Irvine3 Labs, San Valentino Vascular Screening Project, and International Agency for Pharma-Standard Supplements (IA-PSS), Pescara, Italy.
Irvine3 Labs, San Valentino Vascular Screening Project, and International Agency for Pharma-Standard Supplements (IA-PSS), Pescara, Italy -
Minerva Gastroenterol (Torino). 2024 Mar;70(1):36-41. doi: 10.23736/S2724-5985.22.03245-4. Epub 2023 May 10.
The aim of this pilot, supplement study was the evaluation of primary, idiopathic mucosal mouth dryness (xerostomia or dry mouth) in subjects without systemic diseases.
Subjects with xerostomia were managed either with standard management (SM) or with SM and a Pycnogenol mouth spray (Hankintatukku Oy, Karkkila, Finland), at the dosage of 60 mg/day in 30 spurts, for 2 weeks.
A total of 50 subjects were included in the study: 25 controls using only standard management (SM) and 25 subjects using the Pycnogenol mouth spray. No side effects and no tolerability problems were observed with the Pycnogenol mouth spray. The groups were comparable for characteristics and symptoms at baseline. These otherwise healthy subjects had a BMI<26. After 2 weeks, salivary flow and salivary oxidative stress (in Carr Units) were improved significantly with Pycnogenol mouth spray as compared to controls (P<0.05), whereas minimal improvements in salivary flow were seen with SM. The subjective symptomatic dry mouth score and the number of mucosal breaks and ulcerations (all minimal, <1 mm in length or diameter) were significantly decreased with the Pycnogenol mouth spray supplement compared to SM controls (P<0.05). The Pycnogenol mouth spray led to significant improvement in salivary lysozyme levels, compared to controls (P<0.05).
Based on these preliminary results, Pycnogenol mouth spray could be a new supplementary option for the management of primary xerostomia.
本初步研究的目的是评估无系统性疾病受试者原发性、特发性口腔黏膜干燥症（口干或干燥症）。
口干受试者采用标准治疗（SM）或 SM 加碧萝芷口腔喷雾（芬兰 HankintatukkuOy，Karkkila）治疗，剂量为每天 60mg，分 30 次喷入，疗程 2 周。
共有 50 名受试者入组本研究：25 名对照组仅采用标准治疗（SM），25 名受试者采用碧萝芷口腔喷雾。碧萝芷口腔喷雾无副作用，无耐受性问题。两组在基线时的特征和症状具有可比性。这些健康受试者的 BMI<26。治疗 2 周后，与对照组相比，碧萝芷口腔喷雾可显著改善唾液流量和唾液氧化应激（以 Carr 单位计）（P<0.05），而 SM 仅使唾液流量略有改善。与 SM 对照组相比，碧萝芷口腔喷雾补充剂可显著降低主观症状性口干评分以及黏膜破损和溃疡数量（均为微小，长度或直径<1mm）（P<0.05）。与对照组相比，碧萝芷口腔喷雾可显著提高唾液溶菌酶水平（P<0.05）。
基于这些初步结果，碧萝芷口腔喷雾可能成为原发性口干症治疗的一种新的补充选择。
