目的 评估血清IgG4检测对诊断IgG4相关性疾病(IgG4-RD)的临床意义.方法 回顾性研究2011年2月至2013年3月首次在北京协和医院就诊的成年人IgG4-RD患者160例,均有详细的临床资料和最终明确诊断,同时选取126例患者为其他非血清IgG4相关的免疫性疾病对照组,125名来自北京协和医院体检中心的健康体检者作为健康对照组.采用散射比浊法测定血清IgG4,160例患者的血清IgG4结果以首次就诊时检测结果为准.所有数据采用SPSS13.0统计学软件进行统计分析.结果 160例IgG4-RD患者中132例患者血清IgG4高于目前国际上制定的血清IgG4最高参考上限1 350 mg/L,占其总数的82.5%.疾病对照组中有26例血清IgG4水平升高,占其总数的20.6%.IgG4-RD组血清IgG4高于疾病对照组和健康对照组,差异均有统计学意义(x2=110.8、158.6,P均<0.05).而疾病对照组和健康对照组进行统计分析,差异无统计学意义(x2=1.964,P>0.05).通过IgG4-RD组和对照组绘制ROC曲线,计算区分IgG4-RD组和对照组最佳诊断界限值为1575 mg/L.结论 用于诊断中国IgG4-RD的血清IgG4最佳诊断界限值不同于目前国际上通用的标准,建立中国人的参考区间具有重要意义.
Objective To evaluate the clinical applications of serum IgG4 for the diagnosis of IgG4-related disease (IgG4-RD).Methods In this retrospective study,160 adult patients with IgG4-RD who in their first time visit in Peiking Union Medical College Hospital between 2011 to 2013 were reviewed.All patients had detailed clinical reference and final clear diagnosis.Meantime we selected 126 patients with other non-IgG4-related immune disease and 125 healthy subjects as controls from Peiking Union Medical College Hospital physical checkup center,IgG4 was detected by nephelometry,takeing the first testing result for analysis.Statistical analysis was performed using SPSS13.0 software.Results Serum IgG4 levels higher than 1 350 mg/L were seen in 82.5% of the patients (132/160) with IgG4-RD and 20.6% of the patients (26/126) with other diseases respectively.The serum concentrations of IgG4 in IgG4-RD group were significantly higher than other disease group and healthy control group (x2 =110.8,158.6,P < 0.05).There was no significant difference between other disease group and the healthy control group(x2 =1.964,P =0.161 > 0.05).The optimal diagnostic cut-off values for IgG4-RD was 1575mg / L.Conclusion The best diagnostic cut valuse of serum IgG4 for Chinese IgG4-RD is different from the current international standard,and realize that to establish reference vange of Chinese for diagnosis of IgG4-RD has very important significance.