scholarly journals Acceptability of a Sublingual Drug Formulation for Respiratory Tract Infections in Children Aged 3 to 5 Years

Pharmaceutics ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 294
Author(s):  
Andrzej Emeryk ◽  
Thibault Vallet ◽  
Ewelina Wawryk-Gawda ◽  
Arkadiusz Jędrzejewski ◽  
Frederic Durmont ◽  
...  

In pediatrics, acceptability has emerged as a key factor for compliance, and consequently for treatment safety and efficacy. Polyvalent mechanical bacterial lysate (PMBL) in 50-mg sublingual tablets is indicated in children and adults for the prophylaxis of recurrent respiratory tract infections. This medication may be prescribed in children over 3 years of age; the appropriateness of this sublingual formulation should thus be demonstrated amongst young children. Using a multivariate approach integrating the many aspects of acceptability, standardized observer reports were collected for medication intake over the course of treatment (days 1, 2, and 10) in 37 patients aged 3 to 5 years, and then analyzed in an intelligible model: the acceptability reference framework. According to this multidimensional model, 50-mg PMBL sublingual tablets were classified as “positively accepted” in children aged 3 to 5 years on all three days of evaluation. As the acceptability evaluation should be relative, we demonstrated that there was no significant difference between the acceptability of these sublingual tablets and a score reflecting the average acceptability of oral/buccal medicines in preschoolers. These results highlight that sublingual formulations could be appropriate for use in preschoolers.

2019 ◽  
Author(s):  
Karolina Pieniawska-Śmiech ◽  
Kamil Bar ◽  
Mateusz Babicki ◽  
Karol Śmiech ◽  
Aleksandra Lewandowicz-Uszyńska

Abstract Background Primary immunodeficiences (PIDs) are a group of chronic, serious disorders in which the immune response is insufficient. In consequence, it leads to an increased susceptibility to infections. Up to date, there are about 300 different disorders classified in that group. There are also patients suffering from recurrent respiratory tract infections (RRTI), however that group doesn't present any abnormalities in terms of conducted immunological tests. Many factors, including medical, can have an impact on physical development of a child. Data such as birth weight and length, also weight, height, BMI during admission to the hospital were collected from 207 patients' medical histories from their hospitalization at Clinical Immunology and Paediatrics ward of J.Gromkowski Hospital in Wrocław. Investigated groups included patients with PIDs, RRTI and a control group of healthy children. Our purpose was to evaluate the physical growth of children with primary immunodeficiency (PID) and children with recurrent respiratory tract infections (RRTI) by assessment of their height and weight. All of parameters were evaluated using centile charts suitable best for the Polish population. Results The lowest mean birth weight and height was found among the PIDs patients group. Children with PIDs during hospitalization had statistically relevant lower mean weight than the control group and almost 20% of them had their height situated below 3rd percentile. No statistically relevant differences have been found between them and RRTI group. The statistically significant difference was between the nutritional status of PID patients and the control group. Conclusions There is a higher percentage of PID patients with physical growth abnormalities in comparison to healthy children. Our findings indicate a need for further investigation of immune system irregularities and their influence on physical growth of children.


2019 ◽  
Author(s):  
Karolina Pieniawska-Śmiech ◽  
Kamil Bar ◽  
Mateusz Babicki ◽  
Karol Śmiech ◽  
Aleksandra Lewandowicz-Uszyńska

Abstract Background Primary immunodeficiences (PIDs) are a group of chronic, serious disorders in which the immune response is insufficient. In consequence, it leads to an increased susceptibility to infections. Up to date, there are about 300 different disorders classified in that group. There are also patients suffering from recurrent respiratory tract infections (RRTI), however that group doesn't present any abnormalities in terms of conducted immunological tests. Many factors, including medical, can have an impact on physical development of a child. Data such as birth weight and length, also weight, height, BMI during admission to the hospital were collected from 207 patients' medical histories from their hospitalization at Clinical Immunology and Paediatrics ward of J.Gromkowski Hospital in Wrocław. Investigated groups included patients with PIDs, RRTI and a control group of healthy children. Our purpose was to evaluate the physical growth of children with primary immunodeficiency (PID) and children with recurrent respiratory tract infections (RRTI) by assessment of their height and weight. All of parameters were evaluated using centile charts suitable best for the Polish population. Results The lowest mean birth weight and height was found among the PIDs patients group. Children with PIDs during hospitalization had statistically relevant lower mean weight than the control group and almost 20% of them had their height situated below 3rd percentile. No statistically relevant differences have been found between them and RRTI group. The statistically significant difference was between the nutritional status of PID patients and the control group. Conclusions There is a higher percentage of PID patients with physical growth abnormalities in comparison to healthy children. Our findings indicate a need for further investigation of immune system irregularities and their influence on physical growth of children.


