Elevated prevalence of 21-hydroxylase antibody in individuals with type 1 diabetes mellitus: A meta-analysis

Objective Type 1 diabetes mellitus (T1DM) is a chronic disorder resulting from the autoimmune destruction of pancreatic β-cells, frequently accompanied by derangements in immune regulation. The 21-hydroxylase antibody, a specific autoantibody targeting adrenal tissue, has been widely recognized as a pivotal immunological marker for Addison's disease. Considering that the autoimmune mechanism might serve as a shared pathological foundation for both 21-hydroxylase antibody positivity and T1DM, co-occurrence of these two conditions may be observed in certain patients. This meta-analysis aims to provide more robust and statistically valid evidence by integrating the raw data from relevant studies, thereby clarifying whether a statistical association exists between 21-hydroxylase antibody positivity and T1DM.Methods A systematic search was conducted across the PubMed, Web of Science, CNKI, and CBM databases. Based on the data extracted from the retrieved studies, the odds ratio (OR) and its 95% confidence interval (CI) were calculated to assess the statistical association between the two variables.Results A total of 10 independent studies were included in this investigation, encompassing 2 852 patients with T1DM and 1 596 non-diabetic control subjects. The results of the meta-analysis indicated that the prevalence of positive 21-hydroxylase antibody among T1DM patients was significantly higher than that in the control group [OR=3.35, 95%CI(1.80, 6.24)]. Sub-group analyses revealed that, within both the Asian and American populations, the proportion of T1DM patients with positive 21-hydroxylase antibody was notably higher compared to the control groups [OR=2.99, 95%CI(1.17, 7.66); OR=8.79, 95%CI(2.04, 37.98)]. Conversely, no statistically significant association was detected in the European population [OR=1.17, 95%CI(0.36, 3.79)]. The results of sensitivity analyses and publication bias assessments affirmed the sound stability and reliability of the conclusions drawn from this meta-analysis.Conclusion The results of this meta-analysis demonstrate that the prevalence of positive 21-hydroxylase antibody is significantly elevated in patients with T1DM compared to non-diabetic controls, suggesting a potential specific immunological connection between the two entities.

研究目的：1型糖尿病（Type 1 diabetes mellitus, T1DM）是一种由胰腺β细胞自身免疫破坏导致的慢性疾病，常伴随免疫调节紊乱。21-羟化酶抗体（21-hydroxylase antibody）是一种靶向肾上腺组织的特异性自身抗体，已被广泛认定为艾迪生病（Addison's disease）的关键免疫学标志物。鉴于自身免疫机制可能是21-羟化酶抗体阳性与1型糖尿病共有的病理基础，部分患者可观察到两种病症的共存。本荟萃分析旨在整合相关研究的原始数据，提供更具可靠性与统计学严谨性的证据，以明确21-羟化酶抗体阳性与1型糖尿病之间是否存在统计学关联。
研究方法：系统检索了PubMed、Web of Science、中国知网（CNKI）及中国生物医学文献数据库（CBM）。基于检索所得研究中提取的数据，计算比值比（odds ratio, OR）及其95%置信区间（confidence interval, CI），以此评估两个变量间的统计学关联。
研究结果：本研究共纳入10项独立研究，涵盖2852例1型糖尿病患者与1596例非糖尿病对照受试者。荟萃分析结果显示，1型糖尿病患者的21-羟化酶抗体阳性率显著高于对照组[OR=3.35, 95%CI(1.80, 6.24)]。亚组分析表明，在亚洲及美洲人群中，1型糖尿病患者的21-羟化酶抗体阳性比例均显著高于对照组[OR=2.99, 95%CI(1.17, 7.66)；OR=8.79, 95%CI(2.04, 37.98)]。反之，欧洲人群中未检测到具有统计学意义的关联[OR=1.17, 95%CI(0.36, 3.79)]。敏感性分析与发表偏倚评估结果证实，本荟萃分析所得结论具备良好的稳定性与可靠性。
研究结论：本荟萃分析结果显示，与非糖尿病对照人群相比，1型糖尿病患者的21-羟化酶抗体阳性率显著升高，提示二者之间存在潜在的特异性免疫学关联。