Di Pierro Francesco, Colombo Maria, Zanvit Alberto, Risso Paolo, Rottoli Amilcare S
Scientific Department, Velleja Research, Milan, Italy.
Pediatric Department, University of Parma, Parma, Italy.
Drug Healthc Patient Saf. 2014 Feb 13;6:15-20. doi: 10.2147/DHPS.S59665. eCollection 2014.
Streptococcus salivarius K12 is an oral probiotic strain releasing two lantibiotics (salivaricin A2 and salivaricin B) that antagonize the growth of S. pyogenes, the most important bacterial cause of pharyngeal infections in humans also affected by episodes of acute otitis media. S. salivarius K12 successfully colonizes the oral cavity, and is endowed with an excellent safety profile. We tested its preventive role in reducing the incidence of both streptococcal and viral pharyngitis and/or tonsillitis in children.
We enrolled 61 children with a diagnosis of recurrent oral streptococcal disorders. Thirty-one of them were enrolled to be treated daily for 90 days with a slow-release tablet for oral use, containing no less than 1 billion colony-forming units/tablet of S. salivarius K12 (Bactoblis®), and the remaining 30 served as the untreated control group. During treatment, they were all examined for streptococcal infection. Twenty children (ten per group) were also assessed in terms of viral infection. Secondary end points in both groups were the number of days under antibiotic and antipyretic therapy and the number of days off school (children) and off work (parents).
The 30 children who completed the 90-day trial with Bactoblis® showed a significant reduction in their episodes of streptococcal pharyngeal infection (>90%), as calculated by comparing the infection rates of the previous year. No difference was observed in the control group. The treated group showed a significant decrease in the incidence (80%) of oral viral infections. Again, there was no difference in the control group. With regard to secondary end points, the number of days under antibiotic treatment of the treated and control groups were 30 and 900 respectively, days under antipyretic treatment 16 and 228, days of absence from school 16 and 228, and days of absence from work 16 and 228. The product was well tolerated by the subjects, with no side effects, and only one individual reported bad product palatability and dropped out.
Prophylactic administration of S. salivarius K12 to children with a history of recurrent oral streptococcal disease resulted in a considerable reduction of episodes of both streptococcal and viral infections and reduced the number of days under antibiotic and/or antipyretic therapy and days of absence from school or work.
唾液链球菌K12是一种口腔益生菌菌株，可释放两种羊毛硫抗生素（唾液乳杆菌素A2和唾液乳杆菌素B），它们能抑制化脓性链球菌的生长，化脓性链球菌是人类咽部感染的最重要细菌病因，急性中耳炎发作也与之相关。唾液链球菌K12能成功定殖于口腔，且具有良好的安全性。我们测试了其在降低儿童链球菌性和病毒性咽炎和/或扁桃体炎发病率方面的预防作用。
我们招募了61名诊断为复发性口腔链球菌疾病的儿童。其中31名儿童每天服用一片口服缓释片，持续90天，该片剂每片含有不少于10亿个唾液链球菌K12菌落形成单位（Bactoblis®），其余30名儿童作为未治疗的对照组。治疗期间，对他们进行链球菌感染检查。还对20名儿童（每组10名）进行了病毒感染评估。两组的次要终点是接受抗生素和退热治疗的天数以及儿童缺课天数和家长误工天数。
通过比较上一年的感染率计算得出，完成90天Bactoblis®试验的30名儿童的链球菌性咽部感染发作次数显著减少（>90%）。对照组未观察到差异。治疗组的口腔病毒感染发病率显著降低（80%）。对照组同样未观察到差异。关于次要终点指标，治疗组和对照组接受抗生素治疗的天数分别为30天和900天，接受退热治疗的天数分别为16天和228天，缺课天数分别为16天和228天，误工天数分别为16天和228天。受试者对该产品耐受性良好，无副作用，只有一名个体报告产品口感不佳并退出试验。
对有复发性口腔链球菌疾病病史的儿童预防性给予唾液链球菌K12，可显著减少链球菌性和病毒性感染的发作次数，并减少接受抗生素和/或退热治疗的天数以及缺课或误工天数。