2020 ◽  
Author(s):  
Karolina Pieniawska-Śmiech ◽  
Kamil Bar ◽  
Mateusz Babicki ◽  
Karol Śmiech ◽  
Aleksandra Lewandowicz-Uszyńska

Abstract Background: Primary immunodeficiences (PIDs) are a group of chronic, serious disorders in which the immune response is insufficient. In consequence, it leads to an increased susceptibility to infections. Up to date, there are about 350 different disorders classified in that group. There are also patients suffering from recurrent respiratory tract infections (RRTI), however that group doesn't present any abnormalities in terms of conducted immunological tests. Many factors, including medical, can have an impact on physical development of a child. Data such as birth weight and length, also weight, height, BMI during admission to the hospital were collected from 195 patients' medical histories from their hospitalization at Clinical Immunology and Paediatrics Ward of J.Gromkowski Hospital in Wrocław. Investigated groups included patients with PIDs, RRTI and a control group of healthy children. Our purpose was to evaluate the physical growth of children with PID and children with RRTI by assessment of their height and weight. All of parameters were evaluated using centile charts, suitable best for the Polish population. Results: The lowest mean birth weight and height was found among the PIDs patients group. Children with PIDs during hospitalization had statistically relevant lower mean weight than the control group and almost 18% of them had their height situated below 3rd percentile. The statistically relevant differences have been found between them and RRTI group in terms of weight, height and nutritional status. The statistically significant difference was detected between the nutritional status of PID and control group. Conclusions: There is a higher percentage of PID patients with physical growth abnormalities in comparison to healthy children. Our findings indicate a need for further investigation of immune system irregularities and their influence on physical growth of children.


2019 ◽  
Author(s):  
Karolina Pieniawska-Śmiech ◽  
Kamil Bar ◽  
Mateusz Babicki ◽  
Karol Śmiech ◽  
Aleksandra Lewandowicz-Uszyńska

Abstract Background Primary immunodeficiences (PIDs) are a group of chronic, serious disorders in which the immune response is insufficient. In consequence, it leads to an increased susceptibility to infections. Up to date, there are about 300 different disorders classified in that group. There are also patients suffering from recurrent respiratory tract infections (RRTI), however that group doesn't present any abnormalities in terms of conducted immunological tests. Many factors, including medical, can have an impact on physical development of a child. Data such as birth weight and length, also weight, height, BMI during admission to the hospital were collected from 207 patients' medical histories from their hospitalization at Clinical Immunology and Paediatrics ward of J.Gromkowski Hospital in Wrocław. Investigated groups included patients with PIDs, RRTI and a control group of healthy children. Our purpose was to evaluate the physical growth of children with PID and children with RRTI by assessment of their height and weight. All of parameters were evaluated using centile charts suitable best for the Polish population. Results The lowest mean birth weight and height was found among the PIDs patients group. Children with PIDs during hospitalization had statistically relevant lower mean weight than the control group and almost 20% of them had their height situated below 3rd percentile. No statistically relevant differences have been found between them and RRTI group. The statistically significant difference was between the nutritional status of PID patients and the control group. Conclusions There is a higher percentage of PID patients with physical growth abnormalities in comparison to healthy children. Our findings indicate a need for further investigation of immune system irregularities and their influence on physical growth of children.


2019 ◽  
Author(s):  
Karolina Pieniawska-Śmiech ◽  
Kamil Bar ◽  
Mateusz Babicki ◽  
Karol Śmiech ◽  
Aleksandra Lewandowicz-Uszyńska

Abstract Background Primary immunodeficiences (PIDs) are a group of chronic, serious disorders in which the immune response is insufficient. In consequence, it leads to an increased susceptibility to infections. Up to date, there are about 300 different disorders classified in that group. There are also patients suffering from recurrent respiratory tract infections (RRTI), however that group doesn't present any abnormalities in terms of conducted immunological tests. Many factors, including medical, can have an impact on physical development of a child. Data such as birth weight and length, also weight, height, BMI during admission to the hospital were collected from 207 patients' medical histories from their hospitalization at Clinical Immunology and Paediatrics ward of J.Gromkowski Hospital in Wrocław. Investigated groups included patients with PIDs, RRTI and a control group of healthy children. Our purpose was to evaluate the physical growth of children with PID and children with RRTI by assessment of their height and weight. All of parameters were evaluated using centile charts suitable best for the Polish population. Results The lowest mean birth weight and height was found among the PIDs patients group. Children with PIDs during hospitalization had statistically relevant lower mean weight than the control group and almost 20% of them had their height situated below 3rd percentile. No statistically relevant differences have been found between them and RRTI group. The statistically significant difference was between the nutritional status of PID patients and the control group. Conclusions There is a higher percentage of PID patients with physical growth abnormalities in comparison to healthy children. Our findings indicate a need for further investigation of immune system irregularities and their influence on physical growth of children.


