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1.
Rev Fish Biol Fish ; 32(4): 1035-1061, 2022.
Article in English | MEDLINE | ID: mdl-36187439

ABSTRACT

Billfish species (families Istiophoridae and Xiphiidae) are caught in artisanal, recreational, and commercial fisheries throughout the Western Indian Ocean region. However, data and information on the interactions among these fisheries and the ecology of billfish in the WIO are not well understood. Using an in-depth analysis of peer-reviewed articles, grey literature, observation studies, and authors' insider knowledge, we summarize the current state of knowledge on billfish fisheries in 10 countries. To describe historical and current trends, we examined fisheries statistics from governmental and non-governmental agencies, sportfishing clubs' reports, diaries of sportfishing captains, and the catch and effort databases of the Indian Ocean Tuna Commission. We highlight two key points. First, billfish fisheries in the Western Indian Ocean are highly diverse, comprising two distinct segments-coastal and oceanic. However, data are poor for most countries with significant gaps in information especially for sport and artisanal fisheries. Second, the evidence assembled showed that billfish species have immense social, cultural, and economic value. Swordfish are targeted by both large-scale and semi-industrial fisheries, while other billfish species, particularly marlin, are highly sought after by sport fisheries in most countries. Our paper provides a comprehensive review of billfish fisheries and available information in the context of the WIO underscoring the need to strengthen data collection and reporting, citizen science, and collaborative sustainable development and management of billfish. Supplementary Information: The online version contains supplementary material available at 10.1007/s11160-022-09725-8.

2.
Protoplasma ; 259(1): 173-186, 2022 Jan.
Article in English | MEDLINE | ID: mdl-33934215

ABSTRACT

Plants produce a wide variety of secondary metabolites, which often are of interest to pharmaceutical and nutraceutical industry. Plant-cell cultures allow producing these metabolites in a standardised manner, independently from various biotic and abiotic factors difficult to control during conventional cultivation. However, plant-cell fermentation proves to be very difficult, since these chemically complex compounds often result from the interaction of different biosynthetic pathways operating in different cell types. To simulate such interactions in cultured cells is a challenge. Here, we present a microfluidic bioreactor for plant-cell cultivation to mimic the cell-cell interactions occurring in real plant tissues. In a modular set-up of several microfluidic bioreactors, different cell types can connect through a flow that transports signals or metabolites from module to module. The fabrication of the chip includes hot embossing of a polycarbonate housing and subsequent integration of a porous membrane and in-plane tube fittings in a two-step ultrasonic welding process. The resulting microfluidic chip is biocompatible and transparent. Simulation of mass transfer for the nutrient sucrose predicts a sufficient nutrient supply through the membrane. We demonstrate the potential of this chip for plant cell biology in three proof-of-concept applications. First, we use the chip to show that tobacco BY-2 cells in suspension divide depending on a "quorum-sensing factor" secreted by proliferating cells. Second, we show that a combination of two Catharanthus roseus cell strains with complementary metabolic potency allows obtaining vindoline, a precursor of the anti-tumour compound vincristine. Third, we extend the approach to operationalise secretion of phytotoxins by the fungus Neofusicoccum parvum as a step towards systems to screen for interorganismal chemical signalling.


Subject(s)
Catharanthus , Plant Cells , Bioreactors , Cell Communication , Microfluidics
3.
Annu Int Conf IEEE Eng Med Biol Soc ; 2019: 6476-6480, 2019 Jul.
Article in English | MEDLINE | ID: mdl-31947325

ABSTRACT

This paper reports about the initial interaction of bacteria with anodically oxidized Ti6Al4V for the use as dental implant abutment surfaces. Ti6Al4V samples are anodically oxidized in hydrofluoric acid using different voltages. The resulting nanotopographies are characterized by atomic force microscopy, scanning electron microscopy and contact angle measurements. The topographies reach from micro-porous structures with small nanoporosities on top to fully hexagonally aligned nanotubes. For initial bacterial adhesion tests, Escherichia coli and Staphylococcus aureus are used. Samples are incubated for 2 h and afterwards non-adherent cells are washed off. The results of live/dead staining and cell counts are presented. Gram-negative and Gram-positive strains show different behavior in respect to total number of initially adherent cells on different micro/nanotopographies. The observed reduction of adhered microorganisms is mainly based on underlying microporous topographies.


