Di Pierro F, Colombo M, Giuliani M G, Danza M L, Basile I, Bollani T, Conti A M, Zanvit A, Rottoli A S
Scientific Department, Velleja Research, Milan, Italy.
Eur Rev Med Pharmacol Sci. 2016 Nov;20(21):4601-4606.
Streptococcus salivarius K12 (BLIS K12) is a probiotic strain strongly antagonistic to the growth of Streptococcus pyogenes, the most important bacterial cause of pharyngeal infections in humans. Shown to colonize the oral cavity and to be safe for human use, BLIS K12 has previously been reported to reduce pharyngo-tonsillitis episodes in children or adults known to have experienced recurrent streptococcal infection. The present study was focussed upon evaluating the role of BLIS K12 in the control of streptococcal disease and acute otitis media in children attending the first year of kindergarten.
By randomization, 222 enrolled children attending the first year of kindergarten were divided into a treated group (N = 111) receiving for 6 months a daily treatment with BLIS K12 (Bactoblis®) and a control group (N = 111) who were monitored as untreated controls. During the 6 months of treatment and 3 months of follow-up, the children were evaluated for treatment tolerance, and for episodes of streptococcal pharyngo-tonsillitis, scarlet fever and acute otitis media.
During the 6-month trial (N = 111 per group) the incidence of streptococcal pharyngo-tonsillitis, scarlet fever and acute otitis media was approximately 16%, 9% and 44% respectively in the treated group and 48%, 4% and 80% in the control group. During the 3-months follow-up (N = 29 per group) the corresponding rates of infection were 15%, 0% and 12% in the treated group and 26%, 6% and 36% in the controls. No apparent side effects were detected in the treated group either during treatment or follow-up. All of the enrolled children completed the study.
The daily administration of BLIS K12 to children attending their first year of kindergarten was associated with a significant reduction in episodes of streptococcal pharyngitis and acute otitis media. No protection against scarlet fever was detected.
唾液链球菌K12（BLIS K12）是一种益生菌菌株，对化脓性链球菌的生长具有强烈拮抗作用，化脓性链球菌是人类咽部感染最重要的细菌病因。已证明BLIS K12可定殖于口腔且对人体使用安全，此前有报道称其可减少已知患有复发性链球菌感染的儿童或成人的咽扁桃体炎发作次数。本研究重点评估BLIS K12在控制幼儿园一年级儿童链球菌疾病和急性中耳炎方面的作用。
通过随机分组，222名入组的幼儿园一年级儿童被分为治疗组（N = 111），接受为期6个月的每日BLIS K12（Bactoblis®）治疗，以及对照组（N = 111），作为未治疗的对照进行监测。在6个月的治疗期和3个月的随访期内，评估儿童的治疗耐受性，以及链球菌性咽扁桃体炎、猩红热和急性中耳炎的发作情况。
在为期6个月的试验中（每组N = 111），治疗组链球菌性咽扁桃体炎、猩红热和急性中耳炎的发病率分别约为16%、9%和44%，对照组分别为48%、4%和80%。在3个月的随访期内（每组N = 29），治疗组相应的感染率分别为15%、0%和12%，对照组分别为26%、6%和36%。治疗组在治疗期间或随访期间均未检测到明显的副作用。所有入组儿童均完成了研究。
对幼儿园一年级儿童每日服用BLIS K12可使链球菌性咽炎和急性中耳炎的发作次数显著减少。未检测到对猩红热的预防作用。
