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1.
BACKGROUND: Asthma morbidity and mortality are highest among minority inner-city populations. OBJECTIVE: To identify factors associated with acute health care resource utilization and asthma-related quality of life among high-risk, minority patients with asthma. METHODS: We interviewed a prospective cohort of 198 adults hospitalized for asthma in an inner city hospital over a period of 1 year. Detailed information about sociodemographics, asthma history, access to care, asthma medications, and self-reported allergy to aeroallergens was collected at baseline. Data on resource utilization (emergency department visits and hospital admissions for asthma) and asthma-related quality of life were obtained at 6 months after discharge. Multivariate analyses were used to identify predictors of resource utilization and quality of life. RESULTS: The mean age of patients was 49.9 +/- 17.4 years, 78% were women, and 97% were nonwhite. At 6 months, 49% of patients had an emergency department visit or hospitalization. In multivariate analysis, adjusting for age, sex, medication regimen, and asthma severity, patients with a physician in charge of their asthma care had lower odds of resource utilization (odds ratio, 0.4; P=.03). Conversely, a self-reported history of cockroach allergy was associated with greater utilization (odds ratio, 2.3; P=.05). Asthma-related quality of life was worse among patients who spoke mostly Spanish or who reported allergy to cockroaches (P < .004). CONCLUSION: Lack of an established asthma care provider, language barriers, and self-reported allergy to cockroaches are associated with higher resource utilization and worse quality of life among minority, inner-city patients with asthma. Interventions targeting these factors may lead to better outcomes among these patients.  相似文献   

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BACKGROUND: We have previously shown that omalizumab, a recombinant humanized monoclonal anti-IgE antibody, reduces asthma exacerbations and decreases inhaled corticosteroid (ICS) requirement in patients with severe allergic asthma who were symptomatic despite moderate-to-high doses of ICSs. OBJECTIVE: The aim of the present study was to assess the effects of omalizumab on asthma-related quality of life (QOL). METHODS: These analyses were part of a multicenter, 52-week, randomized, double-blind, placebo-controlled study assessing the efficacy, safety, and tolerability of subcutaneous omalizumab (> or =0.016 mg/kg of IgE [in international unit per milliliter] per 4 weeks) in 525 adults with severe allergic asthma. A 16-week steroid-stable phase was followed by a 12-week steroid-reduction phase and a 24-week double-blind extension phase. The effect of treatment on asthma-related QOL was evaluated by using the Asthma Quality of Life Questionnaire (AQLQ) administered at baseline and at weeks 16, 28, and 52. RESULTS: The 2 treatment groups were comparable in terms of baseline AQLQ scores. At weeks 16, 28, and 52, omalizumab-treated patients demonstrated statistically significant improvements across all AQLQ domains, as well as in overall score. Moreover, a greater proportion of patients receiving omalizumab achieved a clinically meaningful improvement in asthma-related QOL during each phase of the study. Greater than 50% of both patients and investigators rated treatment similarly with omalizumab as excellent or good compared with less than 40% of placebo recipients. CONCLUSION: In patients requiring moderate-to-high doses of ICSs for severe allergic asthma, the measurably improved disease control afforded by add-on omalizumab therapy is paralleled by clinically meaningful improvements in asthma-related QOL.  相似文献   

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BACKGROUND: Clinical tools for predicting poor outcomes in asthma patients are lacking. This study investigated the association of asthma control and subsequent severe asthma-related healthcare events in The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) study. METHODS: The extent of asthma control problems was determined from baseline values of the Asthma Therapy Assessment Questionnaire (ATAQ). Patients self-reported the presence of severe asthma-related events at 6- and 12-month follow up. Poisson regression models determined the adjusted association between baseline control and the likelihood of severe asthma-related events. RESULTS: At baseline, 2942 patients (mean age, 49.6 years; female, 71.9%) had an ATAQ score (no control problems, 17.0%; 1 control problem, 20.0%; 2 control problems, 30.8%; 3 or 4 control problems, 32.2%) and at least one severe asthma-related event. After adjustment, subjects with three or four control problems were at greater risk for unscheduled office visits [relative risk (RR) = 2.8; 95% confidence interval (CI): 2.4-3.2], course of oral steroids (RR = 2.9; 95% CI: 2.5-3.3), emergency room visits (RR = 4.1; 95% CI: 2.7-6.2) or hospitalization (RR = 13.6; 95% CI: 7.4-24.9), vs no control problems. Progressively poorer levels of asthma control are associated with increasing risk of severe asthma-related events. CONCLUSIONS: This study provides evidence of an association between poor asthma control and future severe asthma-related healthcare events. A validated questionnaire may help clinicians identify patients requiring intervention to prevent future severe asthma-related events.  相似文献   

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Background

Omalizumab is indicated for the treatment of moderate to severe asthma. There is limited observational evidence on the costs and effectiveness of omalizumab.

