血清IgG4水平对IgG4相关胰-肝胆疾病与非IgG4相关胰-肝胆疾病的鉴别诊断价值

李畅; 闫雷; 王丽; 韩崇旭; 叶耘峰; 靳德甫; 姜玉章

doi:10.3969/j.issn.1001-5256.2022.06.017

血清IgG4水平对IgG4相关胰-肝胆疾病与非IgG4相关胰-肝胆疾病的鉴别诊断价值

DOI: 10.3969/j.issn.1001-5256.2022.06.017

李畅¹,
闫雷¹,
王丽²,
韩崇旭³,
叶耘峰⁴,
靳德甫¹,
姜玉章^1, , ,

1.
南京医科大学附属淮安第一医院医学检验科，江苏淮安 223300
2.
徐州市第一人民医院医学检验科，江苏徐州 221000
3.
苏北人民医院医学检验科，江苏扬州 225000
4.
江苏职业护理学院，江苏淮安 223300

基金项目:

淮安市创新服务能力建设计划-重点实验室建设 (HAP202004)

伦理学声明：本研究于2021年9月16日经由南京医科大学附属淮安第一医院伦理委员会批准，批号为YX-2021-086-01，患者均签署知情同意书。

利益冲突声明：本研究不存在研究者、伦理委员会成员、受试者监护人以及与公开研究成果有关的利益冲突。

作者贡献声明：姜玉章、李畅、叶耘峰负责课题设计；李畅、闫雷负责实验操作，资料分析和撰写论文；王丽、韩崇旭、闫雷参与收集部分数据，修改论文；姜玉章负责拟定写作思路，指导撰写文章并最后定稿。

详细信息

通信作者:
姜玉章，jyz8848@163.com

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出版历程
- 收稿日期: 2021-10-01
- 录用日期: 2021-11-23
- 出版日期: 2022-06-20

Value of serum IgG4 level in differential diagnosis of IgG4-related pancreatic and hepatobiliary diseases and non-IgG4-related pancreatic and hepatobiliary diseases

1.
Department of Clinical Laboratory, Huai'an No. 1 People's Hospital Affiliated to Nanjing Medical University, Huai'an, Jiangsu 223300, China
2.
Department of Clinical Laboratory, Xuzhou First People's Hospital, Xuzhou, Jiangsu 221000, China
3.
Department of Clinical Laboratory, Subei People's Hospital, Yangzhou, Jiangsu 225000, China
4.
Jiangsu College of Nursing, Huai'an, Jiangsu 223300, China

Research funding:

Huai'an City Innovation Service Capacity and Key Laboratory Construction Building Plan (HAP202004)

More Information

Corresponding author: JIANG Yuzhang, jyz8848@163.com (ORCID:0000-0002-8544-9485)