Subject(s)
Bacterial Adhesion , Nanotubes , Aluminum , Cell Adhesion , Microscopy, Electron, Scanning , Oxidation-Reduction , Surface Properties , Titanium , Vanadium
4.
Diabetes Obes Metab ; 17(10): 1003-6, 2015 Oct.
Article in English | MEDLINE | ID: mdl-26095311

ABSTRACT

Increasing evidence points to the cytotoxicity of islet amyloid polypeptide (IAPP) aggregates as a major contributor to the loss of ß-cell mass in type 2 diabetes. Prevention of IAPP formation represents a potential treatment to increase ß-cell survival and function. The IAPP inhibitory peptide, D-ANFLVH, has been previously shown to prevent islet amyloid accumulation in cultured human islets. To assess its activity in vivo, D-ANFLVH was administered by intraperitoneal injection into a human IAPP transgenic mouse model, which replicates type 2 diabetes islet amyloid pathology. The peptide was a potent inhibitor of islet amyloid deposition, resulting in reduced islet cell apoptosis and preservation of ß-cell area leading to improved glucose tolerance. These findings provide support for a key role of islet amyloid in ß-cell survival and validate the application of anti-amyloid compounds as therapeutic strategies to maintain normal insulin secretion in patients with type 2 diabetes.


Subject(s)
Blood Glucose/drug effects , Diabetes Mellitus, Experimental/drug therapy , Diabetes Mellitus, Type 2/drug therapy , Homeostasis/drug effects , Islet Amyloid Polypeptide/antagonists & inhibitors , Animals , Apoptosis/drug effects , Diabetes Mellitus, Experimental/blood , Diabetes Mellitus, Type 2/blood , Disease Models, Animal , Insulin-Secreting Cells/drug effects , Islet Amyloid Polypeptide/therapeutic use , Islets of Langerhans/drug effects , Mice , Mice, Transgenic
5.
Nervenarzt ; 86(7): 857-65, 2015 Jul.
Article in German | MEDLINE | ID: mdl-26076866

ABSTRACT

BACKGROUND: The Psychiatry Personnel Act (Psych-PV) as the basis for personnel assessment in psychiatry becomes invalid on 1 January 2019. Because the Psych-PV previously coupled the personnel quota with the intensity of services provided, current efforts are required to develop an instrument to adapt the extent of financed personnel resources to the manifold new legal requirements and advances in treatment in terms of guideline-based care. OBJECTIVES: Based on a literature search and the additional use of a databank of routine data, an example of a calculation was made to estimate the additional personnel resources which would be necessary for psychoeducation and fulfill the legal requirements from 2019 onwards. An investigation was also carried out to identify which psychiatry guidelines contain time values which can be used for calculation of personnel requirements. MATERIAL AND METHODS: A three-step approach was used: (1) screening of the current guidelines and determination of the average intervention times with respect to nursing staff, (2) exemplary comparison between the times for guideline-based psychoeducation for patients in the diagnosis groups F32-F33 with the times allocated by the Psych-PV and (3) determination of times between education measures prescribed by law and necessary training for which no (sufficient) time contingents are provided in the Psych-PV. RESULTS: Times for individual activities (e.g. psychoeducation), which are also appropriate for nursing personnel can be found in the primary literature on guidelines; however, these include only a small proportion of tasks undertaken by nursing personnel. For psychoeducation it could be shown that additional time contingents would be necessary in the Psych-PV. Furthermore, there are new mandatory but disregarded schooling measures and instructions for nursing staff, the duration of which can be conservatively calculated as 21 min per case per hospital stay. CONCLUSION: The empirical approach presented in this study shows the possibility to identify time resources needed for nursing personnel to provide guideline-based interventions; however, these represent only partial aspects of nursing activities. Further research and analytical methods are needed to calculate the currently needed personnel resources for all nursing activities and other professional groups involved in treatment in inpatient psychiatry.