Objective

To examine the costs and effectiveness of omalizumab for treatment of severe asthma relative to nonusers.

Methods

We conducted a within-person repeated-measures matched cohort study in Ontario, Canada from April 1, 2012 to March 31, 2014. Continuous users of omalizumab were matched with up to 4 nonusers according to age, sex, recent specialist visits, oral corticosteroid use, asthma severity, and Charlson comorbidity score. The primary outcome was direct health care costs. Secondary outcomes were asthma-related hospitalizations or emergency department visits and oral corticosteroid use. The association between omalizumab use and each outcome was assessed using mixed-effects models adjusting for confounders.

Results

Ninety-five omalizumab users and 352 nonusers were matched. Among users, there was a significant increase in health care costs of $1,796 per person owing to the cost of the medication at treatment initiation (P < .0001). Costs did not change significantly among nonusers ($85 increase in average monthly costs per person; P = .59). We found no significant changes in the rates of asthma-related hospitalizations or emergency department visits among omalizumab users (P = .44) or nonusers (P = .99) between pre- and postintervention periods.

Conclusion

The use of omalizumab was associated with increased costs but no evidence of lower rates of clinically important outcomes. These results suggest omalizumab had limited effectiveness in our study population. Future studies should further explore subsets of patients most likely to benefit from omalizumab therapy.  相似文献   

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BACKGROUND: Although health-related quality of life (HRQL) has been increasingly used as an outcome in asthma, its utility for identifying patients at risk for adverse asthma outcomes has not been established. OBJECTIVE: In a prospective cohort study, to evaluate the longitudinal impact of HRQL on future health care utilization and cost among adults with asthma, accounting for known risk factors for utilization. METHODS: A stratified random sample of 3,482 adult Northern CA Kaiser Permanente members with asthma was selected using computerized utilization databases and a screening survey item. Subjects completed a mail survey that included measures of generic (SF-12) and asthma-specific HRQL (ITG-Asthma Short Form battery). During the 12 months after survey completion, computerized utilization and cost data were ascertained. RESULTS: Better baseline asthma-specific HRQL was associated with a decreased risk of asthma-related emergency department visit or hospitalization during longitudinal followup (odds ratio per 10-point score increment 0.84; 95% confidence interval [CI] 0.74 to 0.95), controlling for demographic and clinical factors. Better baseline generic physical HRQL was associated with a decreased risk of future all-cause hospitalization (odds ratio 0.68; 95% CI 0.60 to 0.77). More favorable asthma-specific HRQL scores were also related to decreased asthma-related health care costs during the ensuing year (-0.086 log-dollars per 10-point score increment; 95% CI -0.11 to -0.06). Better generic physical HRQL scores were associated with lower total costs (-0.24 log-dollars; 95% CI -0.32 to -0.17). CONCLUSIONS: In a large cohort of adult health maintenance organization members with asthma, asthma-specific HRQL was associated with future asthma-related utilization and cost.  相似文献   

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BACKGROUND: In 1998, the economic burden of asthma in the United States was estimated to be 12.7 billion dollars. Yet few studies have examined the relationship between the total costs of asthma-related care and measures of asthma morbidity. Understanding the relationship between total costs of asthma-related care and morbidity can assist in designing the most cost-effective asthma care strategies to improve patient outcomes and minimize total costs. OBJECTIVE: To investigate correlates of asthma costs for children with mild-to-moderate persistent asthma and, specifically, to characterize how closely the percentage of predicted forced expiratory volume in 1 second (FEV1) and symptom days were correlated with costs of illness. METHODS: A total of 638 parents and children with mild-to-moderate persistent asthma in 4 managed care delivery systems in 3 different US geographic regions were enrolled. Symptom burden and annual resource utilization were determined from reports of physician visits, hospitalizations, emergency department visits, medication use, and parental missed workdays. Spirometry was conducted on children who were 5 years and older. To characterize the relationship between symptom days and the percentage of predicted FEV1 with costs, we specified a multivariate regression model. RESULTS: The median total annual asthma-related cost for the group was 564 dollars (interquartile range [IQR], 131 dollars-1602 dollars). Indirect costs represented 54.6% of total costs. Medicines accounted for 52.6% of direct costs. The mean percentage of predicted FEV1 was 101.6% (range, 39.3%-183.5%; IQR, 91.6%-111.3%), with 91.4% of patients with a percentage of predicted FEV1 of more than 80%. Based on multivariate modeling, increasing asthma severity, use of peak expiratory flow rate meters, younger age, low-income status and nonwhite race, and longer duration of asthma were significantly associated with increasing cost. Symptom days (P < 0.001) predicted annual costs better than percentage of predicted FEV1 (P < 0.16) in this group of children. CONCLUSIONS: For the large number of children with mild-to-moderate persistent asthma and normal or near-normal lung function, symptom days are predictive of health care costs. For these insured children receiving care from 3 large managed care providers, low-income status and nonwhite race were the strongest correlates for increased asthma-related costs.  相似文献   

