多价机械细菌裂解物对哮喘儿童淋巴细胞数量和活性的影响：一项随机对照试验
Impact of Polyvalent Mechanical Bacterial Lysate on lymphocyte number and activity in asthmatic children: a randomized controlled trial.
作者信息
Bartkowiak-Emeryk Małgorzata, Emeryk Andrzej, Roliński Jacek, Wawryk-Gawda Ewelina, Markut-Miotła Ewa
机构信息
Department of Clinical Immunology, Medical University of Lublin, Lublin, Poland.
Department of Paediatric Pulmonology and Rheumatology, Medical University of Lublin, Lublin, Poland.
出版信息
Allergy Asthma Clin Immunol. 2021 Jan 20;17(1):10. doi: 10.1186/s13223-020-00503-4.
BACKGROUND
Polyvalent Mechanical Bacterial Lysate (PMBL®) contains antigens of bacteria responsible for respiratory infections. PMBL® has been proven to reduce the number of respiratory infections, and in its use, immunological benefits have been seen in allergic patients. PMBL® activates both innate and specific immune responses. The lysate induces dendritic cells, T and B lymphocytes and IgA secretion, as well as the production of antibodies directed against administered bacterial antigens. Moreover, it increases the response against other bacteria and viruses. The immunologic mechanism of lysate's action is not yet clearly determined. The objective of this study was to assess the effect of PMBL® on T cells in children with allergic asthma.
METHODS
This study was a part of the EOLIA study. Herein, 49 children with allergic asthma and house dust mites allergy were included: 21 in PMBL® and 28 in the Placebo group, both, drug and placebo were administered sublingually. The tests were done at baseline and 12 weeks after the last tablet intake. The lymphocytes CD45+, lymphocytes T CD3+, CD3+CD25+, CD3+CD69+, Th CD3+CD4+, CD4+CD25+, CD4+CD25+ high, CD4+CD69+, Treg CD4+CD25+FOXP3, Tc CD3+CD8+, CD8+CD25+, CD8+CD69+, NK-like T CD3+CD16+CD56+ and NK cells CD3-CD16+CD56+ were described.
RESULTS
At baseline, no significant differences between groups relative to blood count cells were observed, except for eosinophils. After 12 weeks, we observed an increase of T lymphocytes count. In addition, CD4+CD25+FOXP3+, CD8+ and CD3-CD16+CD56+ and (insignificantly) Th count increased. However, CD69+ and CD25+ subset of CD3+ significantly decreased.
CONCLUSIONS
The EOLIA study demonstrated that PMBL® administration 10 days per month for 3 months changed the panel of T lymphocytes. Trial registration Clinical Trial Registration: This study was a part of the EOLIA (Efficacy Of mechanical bacterial Lysate In Allergic children), a clinical study NCT02541331. Frederic Durmont, MD Lallemand Pharma International AG. Date of registration 09/08/2013. URL of trial registry record: https://clinicaltrials.gov/ct2/show/study/NCT02541331.
背景
多价机械细菌裂解物（PMBL®）含有引发呼吸道感染的细菌抗原。已证实PMBL®可减少呼吸道感染的次数，并且在其使用过程中，已在过敏患者中观察到免疫益处。PMBL®可激活先天性免疫反应和特异性免疫反应。该裂解物可诱导树突状细胞、T和B淋巴细胞以及IgA分泌，以及针对所给予细菌抗原的抗体产生。此外，它还可增强针对其他细菌和病毒的反应。裂解物作用的免疫机制尚未明确确定。本研究的目的是评估PMBL®对过敏性哮喘儿童T细胞的影响。
方法
本研究是EOLIA研究的一部分。在此，纳入了49例患有过敏性哮喘和屋尘螨过敏的儿童：21例接受PMBL®治疗，28例在安慰剂组，药物和安慰剂均通过舌下给药。在基线时以及最后一次服药后12周进行检测。描述了淋巴细胞CD45+、淋巴细胞T CD3+、CD3+CD25+、CD3+CD69+、辅助性T细胞CD3+CD4+、CD4+CD25+、CD4+CD25+高表达、CD4+CD69+、调节性T细胞CD4+CD25+FOXP3、细胞毒性T细胞CD3+CD8+、CD8+CD25+、CD8+CD69+、自然杀伤样T细胞CD3+CD16+CD56+和自然杀伤细胞CD3-CD16+CD56+。
结果
在基线时，除嗜酸性粒细胞外，各小组之间在血细胞计数方面未观察到显著差异。12周后，我们观察到T淋巴细胞计数增加。此外，CD4+CD25+FOXP3+、CD8+以及CD3-CD16+CD56+和（不显著）辅助性T细胞计数增加。然而，CD3+的CD69+和CD25+亚群显著减少。
结论
EOLIA研究表明，每月服用10天，连续服用3个月的PMBL®改变了T淋巴细胞谱。试验注册 临床试验注册：本研究是EOLIA（机械细菌裂解物在过敏性儿童中的疗效）临床研究NCT02541331的一部分。弗雷德里克·杜蒙特，医学博士 拉勒曼德制药国际公司。注册日期2013年8月9日。试验注册记录的网址：https://clinicaltrials.gov/ct2/show/study/NCT02541331。
Zotero 插件