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OBJECTIVE:To evaluate the efficacy and safety of Bacterial lysates(hereinafter referred to as"Broncho-Vaxom") for recurrent respiratory tract infections (RRTIs) of children,and to provide evidence-based reference for clinic. METHODS:Retrieved from PubMed,EMBase,Cochrane Library,CBM,CNKI,Wanfang database and VIP database,domestic and foreign published randomized controlled trials (RCTs) about Broncho-Vaxom (trail group) vs. placebo (control group) for RRTIs of children were collected during database establishment to Jan. 2018. After literature scanning and data extraction,the risk of bias of included trials were evaluated by using Cochrane 5.1.0 risk bias evaluation tool. Meta-analysis was performed by using Rev Man 5.3 software. RESULTS:A total of 13 RCTs involving 1 228 children were included. The results showed that the trial group was superior to control group in frequency of respiratory infection [MD＝－1.14,95%CI(－1.29,－0.99),P＜0.001],total response rate [RR＝9.47,95%CI(2.33,38.54),P＝0.002],the time of antibiotics use [MD＝－4.36,95%CI(－6.52,－2.21),P＜0.001], infection duration [MD＝－3.89,95%CI(－4.47,－3.04),P＜0.001],febrile time [MD＝－1.81,95%CI(－3.40,－0.22),P＝0.03],serum immunoglobulin (Ig)G level [MD＝1.25,95%CI(0.13,2.37)),P＝0.03],IgA level [MD＝0.77,95%CI(0.07, 1.46),P＝0.03] and the level of T cell subgroup CD4+[MD＝1.33,95%CI(0.90,1.76),P＜0.001] and CD8+[MD＝0.64,95%CI (0.24,1.04),P＝0.002],there was statistical significance. Trail group was similar to control group in respect of cough time [MD＝－6.00,95%CI(－13.86,1.86),P＝0.13] and IgM level [MD＝－0.10,95%CI(－0.32,0.12),P＝0.39] and the incidence of ADR [RR＝0.76,95%CI(0.43,1.35),P＝0.35]. CONCLUSIONS:The current evidence shows that Broncho-Vaxom could effectively prevent the RRTIs of children with good safety.
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Objective To investigate the effect of short course chemotherapy combined with broncho-vaxom on the prognosis of new smear positive pulmonary tuberculosis patients.Methods 80 patients with new smear positive pulmonary tuberculosis were selected as the research subjects.According to the random number table method,they were divided into observation group and control group,40 cases in each group.The control group was treated with 2HRZE/4HR chemotherapy,the observation group was treated with broncho-vaxom tablets based on the treatment of the control group.After 6 months of treatment,the sputum negative conversion rate,pulmonary lesions absorption,the incidence rate of adverse reaction and immune function were compared between the two groups.Results After 2,4,6 months of treatmentt,the sputum negative conversion rates of the observation group were 90.00％,95.00％ and 97.50％,respectively,which were significantly higher than those of the control group(x2 =4.020,4.114,3.914,all P ＜ 0.05).After 2,6 months of treatment,the total effective rates of the observation group were 87.50％ and 97.50％,which were significantly higher than those of the control group (x2 =4.588,5.000,all P ＜ 0.05).After 6 months of treatment,the IgA,IgG,IgM,CD3+,CD4+,CD4+/CD8+ in the observation group were (70.24 ± 6.19) ％,(46.89 ± 6.25) ％,(2.21 ± 0.39),(3.86 ± 1.43) g/L,(14.76 ± 2.58) g/L,(1.47 ± 0.65) g/L,respectively,which were significantly higher than those of the control group(t =-2.116,-2.575,-2.322,-2.138,-4.513,-2.599,all P ＜ 0.05),the CD8+ was (18.85 ± 2.08) ％,which was significantly lower than that in the control group (t =2.609,P ＜ 0.05).There was no statistically significant difference in the incidence of adverse reactions between the two groups (x2 =0.251,P ＞ 0.05).Conclusion Short course chemotherapy regimen combined with bronchovaxom can improve the new smear positive pulmonary tuberculosis patients with recent sputum negative conversion rate and lung lesions absorption effect,improve the immune function of patients and without increasing the incidence of adverse reactions,it is worthy of clinical attention.
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Objective To establish mouse allergic asthma model and observe the effect of bacterial lysates (OM-85BV) on airway inlfammation. Methods Forty-eight 4 to 6 weeks healthy male BALB/c mice were used as research subjects and randomly divided into six groups, a:control group;b:OM-85BV contral group;c:allergic asthma model;d:dexamethasone group (Dex group);e:OM-85BV A group;f:OM-85BV B group (the intervention time was prolonged 10 days than group e). BALB/c mice were sensitized and challenged with ovalbumin (OVA). Mice in groups c, d, e and f were intraperitoneally administered with antigen (OVA)-Al(OH)3 on days 1, 8 and 15, others were administered by PBS. From the 17th day to the 26th day, Mice in group f were treated with OM-85BV and others were treated with normal saline. In the next days, mice in groups c, d, e and f were intranasal given OVA for 5 consecutive days. Additionally, mice in groups b, e and f were treated with OM-85BV before challenge, while mice in the group d were administered by Dex, others were treated with normal saline at the same dose. Twenty four hours after the last intranasal administration, mice were anesthetized and dissected. Lungs were lavaged with PBS and bronchoalveolar lavage lfuid (BALF) was obtained. The total inlfammatory cells and eosinophils in BALF were counted. The total IgE levels of blood serum and IFN-γ/IL-4 levels of lavage were detected. The removed parts of lung tissue were collected for histological examination. Results Compared with groups a and b, lung tissue biopsies by HE staining from the asthma group showed obvious airway inlfammation. The situation of groups d and f was signiifcantly improved than group c, while the differences between groups e and c were not evident. Total cells and the number of eosinophils in BALF of group c (90.3±13.94×104/ml) were signiifcantly higher than that in groups a and b. Compared with the control group, levels of IL-4 in BALF (119.03±19.92 pg/ml) and IgE in serum (15.86±1.97 ng/ml) increased and levels of IFN-γin BALF (90.50±13.51 pg/ml) reduced signiifcantly. The corresponding levels of groups d, e and f were signiifcantly improved than group c (P<0.01). Conclusions Administered by OM-85BV helps regulate the balance between Th1/Th2 in asthmatic mice, reduce airway inlfammation, and prevent the occurrence and development of airway inlfammation.
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Background:Respiratory infection is a disease which the incidence and mortality rank highest among children diseases under 5 years old. The reasons caused respiratory infection are virus, bacterium and parasite. H.Influenzae, St.pneumoniae and M.Cataralis are the main reason leading to respiratory infection. Objectives:This study aims to research on the efficacy of Bronchovaxom in reducing the rate of acute respiratory infection in children. Subjects and method:A descriptive, prospective and cohort study was conducted on 60 patients was used Bronchovaxom for two times with the 6 months of interval in the National Hospital for Pediatric from January 2006 to September 2007. Results:Among the first selection 60 children, 15 children stopped to participate in the study. The age ranged from 32 months to 88 months, the mean age was 55.4 months. Male was 30 (66.7%); female was 15 ( 33.3%). 100% were injected vaccination. There was a clear reduction in the incidence. The frequency of antibiotic use was also reduced. In particular, increased level of IgA in the patient's saliva following treatment with Bronchovaxom. Conclusion:There was a significantly statistical difference on the times of acute recurrentrespiratory infection in one year on the same patient before and after using Bronchovaxom.