Subject(s)
Hospitals, Psychiatric , Needs Assessment/statistics & numerical data , Nurses/statistics & numerical data , Psychiatric Nursing , Workload/statistics & numerical data , Germany , Psychiatric Nursing/statistics & numerical data , Workforce
6.
J Fish Biol ; 85(6): 1868-89, 2014 Dec.
Article in English | MEDLINE | ID: mdl-25469950

ABSTRACT

An integrated socioecological model was developed to evaluate the potential for stock enhancement with hatchery fishes to achieve socioeconomic and conservation objectives in recreational fisheries. As a case study, this model was applied to the red drum Sciaenops ocellatus recreational fishery in the Tampa Bay estuary, Florida, U.S.A. The results suggest that stocking of juvenile fish larger than the size at which the strongest density dependence in mortality occurs can help increase angler satisfaction and total fishing effort (socioeconomic objectives) but are likely to result in decreases to the abundance of wild fishes (a conservation objective). Stocking of small juveniles that are susceptible to density-dependent mortality after release does not achieve socioeconomic objectives (or only at excessive cost) but still leads to a reduction of wild fish abundance. The intensity and type of socioeconomic gains depended on assumptions of dynamic angler-effort responses and importance of catch-related satisfaction, with greatest gains possible if aggregate effort is responsive to increases in abundance and satisfaction that are greatly related to catch rates. These results emphasize the view of stock enhancement, not as a panacea but rather as a management tool with inherent costs that is best applied to recreational fisheries under certain conditions.


Subject(s)
Conservation of Natural Resources , Consumer Behavior , Fisheries/methods , Recreation , Animals , Fisheries/economics , Fishes , Florida , Humans , Models, Theoretical
7.
Swiss Med Wkly ; 144: w13919, 2014.
Article in English | MEDLINE | ID: mdl-24706369

ABSTRACT

QUESTION UNDER STUDY: Handling emergency telephone consultations (ETCs) is a challenging and very important task for doctors. The aims of the study were to document insecurity in medical students during ETCs and to identify the reasons for that insecurity. We hypothesised that insecurity is associated with advising more urgent action (e.g. advice to call for an ambulance) in ETCs. METHODS: We used ETCs with simulated patients (SPs), with each student randomly allocated two of four possible cases. After the training, 137 students reported on any insecurity that they had in the various ETC phases. We analysed the reasons for insecurity using descriptive statistics. The association between the students' advice that urgent action was needed and their insecurity was analysed with Spearman rank correlation. RESULTS: Overall, 95% of the students felt insecure in at least one phase of their ETC. History taking was the phase in which students felt most insecure (63.1%), followed by the phase of analysing the information given by the patient (44.9%). Perceived insecurity was associated with more urgent advice in one case scenario (abdominal pain; correlation r = 0.46; p <0.01). The other two cases (child with fever; chest pain) also had a positive, but not statistically significant, correlation trend (p <0.12; p <0.08). CONCLUSIONS: Insecurity is highly prevalent among medical students in their ETC decision-making. ETC training in medical schools, with a focus on structured history taking and formulating discriminating questions, might help decrease insecurity in ETCs. Medical education should also teach management of insecurity.


Subject(s)
Education, Medical, Undergraduate , Emergencies/psychology , Students, Medical/psychology , Telephone , Clinical Competence , Humans , Medical History Taking , Patient Simulation , Surveys and Questionnaires
8.
Psychiatry Res ; 164(2): 154-9, 2008 Nov 30.
Article in English | MEDLINE | ID: mdl-18930637

ABSTRACT

In this study, we use magnetic resonance spectroscopy (MRS) at 3 Tesla to measure N-acetyl aspartate (NAA), myo-inositol (mI) and choline (Cho) to creatine (Cr) ratios in R (right) and L (left) hippocampi (H) in 8 mildly memory impaired (MMI), 6 probable Alzheimer's Disease (PRAD), and 17 control subjects. NAA/Cr was significantly reduced in the RH in the MMI group and bilaterally in the PRAD group vs. controls. No other metabolite differences were noted between the three groups. Five MMI subjects have converted to PRAD in follow-up. These findings suggest that RH NAA/Cr ratios measured at 3 Tesla may be a sensitive marker of future progression to dementia in a clinically defined population with isolated memory complaints.


