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PubMed2005

Bias in observational study of the effectiveness of nasal corticosteroids in asthma.

BACKGROUND: A recent observational study suggests that intranasal corticosteroids used to treat allergic rhinitis are effective at preventing asthma outcomes, such as emergency visits. The approach to data analysis may have led to biased results because of misclassification of immortal time. OBJECTIVE: To illustrate the bias in the cohort approach and to present the proper time-dependent analysis by replicating the recent study using data from another source. METHODS: From an existing cohort of 30,569 patients with asthma age 5 to 44 years and identified from the Saskatchewan Health databases (1975-1997), we formed the cohort of all subjects who were in the source population between January 1, 1989, and December 31, 1991. Subjects were followed to the first asthma hospitalization. All prescriptions dispensed during follow-up were identified. We replicated the time-fixed approach to data analysis used in the recent study and compared it with time-dependent approaches. RESULTS: The cohort included 20,173 subjects, of whom 1849 were hospitalized for asthma between January 1, 1989, and December 31, 1991. The time-fixed approach misclassified more than 5000 person-years of follow-up, corresponding to 44% of the exposed person-time. As a result, the rate ratio of asthma hospitalization after any use of nasal corticosteroids (NCSs) was 0.57 by the biased time-fixed approach compared with 1.13 by the proper time-dependent approach. The time-fixed approach produced a paradoxical protective effect of NCS with 1 or less canisters dispensed per year (odds ratio, 0.47), which was further exaggerated when the cohort was extended to 5 years (odds ratio, 0.33). Adjusted time-dependent analyses found no protective effect, even when NCSs were dispensed regularly (rate ratio, 1.10; 95% CI, 0.54-2.21). CONCLUSION: The time-fixed approach to the analysis of the effectiveness of NCSs on asthma outcomes leads, by its inherent misclassification of immortal time, to a considerable exaggeration of the protective effect of these medications in preventing severe asthma exacerbations.

Administration, Inhalation↗
PubMed2004

Nasal versus oral fiberoptic intubation via a cuffed oropharyngeal airway (COPA) during spontaneous ventilation.

STUDY OBJECTIVE: To compare the success rate of nasal versus oral fiberoptic intubation in anesthetized patients breathing spontaneously via the cuffed oropharyngeal airway (COPAtrade mark). DESIGN: Prospective, randomized, controlled study. SETTING: Two university-affiliated hospitals. PATIENTS: Patients scheduled for general or plastic surgery of the torso or extremities. INTERVENTIONS: Nasal (n=20) and oral (n=20) fiberoptic intubation were performed in patients while breathing spontaneously via the COPA during standardized anesthesia. MEASUREMENTS: Demographic data, mean arterial pressure, heart rate, end-tidal carbon dioxide (ETCO2), oxygen saturation (SpO2), COPA size, difficult airway predictors, rate of failed ventilation via COPA, and frequency of hypoxemia (SpO2 < 90%) during the procedure, and perioperative untoward events were recorded. MAIN RESULTS: The background, airway difficulty, vital signs and untoward effects were similar in the two groups. Nasal fiberoptic laryngeal view (scale 1-4) was better than the oral grading (3 [median] vs. 2, respectively; p <0.05). Eighty percent of the nasal intubations were successful compared with 40% of the oral intubations (p <0.05). Nasal intubations were accomplished within 153 +/- 15 SD seconds compared with 236 +/- 22 seconds (p <0.05) for the oral intubations, and less propofol was needed in the nasal intubations during the procedures (240 +/- 27 mg [nasal] vs. 277+/- 39 mg [oral]; p <0.05). CONCLUSIONS: Nasal fiberoptic laryngoscopy is more successful and easy than the oral approach in anesthetized patients who are breathing spontaneously through the COPA.

Administration, Inhalation↗
PubMed2006

Anaplastic oligodendroglioma responding favorably to intranasal delivery of perillyl alcohol: a case report and literature review.