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BackgroundComorbidities are common in asthma and may complicate treatment response.ObjectiveTo examine response to omalizumab in patients with moderate-to-severe allergic asthma by asthma-related and allergic comorbidities.MethodsPatients aged 12 years or more from placebo-controlled 008/009 (n = 1071), EXTRA (n = 848), and INNOVATE (n = 419), and single-armed PROSPERO (n = 801) omalizumab studies were included. Poisson regression/analysis of covariance models were used to estimate adjusted exacerbation rates and forced expiratory volume in 1 second (FEV1) change from baseline after omalizumab initiation for subgroups by number of comorbidities (0, 1 [008/009]; 0, 1, ≥2 [EXTRA and INNOVATE]; 0, 1, 2, ≥3 [PROSPERO]). Self-reported comorbidities included allergic rhinoconjunctivitis, chronic rhinosinusitis, recurrent acute sinusitis, nasal polyps, atopic and contact dermatitis, urticaria, food allergy, anaphylaxis, other allergies, gastroesophageal reflux disease, eosinophilic esophagitis, and eosinophilic granulomatosis with polyangiitis.ResultsIn the EXTRA and INNOVATE studies, no consistent pattern was observed for placebo-corrected relative rate reduction in normalized asthma exacerbations among omalizumab-treated comorbidity subgroups. In PROSPERO, on-study exacerbation rates in the comorbidity subgroups were similar (0, 0.68; 1, 0.70; 2, 0.77; ≥3, 0.80). FEV1 improvements were observed throughout the study for omalizumab vs placebo for all comorbidity subgroups. There were no consistent differences in FEV1 improvements among comorbidity subgroups in 008/009, EXTRA, or INNOVATE. Similarly, no among-group differences were observed for FEV1 change from baseline at month 12 in PROSPERO (0, 0.05 L; 1, 0.08 L; 2, 0.00 L; ≥3, 0.04 L). The 95% confidence intervals overlapped substantially in all instances.ConclusionIn these analyses of placebo-controlled/single-armed studies, on-study exacerbation rates and FEV1 improvements with omalizumab treatment were similar irrespective of comorbidity burden.Trial RegistrationClinicalTrials.gov identifiers are as follows: EXTRA, NCT00314574 (https://clinicaltrials.gov/ct2/show/NCT00314574); INNOVATE, NCT00046748 (https://clinicaltrials.gov/ct2/show/NCT00046748); and PROSPERO, NCT01922037 (https://clinicaltrials.gov/ct2/show/NCT01922037).  相似文献   

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BACKGROUND: Although asthma and allergic rhinitis commonly occur together, the nature of the association has yet to be determined. Treatments for one condition could potentially alleviate the coexisting condition. OBJECTIVE: Patients with both allergic rhinitis and asthma were studied to test the hypothesis that treating allergic rhinitis reduces health care utilization for co-morbid asthma. METHODS: A retrospective cohort study was carried out with 1994-1995 MarketScan claims data. The cohort was limited to patients with both allergic rhinitis and asthma, aged 12 to 60 years, who were continuously enrolled and had no evidence of chronic obstructive pulmonary disease. Allergic rhinitis treatment and asthma-related events (hospitalizations and emergency department visits) were identified. An incidence density ratio (IDR) associated with exposure to allergic rhinitis treatment was calculated. A multivariate Poisson regression was estimated, and the parameter estimates were transformed into IDRs for each explanatory variable. An allergic rhinitis treatment indicator was included in all regressions. RESULTS: The study sample population consisted of 4944 patients with allergic asthma, approximately 73% of whom were treated for their allergic rhinitis. Asthma-related events occurred more often for the untreated group compared with the treated group, 6.6% compared with 1.3%. An IDR of 0.49 for the treatment group (P =.001) indicates that the risk of an asthma-related event for the treated group was about half that for the untreated group. CONCLUSION: In summary, those who were treated for allergic rhinitis have a significantly lower risk of subsequent asthma-related events (emergency department visits or hospitalizations) than those who were not treated.  相似文献   