Subject(s)
Aspartic Acid/analogs & derivatives , Dementia/diagnosis , Dementia/metabolism , Hippocampus/metabolism , Hippocampus/pathology , Inositol/metabolism , Magnetic Resonance Spectroscopy , Aged , Aspartic Acid/metabolism , Choline/metabolism , Creatine/metabolism , Female , Functional Laterality , Humans , Male , Severity of Illness Index
9.
Opt Express ; 12(25): 6192-7, 2004 Dec 13.
Article in English | MEDLINE | ID: mdl-19488263

ABSTRACT

Optical gain and output power as a function of pump power has been calculated for short Er/Yb doped single mode fibers for various fiber parameters. The calculation shows that long fiber lengths provide both higher small signal gain and higher output power. Gain of 14 dB has been observed in a 30 mm long fiber at 400 mW of input pump power. The observed small signal gain is found to be linearly proportional to the length of the fiber with a slope of 0.44 dB/mm at 400 mW of pump power.

12.
Am J Respir Crit Care Med ; 164(7): 1138-45, 2001 Oct 01.
Article in English | MEDLINE | ID: mdl-11673199

ABSTRACT

Clinical studies comparing the potency of inhaled corticosteroids require steep dose-response slopes (b) and minimal response variability (s), as statistical power is inversely related to the s/b ratio. To evaluate a new study model, we performed a randomized, crossover study of 12 adult asthmatics who required 800 to 2,000 microg of inhaled corticosteroids daily, and calculated s/b for 21 raw clinical outcomes and 36 mathematically derived variables based on these raw outcomes. Each of two 21-d treatment periods was preceded by 4 to 7 d of oral prednisone to maximize asthma control and minimize carry-over of previous inhaled treatment. Treatments were 100 and 800 micron/d of an HFA-134a beclomethasone dipropionate formulation. Assessments included daily home spirometry, histamine challenge, inhaled albuterol use, and asthma symptom scores. Efficacy variables with the greatest power (lowest s/b values) were A.M.FEF25-75, A.M.FEV1, and A.M.PEF, (s/b = 0.46, 0.48, and 0.59). Carry-over between treatment periods was not significant. Crossover study sample size calculations using these ratios yielded samples of 23, 25, and 37 patients, respectively. Otherwise identical parallel studies would require sample sizes of 657, 1,438, and 2,261 patients. These results support the use of a crossover asthma stability model after a short course of oral prednisone as a clinical study model for comparing topical potency of inhaled corticosteroids.


Subject(s)
Anti-Asthmatic Agents/administration & dosage , Asthma/drug therapy , Beclomethasone/administration & dosage , Glucocorticoids/administration & dosage , Prednisone/administration & dosage , Administration, Inhalation , Administration, Oral , Adult , Asthma/physiopathology , Cross-Over Studies , Dose-Response Relationship, Drug , Female , Forced Expiratory Volume/drug effects , Humans , Hydrocarbons, Fluorinated , Male , Peak Expiratory Flow Rate/drug effects
13.
Ann Allergy Asthma Immunol ; 87(6): 482-7, 2001 Dec.
Article in English | MEDLINE | ID: mdl-11770695

