Department of Pulmonary Diseases and Children Rheumatology, Medical University of Lublin, Lublin, Poland.
Department of Clinical Immunology, Medical University of Lublin, Lublin, Poland.
Front Immunol. 2023 Jan 17;14:1073788. doi: 10.3389/fimmu.2023.1073788. eCollection 2023.
There are many drugs for allergic rhinitis (AR), however, these drugs show variable clinical effectiveness and some side effects. Therefore, new methods of AR pharmacotherapy are being sought.
The objectives of this study were to evaluate the efficacy of polyvalent mechanical bacterial lysate (PMBL) therapy in improving the clinical course of grass pollen-induced AR (seasonal AR, SAR) in children and its effect on changes in the blood level of the γδT, iNKT and cytotoxic T cell subsets.
Fifty children with SAR were enrolled in this study and were randomly assigned to either the PMBL group or the placebo group. The severity of SAR symptoms was assessed using the total nasal symptom score (TNSS) and visual analogue scale (VAS). During two visits (V1, V2), peak nasal inspiratory flow (PNIF) was measured and peripheral blood was collected for immunological analyses. The study also included 2 telephone contacts (TC1, TC2).
The severity of the nasal symptoms of SAR on the TNSS scale was revealed to have a significantly lower impact in the PMBL group vs the placebo group at measuring points TC1 and V2 (p = 0.01, p = 0.009, respectively). A statistically significantly lower mean severity of nasal symptoms of SAR on the VAS scale was recorded for children in the PMBL group compared to the placebo group at measuring points TC1, V2 and TC2 (p = 0.04, p = 0.04, p = 0.03, respectively). The compared groups do not show significant differences in terms of PNIF values at individual measuring points. There were no statistically significant changes in immune variables. For both groups, there was a statistically significant association between the level of Th1-like γδT cells and the severity of SAR symptoms expressed on the TNSS scale (p = 0.03) - the lower the level of Th1-like γδT cells, the higher the TNSS value.
Administration of sublingual PMBL tablets during the grass pollen season proves to have a high efficacy in alleviating SAR symptoms in children sensitized to grass pollen allergens. Th1-like γδT cells may be used as potential markers for SAR severity in children.
ClinicalTrials.gov, identifier (NCT04802616).
有许多治疗过敏性鼻炎 (AR) 的药物，但这些药物的临床疗效存在差异，且有些具有副作用。因此，人们正在寻找新的 AR 药物治疗方法。
本研究旨在评估多价机械细菌裂解物 (PMBL) 疗法对改善儿童花粉季节变应性鼻炎 (季节性 AR，SAR) 临床病程的疗效及其对 γδT、iNKT 和细胞毒性 T 细胞亚群血液水平变化的影响。
本研究纳入了 50 名 SAR 患儿，他们被随机分配到 PMBL 组或安慰剂组。采用总鼻症状评分 (TNSS) 和视觉模拟评分 (VAS) 评估 SAR 症状严重程度。在两次就诊 (V1、V2) 时测量鼻峰吸气流量 (PNIF)，并采集外周血进行免疫分析。研究还包括 2 次电话随访 (TC1、TC2)。
在 PMBL 组，与安慰剂组相比，在 TC1 和 V2 测量点时，SAR 鼻症状的 TNSS 评分显示出显著更低的严重程度 (p = 0.01，p = 0.009)。PMBL 组患儿在 TC1、V2 和 TC2 测量点时，SAR 鼻症状的 VAS 评分的平均严重程度显著低于安慰剂组 (p = 0.04，p = 0.04，p = 0.03)。两组在各测量点的 PNIF 值方面无显著差异。免疫变量无显著变化。对于两组，Th1 样 γδT 细胞水平与 TNSS 评分表示的 SAR 症状严重程度之间存在显著关联 (p = 0.03) - Th1 样 γδT 细胞水平越低，TNSS 值越高。
在花粉季节给予舌下 PMBL 片剂，可显著缓解儿童对花粉变应原致敏的 SAR 症状。Th1 样 γδT 细胞可作为儿童 SAR 严重程度的潜在标志物。
ClinicalTrials.gov，标识符 (NCT04802616)。
