Ege University, The Medical School, Department of Pediatric Immunology, Izmir, Turkey.
Int Immunopharmacol. 2011 Nov;11(11):1747-51. doi: 10.1016/j.intimp.2011.06.009. Epub 2011 Jul 21.
IgA deficiency (IgAD) is the most common primary antibody deficiency. Although two-third of the cases are reported to be asymptomatic, some IgAD children may have frequent infections that urge the clinicians to search for prophylactic measures. OM-85 BV is one of these agents that is known to stimulate mucosa associated lymphoid tissue, and upregulate Th-1 response. This study was performed to determine a possible role of OM-85 BV in triggering autoimmunity in IgAD children within a four-year-follow up period.
Sixty-three children (34 males (54%), 29 females (46%)) with sporadic IgAD and recurrent febrile infections were included. Patients were carefully screened for autoimmunity both on admission and in follow-up: Those with autoimmune features or under immunosuppressant treatment were excluded. Patients were randomly divided into two groups: Group I received bacterial lysate propylaxis (OM-85 BV) (n:37), and Group 2 received no prophylactic regimen (n:26). Development of clinical autoimmune findings or autoantibodies (anti-nuclear antibody (ANA), ANA profile (14 antigens), anti-cytoplasmic antibodies (ANCA), anti-cardiolipin antibodies IgG and IgM (aCL), rheumatoid factor (RF), direct Coombs test, anti-thyroglobulin (anti-T) and anti-thyroid microsomal antigen (anti-M)) were evaluated.
Mean age of the study group, age at the onset of infectious symptoms and at admission were 102.9±42.2, 27.1±24.9, and 55.2±25.1 months, respectively. Follow-up duration of the whole study group was 48.3±23.1 months. Number of infections was 6.2±2.7 per year in the whole study group. Sixteen patients (25.4%) of the whole study group showed ANA positivity in different patterns and titers. Frequency of ANA, ANCA and RF positivity was 24.3%, 5.4%, 2.7% in Group 1, and 26.9%, 11.5%, 3.8% in Group 2, respectively. Statistical comparisons revealed no significant difference between the two groups.
Significant clinical or laboratory markers for autoimmunity in follow-up were not observed between receivers or non-receivers of OM-85 BV. Frequency of ANA positivity was comparable to the previously reported values in IgAD children which was not affected by OM-85 BV usage. Possible effect of triggering autoimmunity with repeated cures of bacterial lysates needs to be further clarified. Side effects requiring the cessation of treatment were not recorded.
IgA 缺乏症（IgAD）是最常见的原发性抗体缺乏症。尽管三分之二的病例报告为无症状，但一些 IgAD 儿童可能会频繁感染，这促使临床医生寻找预防措施。OM-85BV 是一种已知能刺激黏膜相关淋巴组织并上调 Th1 反应的药物。本研究旨在确定 OM-85BV 在四年随访期间是否会在 IgAD 儿童中引发自身免疫。
纳入 63 例（34 名男性（54%），29 名女性（46%））散发性 IgAD 伴复发性发热性感染的儿童。对所有患者均进行自身免疫筛查，包括入院时和随访时：有自身免疫特征或正在接受免疫抑制治疗的患者被排除。患者被随机分为两组：一组接受细菌裂解物预防（OM-85BV）（n=37），另一组不接受预防方案（n=26）。评估临床自身免疫表现或自身抗体（抗核抗体（ANA）、ANA 谱（14 种抗原）、抗细胞质抗体（ANCA）、抗心磷脂抗体 IgG 和 IgM（aCL）、类风湿因子（RF）、直接抗人球蛋白试验、抗甲状腺球蛋白（anti-T）和抗甲状腺微粒体抗原（anti-M））的发展情况。
研究组的平均年龄、感染症状开始年龄和入院年龄分别为 102.9±42.2、27.1±24.9 和 55.2±25.1 个月。整个研究组的随访时间为 48.3±23.1 个月。整个研究组每年感染 6.2±2.7 次。整个研究组中有 16 名（25.4%）患者出现不同模式和滴度的 ANA 阳性。组 1 的 ANA、ANCA 和 RF 阳性率分别为 24.3%、5.4%和 2.7%，组 2 分别为 26.9%、11.5%和 3.8%。统计学比较显示两组间无显著差异。
在接受或不接受 OM-85BV 的患者中，在随访期间未观察到自身免疫的显著临床或实验室标志物。ANA 阳性率与 IgAD 儿童先前报道的值相当，不受 OM-85BV 使用的影响。反复使用细菌裂解物引发自身免疫的可能影响需要进一步澄清。未记录到因不良反应而停止治疗的情况。
