Primary Sjögren's disease (pSjD) is a chronic autoimmune disease characterized by lymphocytic infiltration of exocrine glands, presenting mainly with xerostomia and xerophthalmia, and potentially involving multiple systems. Epidemiological studies indicate a prevalence of approximately 0.06%-0.08%, with an increasing trend over time. In recent years, expert consensus in traditional Chinese medicine (TCM) has recognized the dryness and blood-stasis pattern as one of the common syndromes; however, its clinical characteristics, influencing factors, and prognosis have not been systematically investigated.

To explore the integrative clinical features, influencing factors, and prognostic outcomes of patients with pSjD of dryness and blood-stasis syndrome.

A total of 970 patients with pSjD treated at the China-Japan Friendship Hospital from 2017 to 2022 were enrolled, including 185 with pSjD of dryness and blood-stasis syndrome and 785 without pSjD of dryness and blood-stasis syndrome. General information, clinical symptoms, laboratory indicators, and disease activity scores (EULAR Sjögren's Syndrome Disease Activity Index, ESSDAI) were compared between groups. Multivariate Logistic regression analysis was used to identify independent factors associated with pSjD of dryness and blood-stasis syndrome. Survival outcomes, including all-cause mortality, malignancy, and incident interstitial lung disease (ILD), were analyzed using Kaplan-Meier survival curves and compared by the Log-rank test.

Compared with the non-dryness and blood-stasis syndrome group, patients with pSjD of dryness and blood-stasis syndrome were more frequently female, had longer disease duration, and were younger at disease onset and enrollment (P<0.05). The top five symptoms in the pSjD of dryness and blood-stasis syndrome group were xerostomia (75.1%), xerophthalmia (75.1%), arthralgia (54.6%), fatigue (43.2%), and rampant caries (33.5%). The proportions of xerostomia, arthralgia, Raynaud's phenomenon, lymphadenopathy, parotid gland enlargement, purpura-like rash, arthritis, and bleeding were significantly higher in the pSjD of dryness and blood-stasis syndrome group, whereas cough and dyspnea were less frequent (P<0.05). Multivariate Logistic regression analysis identified older age at enrollment (OR=0.979, 95%CI=0.965-0.993, P=0.004) and higher platelet counts (OR=0.997, 95%CI=0.994-0.999, P=0.007) as independent protective factors for pSjD of dryness and blood-stasis syndrome, while anti-RNP positivity (OR=2.352, 95%CI=1.305-4.238, P=0.004), anti-CENP-B positivity (OR=2.490, 95%CI=1.404-4.415, P=0.002), anti-β2GP1 positivity (OR=2.269, 95%CI=1.057-4.872, P=0.036), and higher ESSDAI scores (OR=1.037, 95%CI=1.011-1.064, P=0.006) were identified as independent risk factors. Kaplan-Meier survival analysis showed no significant differences between groups in all-cause mortality, malignancy, or incident ILD (P>0.05).

Nearly 20% of pSjD patients had dryness and blood-stasis syndrome, and these patients exhibited a more chronic disease course, higher ESSDAI scores, and more prominent hematological involvement, although with a lower proportion of ILD. Older age at enrollment and higher platelet counts may be the independent protective factors for pSjD of dryness and blood-stasis syndrome, while anti-RNP positivity, anti-CENP-B positivity, anti-β2GP1 positivity, and higher ESSDAI scores may be identified as independent risk factors. No significant differences were observed in all-cause mortality, malignancy, or incident ILD between the two groups.