ABSTRACT

BACKGROUND: Administration of inhaled medications to very young children is sometimes difficult. Administration of inhaled medications via metered dose inhalers (MDIs) to pediatric patients younger than 4 years of age requires use of a holding chamber/spacer with an attached facemask. OBJECTIVE: This in vitro study was conducted to determine the particle size distribution and overall dose of salmeterol delivered in conjunction with the use of various US-marketed valved holding chambers (VHCs) in comparison to the dose-delivered via MDI without VHCs. METHODS: Cascade impaction methodology with high-performance liquid chromatography was used to evaluate the fine particle mass (FPM) of salmeterol administered without and with the use of the following VHCs: Optichamber, medium and large Aerochambers, adult Aerochamber, and medium Aerochamber Plus. RESULTS: Particle size distributions for the Optichamber, various sizes of Aerochamber, and the Aerochamber Plus were very similar and the particle size distributions for all VHCs were similar to the distribution of the control. The FPM for particles ranging from 0.7 to <3.3 microm in diameter (in the range shown to provide the greatest lung dose to negotiate the small airways of infants) was similar across the various VHCs tested. Statistical comparison of the fine particle fraction for these stages shows a very similar profile when differences from the salmeterol MDI control were evaluated. CONCLUSIONS: In vitro results obtained under these test conditions demonstrate that all FPM values for the VHCs tested were within 15% of the control range, a difference that is unlikely to be clinically meaningful. These results indicate that the difference in FPM does not warrant a change in the recommended dosage of salmeterol administered when using the VHCs tested. Our results demonstrate that the use of an MDI and VHC provides a reasonable therapeutic approach for administration of salmeterol MDI to young children and other patients who have difficulties administering the MDI alone.


Subject(s)
Albuterol/analogs & derivatives , Albuterol/administration & dosage , Bronchodilator Agents/administration & dosage , Nebulizers and Vaporizers , Administration, Inhalation , Asthma/drug therapy , Child, Preschool , Chromatography, High Pressure Liquid , Equipment Design , Humans , Infant , Masks , Nebulizers and Vaporizers/standards , Particle Size , Salmeterol Xinafoate
14.
Am J Gastroenterol ; 95(8): 1932-8, 2000 Aug.
Article in English | MEDLINE | ID: mdl-10950038

ABSTRACT

OBJECTIVE: The safety and efficacy of Minimicrospheres, which are enteric-coated, delayed-release pancrelipase capsules, on fat absorption in pediatric/adolescent and adult cystic fibrosis (CF) patients was assessed. Exocrine pancreatic insufficiency, common in CF patients, causes steatorrhea due to insufficient release of pancreatic enzymes. METHODS: In the open-label phase, 97 CF patients with pancreatic insufficiency and steatorrhea were stabilized on a high-fat diet and administered pancrelipase. Seventy-four patients with >80% coefficient of fat absorption received placebo or pancrelipase in the double-blind phase. Fat intake and excretion, stool frequency and consistency, and clinical global improvement were recorded. RESULTS: Average daily fat intake was comparable between treatment groups within each age group (adults vs pediatric/adolescent), but placebo patients had a significant (p < 0.001) mean decrease in coefficient of fat absorption (adult, 36.9 percentage points; pediatric/adolescent, 34.9 percentage points) from open-label to double-blind treatment compared to pancrelipase patients (adult, 2 percentage points; pediatric/adolescent, 3.25 percentage points); this difference was caused by a greater (p < or = 0.001) increase in mean fecal fat excretion (grams per day) in the placebo groups compared to pancrelipase groups (adult: 61.9 vs 2.3; pediatric/adolescent: 45.4 vs 4.1). Change in mean stool frequency from open-label to double-blind phases was significantly different (p < or = 0.002) between treatment groups, with increases in placebo groups and no difference (adult) or decrease (pediatric/adolescent) in pancrelipase groups. Pancrelipase patients' stool consistency remained about the same from open-label to double-blind. Placebo patients' stool consistency decreased (became softer) from open-label pancrelipase to double-blind placebo. Clinical global improvement data showed that > or =83% of pancrelipase patients improved or remained unchanged. CONCLUSIONS: Enteric-coated, delayed-release (Minimicrospheres) pancrelipase capsules are an effective treatment for steatorrhea associated with pancreatic insufficiency in patients with cystic fibrosis.


