Hui Niu1, Rui Wang1, Yu-Ting Jia1, Yun Cai2. 1. Center of Medicine Clinical Research, Department of Pharmacy, PLA General Hospital, 28 Fu Xing Road, Beijing 100853, People's Republic of China. 2. Center of Medicine Clinical Research, Department of Pharmacy, PLA General Hospital, 28 Fu Xing Road, Beijing 100853, People's Republic of China. Electronic address: caicai_hh@126.com.
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 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.
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.
Authors: Désirée Larenas-Linnemann; Noel Rodríguez-Pérez; Alfredo Arias-Cruz; María Virginia Blandón-Vijil; Blanca E Del Río-Navarro; Alan Estrada-Cardona; José E Gereda; Jorge A Luna-Pech; Elsy Maureen Navarrete-Rodríguez; Ernesto Onuma-Takane; César Fireth Pozo-Beltrán; María Isabel Rojo-Gutiérrez Journal: World Allergy Organ J Date: 2020-10-09 Impact factor: 4.084
Authors: Elena Chiappini; Francesca Santamaria; Gian Luigi Marseglia; Paola Marchisio; Luisa Galli; Renato Cutrera; Maurizio de Martino; Sara Antonini; Paolo Becherucci; Paolo Biasci; Barbara Bortone; Sergio Bottero; Valeria Caldarelli; Fabio Cardinale; Guido Castelli Gattinara; Martina Ciarcià; Daniele Ciofi; Sofia D'Elios; Giuseppe Di Mauro; Mattia Doria; Luciana Indinnimeo; Andrea Lo Vecchio; Francesco Macrì; Roberto Mattina; Vito Leonardo Miniello; Michele Miraglia Del Giudice; Guido Morbin; Marco Antonio Motisi; Andrea Novelli; Anna Teresa Palamara; Maria Laura Panatta; Angela Pasinato; Diego Peroni; Katia Perruccio; Giorgio Piacentini; Massimo Pifferi; Lorenzo Pignataro; Emanuela Sitzia; Chiara Tersigni; Sara Torretta; Irene Trambusti; Giulia Trippella; Diletta Valentini; Sandro Valentini; Attilio Varricchio; Maria Carmen Verga; Claudio Vicini; Marco Zecca; Alberto Villani Journal: Ital J Pediatr Date: 2021-10-25 Impact factor: 2.638