Yang Yushu, Qi Xuan, Ding Meng, Wang Wei, Guo Huifang, Gao Lixia
Department of Rheumatology and Immunology, the Second Hospital of Hebei Medical University, Shijiazhuang 050011, China.
Beijing Da Xue Xue Bao Yi Xue Ban. 2024 Oct 18;56(5):845-852. doi: 10.19723/j.issn.1671-167X.2024.05.015.
To assess the diagnostic value of anti-salivary gland protein-1 (SP1) antibody combined with anti-parotid secretory protein (PSP) antibody for Sjögren's syndrome (SS).
A total of 60 patients with primary SS (pSS) who were treated in the outpatient and inpatient department of Department of Rheumatology and Immunology of the Second Hospital of Hebei Medical University from January 2020 to December 2022 were collected. Thirty patients with other autoimmune diseases accompanied by dry mouth and/or dry eyes were collected as disease control group. Thirty healthy subjects from the physical examination center were collected for healthy control group, serum samples were obtained from all of them. Their general features and clinical information including clinical manifestations, laboratory examinations and other examinations were recorded. The 2016 American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) classification criteria were adopted as the diagnostic standard of pSS. Immunoglobulin G (IgG) subtype of anti-SP1 antibody and anti-PSP antibody were detected by chemiluminescence immunoassay. The receiver operating characteristic (ROC) curve was used to evaluate the accuracy of anti-SP1 antibody and anti-PSP antibody in diagnosing pSS.The cli-nical characteristics of anti-SP1 antibody and anti-PSP antibody positive patients and negative patients in pSS group were further compared. Independent samples test, Mann-Whitney test, variance analysis, Kruskal-Wallis test, Chi-square test or Fisher's exact test and Spearman correlation analysis were used for statistical analysis.
There was no significant difference in age (=1.406, =0.495) and gender (=2.105, =0.349) among pSS group, disease control group and healthy control group. The expression levels of anti-SP1 antibody (=16.73, < 0.001) and anti-PSP antibody (=26.09, < 0.001) were statistically different among the three groups. An intergroup comparison of anti-SP1 antibody expression levels showed that there was a statistically significant difference between pSS and healthy control group ( < 0.001), but no statistically significant difference between the other groups. Comparison of anti-PSP antibody expression levels between the groups showed that there were statistically significant differences between pSS and healthy control group ( < 0.001), and between disease control group and healthy control group (=0.009), while no statistically significant differences between the other groups. The positive rate of anti-SP1 antibody in pSS group was significantly higher than that in disease control group and healthy control group (58.33% 40.00% 13.33%, < 0.001). The positive rate of anti-PSP antibody in pSS group was significantly higher than that in disease control group and healthy control group (75.00% . 56.17% . 16.67%, < 0.001). The area under the curve for anti-SP1 antibody was 0.688 ( < 0.001). The sensitivity and specificity of anti-SP1 antibody were 58.33% (35/60) and 70.00% (42/60) respectively, the positive predictive value was 66.04% (35/53) and the negative predictive value was 54.55% (42/77) of anti-SP1 antibody.The area under the curve of anti-PSP antibody was 0.720 ( < 0.001), with a sensitivity was 75.00% (45/60), and specificity was 63.33% (38/60).The positive predictive value and negative predictive value of anti-PSP antibody were 67.16% (45/67) and 71.70% (38/53) respectively. All the 13 pSS patients were negative for anti-Sjögren's syndrome A (SSA, including SSA52 and SSA60) antibody and anti- Sjögren's syndrome B (SSB) antibody. Among them, 11 patients were positive for both anti-SP1 antibody and anti-PSP antibody, 1 patient was positive for anti-SP1 antibody and 1 patient was positive for anti-PSP antibody. The clinical features of anti-SP1 antibody and anti-PSP antibody positive and negative groups were compared in pSS patients. The duration of disease in anti-SP1 antibody positive group was shorter (=-2.277, =0.023) when compared with the negative patients. The patients with positive anti-PSP antibody were younger than those in the negative group (=2.598, < 0.05), the positive rate of rheumatoid factor (=0.002) and the serum level of IgG (=3.806, =0.003) in anti-PSP antibody positive group were higher than in the negative group. Analysis of the correlation between anti-SP1 antibody and anti-PSP antibody in the pSS patients showed that there was significant correlation between them (=0.801, < 0.001).