Subject(s)
Celiac Disease/drug therapy , Celiac Disease/etiology , Cystic Fibrosis/complications , Exocrine Pancreatic Insufficiency/etiology , Gastrointestinal Agents/adverse effects , Gastrointestinal Agents/therapeutic use , Pancrelipase/adverse effects , Pancrelipase/therapeutic use , Adult , Dose-Response Relationship, Drug , Double-Blind Method , Female , Humans , Male , Placebos/adverse effects , Placebos/therapeutic use , Time Factors
16.
Chest ; 117(3): 714-21, 2000 Mar.
Article in English | MEDLINE | ID: mdl-10712996

ABSTRACT

STUDY OBJECTIVE: To use histamine bronchoprovocation and bioassay statistical procedures to evaluate the in vivo bioequivalence of a generic albuterol metered-dose inhaler (MDI). DESIGN: A randomized, double-blind, balanced, crossover design was used to determine the potency of each generic albuterol MDI actuation relative to Ventolin (Glaxo Wellcome; Research Triangle Park, NC) administration. One treatment was administered on each of 4 study days. A histamine bronchoprovocation procedure was initiated 1.25 h before and 15 min after administration of the study treatment. PATIENTS: Twenty-four nonsmoking subjects with mild-to-moderate asthma were studied (18 to 65 years of age; FEV(1), > 60% of predicted; and provocative concentration of histamine causing a 20% fall in FEV(1) [PC(20)], < or = 8 mg/mL at screening). INTERVENTIONS: One and four actuations (90 and 360 microg, respectively) of the generic MDI and of Ventolin MDI. Placebo inhalers were used to maintain blinding of inhaler and doses. MEASUREMENTS AND RESULTS: The primary outcome variable was histamine PC(20) measured after study treatment administration. A significant dose-effect relationship was present (p < 0.0001). Deviation from parallelism of the generic and Ventolin dose-response curves (p = 0.95) and differences in overall mean response between the two formulations (p = 0.68) were not significant. Using Finney 2 x 2 bioassay statistical procedures, we estimated that one actuation of the generic albuterol MDI was equivalent to 1.01 puffs of Ventolin (90% confidence interval, 0.69 to 1.50). CONCLUSION: The generic albuterol MDI delivers a quantity of albuterol to the beta(2)-receptor site in the lung that is the bioequivalent to Ventolin. Further, this study reinforces the validity of this statistical methodology for determining in vivo bioequivalence.


Subject(s)
Albuterol/administration & dosage , Asthma/drug therapy , Therapeutic Equivalency , Adolescent , Adult , Aged , Albuterol/adverse effects , Albuterol/pharmacokinetics , Asthma/blood , Biological Availability , Bronchial Provocation Tests , Cross-Over Studies , Dose-Response Relationship, Drug , Double-Blind Method , Female , Humans , Male , Middle Aged , Nebulizers and Vaporizers
17.
Am J Respir Crit Care Med ; 160(4): 1238-43, 1999 Oct.
Article in English | MEDLINE | ID: mdl-10508813

ABSTRACT

Because chlorofluorocarbons (CFCs) contribute to depletion of stratospheric ozone, CFC-containing metered-dose inhalers (MDIs) such as Ventolin and Proventil are being phased out of production. In terms of delivery of albuterol to the lungs, we compared an alternative delivery system, the Spiros dry-powder inhaler (DPI), with Ventolin, using a methacholine challenge-based clinical bioassay. Twenty-four adults and adolescents with asthma completed this double-blind, four-period crossover study. Doses evaluated were one and three actuations each of Spiros and Ventolin (90- and 270-microgram albuterol base). A methacholine challenge (Cockcroft method) was initiated 3 h before and 0.25 h after albuterol. Predose PC(20)FEV(1) values were not significantly different between study days. Postdose PC(20)FEV(1) results met standard bioassay study validity criteria: i.e., a significant dose-response relationship was present (p = 0.0002); tests for deviation from parallelism and overlap of dose-response curves were nonsignificant (p = 0.08, 0.69). By using Finney 2-by-2 bioassay analysis, we estimate that each Spiros actuation delivers 1.12 times as much albuterol to the airways as one Ventolin actuation (90% confidence interval, 0.68 to 1.94). There were no significant differences in markers of systemic effects (vital signs, potassium, and blood glucose concentrations). We conclude that Spiros and Ventolin inhalers deliver comparable quantities of albuterol to the airways.