BACKGROUND: In recent years, molecular genetics and biology are exerting significant influence on the practice of neuro-oncology, with oligodendrogliomas being the most prominent example. To explore therapeutic strategies and evaluate the clinical results, we report a case of a patient with anaplastic oligodendroglioma managed with intranasal delivery of POH. CASE DESCRIPTION: A 62 year-old white woman presented with complaints of seizures and frontal headache in June 1999. Nervous system examination was normal. Her Karnofsky performance score was 90. A contrast-enhanced MRI scan of the brain revealed a regular space-occupying lesion in the right frontal lobe that enhanced with gadolinium. A radical surgical excision of the tumor was carried out, and the histopathological diagnosis was an anaplastic oligodendroglioma. Subsequently, there were 2 recurrent/progressive lesions, in July 2002 and October 2004, despite combination treatment using surgery, radiotherapy, and chemotherapy. Intranasal delivery of 0.3% concentration of POH 4 times daily was performed. A follow-up MRI scan after 5 months of treatment revealed reduction in size of the enhancing lesion. CONCLUSION: Whereas surgery continues to be the primary treatment for oligodendroglioma, the scheme for postoperative therapy has shifted primarily because of the lesion's relative chemosensitivity. This article evaluates the effects of intranasal delivery of POH in a case of regression of anaplastic oligodendroglioma.

Administration, Inhalation↗
PubMed2004

Identification of contact and respiratory sensitizers using flow cytometry.

Identification of the chemicals responsible for respiratory and contact allergies in the industrial area is an important occupational safety issue. This study was conducted in mice to determine whether flow cytometry is an appropriate method to analyze and differentiate the specific immune responses to the respiratory sensitizer trimellitic anhydride (TMA) and to the contact sensitizer dinitrochlorobenzene (DNCB) used at concentrations with comparable immunogenic potential. Mice were exposed twice on the flanks (days 0, 5) to 10% TMA or 1% DNCB and challenged three times on the ears (days 10, 11, 12) with 2.5% TMA or 0.25% DNCB. Flow cytometry analyses were conducted on draining lymph node cells harvested on days 13 and 18. Comparing TMA and DNCB immune responses on day 13, we found obvious differences that persisted for most of them on day 18. An increased proportion of IgE+ cells correlated to total serum IgE level and an enhancement of MHC II molecule expression were observed in the lymph node B lymphocytes from TMA-treated mice. The percentage of IL-4-producing CD4+ lymphocytes and the IL-4 receptor expression were clearly higher following TMA exposure. In contrast, higher proportions of IL-2-producing cells were detected in CD4+ and CD8+ cells from DNCB-treated mice. Both chemicals induced a significant increase in the percentage of IFN-gamma-producing cells among CD8+ lymphocytes but to a greater proportion following TMA treatment. In conclusion, this study encourages the use of flow cytometry to discriminate between contact and respiratory sensitizers by identifying divergent expression of immune response parameters.

Administration, Inhalation↗
PubMed2003

Acute hemodynamic effects and home therapy using a novel pulsed nasal nitric oxide delivery system in children and young adults with pulmonary hypertension.

In 26 patients, we evaluated a novel pulsed nasal delivery system for nitric oxide (NO) that, in the short term, was as effective as continuous delivery for decreasing pulmonary artery pressure and pulmonary vascular resistance. In 2 patients, NO delivered in the home using this pulsing system was well tolerated for up to 2 years. The long-term safety, efficacy, and acceptability of NO delivered in the home remains to be studied.

Administration, Inhalation↗
PubMed2000

Effects of route of administration on cocaine induced dopamine transporter blockade in the human brain.

