Jia-Yi Liao1, Tao Zhang. 1. Department of Respiratory Disease, Guangzhou Children's Hospital of Yuexiu District, Guangzhou 510115, China. zhangtaovip2001@163.com.
Abstract
OBJECTIVE: To observe the clinical therapeutic effect of OM-85 BV(OM-85 Broncho-Vaxom) in children with asthma and recurrent respiratory tract infection, and the effect of OM-85 BV on human β-defensins 1 (hBD-1) and immunoglobulin levels. METHODS:Sixty-two children with asthma and recurrent respiratory infection treated between 2011 January and December were divided into two groups by the randomized, double blind method: a treatment group and a control group. With inhaling corticosteroids, the treatment group was given OM-85 BV, and the control group was given a placebo. Clinical curative effects and adverse reactions were observed. Serum levels of hBD-1, IgA, IgG, IgM and urea and alanine aminotransferase (ALT) were measured before treatment and 6 months and 12 months after treatment. RESULTS: Compared with the control group and before treatment, the frequency of respiratory tract infection was reduced in the treatment group 6 months and 12 months after treatment (P<0.05), and serum levels of hBD-1, IgA and IgG in the treatment group increased significantly (P<0.05). There was no significant difference in serum levels of urea, ALT and IgM between the control and treatment groups (P>0.05). Mild adverse reactions occurred in 3 cases in the two groups, 2 cases of abdominal pain and 1 cases of constipation. CONCLUSIONS:OM-85 BV can improve serum levels of hBD-1, IgA and IgG, reduce the occurrence of acute respiratory tract infection and cause mild adverse reactions, suggesting its satisfactory therapeutic effect and safety in the treatment of asthma combined with recurrent respiratory tract infection in children.
RCT Entities:
OBJECTIVE: To observe the clinical therapeutic effect of OM-85 BV(OM-85 Broncho-Vaxom) in children with asthma and recurrent respiratory tract infection, and the effect of OM-85 BV on human β-defensins 1 (hBD-1) and immunoglobulin levels. METHODS: Sixty-two children with asthma and recurrent respiratory infection treated between 2011 January and December were divided into two groups by the randomized, double blind method: a treatment group and a control group. With inhaling corticosteroids, the treatment group was given OM-85 BV, and the control group was given a placebo. Clinical curative effects and adverse reactions were observed. Serum levels of hBD-1, IgA, IgG, IgM and urea and alanine aminotransferase (ALT) were measured before treatment and 6 months and 12 months after treatment. RESULTS: Compared with the control group and before treatment, the frequency of respiratory tract infection was reduced in the treatment group 6 months and 12 months after treatment (P<0.05), and serum levels of hBD-1, IgA and IgG in the treatment group increased significantly (P<0.05). There was no significant difference in serum levels of urea, ALT and IgM between the control and treatment groups (P>0.05). Mild adverse reactions occurred in 3 cases in the two groups, 2 cases of abdominal pain and 1 cases of constipation. CONCLUSIONS: OM-85 BV can improve serum levels of hBD-1, IgA and IgG, reduce the occurrence of acute respiratory tract infection and cause mild adverse reactions, suggesting its satisfactory therapeutic effect and safety in the treatment of asthma combined with recurrent respiratory tract infection in children.
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