alleles did not significantly differ between cases and controls. The G-6A polymorphism of the AGT gene was not associated with disease severity at diagnosis. The presence of the A allele was strongly associated with increased alveolar arterial oxygen tension difference during follow-up, after controlling for the confounding factors. Higher alveolar arterial oxygen tension changes over time were observed in patients with the AA genotype (0.37+/-0.7 mmHg (0.049+/-0.093 kPa) per month) compared to GA genotype (0.12+/-1 mmHg (0.016+/-0.133 kPa) per month) and GG genotype (0.2+/-0.6 mmHg (0.027+/-0.080 kPa) per month). G-6A polymorphism of the angiotensinogen gene is associated with idiopathic pulmonary fibrosis progression but not with disease predisposition. This polymorphism could have a predictive significance in idiopathic pulmonary fibrosis patients.

Asthma control in Spain. Do season and treatment pattern matter? The ESCASE study.

The aim of this study was to assess the degree of asthma control according to GINA criteria during two different seasons in Spain. An multicenter, longitudinal, epidemiological study with the participation of a sample of physicians in Spain was conducted. Consecutive asthma patients, 18 years of age and older, seeking primary and specialist care were included in the study. Patients were seen during the winter and spring 2004 and were asked about asthma control according to GINA control criteria (daytime and nighttime symptoms, asthma exacerbations, limitations of physical activity, and visits to the emergency department) during the 4 weeks prior to the visit. Control was defined according to daytime and nighttime symptoms. A total of 614 patients participated in the study. The proportion of patients reporting daytime symptoms "every day" or "most days" during the winter versus spring was 40.1% vs. 23% (P<0.01); 26.9% vs. 14.1% presented symptoms at night (P<0.01); 11.5% vs. 8.3% had severe exacerbations; 33.5% vs. 35.7% presented symptoms accompanying exercise, and 9.4% vs. 4.3% (P<0.01) had required emergency visits. The number of patients with inadequate control was slightly higher in winter than in spring (74.4% vs. 71%) (P<0.01). The most commonly prescribed treatment was ICS plus LABAs for both periods. Asthma is poorly controlled in Spain and strategies are needed to improve management of this illness.

Maxillomandibular advancement as the initial treatment of obstructive sleep apnoea: Is the mandibular occlusal plane the key?

Maxillomandibular advancement (MMA) can be effective for managing obstructive sleep apnoea (OSA); however, limited information is available on the predictor surgical variables. This study investigated whether normalization of the mandibular occlusal plane (MOP) was a determinant factor in curing OSA. Patients with moderate or severe OSA who underwent MMA were evaluated by preoperative and postoperative three-dimensional (3D) scans and polysomnograms. The postoperative value of MOP and the magnitude of skeletal advancement were the predictor variables; change in the apnoea-hypopnoea index (AHI) was the main outcome variable. Thirty-four subjects with a mean age of 41±14years and 58,8% female were analysed. The Epworth Sleepiness Scale (ESS) was 17.4±5.4 and AHI was 38.3±10.7 per hour before surgery. Postoperative AHI was 6.5±4.3 per hour (P<0.001) with 52.94% of the patients considered as cured, and 47.06% suffering from a mild residual OSA with ESS 0.8±1.4 (P<0.001). 3D changes revealed a volume increase of 106.3±38.8%. The mandible was advanced 10.4±3.9mm and maxilla 4.9±3.2mm. MOP postoperative value was concluded to be the best predictor variable. Treatment planning should include MOP normalization and a mandibular advancement between 6 and 10mm. The maxillary advancement would depend on the desired aesthetic changes and final occlusion.

Tobramycin inhalation powder (TOBI Podhaler) for the treatment of lung infection in patients with cystic fibrosis.

Cystic fibrosis (CF) is an autosomal recessive inherited disease secondary to a defect in the CF transmembrane conductance regulator gene (CFTR). Mortality in CF is associated with impairment of lung function in which bacterial infection plays a fundamental role. The microorganism Pseudomonas aeruginosa (P. aeruginosa) is a marker of poor prognosis. Tobramycin was the first parenteral antibiotic to be used as inhaled medication in CF. Owing to its beneficial effects; it was subsequently used in designed inhaled formulations. The first formulation was the inhalation solution, which improved lung function, lowered hospitalization rates, and reduced the courses of intravenous antibiotic. However, the high associated costs and time necessary to administer the medication negatively affected quality of life. The recent development of tobramycin inhalation powder has optimized treatment. The dry powder inhaler is a simple device that reduces administration time and improves adherence. As there is no risk of bacterial contamination, disinfection is unnecessary.

