BACKGROUND: Several studies have been conducted on young children with recurrent respiratory infections using several compounds (synthetic derivates or lyophilized bacterial extracts) causing improvement in the clinical process. METHODS: We conducted a prospective, randomized study comparing the clinical results and the changes of the respiratory epithelium function after the administration of immunostimulating drug (Pidotimod) to children with respiratory infections over a 9 month period. A total of 32 children (group A) were randomly assigned to receive Pidotimod therapy while a second group of 18 children (group B) weren't. All the children in group A received Pidotimod (400 mg x 2 daily) for fifteen days and 400 mg daily for the next twenty days. The proper function of the ciliary respiratory epithelium in all children was checked, using the Edicol Orange and CaH PO4 2H2O, coloring method before the therapeutic intervention and after the first and the sixth month. RESULTS: 87.5% of group A, responded exceptionally well to treatment presenting two or less infections in the nine month period, whereas only 33.3% of group B showed improvement (p<0.001). In group A, the clearance of the respiratory epithelium, from a primary 37 minutes decreased to 32 minutes in the first month and 19'5" six months after the therapy. In group B, the corresponding time was decreased from a primary 36'4" to 34'2" and 31' respectively (p=0.01). CONCLUSIONS: Our results suggest that Pidotimod therapy is a reliable, simple and safe approach to treat children with recurrent respiratory infections and it can reduce the frequency of such infections as a result of improvement of the ciliary respiratory epithelium.
RCT Entities:
BACKGROUND: Several studies have been conducted on young children with recurrent respiratory infections using several compounds (synthetic derivates or lyophilized bacterial extracts) causing improvement in the clinical process. METHODS: We conducted a prospective, randomized study comparing the clinical results and the changes of the respiratory epithelium function after the administration of immunostimulating drug (Pidotimod) to children with respiratory infections over a 9 month period. A total of 32 children (group A) were randomly assigned to receive Pidotimod therapy while a second group of 18 children (group B) weren't. All the children in group A received Pidotimod (400 mg x 2 daily) for fifteen days and 400 mg daily for the next twenty days. The proper function of the ciliary respiratory epithelium in all children was checked, using the Edicol Orange and CaH PO4 2H2O, coloring method before the therapeutic intervention and after the first and the sixth month. RESULTS: 87.5% of group A, responded exceptionally well to treatment presenting two or less infections in the nine month period, whereas only 33.3% of group B showed improvement (p<0.001). In group A, the clearance of the respiratory epithelium, from a primary 37 minutes decreased to 32 minutes in the first month and 19'5" six months after the therapy. In group B, the corresponding time was decreased from a primary 36'4" to 34'2" and 31' respectively (p=0.01). CONCLUSIONS: Our results suggest that Pidotimod therapy is a reliable, simple and safe approach to treat children with recurrent respiratory infections and it can reduce the frequency of such infections as a result of improvement of the ciliary respiratory epithelium.
Authors: Susanna Esposito; Manuel E Soto-Martinez; Wojciech Feleszko; Marcus H Jones; Kun-Ling Shen; Urs B Schaad Journal: Curr Opin Allergy Clin Immunol Date: 2018-06