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BACKGROUND: Age-related sex differences in asthma hospitalizations and emergency department (ED) visits have been reported, but relationships of these differences to disease prevalence and outpatient management have not been defined. OBJECTIVE: To define the relationships of sex to asthma-related health care utilization and medications, accounting for age-related differences in asthma prevalence. METHODS: Computerized data from Southern California Kaiser-Permanente were used to identify asthmatic patients, aged 2 to 64 years, enrolled continuously during 1999 and 2000. Age-specific asthma prevalence in 1999 was calculated to identify ages of male or female predominance. Males and females were compared with regard to asthma-related health care utilization outcomes (outpatient clinic visits, ED visits, and hospitalizations) and medication use (beta-agonists, inhaled steroids, and oral steroids). Hospitalizations, ED visits, and oral steroid use were considered markers of disease severity. RESULTS: Of the 60,694 subjects, the female-male prevalence ratio was approximately 35:65 at each age between 2 and 13 years, it was inverse (65:35) between the ages of 23 and 64 years, and prevalences were relatively similar at the ages of 14 to 22 years. In patients aged 2 to 13 years, most utilization and medication variables were significantly greater in males (P < .01). Females aged 14 to 22 years had more outpatient and ED visits and used more oral steroids than males. In patients aged 23 to 64 years, all utilization variables were significantly greater in females, except beta-agonist use and mean inhaled steroid dispensings. CONCLUSIONS: Asthma utilization and severity appear greater in males aged 2 to 13 years, somewhat greater in females aged 14 to 22 years, and definitely greater in females aged 23 to 64 years. The mechanisms for these striking sex differences merit further investigation.  相似文献   

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BACKGROUND: People with airway disease are high utilizers of health care resources. Few studies document the value of alternative therapies in reducing utilization. Studies examining theophylline, which demonstrate reduction in resource utilization, have been primarily of short duration in hospitalized settings with small samples. OBJECTIVE: The purpose of this study was to examine the role of oral extended-release theophylline in reducing health care utilization over an extended period of time when added to existing inhaler therapy for ambulatory patients with airway disease. METHODS: We used a retrospective, pretest/posttest design in examining the 1990-1993 South Carolina Medicaid database to compare health care utilization of 455 ambulatory patients for 4 months before and 6 months after extended-release theophylline was added to their treatment regimen. We assessed the following three outcomes: inhaler use, physician office visits, and emergency department visits, all measured in units/person/month. RESULTS: Our sample consisted of patients taking beta2-agonist only (n = 393), steroid only (n = 25), and beta2-agonist plus steroid (n = 37). Inhaler use and physician office visits declined significantly among beta2-agonist users, as well as within the entire sample. Initiation of extended-release theophylline therapy was associated with a 30% decline in utilization of inhaler and physician office visits, influenced mostly by the decline with the beta2-agonist group. CONCLUSION: The results of this effectiveness study using an administrative claims database are consistent with the published randomized clinical trials that document the value of extended-release theophylline when added to existing inhaler therapy.  相似文献   

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OBJECTIVE: To determine whether a multi-dimensional cumulative risk index (CRI) is a stronger predictor of asthma morbidity in urban, school-aged children with asthma, than poverty or severity alone. METHODS: A total of 163 children with asthma, ages 7-15 years (42% female; 69% ethnic minority) and their primary caregivers completed interview-based questionnaires, focusing on potential cultural, contextual, and asthma-specific risks that can impact asthma morbidity. RESULTS: Higher levels of cumulative risks were associated with more asthma morbidity, after controlling for poverty level or asthma severity. Analyses by ethnic group and subgroup also supported the relationship between the CRI and specific indices of asthma morbidity. CONCLUSIONS: This study demonstrates the utility of multiple-dimensional risk models for predicting variations in asthma morbidity in urban children. Research efforts with urban families who have children with asthma need to consider the context of urban poverty as it relates to children's cultural backgrounds and specific asthma outcomes.  相似文献   