[Nontuberculous mycobacteria in patients with cystic fibrosis]. / Micobacterias ambientales en pacientes adultos con fibrosis quística.

OBJECTIVE: Patients with cystic fibrosis are at great risk of infection by nontuberculous mycobacteria from the environment because of certain predisposing factors such as bronchiectasis, malnutrition, and diabetes. The aim of this study was to analyze the mycobacterial content of sputum smears and cultures from adult patients with cystic fibrosis attended at a specialized unit for adults from March 1997 through December 2001. PATIENTS AND METHODS: Sputum samples were collected prospectively according to a protocol applied at each visit, and during most exacerbations staining and culture for mycobacteria were ordered in addition to the usual cultures for bacteria and fungi. A tuberculin test was performed at the end of the study. RESULTS: Twenty-eight patients (16 men) with cystic fibrosis were enrolled. The mean (SD) age was 25.3 (6.7) years. A total of 251 samples were cultured (range in number of samples per patient, 1-31). The mean period of follow up was 40.3 (22.1) months. The sputum smear was positive in 29 cases (4 patients); the culture was positive in 7 patients. More than 3 samples were positive in only 4 patients. Mycobacterium abscessus was isolated in 3 cases, Mycobacterium avium complex in 2 and Mycobacterium simiae in 1 and other an unidentified rapid growth Mycobacterium species. The Mantoux test was positive in 5 patients. Two of the 4 patients in whose samples mycobacteria were isolated repeatedly required treatment. CONCLUSIONS: The prevalence of nontuberculous mycobacterial infection is high in patients with cystic fibrosis. Staining and culture for mycobacteria should be carried out regularly and whenever exacerbation of pulmonary symptoms cannot be attributed to bacteria usually found in such patients. Patients with recurrent isolations of mycobacteria should be monitored closely.

Expression of lymphocyte activation surface antigens in bronchoalveolar lavage and peripheral blood cells from young healthy subjects.

Cell surface phenotypes of bronchoalveolar lavage (BAL) and peripheral blood lymphocytes (PBL) obtained from a group of young healthy volunteers, including smokers and nonsmokers were studied. Results indicate that the proportions of T (CD3+) and B (CD19+) lymphocytes were comparable in PBL and BAL lymphocytes, whereas the numbers of cells bearing natural killer cell-associated markers (CD16, CD11b, CD56, and CD57) were significantly higher in PBL; in BAL lymphocytes of smokers, the CD4+/CD8+ ratio was < 1. The surface density of CD3 in every case was lower in BAL T cells. The expression of different surface antigens considered to reflect lymphocyte activation was variable; the human lymphocyte antigen (HLA)-DR, CD25 (alpha chain of the interleukin-2 receptor), and CD71 (transferrin receptor) were displayed at low levels in both types of samples. In contrast, the expression of 4F2, CD49a, and particularly, the early activation antigen CD69 were significantly higher in BAL cells compared with PBL; BAL samples from smokers included significantly lower proportions of lymphocytes bearing the CD69, HLA-DR, and 4F2 activation antigens.

Bronchoalveolar lavage cell composition in allogeneic bone marrow transplant patients without symptomatic lung complications.

The purpose of this study was to assess the cytological composition of bronchoalveolar lavage (BAL) fluid in allogeneic BMT patients without lung complications and compare it with that obtained from healthy volunteers. During the first 6 months post-BMT we studied the differential cell counts of 98 BALs from 56 patients as well as the total cell count of 44 BALs from 27 patients. The BAL cellular composition in BMT patients was clearly different from that of healthy subjects: there was a marked increase in alveolar neutrophils (in 82% of the patients when sequential BALs were performed) and an increase in lymphocytes, with a lower percentage of macrophages and similar numbers of eosinophils. A greater variation in cellular populations was found without an evident cause. The total number of cells per ml of fluid recovered appeared similar to that of healthy volunteers. A high frequency of neutrophilic alveolitis was found in patients with asymptomatic CMV on BAL. Owing to the variability of BAL cellular composition in asymptomatic BMT patients and its difference from that in healthy volunteers, great caution should be taken when interpreting the BAL composition data from patients with lung complications. In order to avoid drawing wrong conclusions these data should be compared with those obtained from a control group of BMT patients without lung complications and not from healthy volunteers.

