Pidotimod, an immunostimulant in pediatric recurrent respiratory tract infections: A meta-analysis of randomized controlled trials.
Int Immunopharmacol
; 67: 35-45, 2019 Feb.
Article
em En
| MEDLINE
| ID: mdl-30530167
ABSTRACT
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 14â¯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 <14â¯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, pâ¯<â¯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 (RRâ¯=â¯1.05, 95% CI 0.72-1.54, pâ¯=â¯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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Contexto em Saúde:
1_ASSA2030
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2_ODS3
Base de dados:
MEDLINE
Assunto principal:
Ácido Pirrolidonocarboxílico
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Infecções Respiratórias
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Linfócitos T
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Adjuvantes Imunológicos
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Subpopulações de Linfócitos T
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Tiazolidinas
Tipo de estudo:
Clinical_trials
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Guideline
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Systematic_reviews
Limite:
Child
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Child, preschool
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Humans
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Infant
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Newborn
Idioma:
En
Revista:
Int Immunopharmacol
Ano de publicação:
2019
Tipo de documento:
Article