Objective: To investigate the current status and challenges of carrying out the four objective indicators which are necessary for the Sjögren's syndrome (SS) diagnosis in hospitals all over China. Methods: A questionnaire survey was conducted online by Questionstar from May to July 2023 among rheumatologists nationwide, to investigate whether unstimulated salivary flow (UWSF), Van Bijsterveld score (VBS), Schirmer test and labial gland focus score (FS) are carried out in their hospitals and the challenges that hinder their development. A cohort of patients with established SS was enrolled to verify the importance of the four objective indicators in diagnosing SS. Statistical analyses were performed using the chi-square test. Results: The questionnaire was completed by rheumatologists from 660 hospitals in 225 cities of 32 provinces, autonomous regions and municipalities all over China (one doctor from each hospital completed the questionnaire), of which 548 (83.0%) were tertiary care hospitals. The rate of carrying out the objective indicators in 660 hospitals was low: UWSF (290/660, 43.9%), FS (497/660, 75.3%) and VBS (393/660, 59.5%). The percentage of hospitals who consider it difficult to carry out UWSF, VBS, minor labial gland biopsy and Schirmer test was 92.6%(611/660), 69.4%(458/660), 59.8%(395/660) and 58.6%(387/660), respectively. All four objective indicators mentioned above could be carried out in only 139 (21.1%) hospitals. In 521 hospitals in which less than four objective indicators could be carried out, 23.2% (121/521) of rheumatologists selected clinical experience to diagnose SS. A total of 180 patients with SS diagnosed by perfecting all objective indices and meeting the 2016 the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria were included, 173 females (96%), aged (46.6±13.6) years, with the missed diagnosis rate was 17.8% (32/180) assuming their labial FS was unavailable. In 166 patients with established SS who met the classic 2002 AECG criteria, 160 females (96%), aged (47.0±13.6) years, the missed diagnosis rate was 52.4% (87/166) assuming their labial FS was unavailable; or 10.8% (18/166) assuming their UWSF was unavailable. SS diagnosis couldn't be estimated according to 2002 AECG criteria, assuming both labial FS and UWSF were unavailable in 156 (94.0%) patients with positive anti-SSA/Ro; or assuming either labial FS or UWSF was unavailable in 10 (6.0%) patients with negative anti-SSA/Ro. Conclusion: The application rates of four objective indicators necessary for SS diagnosis are low, the rate of carrying out labial gland biopsy should be increased, and the labial FS reports and UWSF test should be standardized.
目的： 了解我国医院开展干燥综合征（SS）诊断所需4项客观指标的开展情况及其存在困难。 方法： 现状调查。2023年5至7月通过问卷星于线上对全国风湿科医师进行问卷调查，了解所在医院非刺激唾液流率（UWSF）、角膜荧光染色评分（VBS）、Schirmer试验及唇腺灶性指数等4项客观指标的开展情况及存在的困难。通过确诊SS患者队列验证4项客观指标对SS诊断的重要性。采用χ2检验进行统计学分析。 结果： 全国共32个省份、自治区、直辖市225个地区660家医院医师完成问卷调查，每家医院1位医师回答问卷。其中548家（83.0%）为三级医院。4项客观指标在660家医院中的开展率较低的是UWSF（290/660，43.9%）、唇腺活检（497/660，75.3%）和VBS（393/660，59.5%）。认为开展UWSF、VBS、唇腺活检和Schirmer试验有困难的医院分别占92.6%（611/660）、69.4%（458/660）、59.8%（395/660）和58.6%（387/660）。仅139家（21.1%）医院可全部检测上述4项客观指标，未能全部开展4项客观指标的521家医院中23.2%（121/521）的医师会选择临床经验诊断SS。共纳入180例完善所有客观指标且符合2016年美国风湿病学会/欧洲抗风湿病联盟（ACR/EULAR）标准而确诊的SS患者，女173例（占96%），年龄（46.6±13.6）岁，假若缺少唇腺灶性指数的漏诊率为17.8%（32/180）。使用更经典的2002年美欧共识小组（AECG）标准而确诊的166例SS患者，女160例（占96%），年龄（47.0±13.6）岁，假若缺少唇腺灶性指数的漏诊率为52.4%（87/166），缺少UWSF的漏诊率为10.8%（18/166）；其中156例（94.0%）抗干燥综合征抗原A/Ro（SSA/Ro）抗体阳性患者，同时缺少UWSF和唇腺灶性指数则无法判断是否符合SS诊断，10例（6.0%）抗SSA/Ro抗体阴性患者，缺少唇腺灶性指数或UWSF则无法判断是否符合SS诊断。 结论： 目前我国SS规范化诊断4项客观指标的开展率较低，需提高唇腺活检的实施率、规范唇腺灶性指数病理报告以及标准化UWSF以规范SS的诊治。.