Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano, Milan, Italy.
Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy.
Eur J Pediatr. 2024 Jan;183(1):289-294. doi: 10.1007/s00431-023-05192-w. Epub 2023 Oct 24.
Chronic adenoiditis (CA) is generally sustained by some infectious foci mainly located within the nasopharynx or in the deep adenoidal pads and it is characterized by a complex interplay between bacterial species. The aim of this study was to assess the efficacy and safety of the topical nasal administration of a probiotic compound based on S. salivarius 24SMB and S. oralis 89a in children with CA in terms of reduction in: the number of acute adenoidal infections (primary outcome), and in the blockage of the nasopharynx space by hypertrophic adenoids (secondary outcome). A prospective, double-blind, 1:1 randomized controlled study was performed to test the effectiveness of a 90-day treatment with Rinogermina spray (DMD ITALIA s.r.l, Rome), 1 puff each nostril twice a day for 90 days, to nasal spray placebo in children with CA (in terms of number of acute exacerbations and blockage of nasopharynx space assessed after 90 days of treatment- T1, and 90 days later- T2). The final analysis was based on 152 children (males = 48.0%; mean age = 49.2 ± 14.1 months). Compared to the baseline, no significant differences in terms of number of acute exacerbations at T1 and T2 follow-up visits were detected in both groups. After treatment, a significant reduction in the blockage of nasopharynx space by hypertrophic adenoids (0.002 < p-value < 0.007) compared to the baseline was attested in the study group at T1 and T2, but not in the control group.
Our findings document a positive effect of Rinogermina spray in achieving reduction in the blockage of nasopharynx space by hypertrophic adenoids, thus suggesting that its use into the integrated therapeutic management of children with CA could be of a certain utility.
• Chronic adenoiditis in children results from an imablance in baterial homeostasis at the nasophaynx, with impairment in respiratory microbiota. • The modulatory effect of target transnasal bacteriotheray by means of S. salivarius has been considered in children with chronic adenoiditis in children with recurrent acute otitis media with preliminary positive results.
• This randomized controlled study, specifically designed on a cohrt of children with chronic adenoiditis, documents a certain effectiveness of the probiotic treatment in achieving a reduction in the grade of adenoidal hypertropy, compared to placebo.
目的：本研究旨在评估鼻腔局部应用基于 S. salivarius 24SMB 和 S. oralis 89a 的益生菌复合制剂治疗儿童慢性腺样体炎（CA）的疗效和安全性，具体表现为减少：急性腺样体感染次数（主要结局）和腺样体肥大引起的鼻咽腔阻塞（次要结局）。
方法：采用前瞻性、双盲、1:1 随机对照研究，对 152 例（男 48.0%；平均年龄 49.2±14.1 个月）CA 患儿进行为期 90 天的治疗，90 天治疗后（T1）和 90 天后（T2）评估急性加重和鼻咽腔阻塞的数量。试验组采用 Rinogermina 喷雾剂（DMD ITALIA s.r.l，罗马），每日每侧鼻腔喷 1 次，每次 1 喷，共 90 天；对照组采用鼻腔喷雾安慰剂。
结果：与基线相比，两组在 T1 和 T2 随访时急性加重的次数均无显著差异。治疗后，研究组 T1 和 T2 时腺样体肥大引起的鼻咽腔阻塞程度均显著降低（0.002<p<0.007），而对照组无显著降低。
结论：本研究结果表明，Rinogermina 喷雾剂可有效减轻腺样体肥大引起的鼻咽腔阻塞，提示其在儿童 CA 的综合治疗管理中可能具有一定的应用价值。
