Abstract: Background　Blood stasis syndrome is a significant concurrent syndrome in primary Sjögren's syndrome （pSS）. However，the quantitative characteristics and clinical correlations remain insufficiently explored. Objective　To investigate the quantitative characteristics of blood stasis syndrome in pSS patients and the association with glandular secretory function，imaging features，serum indicators，and the risk of systemic involvement. Methods　This study adopted a prospective cohort design，enrolling 171 patients with suspected pSS who were treated at Yueyang Hospital of Integrated Traditional Chinese and Western Medicine，Shanghai University of Traditional Chinese Medicine，from July 2022 to January 2024. Based on the 2016 ACR/EULAR classification criteria，patients were divided into a pSS group（130 cases） and non-pSS group（41 cases）. General information was collected，including gender，age，clinical manifestations，presence of other autoimmune diseases， other medical history，and medication history. Clinical indicators included unstimulated salivary flow rate，visual analog scale（VAS） score for dry mouth，salivary gland ultrasound（SGUS），and labial gland biopsy results. Laboratory indicators included antinuclear antibodies（ANA），anti-SSA/Ro antibodies，IgG，erythrocyte sedimentation rate（ESR），rheumatoid factor，C3/C4，and systemic involvement. Blood stasis syndrome scores were calculated using the International Diagnostic Guidelines for blood stasis syndrome. Differences in general information，clinical indicators，and blood stasis syndrome scores between the two groups were compared. Pearson or Spearman correlation analyses were used to evaluate the correlations between blood stasis scores and clinical indicators. The distribution of high-frequency blood stasis syndrome scores was also analyzed. Results　The rates of positive blood stasis syndrome，blood stasis syndrome scores，VAS scores for dry mouth，total SGUS grades for bilateral glands，positive rates of labial gland biopsy，positive rates of anti-SSA/Ro antibodies，ANA titers，ESR，and IgG levels of pSS group were higher than non-pSS group，and the unstimulated salivary flow rate was lower than non-pSS group，with a statistically significant difference（P<0.05）. Correlation analysis revealed that blood stasis scores in the pSS group were positively correlated with VAS scores for dry mouth（r=0.520，P<0.05） and total SGUS grades for bilateral glands（rs=0.492，P<0.05），negatively correlated with unstimulated salivary flow rate（r=-0.491，P<0.05）. The rate of systemic involvement in the moderate to severe blood stasis group was higher than the mild group（P<0.05）. Analysis of high-frequency blood stasis items showed that purple-dark tongue or sublingual venous engorgement，fixed pain，limb numbness/joint deformity，and pathological masses had higher positive rates in the blood stasis syndrome differentiation of pSS patients. In salivary gland ultrasound grading，the blood stasis scores in the grade 3 groups for both parotid and submandibular glands were higher than those in the lower-grade groups，with statistically significant differences（P<0.05）. Conclusion　Blood stasis syndrome is prevalent in pSS patients，and its severity is closely associated with glandular dysfunction，abnormalities in SGUS imaging，and the risk of systemic involvement. SGUS can serve as an objective assessment tool for blood stasis syndrome，supporting the TCM theory of blood stasis leading to dryness，and providing a theoretical basis and clinical reference for the personalized diagnosis and treatment of pSS.

Key words: Primary sj?gren's syndrome, Blood stasis syndrome, Dryness impediment, Salivary gland ultrasound, Prospective cohort study

摘要： 背景　血瘀证是原发性干燥综合征（pSS）的重要兼证，但其量化特征及临床关联研究不足。目的　探讨pSS患者血瘀证的量化特征及其与腺体分泌功能、影像学特征、血清指标及系统累及风险的关联。方法　本研究采用前瞻性队列设计，纳入2022年7月—2024年1月于上海中医药大学附属岳阳中西医结合医院诊治的171例疑似pSS患者为研究对象，根据2016年美国风湿病学会（ACR）与欧洲抗风湿病联盟（EULAR）分类标准分为pSS组（130例）和非pSS组（41例）。收集患者性别、年龄、临床表现、合并其他自身免疫性疾病、其他疾病史、药物使用史等一般资料，临床指标，包括：非刺激唾液流率、口干视觉模拟（VAS）评分、唾液腺超声（SGUS）、唇腺活检结果，实验室指标，包括：抗核抗体（ANA）、抗干燥综合征A（SSA）/Ro抗体、IgG、红细胞沉降率（ESR）、类风湿因子、C3/C4及系统累及情况，采用《国际血瘀证诊断指南》计算血瘀证积分，比较两组一般资料、临床指标以及血瘀证积分差异。采用Pearson或Spearman相关性分析血症积分与各临床指标间的相关性。分析高频血瘀证积分分布情况。结果　pSS组血瘀证阳性率、血瘀证积分、口干VAS评分、双侧SGUS总分级、唇腺活检阳性率、抗SSA/Ro抗体阳性率、ANA滴度、ESR及IgG水平高于非pSS组（P<0.05），非刺激唾液流率低于非pSS组，差异有统计学意义（P<0.05）。相关性分析结果显示，pSS组血瘀积分与口干VAS评分（r=0.520，P<0.05）、双侧SGUS总分级（rs=0.492，P<0.05）呈正相关，与非刺激唾液流率（r=-0.491，P<0.05）呈负相关。中重度血瘀组的系统累及率高于轻度组（P<0.05）。高频血瘀条目分析结果显示，舌质紫暗/舌下脉络瘀滞、固定性疼痛、肢体麻木/关节畸形、病理性肿块在pSS患者血瘀辨证中阳性率较高。唾液腺超声分级中，腮腺及颌下腺3级组的血瘀积分高于较低分级组，差异有统计学意义（P<0.05）。结论　pSS患者血瘀证普遍存在，其严重程度与腺体功能障碍、SGUS影像学异常及系统累及风险密切相关。SGUS可作为血瘀证的客观评估工具，佐证“瘀血致燥”的中医理论，为pSS的个性化诊治提供了理论依据和临床参考。

关键词: 原发性干燥综合征, 血瘀证, 燥痹, 唾液腺超声, 前瞻性队列研究