Both anti-SP1 antibody and anti-PSP antibody are valuable in the diagnosis of SS, and anti-SP1 antibody is helpful for the early diagnosis of pSS. The combined detection of anti-SP1 antibody and anti-PSP antibody is helpful for the early diagnosis of pSS patients with negative anti-SSA antibody and anti-SSB antibody.
评估抗唾液腺蛋白-1(SP1)抗体联合抗腮腺分泌蛋白(PSP)抗体对干燥综合征(SS)的诊断价值。
收集2020年1月至2022年12月在河北医科大学第二医院风湿免疫科门诊及住院治疗的60例原发性干燥综合征(pSS)患者。收集30例伴有口干和/或眼干的其他自身免疫性疾病患者作为疾病对照组。收集体检中心的30例健康受试者作为健康对照组,采集所有研究对象的血清样本。记录其一般特征及临床表现、实验室检查等临床资料。采用2016年美国风湿病学会(ACR)/欧洲抗风湿病联盟(EULAR)分类标准作为pSS的诊断标准。采用化学发光免疫分析法检测抗SP1抗体和抗PSP抗体的免疫球蛋白G(IgG)亚型。采用受试者工作特征(ROC)曲线评估抗SP1抗体和抗PSP抗体诊断pSS的准确性。进一步比较pSS组中抗SP1抗体和抗PSP抗体阳性及阴性患者的临床特征。采用独立样本t检验、Mann-Whitney U检验、方差分析、Kruskal-Wallis检验、卡方检验或Fisher确切概率法及Spearman相关分析进行统计学分析。
pSS组、疾病对照组和健康对照组在年龄(F = 1.406,P = 0.495)和性别(χ² = 2.105,P = 0.349)方面差异均无统计学意义。三组间抗SP1抗体(F = 16.73,P < 0.001)和抗PSP抗体(F = 26.09,P < 0.001)的表达水平差异有统计学意义。抗SP1抗体表达水平的组间比较显示,pSS组与健康对照组之间差异有统计学意义(P < 0.001),而其他组间差异无统计学意义。抗PSP抗体表达水平的组间比较显示,pSS组与健康对照组之间差异有统计学意义(P < 0.001),疾病对照组与健康对照组之间差异有统计学意义(P = 0.009),而其他组间差异无统计学意义。pSS组抗SP1抗体阳性率显著高于疾病对照组和健康对照组(58.33% vs 40.00% vs 13.33%,P < 0.001)。pSS组抗PSP抗体阳性率显著高于疾病对照组和健康对照组(75.00% vs 56.17% vs 16.67%,P < 0.001)。抗SP1抗体的曲线下面积为0.688(P < 0.001)。抗SP1抗体的敏感性和特异性分别为58.33%(35/60)和70.00%(42/60),阳性预测值为66.04%(35/53),阴性预测值为54.55%(42/77)。抗PSP抗体的曲线下面积为0.720(P < 0.0),敏感性为75.00%(45/60),特异性为63.33%(38/60)。抗PSP抗体的阳性预测值和阴性预测值分别为67.16%(45/67)和71.70%(38/53)。13例pSS患者抗干燥综合征A(SSA,包括SSA52和SSA60)抗体和抗干燥综合征B(SSB)抗体均为阴性。其中,11例患者抗SP1抗体和抗PSP抗体均为阳性,1例患者抗SP1抗体阳性,1例患者抗PSP抗体阳性。比较pSS患者中抗SP1抗体和抗PSP抗体阳性及阴性组的临床特征。抗SP1抗体阳性组的病程短于阴性患者(t = -2.277,P = 0.023)。抗PSP抗体阳性患者比阴性组患者年龄小(t = 2.598,P < 0.05),抗PSP抗体阳性组类风湿因子阳性率(P = 0.002)及血清IgG水平(F = 3.806,P = 0.003)高于阴性组。分析pSS患者中抗SP1抗体与抗PSP抗体的相关性,二者之间存在显著相关性(r = 0.801,P < 0.001)。
抗SP1抗体和抗PSP抗体对SS的诊断均有价值,抗SP1抗体有助于pSS的早期诊断。抗SP1抗体和抗PSP抗体联合检测有助于抗SSA抗体和抗SSB抗体阴性的pSS患者的早期诊断。