The route of administration influences the reinforcing effects of cocaine. Here we assessed whether there were differences in the efficacy of cocaine to block the dopamine transporters (major target for cocaine's reinforcing effects), as a function of route of administration. Positron emission tomography and [11C]cocaine, a dopamine transporter radioligand, were used to compare the levels of dopamine transporter blockade induced by intravenous, smoked and intranasal cocaine in 32 current cocaine abusers. In parallel, the temporal course for the self-reports of "high" were obtained. Cocaine significantly blocked dopamine transporters. The levels of blockade were comparable across all routes of administration and a dose effect was observed for intravenous and intranasal cocaine but not for smoked cocaine. For equivalent levels of cocaine in plasma and DAT blockade, smoked cocaine induced significantly greater self reports of "high" than intranasal cocaine and showed a trend for a greater effect than intravenous cocaine. The time to reach peak subjective was significantly faster for smoked (1.4+/-0.5 min) than for intravenous cocaine (3.1+/-0.9 min), which was faster than intranasal cocaine (14.6+/-8 min). Differences in the reinforcing effects of cocaine as a function of the route of administration are not due to differences in the efficacy of cocaine to block the dopamine transporters. The faster time course for the subjective effects for smoked than intravenous and for intravenous than for intranasal cocaine highlights the importance of the speed of cocaine's delivery into the brain on its reinforcing effects.

Administration, Inhalation↗
PubMed1997

Chemically-induced nasal carcinogenesis and epithelial cell proliferation: a brief review.

An increased rate of cell proliferation has long been recognized as an important factor in both human and experimental carcinogenesis, and may be a major risk factor for cancer development in a number of tissues. Limited information exists, however, regarding the relevance of increased cell proliferation and nasal cancer. Examples of toxicological studies utilizing nasal cell proliferation data as an important endpoint are briefly reviewed. Data for one of the most extensively studied chemicals, the weakly genotoxic carcinogen formaldehyde, support the contention that the concentration-response relationship for tumor incidence is a function of formaldehyde-induced target cell proliferation, in addition to other factors including target cell population size. The increasing importance of utilizing cell proliferation data in determining dose-response relationships and in biologically-based risk assessment models is discussed.

Administration, Inhalation↗
PubMed1994

Novel therapies for acute respiratory failure.

Mortality in acute respiratory failure in the non-neonatal pediatric patient has not changed substantially in 20 years, despite advances and refinements in conventional therapeutic strategies and technology. A host of innovative therapies are currently in various stages of investigation, including high frequency ventilation, pressure control ventilation, permissive hypercapnia, extracorporeal membrane oxygenation, exogenous surfactant administration, inhaled nitric oxide, and liquid ventilation. While none of these therapies has yet been prospectively studied in non-neonatal pediatric patients, all show much promise by virtue of their emphasis on either directly addressing pathophysiologic derangements associated with acute respiratory failure or by reducing the complications associated with conventional therapy.

Acute Disease↗
PubMed2002

CT of emphysema.

This article focuses on three main topics: (1) the importance of emphysema as a serious respiratory disease, (2) qualitative assessment of emphysema using CT, and (3) the emerging importance of quantitative CT in the evaluation of patients with emphysema for surgery and drug therapy. CT also can identify the major anatomic subtypes of emphysema. CT is critical in the assessment of patients with the potential for lung volume reduction surgery. CT may well be superior to pulmonary function tests in the longitudinal assessment of current and proposed drug therapies for the treatment of emphysema.

Administration, Inhalation↗
PubMed1983

Availability of toxic trace metals to the conceptus.

Energy production releases numerous toxic metals into the environment. Among those metals which have been shown to be toxic to the conceptus are cadmium, lead, mercury, plutonium and vanadium. This paper reviews the results from the authors' studies of pregnant rats exposed to these metals by parenteral administration, inhalation or gastric intubation. In addition, direct measurements were made of maternal blood flow and clearance of metals across the guinea pig placenta to serve as conceptual examples of factors which regulate the effects of the metals on the fetus. Discussion includes the influence of route of maternal exposure and subsequent absorption, gestational age at exposure, metal behavior in the maternal bloodstream, movement of metals across the placenta, and distribution of metals in the products of conception.

