clinical evaluation of the effect of anti-allergic mattress covers in patients with moderate to severe asthma and house dust mite allergy: a randomised double blind placebo controlled study

2020/06/15
Background: Using
Allergic mattress covers in asthma patients can lead to a significant reduction in the level of house dust allergens in dust samples.
In addition to tissue amine-induced decreased airway hyperresponsiveness, there is little data to suggest the impact of mattress covers on clinical efficacy and quality of life in patients with moderate to severe asthma.
Methods: Thirty patients with asthma and house dust mites allergy were studied in a randomized, double-blind, placebo-controlled study.
Before and after use
Allergy cover for 1 year collect dust from mattress to determine concentration of dermat in House (Der p 1)
The airway hyperreactivity and quality of life were measured.
The patient scored the symptoms (lungs and nose)
, Morning and evening peak flow value, rescue medication 14 days before and after the intervention.
Results: compared with pre-treatment, the concentration of Der p1 in the dust collected by the mattress in the active treatment group decreased significantly after 1 year;
No changes were found in the placebo group.
In the active treatment and placebo groups, there was no significant improvement in PC20 tissue amine.
The quality of life in both groups has improved similarly.
In both groups, there was no significant change in the symptom score of the lower airway.
Compared with pre-treatment, the nasal symptom score of the active treatment group decreased significantly, but there was no significant difference between the two groups.
Neither group found changes in morning and evening peak flow values, peak flow variability, and rescue drug use.
Conclusion: Use resistance
Allergic mattress coverage leads to a significant decrease in Der p1 concentration in the carpetfree bedrooms.
However, in patients with moderate to severe asthma, this effective allergen avoidance does not affect airway hyperresponsiveness and clinical parameters.
Methods from January 1996 to December 1998, 38 patients aged 11-44 with a history of asthma and house dust allergy were recruited from the asthma clinic in hilverum, Netherlands.
Informed consent was obtained from the patient or from his or her parents.
These patients were selected based on an increase in airway responsiveness to the inhalation of tissue amine (
PC20 1 μ g Der p 1/g dust).
More than 60% of all patients (Forecast value).
Patients had no history of respiratory infections in the last 6 weeks and had no severe asthma attacks in the last 6 months.
In the past six months, no one has received oral steroids.
All patients had informed consent.
The medical ethics committee of Asthmacenter heuvel approved the study.
Study design this study was a randomized, placebo-controlled, double-blind, parallel-group design that compared the effects of allergen non-penetration packaging on mattresses, pillows, and bed covers within 1 year and matched placebo packaging.
At the beginning of the study, a trained respiratory nurse visited the patient, collected dust samples from the patient\'s mattress for Der p1 measurements, and recorded allergen avoidance measures that were already present at home.
All patients included in the study had smooth bedroom floors.
The patient was instructed to clean the sheets at 60 °c per week
In addition to the mattress packaging, no other measures were taken to avoid allergens.
At the end of the study, the same nurse visited the houses again to collect dust from the bed pads.
The patient was included throughout the year;
The inclusion period is 2 years.
Patients with pollen allergy were tested outside the pollen season.
At the first visit, the patient was assessed clinically.
Life capacity (VC)
Values were measured, skin tests were performed, and PC20 tissue Amine was evaluated.
Stop taking drugs before the study period: Inhaled steroids and sodium acetate for 1 week before the trachea tissue amine stimulation test;
Before the test, theophylline, oral beta 2 adrenaline drugs, long-acting inhaled beta 2 adrenaline drugs, and antihistine lasted for 48 hours, and the inhalation of short-acting beta 2 adrenaline drugs lasted for 6 hours.
Collection and extraction of house dust before, 4 and 8 months of intervention and at the end of the intervention is collected by the same vacuum cleaner (
Philips Vitall 377,1300 Watt, Philips, Eindhoven, Netherlands)
Use a special filtration device from the entire mattress in 2 minutes (
ALK in holsham, Denmark).
At the beginning of the study, collect dust directly from the mattress;
At the end of the study, dust was collected at the top of the camp.
The filter is stored in the refrigerator at-20 °c until analysis is performed at the end of the study.
Determination of Der P1 antigen by elisa (ELISA).
Monoclonal antibody against Der p1 was fixed at 96-well plate.
After incubation with the dust extract, the second step was incubated with a multi-valent antibody (
Sunflower over-enzyme.
After adding 1, 2-
For diamine HCl (OPD)
As a substrate, absorption at 490 nm was measured using an ELISA reader.
Tissue amine phosphate solution (
Double concentration from 0. 25 to 32 mg/ml)
Administered via De Vilbiss 646 nebulizer with an output of 0. 13 mg/ml.
The nebulizer is mounted on a valve box with an aerosol filter.
The atomization time was 30 seconds during which the patient was instructed to breathe quietly.
This experiment started with the inhalation of phosphate buffer aerosol.
Three VC and fev measurements before inhalation (
Masterscreen).
V1 was measured after each concentration.
PC20 tissue amine is derived by linear interpolation.
Mattresses, pillows and bedding for the intervention group were wrapped in a LID provided by Carla c\'air (
Allergy Control AC btm Velserbroek, Netherlands).