摘要

摘要: 目的探讨血清IgG4水平在鉴别诊断IgG4相关胰-肝胆疾病(IgG4-PHD)与非IgG4相关性疾病(IgG4-RD)的自身免疫性疾病中的应用价值。方法选择2014年8月— 2021年4月于南京医科大学附属淮安第一医院、苏北人民医院及徐州医科大学附属第一医院住院治疗的541例就诊患者和健康体检人群的临床资料，分为4组：IgG4-PHD组(n=20);非IgG4-RD自身免疫性疾病组(n=431)，包括系统性红斑狼疮104例，类风湿性关节炎79例，干燥综合征174例，强直性脊柱炎16例，硬皮病11例，成人Still病4例，肌炎30例，银屑病3例，原发性硬化性胆管炎10例；胰腺肝脏胆囊恶性肿瘤组(n=40)；健康对照组(n=50)。使用免疫散射比浊法测定各组样本血清IgG4水平。计量资料组间比较使用两样本Mann-Whitney U检验，计数资料组间比较采用Fisher精确检验。绘制受试者工作特征曲线(ROC曲线)，确定IgG4诊断IgG4-PHD的最佳临界值。结果 IgG4-PHD组血清IgG4水平均明显高于非IgG4-RD自身免疫性疾病各组、胰腺肝脏胆囊恶性肿瘤组和健康对照组(P值均＜0.05)，单独干燥综合征组血清IgG4水平显著低于健康对照组(Z=2.958，P＜0.05)。分别以血清IgG4≥1.35 g/L和IgG4≥2.01 g/L作为临界值，IgG4-PHD组的阳性率明显高于非IgG4-RD自身免疫性疾病组和健康对照组，差异均具有统计学意义(P值均＜0.05)。ROC曲线显示，以IgG4≥2.21 g/L作为鉴别诊断IgG4-PHD与非IgG4-RD自身免疫性疾病的临界值时，敏感度为100.00%，特异度为94.00%，AUC为0.980。结论非IgG4-RD自身免疫性疾病也可出现血清IgG4水平升高，而以2.21 g/L作为诊断临界值，能提升对IgG4-PHD与非IgG4-RD自身免疫性疾病的鉴别诊断效能，但仍需在临床中进一步验证。
- 免疫球蛋白G /
- 自身免疫疾病 /
- 诊断
Abstract: Objective To investigate the value of serum IgG4 level in the differential diagnosis of IgG4-related pancreatic and hepatobiliary disease (IgG4-PHD) and non-IgG4-related disease (non-IgG4-RD). Methods Clinical data were collected from 491 patients who were hospitalized and 50 individuals who underwent physical examination in Huaian No. 1 People's Hospital Affiliated to Nanjing Medical University, Subei People's Hospital, and The First Affiliated Hospital of Xuzhou Medical University from August 2014 to April 2021. The 491 patients were divided into IgG4-PHD group with 20 patients, non-IgG4-RD autoimmune disease group with 431 patients (104 patients with systemic lupus erythematosus, 79 with rheumatoid arthritis, 174 with Sjogren's syndrome, 16 with ankylosing spondylitis, 11 with scleroderma, 4 with adult-onset Still's disease, 30 with myositis, 3 with psoriasis, and 10 with primary sclerosing cholangitis), and malignant pancreatic/hepatobiliary tumor group with 40 patients, and the 50 individuals undergoing physical examination were enrolled as healthy control group. Scattering immunoturbidimetric assay was used to measure serum IgG4 concentration. The two-sample Mann-Whitney U test was used for comparison of normally distributed continuous data between groups, and the Fisher's exact test was used for comparison of categorical data between groups. The receiver operating characteristic (ROC) curve was plotted to determine the optimal cut-off value of serum IgG4 in the diagnosis of IgG4-PHD. Results The IgG4-PHD group had a significantly higher serum IgG4 level than the non-IgG4-RD autoimmune disease groups, the malignant pancreatic/hepatobiliary tumor group, and the healthy control group (all P < 0.05), and the Sjogren's syndrome group had a significantly lower serum IgG4 level than the healthy control group (Z=2.958, P < 0.05). With serum IgG4 ≥1.35 g/L and IgG4 ≥2.01 g/L as the cut-off values, the IgG4-PHD group had a significantly higher positive rate than the non-IgG4-RD autoimmune disease group and the healthy control group (all P < 0.05). The ROC curve analysis showed that IgG4 had an area under the ROC curve of 0.980 in the differential diagnosis of IgG4-PHD and non-IgG4-RD autoimmune diseases, with a sensitivity of 100.00% and a specificity of 94.00% at the optimal cut-off value of 2.21 g/L. Conclusion Serum IgG4 level may also increase in non-IgG4-RD autoimmune diseases, while the cut-off value of 2.21 g/L can improve the differential diagnosis of IgG4-PHD and non-IgG4-RD autoimmune diseases, which requires further verification in clinical practice.
- Immunoglobulin G /
- Autoimmune Diseases /
- Diagnosis

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图 1 各组IgG4水平的比较

Figure 1. Comparison of IgG4 level among groups

下载: 全尺寸图片幻灯片

图 2 血清IgG4诊断IgG4-PHD的ROC曲线

Figure 2. ROC curve of serum IgG4 for diagnosing IgG4-PHD

下载: 全尺寸图片幻灯片

表 1 各组研究对象资料

Table 1. Basic information of subjects in each group

组别	例数	男/女(例)	年龄(岁)
IgG4-PHD组	20	18/2	65(61~69)
非IgG4-RD自身免疫性疾病组
SLE	104	10/94	40±14
RA	79	20/59	56±12
SS	174	20/154	54±13
AS	16	7/9	41±15
SD	11	2/9	47±10
AOSD	4	3/1	42±4
MS	30	17/13	56(43~67)
PR	3	2/1	51±13
PSC	10	4/6	59±15
PHT组	40	27/13	56±16
健康对照组	50	24/26	47±15
注：SLE，系统性红斑狼疮；RA，类风湿性关节炎；SS，干燥综合征；AS，强直性脊柱炎；SD，硬皮病；AOSD，成人Still病；MS，肌炎；PR，银屑病；PSC，原发性硬化性胆管炎。

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表 2 不同IgG4诊断标准下各组血清IgG4阳性率比较

Table 2. Comparison of the positive rate of serum IgG4 in each group under different diagnostic criteria of IgG4

组别	例数	阳性[例(%)]
组别	例数	IgG4≥1.35 g/L	IgG4≥2.01 g/L
IgG4-PHD组	20	20(100.00)	20(100.00)
非IgG4-RD自身免疫性疾病组	431	48(11.14)¹⁾	27(6.26)¹⁾
PHT组	40	6(15.00)¹⁾	0¹⁾
健康对照组	50	4(8.00)¹⁾	2(4.00)¹⁾
P值		＜0.001	＜0.001
注：与IgG4-PHD组比较，1)P＜0.001。

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