[Controlled randomized clinical trials of immunomodulators diucifon and sodium nucleinate in children with recurrent suppurative infections]
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Sodium nucleinate and diucifon treatments significantly reduced recurrent purulent infections in children compared to placebo. Immunological tests showed no significant changes, suggesting efficacy independent of immune status.
Area of Science:
- Pediatric Immunology
- Infectious Diseases
- Pharmacology
Background:
- Recurrent purulent infections pose a significant health challenge in children.
- Understanding the efficacy of immunomodulatory agents is crucial for treatment.
- Previous studies may not have fully elucidated the role of immune status in treatment response.
Purpose of the Study:
- To evaluate the clinical efficacy of sodium nucleinate and diucifon in children with recurrent purulent infections.
- To assess the impact of these treatments on infection rates and severity.
- To investigate potential correlations between treatment response and immune status.
Main Methods:
- A randomized clinical trial involving three groups of children.
- Group 1 received sodium nucleinate, Group 2 received diucifon, and Group 3 received a placebo (calcium gluconate).
- Clinical outcomes were monitored over six months, alongside immunological assessments (Level I tests).
Main Results:
- A significant reduction in the rate and severity of exacerbations was observed in 68% of patients treated with sodium nucleinate or diucifon.
- Only 39% of placebo group patients showed similar improvements (p < 0.05).
- Immunological tests revealed no significant changes in indicators before or after treatment, regardless of clinical response.
Conclusions:
- Sodium nucleinate and diucifon are clinically effective in managing recurrent purulent infections in children.
- Treatment efficacy appears independent of baseline immune status as assessed by Level I tests.
- These agents can be considered for clinical use in indicated cases, even with normal immune parameters.
Abstract:
There were 3 groups of children with recurrent purulent infections, who were entered into randomized clinical studies. Group 1 received sodium nucleinate, group 2 diucifon and group 3 placebo (calcium gluconate). After 6 months a well-defined clinical effect manifested by the lowering of the rate and gravity of exacerbations was recorded in 68% of the patients belonging to groups 1 and 2 and in 39% of group 3 patients, which is much more seldom (p less than 0.05). During immunological studies according to the level I tests, no significant changes in the indicators were recorded either before or after the treatment both among the patients who responded to immunotherapy and among those who did not respond to it. The conclusion is drawn that if indicated clinically, sodium nucleinate of diucifon can be administered in spite of the normal immune status in accordance with the level I tests.