[Production of tumor necrosis factor alpha and interleukin-6 by alveolar macrophages from patients with rheumatoid arthritis and interstitial pulmonary disease]. / Producción de factor de necrosis tumoral alfa e interleucina 6 por los macrófagos alveolares de pacientes con artritis reumatoide y enfermedad pulmonar intersticial.

The aim of this study was to measure the production of tumor necrosis factor-alpha (TNF-alpha) and interleukin-6 (IL-6) by alveolar macrophages in patients with rheumatoid arthritis and interstitial lung disease (ILD). Rheumatoid arthritis patients diagnosed by ACR criteria (n = 8) with associated ILD documented by pulmonary function tests and high resolution computerized tomography scanning, and 12 healthy volunteers (6 smokers and 6 nonsmokers). We determined the spontaneous and induced production of bacterial lipopolysaccharides (LSP), TNF-alpha and IL-6 by alveolar macrophages obtained by bronchoalveolar lavage. The macrophages were isolated by Ficoll-Hypaque gradient centrifugation and plastic adherence and cultured in serum-containing medium (low endotoxin) in the presence and absence of LPS (100 ng/ml). TNF-alpha and IL-6 levels contents were determined in supernatants by ELISA. In the patient group both spontaneous and induced production of TNF-alpha were significantly higher than in controls (p < 0.01). Macrophages stimulated with LPS in patients with rheumatoid arthritis and ILD also released greater amounts of IL-6 than did those of the healthy controls. IL-6 spontaneous and induced production was significantly lower in smokers than in nonsmokers. TNF-alpha and IL-6 production in patients with rheumatoid arthritis and ILD, studied in bronchoalveolar lavage specimens reveals that alveolar macrophages are hyperreactive in these patients, who are possibly sensitized as a consequence of the inflammatory lung process inherent to the disease. Further study is needed to define the pathogenic role of these mediators.

[Polyradiculitis and Wegener's granulomatosis]. / Polirradiculitis y enferedad de Wegener.

Wegener's granulomatosis is a systemic vasculitis of unknown etiology, primarily affecting the upper and lower respiratory tract and the kidneys, although there is a form restricted to the lungs. Wegener's granulomatosis occurs infrequently, with an estimated annual incidence of 8.5 cases per million. The principal symptoms at onset usually involve the upper and lower airway. The central nervous system is involved in approximately 22% of cases, but neurological signs occur infrequently among the initial clinical manifestations. Proteinase 3-specific antineutrophil cytoplasmic antibodies are useful serological markers for establishing a diagnosis, which should, however, be confirmed by a tissue biopsy of the affected organ.

[Quality of life in asthma: reliability and validity of the short form generic questionnaire (SF-36) applied to the population of asthmatics in a public health area]. / Calidad de vida en asma: fiabilidad y validez del cuestionario genérico SF-36 aplicado a la población asmática de un área sanitaria.

OBJECTIVE: To analyze the reliability and validity of the short form of the generic quality of life scale (SF-36) when used with our asthmatic patients. METHODS: Two hundred nineteen adults with asthma of any etiology and without limits on sex, type or severity of asthma who were being treated at 10 health clinics (Madrid, Area 2) filled in the questionnaire. Reliability was calculated by an analysis of internal consistency and validity by studying the correlation among certain variables (patient age, age of onset, PEF, FEV1 and severity according to consensus criteria) and the analysis of differences on each of the dimensions encompassing such variables. RESULTS: The highest score (best quality of life) was observed in the dimension of role limitations due to emotional problems (80 37) and the lowest was seen for perception of general health (50.4 24). The percentage of patients with the lowest scores ranged from 0 to 5.8% and the percentage with the highest scores ranged from 0.4 to 19.8%. The Cronbach alpha coefficient was greater than 0.7 (range 0.77-0.80). Mean scores related to level of severity were significantly better for men than for women on only three dimensions and for mild and moderate severity groups. All dimensions except role limitations due to emotional and physical problems were significantly related to FEV1%. CONCLUSION: The reliability and validity of the Spanish version of the SF-36 questionnaire is satisfactory when applied to asthmatic patients, making it an appropriate way to assess quality of life.