Animals↗
PubMed1998

Effect of fluticasone propionate aqueous nasal spray versus oral prednisone on the hypothalamic-pituitary-adrenal axis.

BACKGROUND: Fluticasone propionate is a glucocorticoid with negligible oral bioavailability and very low intranasal bioavailability that is used as an intranasal spray for the treatment of rhinitis. OBJECTIVE: The purpose of this study was to evaluate the hypothalamic-pituitary-adrenal (HPA)axis effects of fluticasone propionate aqueous nasal spray (FP ANS) compared with oral prednisone and placebo by using a 6-hour cosyntropin infusion test. METHODS: In a 4-week, randomized, double-blind, double-dummy, placebo-controlled parallel-group study, 105 adult patients with allergic rhinitis were randomly assigned to receive FP ANS 200 microg once daily, FP ANS 400 microg twice daily, oral prednisone 7.5 mg once daily, oral prednisone 15 mg once daily, or placebo. HPA-axis function was assessed at the screening visit and after 4 weeks of treatment by measuring morning plasma cortisol concentrations and poststimulation concentrations of plasma and urinary cortisol. RESULTS: There was no evidence of altered HPA-axis response to cosyntropin by the end of treatment with FP ANS 200 microg once daily or FP ANS 400 microg twice daily when compared with placebo. In contrast, 4 weeks of treatment with oral prednisone 7.5 or 15 mg once daily was associated with significant (p < 0.05 vs placebo) reduction in HPA-axis function, as evidenced by lower plasma cortisol concentrations (area under the plasma concentration-time curve and peak concentrations) after cosyntropin stimulation and reduced mean 24-hour urinary cortisol excretion. FP ANS 400 microg twice daily and both prednisone regimens were associated with a significant (p < 0.05 vs placebo) reduction in mean morning plasma cortisol concentrations. CONCLUSION: These results indicate that a 4-week course of FP ANS at four times the recommended dose does not suppress adrenal function in response to a 6-hour cosyntropin stimulation test.

Administration, Inhalation↗
PubMed1999

Asthma from the perspective of the patient.

BACKGROUND: The published literature is lacking in data on the frequency and severity of medication side effects in the general asthma population. METHODS: Questionnaires regarding asthma severity, treatment, and medication side effects were answered by 1230 and 604 pediatric and adult asthmatics, respectively, 70% to 75% of whom were consulting a specialist. RESULTS: Most respondents (58%-79%) reported unwanted side effects from their bronchodilators, most of which had been racemic albuterol prescribed in either generic or name brand form. Side effects were most common in nebulizer users of all ages and in pediatric patients using oral medications. The most common troublesome side effects were jitteriness (58%), restlessness (57%), tachycardia (56%) and cough (56%) in the pediatric patients and tachycardia (64%), jitteriness (60%), shaky hands (43%), and restlessness (42%) in the adult respondents. Most patients had spoken to their physicians about their side effects, and the most common response was to change brands within the same class of medication, adjust the dose, or advise the patients to tolerate the side effects because the medications were necessary and side effects were to be expected. Fewer than 4% of all respondents viewed their physicians as "caring/sympathetic/willing to listen/discuss their bronchodilator side effects." Twenty-five to thirty percent of patients had reduced their bronchodilator dose on their own, and 14% to 24% had skipped doses to avoid unwanted side effects. Hospitalizations were infrequent and were most commonly seen in the nebulizer users, who were also rated by their physicians as more likely to have severe asthma. Other markers of asthma control (such as emergency room visits, unscheduled doctor visits, and being sent home from school/work for asthma symptoms) were not only common in the nebulizer user group but also in children who used oral medications. This group was more likely to have been classified by their physicians as having mild asthma, suggesting perhaps a need for more intensive asthma education in this group. CONCLUSION: Medication side effects are common in individuals with asthma and are most often ascribed by the patients to their bronchodilators. There is a need for new, rapid-acting bronchodilators with fewer side effects.

Administration, Inhalation↗