2019 ◽  
Author(s):  
Karolina Pieniawska-Śmiech ◽  
Kamil Bar ◽  
Mateusz Babicki ◽  
Karol Śmiech ◽  
Aleksandra Lewandowicz-Uszyńska

Abstract Background Primary immunodeficiences (PIDs) are a group of chronic, serious disorders in which the immune response is insufficient. In consequence, it leads to an increased susceptibility to infections. Up to date, there are about 300 different disorders classified in that group. There are also patients suffering from recurrent respiratory tract infections (RRTI), however that group doesn't present any abnormalities in terms of conducted immunological tests. Many factors, including medical, can have an impact on physical development of a child. Data such as birth weight and length, also weight, height, BMI during admission to the hospital were collected from 207 patients' medical histories from their hospitalization at Clinical Immunology and Paediatrics ward of J.Gromkowski Hospital in Wrocław. Investigated groups included patients with PIDs, RRTI and a control group of healthy children. Our purpose was to evaluate the physical growth of children with PID and children with RRTI by assessment of their height and weight. All of parameters were evaluated using centile charts suitable best for the Polish population. Results The lowest mean birth weight and height was found among the PIDs patients group. Children with PIDs during hospitalization had statistically relevant lower mean weight than the control group and almost 20% of them had their height situated below 3rd percentile. No statistically relevant differences have been found between them and RRTI group. The statistically significant difference was between the nutritional status of PID patients and the control group. Conclusions There is a higher percentage of PID patients with physical growth abnormalities in comparison to healthy children. Our findings indicate a need for further investigation of immune system irregularities and their influence on physical growth of children.


2020 ◽  
Author(s):  
Karolina Pieniawska-Śmiech ◽  
Kamil Bar ◽  
Mateusz Babicki ◽  
Karol Śmiech ◽  
Aleksandra Lewandowicz-Uszyńska

Abstract Background Primary immunodeficiences (PIDs) are a group of chronic, serious disorders in which the immune response is insufficient. In consequence, it leads to an increased susceptibility to infections. Up to date, there are about 300 different disorders classified in that group. There are also patients suffering from recurrent respiratory tract infections (RRTI), however that group doesn't present any abnormalities in terms of conducted immunological tests. Many factors, including medical, can have an impact on physical development of a child. Data such as birth weight and length, also weight, height, BMI during admission to the hospital were collected from 207 patients' medical histories from their hospitalization at Clinical Immunology and Paediatrics ward of J.Gromkowski Hospital in Wrocław. Investigated groups included patients with PIDs, RRTI and a control group of healthy children. Our purpose was to evaluate the physical growth of children with PID and children with RRTI by assessment of their height and weight. All of parameters were evaluated using centile charts suitable best for the Polish population. Results The lowest mean birth weight and height was found among the PIDs patients group. Children with PIDs during hospitalization had statistically relevant lower mean weight than the control group and almost 20% of them had their height situated below 3rd percentile. No statistically relevant differences have been found between them and RRTI group. The statistically significant difference was between the nutritional status of PID patients and the control group. Conclusions There is a higher percentage of PID patients with physical growth abnormalities in comparison to healthy children. Our findings indicate a need for further investigation of immune system irregularities and their influence on physical growth of children.


2020 ◽  
Vol 8 (B) ◽  
pp. 104-108
Author(s):  
Shams Kholoussi ◽  
Naglaa Kholoussi ◽  
Hala El Nady ◽  
Engy A. Ashaat ◽  
Rania Fawzy Mahmoud Abdelkawy ◽  
...  

BACKGROUND: Recurrent respiratory tract infections (RRI) are one of the extremely high common reasons for pediatric visits and hospitalization. Immunodeficiencies are considered as important conditions that may increase the probability of occurrence of RRI. Mannose-binding lectin (MBL2) is a protein of the innate immune system involved in the opsonization and the complement activation. MBL2 deficiency is associated with infectious diseases mainly chest infections; however, subnormal MBL2 levels are also seen in healthy subjects. Primary immunedeficiencies are associated with recurrent infections which mainly appear in early childhood. AIM: The aim of the study was to estimate T and B and natural killer cells percentage and to investigate the MBL2 and immunoglobulins (Igs) serum levels in children with recurrent RRIs in different genetic disorders compared to normal control. METHODS: This study included 50 children having a history of recurrent RRIs. All patients had genetic disorders and referred to National Research Centre for follow-up, in addition to, 25 children, age- and sex-matched as a healthy control group. They were subjected to full clinical examination and laboratory investigations including complete blood count (CBC), CD3, CD4, CD8, CD16, and CD19 by flow cytometry, MBL2 by enzyme-linked immunosorbent assay (ELISA), and Igs serum concentrations by nephelometry. RESULTS: CD16 showed a non-statistical significant difference between both patient groups. Serum levels of IgA in patient groups showed a significant decrease compared to the control group. Moreover, the serum level of IgM results shows a highly significant decrease when compared with the control group. There was no statistically significant difference in MBL2 and IgG serum levels between patient groups and control group. CONCLUSION: Children with genetic disorders and recurrent RRIs showed a statistically significant decrease of IgA and IgM serum levels as compared to the control group, while the serum level of MBL2 did not show significant results.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Jayaweera Arachchige Asela Sampath Jayaweera ◽  
Mohammed Reyes ◽  
Anpalaham Joseph

Editor's Note: this Article has been retracted; the Retraction Note is available at https://doi.org/10.1038/s41598-021-90018-8.


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