Belcaro Gianni, Cesarone M Rosaria, Cornelli Umberto, Scipione Claudia, Scipione Valeria, Dugall Mark, Hu Shu, Feragalli Beatrice, Hosoi Morio, Maione Claudia, Cotellese Roberto, Cesinaro Di Rocco Paola
Irvine3 Labs, Department of Medical and Oral Sciences and Biotechnologies, G. d'Annunzio University, Pescara, Italy -
International Agency for Pharma-Standard Supplements (IA-PSS), Pescara, Italy -
Minerva Stomatol. 2019 Dec;68(6):303-307. doi: 10.23736/S0026-4970.19.04311-5.
The aim of this pilot study was the evaluation of primary, idiopathic mucosal dryness (xerostomia or dry mouth) in subjects without cancer.
A group of non-diabetic subjects and a group of diabetics were managed with standard management (SM) or with SM+Pycnogenol® (150 mg/day) for 2 weeks.
In total, 48 subjects were included in the study; 24 diabetics and 24 non-diabetics. 12 diabetics and 12 non-diabetics took Pycnogenol® and 12 diabetics and 12 non-diabetics were followed up with standard management only and served as controls. No side effects and no tolerability problems were observed with Pycnogenol®. The registry groups were comparable for characteristics and symptoms at baseline. All otherwise healthy subjects had a BMI<26 kg/m2. In 2 weeks, salivary flow and oxidative stress improved significantly in both groups of subjects (non-diabetics and diabetics) with 150 mg/day Pycnogenol® (P<0.05), while minimal improvements in salivary flow were seen with SM. The subjective score and the number of mucosal breaks and ulcerations, all minimal (<1 mm in length or diameter), were significantly decreased with Pycnogenol® supplementation (P<0.05) with minimal variations in the SM controls. Finally, the mean lysozyme level in parotid saliva samples was significantly increased in the Pycnogenol® group (P<0.05) both in diabetics and non-diabetics.
Based on these preliminary results, Pycnogenol® could be a new, valid option for the treatment of xerostomia.
本初步研究的目的是评估无癌症受试者的原发性特发性黏膜干燥（口干症或口腔干燥）情况。
一组非糖尿病受试者和一组糖尿病患者分别采用标准治疗（SM）或标准治疗+碧萝芷®（150毫克/天）治疗2周。
本研究共纳入48名受试者，其中24名糖尿病患者和24名非糖尿病患者。12名糖尿病患者和12名非糖尿病患者服用碧萝芷®，12名糖尿病患者和12名非糖尿病患者仅接受标准治疗作为对照。未观察到碧萝芷®有任何副作用和耐受性问题。各登记组在基线时的特征和症状具有可比性。所有其他方面健康的受试者体重指数（BMI）均<26千克/平方米。两周内，服用150毫克/天碧萝芷®的两组受试者（非糖尿病患者和糖尿病患者）唾液流量和氧化应激均显著改善（P<0.05），而标准治疗组唾液流量改善甚微。补充碧萝芷®后，主观评分以及黏膜破损和溃疡的数量（均极小，长度或直径<1毫米）均显著降低（P<0.05），标准治疗对照组变化极小。最后，碧萝芷®组糖尿病患者和非糖尿病患者腮腺唾液样本中的溶菌酶平均水平均显著升高（P<0.05）。
基于这些初步结果，碧萝芷®可能是治疗口干症的一种新的有效选择。