Subject(s)
Adrenergic beta-Agonists/administration & dosage , Albuterol/administration & dosage , Asthma/drug therapy , Bronchial Provocation Tests , Bronchodilator Agents/administration & dosage , Nebulizers and Vaporizers , Adolescent , Adult , Asthma/physiopathology , Bronchoconstrictor Agents , Child , Cross-Over Studies , Dose-Response Relationship, Drug , Double-Blind Method , Female , Humans , Male , Methacholine Chloride , Middle Aged , Powders , Therapeutic Equivalency
18.
Ann Allergy Asthma Immunol ; 82(4): 377-82, 1999 Apr.
Article in English | MEDLINE | ID: mdl-10227336

ABSTRACT

STUDY OBJECTIVE: This study compares the efficacy and safety of one and two actuations of albuterol sulfate powder delivered via a breath-actuated, effort-assisted, investigational inhaler (Spiros, Dura Pharmaceuticals, Inc) and albuterol delivered via a conventional propellant-driven metered dose inhaler (Ventolin, Glaxo, Inc). DESIGN: Randomized, double-blind, placebo-controlled, 5-way crossover study. PARTICIPANTS: Sixty patients with mild-to-moderate asthma (FEV1 59% predicted) were enrolled and 44 completed the study. MEASUREMENTS AND RESULTS: FEV1 values over 6 hours were analyzed by ANCOVA and the Finney relative potency model. The relative potency of the inhalers (albuterol MDI: albuterol DPI) was 1.132 (90% CI, 0.680 to 2.252) indicating 1.132 actuations of albuterol MDI provided the same bronchodilation as one actuation of albuterol DPI. ANCOVA analyses further indicated that there were no significant differences between the two delivery systems with respect to FEV1, FVC, FEF25-75%, or PEF. Both inhalers had similar effects on serum potassium levels, QTc interval, blood pressure, and heart rate. CONCLUSIONS: In patients with mild-to-moderate asthma in this study, the albuterol DPI was determined to be therapeutically comparable to albuterol MDI in the delivery of one and two actuations of albuterol.


Subject(s)
Albuterol/administration & dosage , Albuterol/therapeutic use , Asthma/drug therapy , Nebulizers and Vaporizers , Administration, Inhalation , Adolescent , Adult , Aged , Albuterol/adverse effects , Cross-Over Studies , Female , Forced Expiratory Volume/drug effects , Humans , Male , Middle Aged , Time Factors
19.
J Pediatr ; 133(4): 486-91, 1998 Oct.
Article in English | MEDLINE | ID: mdl-9787685

ABSTRACT

The purpose of this study was to assess the delivery to the lungs and the short-term safety of recombinant human deoxyribonuclease (rhDNase, Pulmozyme) in children with cystic fibrosis younger than 5 years of age compared with older children. Patients between the ages of 3 months and 10 years had bronchoscopic examination with bronchoalveolar lavage (BAL) after administration of an aerosol dose of 2.5 mg of rhDNase. After recovery from the procedure, patients were discharged home for an additional 13 days of rhDNase therapy. During this time adverse events were recorded to assess short-term safety. A total of 98 patients were enrolled, 65 (66%) aged 3 months to 5 years and 33 (34%) aged 5 years to 10 years. Deoxyribonuclease concentrations in BAL fluid were variable (interquartile range, 752 to 3943 micrograms/mL epithelial lining fluid [ELF]) and did not depend on patient age, weight, or height or differ when delivered through a mouthpiece or mask. The median value for the BAL DNA concentration in the younger group was 432 micrograms/mL ELF compared with 703 micrograms/mL ELF in the older patients. This study demonstrates the value of bronchoscopy and BAL for assessing nebulized medication delivery in young children and shows that aerosolized medications can be delivered to and are present in comparable amounts in the lower airways of younger and older children. Exposure to rhDNase appears to be safe over 2 weeks in infants and young children with cystic fibrosis.


Subject(s)
Bronchoscopy/methods , Cystic Fibrosis/diagnosis , Cystic Fibrosis/drug therapy , Deoxyribonucleases/adverse effects , Aerosols , Age Factors , Antibodies, Catalytic , Antibody Formation/immunology , Bronchoalveolar Lavage/methods , Child , Child, Preschool , Deoxyribonucleases/immunology , Female , Follow-Up Studies , Humans , Infant , Male , Nebulizers and Vaporizers
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