Ju Yin1, Baoping Xu1, Xiantao Zeng2, Kunling Shen3. 1. Department of Respiratory, Beijing Children's Hospital, Capital Medical University, China National Clinical Research Center for Respiratory Diseases, 100045 Beijing, China. 2. Center for Evidence-Based and Translational Medicine, Zhongnan Hospital of Wuhan University, Wuhan 430071, China; Center for Evidence-Based and Translational Medicine, Wuhan University, Wuhan 430071, China; Department of Evidence-Based Medicine and Clinical Epidemiology, The Second Clinical College, Wuhan University, Wuhan 430071, China. 3. Department of Respiratory, Beijing Children's Hospital, Capital Medical University, China National Clinical Research Center for Respiratory Diseases, 100045 Beijing, China. Electronic address: kunlingshen1717@163.com.
Abstract
OBJECTIVES: Assess the efficacy and safety of Broncho-Vaxom in pediatric recurrent respiratory tract infections (RRTIs). METHODS: Published randomized controlled trials (RCTs) of Broncho-Vaxom for pediatric RRTI were searched using PubMed, Embase, Cochrane Library, CBM, CNKI, WanFang Data, and VIP databases up to January 2017. Risk of bias was evaluated in accordance to the guidelines of the Cochrane collaboration and the level of evidence was graded according to the GRADE. RESULTS: 53 RCTs involving 4851 pediatric patients were included in this meta-analysis. It showed that Broncho-Vaxom was positively correlated with a reduction in the frequency of respiratory infection [MD=-2.33, 95% CI (-2.75, -1.90), P<0.00001] compared to the control group. The Broncho-Vaxom group was more effective than control groups in relation to the duration of antibiotics course, infections, fever, cough, and wheezing, increasing serum immunoglobulin levels (IgG, IgA or IgM), and T-lymphocytes subtype (CD3+, CD4+, or CD8+). However, Broncho-Vaxom had higher adverse event rates [RR=1.39, 95% CI (1.02, 1.88), P=0.04]; these were not serious and did not influence the treatment course. CONCLUSION: Broncho-Vaxom shows a good efficacy for pediatric RRTIs on the basis of routine therapy (e.g. anti-infection and antiviral therapy). However, the level of evidence was low and more international multicenter clinical trials are needed to explore the efficacy and safety of Broncho-Vaxom.
OBJECTIVES: Assess the efficacy and safety of Broncho-Vaxom in pediatric recurrent respiratory tract infections (RRTIs). METHODS: Published randomized controlled trials (RCTs) of Broncho-Vaxom for pediatric RRTI were searched using PubMed, Embase, Cochrane Library, CBM, CNKI, WanFang Data, and VIP databases up to January 2017. Risk of bias was evaluated in accordance to the guidelines of the Cochrane collaboration and the level of evidence was graded according to the GRADE. RESULTS: 53 RCTs involving 4851 pediatric patients were included in this meta-analysis. It showed that Broncho-Vaxom was positively correlated with a reduction in the frequency of respiratory infection [MD=-2.33, 95% CI (-2.75, -1.90), P<0.00001] compared to the control group. The Broncho-Vaxom group was more effective than control groups in relation to the duration of antibiotics course, infections, fever, cough, and wheezing, increasing serum immunoglobulin levels (IgG, IgA or IgM), and T-lymphocytes subtype (CD3+, CD4+, or CD8+). However, Broncho-Vaxom had higher adverse event rates [RR=1.39, 95% CI (1.02, 1.88), P=0.04]; these were not serious and did not influence the treatment course. CONCLUSION: Broncho-Vaxom shows a good efficacy for pediatric RRTIs on the basis of routine therapy (e.g. anti-infection and antiviral therapy). However, the level of evidence was low and more international multicenter clinical trials are needed to explore the efficacy and safety of Broncho-Vaxom.
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