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Pidotimod, an immunostimulant in pediatric recurrent respiratory tract infections: A meta-analysis of randomized
Hui Niu1, Rui Wang1, Yu-Ting Jia1
1Center of Medicine Clinical Research, Department of Pharmacy, PLA General Hospital, 28 Fu Xing Road, Beijing 100853, People's Republic of China.
Insights
Pidotimod (PDT) effectively treats recurrent respiratory tract infections (RRTIs) in children, reducing illness duration and antibiotic use. This immunostimulant demonstrated safety and improved immune markers without increasing adverse events.
Area of Science:
- Pediatric Immunology
- Infectious Diseases
- Clinical Trials
Background:
- Recurrent respiratory tract infections (RRTIs) pose significant challenges in pediatrics.
- Effective treatments for pediatric RRTIs are limited, increasing complication risks.
Purpose of the Study:
- To evaluate the efficacy and safety of pidotimod (PDT) for treating RRTIs in children under 14.
- To synthesize evidence from randomized controlled trials (RCTs) on PDT's impact on pediatric RRTIs.
Main Methods:
- A systematic review and meta-analysis of RCTs published up to February 2018.
- Searched major databases including PubMed, EMBASE, Web of Science, and Cochrane Library.
- Included studies involving children under 14 treated with PDT versus conventional therapy or placebo.
Main Results:
- Meta-analysis of 29 RCTs (4344 patients) showed PDT significantly increased lower RTI recovery (RR 1.59).
- PDT treatment reduced the duration of cough and fever and decreased antibiotic use.
- PDT improved serum immunoglobulin and T-lymphocyte levels, with no increased risk of adverse events.
Conclusions:
- Pidotimod (PDT) demonstrates good efficacy and safety in treating pediatric RRTIs.
- Further high-quality, large-scale RCTs are needed to confirm these findings.
Objectives:
Recurrent respiratory tract infections (RRTIs) remain a great challenge to pediatricians, because they can increase the risk of various complications and there is no confirmed effective treatment. In the present study, we aimed to assess the effectiveness and safety of pidotimod (PDT), an immunostimulant, in treatment of RRTIs in children aged 14 years and under.
Methods:
PubMed, EMBASE, Web of Science, Cochrane Library, ClinicalTrials.gov, CBM and CNKI were searched from their inception up to February 2018. All randomized controlled trials (RCTs) using PDT with various treatment durations and enrolling participants <14 years of age were included in the present review. The interventions were PDT plus conventional treatment (e.g. anti-bacterial and antiviral therapy) or PDT alone versus the conventional treatment plus placebo or conventional treatment alone.
Results:
A total of 29 RCTs consisting of 4344 pediatric patients were included in this meta-analysis. Ten RCTs were published from Italy, Russia or Greece, and 19 RCTs were published by Chinese groups. However, appropriate randomization methods were only used in 15 trials. Only one study had explicit allocation concealment. Since only eight RCTs were double-blind and placebo controlled, the evidence was not assessed as high quality. The meta-analysis indicates that treatment with PDT resulted in a significant increase in the proportion of participants who had lower RTIs (RR 1.59; 95% CI 1.45-1.74, p < 0.00001) compared with the conventional treatment. PDT could significantly decrease the duration of cough and fever. The number of patients in using antibiotics was also remarkably decreased in the PDT treatment group. Moreover, PDT administration improved the levels of serum immunoglobulin (IgG, IgA, or IgM) and T-lymphocyte subtypes (CD3+, CD4+). Besides, PDT administration did not increase the risk of adverse events of any cause (RR = 1.05, 95% CI 0.72-1.54, p = 0.80).
Conclusions:
PDT showed a good efficacy and safety in treatment of pediatric RRTIs. Further high-quality and large-scale RCTs are still required to provide confirmatory evidence.
Trial Registration:
The protocol of this study can be found at PROSPERO with the registration number of CRD42018093541.
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