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BACKGROUND: Since eosinophils are implicated in asthma pathogenesis, we investigated whether these cells were activated in severe asthma. METHODS: Twenty-six asthmatics with different clinical responses to oral corticosteroid (CS), i.e. sensitive [change in forced expiratory volume in 1 s (DeltaFEV(1)) >/= 25% after oral methylprednisolone, 40 mg daily, for 14 days, n = 7], resistant (DeltaFEV(1) /= 20 mg oral prednisone daily for acceptable asthma control, n = 10), were studied. RESULTS: Calcium ionophore-induced leukotriene (LT) C(4) release of purified blood eosinophils was similar in the three groups. Cell incubation with granulocyte-macrophage colony-stimulating factor (GM-CSF) enhanced ionophore-induced LTC(4) release, and this effect was higher in CS-sensitive (5-fold) than in CS-resistant subjects (1.7-fold) (p = 0.02). CS treatment decreased blood eosinophil counts in these two groups of subjects (p 相似文献   

18.

Background

Patients with severe asthma can have eosinophilic inflammation and/or allergen sensitization. Benralizumab is an anti-eosinophilic monoclonal antibody indicated for add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.

Objective

To investigate the efficacy of benralizumab by atopic status and serum immunoglobulin E (IgE) concentrations.

Methods

We analyzed pooled results from the SIROCCO (NCT01928771) and CALIMA (NCT01914757) phase III studies. Patients 12 to 75 years old with severe, uncontrolled asthma on high-dosage inhaled corticosteroids plus long-acting β2-agonists received 30?mg of subcutaneous benralizumab every 4 weeks or every 8 weeks (first 3 doses every 4 weeks) or placebo every 4 weeks. The analysis stratified patients who did and did not meet similar omalizumab-qualifying criteria of atopy and serum IgE levels 30 to 700?kU/L. Patients also categorized as having high serum IgE (≥150?kU/L) or low serum IgE (<150?kU/L) and as having atopy or no atopy. Efficacy outcomes were for all patients and by blood eosinophil counts and included annual exacerbation rate ratio and pre-bronchodilator forced expiratory volume in 1 second change at treatment end vs placebo.

Results

Benralizumab every 8 weeks decreased exacerbations by 46% (95% confidence interval 26–61, P?=?.0002) and increased forced expiratory volume in 1 second by 0.125?L (95% confidence interval 0.018–0.232, P?=?.0218) vs placebo for patients with at least 300 eosinophils/μL who met the atopy and IgE criteria. For patients with eosinophilia and high or low IgE, treatment with benralizumab every 8 weeks resulted in 42% and 43% decreases in exacerbation rate (P?≤?.0004) and 0.123- and 0.138-L increases in forced expiratory volume in 1 second (P?≤?.0041) vs placebo, respectively.

Conclusion

Benralizumab treatment decreased exacerbations and improved lung function for patients with severe, uncontrolled eosinophilic asthma regardless of serum IgE concentrations and atopy status.  相似文献   

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Background About 5–10% of patients with asthma suffer from poorly-controlled disease despite corticosteroid (CS) therapy.
Objective We determined whether there were any differences in inflammatory biomarkers between severe and non-severe asthma patients.
Methods Nineteen severe and 20 non-severe asthma patients were recruited and underwent collection of induced sputum, bronchoalveolar lavage (BAL) fluid and bronchial biopsies.
Results Biopsy results showed no differences in eosinophils (major basic protein positive), neutrophils, macrophages, T cells and mast cells in the bronchial submucosa. However, subbasement membrane (SBM) thickness and smooth muscle area were increased in the biopsies. No significant differences were observed in the induced sputum inflammatory cells. In BAL fluid, there was a significant increase in neutrophils but a significant decrease in macrophages. Eosinophil counts were non-significantly increased threefold in both sputum and BAL in severe asthma. Levels of IL-8 and IL-13 in sputum supernatants were similar in both groups of asthma patients. There was a significant inverse correlation between post-bronchodilator forced expiratory volume in 1 s and provocative concentration of methacholine causing a 20% fall in FEV1 with SBM thickness.
Conclusion Differences in inflammatory cells were observed mainly in terms of increased neutrophils and reduction in macrophage numbers in BAL fluid with a trend towards increased eosinophils in severe asthma compared with non-severe asthma. However, the most notable features are the increase in features of airway wall remodelling of SBM thickness and smooth muscle area.  相似文献   

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