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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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Aims: To identify the effect of the oral bacterial extract OM-85 on essential parameters of asthma control. Study Design: This was a double blind, prospective study, consistent of a 4 week run-in and a 24 week double blind period. Place and Duration of Study: An outpatient clinic, in collaboration with “St Andrew’s’’ General State Hospital in Patras/Greece, between October 2010 and April 2011. Methods: Patients (aged 15-57, N=130) with persistent allergic asthma, were assessed and divided accordingly, in three strata: Stratum I (not controlled asthma, NCA), stratum 2 (partly controlled asthma, PCA) and stratum 3 (controlled asthma, CA). At the end of the run-in period were randomized to receive additionally to their standard treatment (appropriate doses inhaled budesonide and formoterol), 7mg oral OM-85 BV or matching placebo. Primary end-point was the proportion of patients with controlled asthma in every group. Change from baseline budesonide, mean FEV1, PEF, daytime asthma symptoms score, night awakenings, rescue b2-agonist use and serum interferon-γ (INF-γ) levels were also recorded and included in the final analysis. Results: At the end of the 24 week follow up, stratum I patients, treated additionally with OM-85 BV, presented significantly higher proportion of subjects with controlled (28.09% versus 18.7%, P<0.001), and partly controlled asthma (57% versus 43.7%, (P= 0.04). Almost all patients demonstrated significant increases (P<0.001) from baseline in FEV1.The percentage change from baseline FEV1 was 21.8% for OM-85 BV versus 12.1% for the placebo group. Same tendencies were recorded in every stratum and concerned al secondary end points, despite a lower dose of budesonide. Conclusions: Patients treated additionally with OM-85 BV achieved better asthma control despite a lower dose of budesonide.
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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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Antecedentes: Meta-análisis para evaluar la eficacia de OM-85 BV (Broncho-Vaxom) en la prevención de las infecciones respiratorias recurrentes (IRRs) en niños. Se define a las IRRs como 23 infecciones por semestre (otoño e invierno) y se definen como el evento final primario. Métodos: Se identificaron los estudios en bases de datos. Se excluyó once estudios que no fueron doble-ciego y uno referente a la prevención primaria; y se incluyó en el meta-análisis ocho estudios controlados y randomizados. Se compararon los resultados a 6 meses. Se examinó la base de datos de acuerdo con los lineamientos Cochrane. Resultados: De los pacientes tratados con OM-85 BV (n= 435), un32% tuvo IRRs (esto es, 23 RTI/periodo de 6 meses) vs. 58.2% en la población que recibió placebo (n= 416; P<0.001). Los resultados también fueron positivos para el tratamiento activo con respecto a las variables secundarias. Conclusiones: El presente meta-análisis demuestra, que la población tratada con OM-85BV tuvo significativa y consistentemente menos casos del IRRs. El efecto es mayor en los pacientes con un mayor riesgo para desarrollar IRRs.