Safety and Efficacy of Two Courses of OM-85 BV in the Prevention of Respiratory Tract Infections in Children During 12 Months

Gutiérrez-Tarango, María Dolores; Berber, Arturo

doi:10.1378/chest.119.6.1742

Cited by 95 publications

(102 citation statements)

References 29 publications

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“…The results showed a reduction in the number of infectious episodes, and a more significant reduction in both antibiotic requirements and duration of the infection episodes in the treated group compared with placebo (5.04 Ϯ 1.99 vs 8.0 Ϯ 2.55). 36 A RCT including 232 children aged 3-5 years showed that the treatment with PMBL significantly reduced the rate of upper respiratory tract infections (16% decrease in pharyngitis and otitis media) , being this reduction higher in children affected more frequently by this kind of infections; the drug was also safe and well tolerated compared with placebo (P Ͻ 0.05). 37 A pilot study involving 89 children pointed out that the administration of PMBL could lead to a significant decrease in recurrent respiratory infections, compared with the control group represented by the same children during the previous year (7.84 vs 4.78, P Ͻ 0.05 with PMBL; 6.78 vs 4.78, P Ͻ 0.05 without PMBL); also phlogosis indexes were significantly lower in the treated group, and the values of Blymphocytes were found to be increased (9.9 with PMBL vs 5.9 without PMBL).…”

Section: Pediatric Trials: Resultsmentioning

confidence: 99%

May We Strengthen the Human Natural Defenses with Bacterial Lysates?

Villa

Garelli

Braido

et al. 2010

World Allergy Organization Journal

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During the last twenty years bacterial lysates have gained a new interest and their use has obtained a progressively larger consensus in the medical practice. They are commonly used as immunomodulators, in order to up-regulate immune responses against infectious damages. As a matter of fact, the role of these lysate seems relevant in upper and lower respiratory tract infections prevention, frequently observed both in paediatric and elder ages, and which represent a relevant problem also in terms of socioeconomical implications. The effects of bacterial lysates as immunostimulatory agents have become the central point of many studies. The aim of those in vivo and in vitro studies was to understand and evaluate the capacity of this kind of treatments to create a better answer of the immune system against microbial infections, eventually leading to a reduction in their number. All the in vivo and in vitro findings analyzed support the evidence that bacterial lysates are powerful inducers of a specific immune response against bacterial infections. Both in paediatric and adult clinical trials, a positive trend has been found in terms of overall reduction of infection rates and duration, beneficial effect on symptoms, reduction in antibiotics use and possibility to improve the patient's quality of life in several diseases. Further well-designed trials in terms of blinding and randomization procedures and including a higher number of patients, selected according to the disease and its severity, are needed.

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Section: Pediatric Trials: Resultsmentioning

confidence: 99%

May We Strengthen the Human Natural Defenses with Bacterial Lysates?

Villa

Garelli

Braido

et al. 2010

World Allergy Organization Journal

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“…In a randomized, double-blind, placebo-controlled study, Gutierrez-Tarango and Berber 34 assessed the protective effect of 2 courses of OM-85 BV for 12 months. The mean (SD) number of acute RTIs was 5.04 (1.99) in the OM-85 BV group versus 8.0 (2.55) in the placebo group (P Ͻ 0.001).…”

Section: Discussionmentioning

confidence: 99%

“…In another study 36 in 11 patients with common variable immunodeficiency, a significant increase in serum IgA level was observed after OM-85 BV treatment, although no significant improvement was found in the clinical state. In several pediatric studies, 12,31,34 the therapeutic regimen was OM-85 BV 3.5 mg/d for the first 10 consecutive days of each month for 3 consecutive months, then daily for 30 days, followed by a repeat course of 10 consecutive days of therapy per month for 3 months. In our study, we preferred the first regimen, and we found that the number of infections and antibiotic courses was reduced significantly.…”

Section: Discussionmentioning

confidence: 99%

Prospective, randomized comparison of OM-85 BV and a prophylactic antibiotic in children with recurrent infections and immunoglobulin A and/or G subclass deficiency

Genel

Kütükçüler

2003

Current Therapeutic Research

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Background: Patients with immunoglobulin (Ig)A and/or IgG subclass deficiency may be asymptomatic or may have recurrent, mainly respiratory infections.Objective: This study compared the clinical efficacy and tolerability of prophylactic therapy with either the oral immunomodulator bacterial extract OM-85 BV or benzathine penicillin G (BPG) in the prevention of recurrent infections in symptomatic patients.Methods: In this 26-month, prospective, randomized study conducted at the Department of Pediatric Immunology, Ege University (Izmir, Turkey), children aged 1 to 12 years with recurrent infections and IgA and/or IgG subclass deficiency were enrolled. After an initial 12-month control period, patients were randomized to receive OM-85 BV or BPG. OM-85 BV (3.5-mg capsule) was given once daily for the first 10 days of each month for the first 3 months of the study. IM injections of BPG were given at a dose of 1.2 million units (for patients with body weight Ͼ27 kg) or at a half-dose (for patients with body weight Յ27 kg) every 3 weeks for 12 months. In nonresponders (ie, those who continued to have recurrent infections at 12-month follow-up), IV immunoglobulin (IVIG) replacement therapy at 400 mg/kg body weight was given every 4 weeks for an additional 12 months. The results of IVIG therapy were assessed by the authors using clinical observation. Adverse effects and adverse drug reactions were documented by the authors for each vaccine, prophylactic therapy, and IVIG.Results 52] months; P ϭ 0.036) and had lower serum IgG (P Ͻ 0.001), IgG1 (P ϭ 0.006), IgG2 (P ϭ 0.003), IgG3 (P ϭ 0.035), and IgM (P ϭ 0.008) levels and antibody responses to tetanus toxoid and Haemophilus influenzae type b (Hib) vaccines (P ϭ 0.036 and 0.013, respectively). At 12-month follow-up, a protective effect of the prophylactic IVIG therapy was seen, with a statistically significant reduction in the number of infections to 3.3 (2.4) and in the number of antibiotic courses to 2.7 (2.5) (both P ϭ 0.005). Conclusions:In this study population of children with recurrent infections and IgA and/or IgG subclass deficiency, prophylactic therapy with either OM-85 BV or an antibiotic significantly decreased the number of infections per year. In addition, nonresponders benefited from IVIG replacement therapy. (Curr Ther Res Clin Exp. 2003;64:600-615)

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“…У детей, посещающих детские учреждения, отмечено снижение частоты ОРИ, обострений рецидивирующего бронхита [15]. Терапия с включением данного препарата значительно уменьшала частоту (на 38%) и продолжительность бронхообструктивного синдро-ма на фоне ОРИ у детей дошкольного возраста [25]; часто-ту развития отитов (на 79%) по сравнению с плацебо [26]. Доказано, что профилактика респираторных заболеваний у детей путем применения Бронхо-Ваксома имеет суще-ственный фармакоэкономический эффект [27].…”

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