血清IgG4 水平检测在IgG4 相关肝胆胰疾病诊断及疗效评估的价值研究

目的 研究血清免疫球蛋白(Ig)G4 水平在IgG4 相关肝胆胰疾病的诊断及疗效评估中的价值。方法 通过收集2020 年 8 月～ 2022 年 3 月来广东省人民医院检验科进行血清 IgG4 水平检测且明确诊断为肝胆胰疾病的患者267 例，将其分为IgG4 相关肝胆胰疾病组(n=19)和非IgG4 相关肝胆胰疾病组(n=248)。另外选取 50 例体检健康者作为对照组。采用乳胶免疫比浊法检测血清IgG4，比较各组血清IgG4 水平。应用ROC 曲线评价血清IgG4 水平鉴别诊断IgG4 相关肝胆胰疾病的最佳诊断界值及敏感度和特异度。收集实验室检测资料，分析其他实验室指标与血清IgG4 水平之间的相关性。结果 IgG4 相关肝胆胰疾病组血清IgG4 水平3.86(2.25，6.90)g/L] 显著高于非IgG4 相关肝胆胰疾病组0.75(0.47，1.29)g/L] 和健康对照组0.71(0.40，1.03)g/L]，差异具有统计学意义(Z = 3.641,6.314, 均P ＜ 0.01)。非IgG4 相关肝胆胰疾病中胆管肿瘤疾病组有20%(4/20) 的患者IgG4 水平高于正常值，在非IgG4 相关肝胆胰疾病中阳性率最高。通过IgG4 相关肝胆胰疾病组和其他对照组绘制ROC 曲线，最佳诊断界值为2.02g/L，AUC 为0.875(95%CI:0.953 ～ 0.995)。血清IgG4 水平仅与IgG 呈显著正相关(r=0.943，P ＜ 0.05)。IgG4 相关肝胆胰疾病组中其他实验室指标阳性率排名前三的是GGT(75.00%)，ALP(68.75%)和空腹GLU(61.11%)。IgG4 相关肝胆胰疾病患者有效治疗后血清IgG4 水平均明显降低(Z=-2.547，P=0.011)。结论 血清IgG4 水平鉴别诊断 IgG4 相关肝胆胰疾病最佳诊断界值为2.02g/L。动态观察血清IgG4 水平对诊断IgG4 相关肝胆胰疾病有重大提示作用。血清IgG4 也是判断临床治疗有效的重要指标。

Value of Serum IgG4 Level in the Diagnosis and Therapeutic Effect Evaluation of IgG4-related Hepatobiliary and Pancreatic Diseases

Objective To study the value of serum immunoglobulin (Ig) G4 level in the diagnosis and therapeutic effect evaluation of IgG4-related hepatobiliary and pancreatic diseases. Methods From August 2020 to March 2022, 267 patients who came to the Department of Clinical Laboratory, Guangdong Provincial People’s Hospital for serum IgG4 level detection and were diagnosed with hepatobiliary and pancreatic diseases were collected and divided into IgG4-related hepatobiliary and pancreatic disease groups (n=19) and non-IgG4-related hepatobiliary and pancreatic disease group (n=248). In addition, 50 healthy subjects were selected as the control group. Serum IgG4 was detected by latex immunoturbidimetry, and the levels of serum IgG4 in each group were analyzed and compared. The ROC curve was used to evaluate the optimal diagnostic cut-off value, sensitivity and specificity of serum IgG4 levels for differential diagnosis of IgG4-related hepatobiliary and pancreatic diseases. Collected test data of laboratory and analyzed the correlation between other laboratory indicators and serum IgG4 levels. Results The serum IgG4 level in the IgG4-related hepatobiliary and pancreatic disease group 3.86 (2.25, 6.90) g/L] was significantly higher than that in the non-IgG4-related hepatobiliary and pancreatic disease group 0.75 (0.47, 1.29) g/L] and the healthy control group 0.71 (0.40, 1.03)g/L], and the differences were statistically significant (Z=3.641, 6.314, all P<0.01). Among the non-IgG4-related hepatobiliary and pancreatic diseases, 20% (4/20) of the patients in the bile duct tumor disease group had IgG4 levels higher than the normal value, and the positive rate was the highest in the non-IgG4-related hepatobiliary and pancreatic diseases. The ROC curve was drawn by the IgG4-related hepatobiliary and pancreatic disease group and other control groups, the optimal diagnostic cutoff was 2.02 g/L, and the AUC was 0.875 (95%CI: 0.953~0.995). Serum IgG4 levels were only significantly correlated with IgG (r=0.943, P ＜ 0.05). The top three positive rates of other laboratory indicators in the IgG4-related hepatobiliary and pancreatic disease group were GGT (75%), ALP (68.75%) and fasting GLU (61.11%). Serum IgG4 levels were significantly decreased in patients with IgG4-related hepatobiliary and pancreatic diseases after effective treatment (Z=-2.547, P=0.011). Conclusion The optimal diagnostic cut-off value of IgG4-related hepatobiliary and pancreatic diseases for differential diagnosis of IgG4-related hepatobiliary and pancreatic diseases was 2.02g/L. Dynamic observation of serum IgG4 levels has a significant hinting effect on the diagnosis of IgG4-related hepatobiliary and pancreatic diseases. Serum IgG4 was also an important indicator to judge the effectiveness of clinical treatment.