The matching placebo cover was made by the same company.
The camp, arranged by a research nurse, stayed in place for 1 year.
Quality of life through the quality of life questionnaire for respiratory diseases (QoL-RIQ). 17 The QoL-
RIQ is a disease-specific quality of life questionnaire for patients with asthma and chronic asthma, consisting of 55 items, divided into seven areas: respiratory problems (9 items)
Physical problems (9 items), emotions (9 items)
, Trigger/enhance the situation of breathing problems (7 items)
General activities (4 items)
Daily and domestic activities (10 items)
Social activities, interpersonal relationships and sexuality (7 items).
In order to focus the problem on the patient\'s experience, the project is based on the \"how much trouble\" they experience from the above symptoms or emotions.
In terms of activities-related projects, the question is \"how much they are hindered in carrying out this specific activity \".
Patients were asked to give their answers on the 70-point Likert scale, from \"not at all\" to \"extreme\" distress or obstruction. Reliability (test-
Re-examination, internal consistency)
And proved its effectiveness.
17 clinical parameters during the 14-day period before the intervention and at the end of the 12-month dry expectation require patients to record diary cards for asthma and nasal symptoms, peak flow values, and record medication twice a day.
Symptoms of asthma include breathing difficulties, cough, cough and breathing.
Nasal symptoms include nasal congestion, sneezing and itching.
Each item is divided from 0 points (no symptoms)to 4 (Severe symptoms).
Patients were trained to perform peak flow drills using micro-equipmentWright meter.
They were instructed to make three readings and record the highest values when they woke up in the morning and before going to bed at night.
Patients were asked to continue with normal inhalation medication and to record additional salvage medication in case they needed it.
Data analysis and statistical analysis were performed with SPSS.
Group comparison (
Before and after intervention)
Performed with the Wilcoxon signature review.
Analyze log data using symbol tests. The Mann-
The Whitney U test was used for inter-group comparison. p values of 0. 5)
In the treatment group and placebo group, there were 18 points for respiratory problems, physical problems associated with chest problems, trigger/enhancement, and total score.
Although there was no significant difference in the improvement margin between the two groups, the improvement within the treatment group was significant.
There was no significant difference in baseline values of clinical parameters for asthma symptom scores between groups (table 2).
The median lung symptom score of the two groups did not change significantly within 1 year.
The nasal symptom score of the treatment group decreased significantly (p=0. 04)
But not in the placebo group.
The difference between the two groups was not significant.
Baseline ef value (
Morning and Evening)
The two groups are comparable (table 3).
After 1 year of intervention, there was no significant change in the morning and evening ef, peak flow variability or use of rescue drugs in both groups of patients.
View this table: View the inline View pop-up table 2 symptom score before and after intervention (
Median registration in 14 days)
View this table: View the inline View pop-up table 3 peak traffic value before and after the intervention (
Median registration in 14 days)
The purpose of this study is to study
In an allergic mattress package in a carpet-free bedroom, exposed to Der p1 on the bed, allergic to house dust mites in patients with moderate to severe asthma.
We found a significant decrease in the concentration of Der p1 in the dust collected by the mattress in the active treatment group compared to the placebo group.
PC20 tissue Amine did not improve during the 1-year intervention.
Although significant improvements in nasal symptoms and quality of life were observed only in the active treatment group, we found no significant difference between the placebo group and the active treatment group in changes in lung and nasal symptoms, quality of life, peak flow values, and use of rescue drugs.
Early studies using several different types of mattress packaging also showed a decrease in Der p1 exposure at the top of the mattress (table 4).
However, other studies did not show a decrease in the concentration of Der p1, and in these studies the carpet in the bedroom was not removed.
21,22 we exclude the Der p1 contamination issue from floor 13 by including only patients with no carpet in the bedroom.
This may lead to the fact that, although our baseline Der p1 concentration is higher than other studies, we can significantly decrease in the actively treated group.
22, 23 the decrease in allergen concentration reached after 4 months and remained unchanged throughout the study period.
View this table: View inline View pop-up table 4 Summary of results and settings of controlled mattress covering study although the concentration of Der p1 in the active treatment group was significantly reduced compared to the placebo group, we did not find a significant decrease in airway hyperresponsiveness.
Other studies have also failed to demonstrate an improvement in airway hyperresponsiveness.
Two studies 22, 23, 10, 11, 22 did not find a significant decrease in allergen concentration in dust, which explained the lack of improvement in airway hyperreactivity.
Frederick et al said that all patients were reasonably controlled in regular preventive treatment, so there was little or no change in clinical parameters.
Even Cloosterman and his colleagues, 11 people who tried to avoid this therapeutic effect by only including patients who did not use inhaled steroids or were able to stop them, did not find a significant improvement in airway hyperresponsiveness, no significant improvement in any of the clinical parameters used, such as symptom scores, ef variability, and the reversible of F1.
How can we coordinate these opinions?
Despite the relatively high dose of inhaled cortisol, patients involved in our study had severe hyperreactivity (> 800 μg)
In contrast, the PC20
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