Elevated positive rate of 21-hydroxylase antibodies in the population with type 1 diabetes mellitus: A meta-analysis

Objective Given that the autoimmune mechanism might be the common pathological basis for 21-hydroxylase antibody positivity and type 1 diabetes mellitus (T1DM), these two conditions may coexist in some patients. This meta-analysis aims to provide more reliable and powerful evidence by systematically integrating and analyzing the raw data of all relevant studies, in order to clarify whether there is a statistically significant association between 21-hydroxylase antibody positivity and T1DM.Methods To screen and evaluate relevant studies on the association between 21-hydroxylase antibodies and T1DM, we systematically searched the PubMed, Web of Science, CNKI, and CBM databases. The search period was set from January 1995 to December 2024, and the languages of the included literature were limited to English or Chinese. Based on the extracted data, the odds ratio (OR) and its 95% confidence interval (CI) and P value were calculated to assess the statistical association between the two.Results A total of 10 independent studies were included in this research, with a total of 2 852 T1DM patients and 1 596 non-diabetic control individuals. The results of the meta-analysis showed that the positive rate of 21-hydroxylase antibodies in T1DM patients was significantly higher than that in the control group (OR=3.35, 95%CI 1.80 to 6.24). The publication bias test did not detect any significant bias, and the sensitivity analysis further confirmed the stability and reliability of the analysis results.Conclusion The results of this meta-analysis indicate that the positive rate of 21-hydroxylase antibodies in T1DM patients is significantly higher compared to the non-diabetic control population, suggesting a potential immune association between the two. It is worthy of further exploration of the underlying mechanism in future studies.

研究目的：鉴于自身免疫机制可能是21-羟化酶抗体（21-hydroxylase antibody）阳性与1型糖尿病（T1DM）共通的病理基础，二者可在部分患者中共同发生。本荟萃分析旨在系统整合并分析所有相关研究的原始数据，以提供更为可靠且有力的证据，明确21-羟化酶抗体阳性与T1DM之间是否存在具有统计学意义的关联。

研究方法：为筛选并评估21-羟化酶抗体与T1DM关联的相关研究，我们系统检索了PubMed、Web of Science、中国知网（CNKI）及中国生物医学文献数据库（CBM），检索时限设置为1995年1月至2024年12月，纳入文献的语言限定为英文或中文。基于提取的研究数据，计算比值比（OR）及其95%置信区间（CI）与P值，以评估二者间的统计学关联。

研究结果：本研究共纳入10项独立研究，总计纳入2852例T1DM患者与1596例非糖尿病对照个体。荟萃分析结果显示，T1DM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）。发表偏倚检验未检出显著偏倚，敏感性分析进一步证实了本分析结果的稳定性与可靠性。

研究结论：本荟萃分析结果表明，T1DM患者的21-羟化酶抗体阳性率显著高于非糖尿病对照人群，提示二者间存在潜在的免疫关联，其潜在发病机制值得在未来研究中进一步探索。