By analyzing the differential proteins in exosomes, this study aims to understand the pathological mechanisms of SJS and DES, identify potential diagnostic and therapeutic methods, and advance the diagnosis and treatment of these diseases.
Background: A 2015 survey in Taiwan revealed that the prevalence of Dry Eye Syndrome (DES) is 4.87%, with 4.8% of these cases likely to develop into Sjögren's Syndrome (SJS). An American study indicated that 11.6% of DES cases could be diagnosed as SJS, and SJS patients showed significantly more severe conjunctival and corneal staining, Schirmer's test results, clinical symptoms, anti-nuclear antibody, and rheumatoid factor compared to non-SJS patients. Various autoimmune diseases (such as SJS, SLE, RA, SSc, AS, etc.) also affect the severity of dry eye symptoms. Recent studies have employed exosome proteomics to investigate cell-to-cell communication, molecular mechanisms of diseases, and the development of new diagnostic markers and therapeutic targets. While these studies have significant research value for understanding disease mechanisms, diagnosis, and treatment, few have specifically focused on the impact of exosome proteomics in SJS and DES. Objective: By analyzing the differential proteins in exosomes, this study aims to understand the pathological mechanisms of SJS and DES, identify potential diagnostic and therapeutic methods, and advance the diagnosis and treatment of these diseases. Methods: This study will develope on previous research projects conducted at Taipei Veterans General Hospital (TBDESJS,V112C-190) and the National Science and Technology Council (ACUDES). TBDESJS focused on evaluating the use of a herbal tea TBDESJS for relieving dry eye and mouth symptoms in DES and SJS patients, and ACUDES explored the immediate and long-term effects of acupuncture on treating dry eye and mouth symptoms in DES and SJS patients by using the GB20 (Fengchi) and BL2 (Zanzhu) acupuncture points. 1. TBDESJS Study: Included 30 DES patients, 60 SJS patients, and 10 healthy controls (NHC) to evaluate the efficacy of the Traditional Chinese Medicine (TCM) herbal tea in improving dry eye and mouth symptoms. 2. ACUDES Study: Included 50 DES patients, 50 SJS patients, and 20 NHC to evaluate the efficacy of acupuncture GB20 and BL2 in improving dry eye and mouth symptoms. The study will further analyze the remaining samples from these two projects with consent from the participants (45 SJS, 28 DES, and 10 NHC from TBDESJS; 47 SJS, 40 DES, and 20 NHC from ACUDES). In total, 92 SJS, 68 DES, and 30 NHC participants will be included. We will select 40 participants with significant therapeutic improvement from the ACUDES study and 40 from the TBDESJS study for pre- and post-treatment comparison, along with 20 NHC participants, total 100 subjects and 180 person-times. Additionally, we will perform comprehensive cross-analyses incorporating whole-genome genotyping, cytokines, Schirmer's test, tear breakup time, TCM constitution scale, OSDI, ESSPRI, PSQI, FIRST, TCM pulse diagnosis, TCM tongue diagnosis, and TCM heart rate variability measurements. This will help us understand the potential pathways by which the TBDESJS and ACUDESJS regulate immunity, aiming for future clinical applications in SJS and DES patients, ultimately achieving the goal of Holistic Health Care. Expected Outcomes: 1. Purify exosomes from the plasma of SJS and DES patients, identify differential proteins between healthy individuals and patients, and investigate the roles of these proteins in immune cell regulation and their potential as diagnostic tools. 2. Analyze the differential proteins in plasma exosomes of SJS and DES patients before and after treatment with the TBDESJS and ACUDES to explore their therapeutic mechanisms. 3. Explore the possible pharmacological mechanisms of the TBDESJS and ACUDES.
Study Type
OBSERVATIONAL
Enrollment
220
acupuncture at acupoint GB20 or GB20 plus BL2 twice a week 8 weeks for efficacy evaluation.
Chinese herbal tea TBDESJS 8 weeks on Nourishing Yin and Moistening Dryness the ocular dryness evaluation.
Ching-Mao
Taipei, Taiwan, Taiwan
RECRUITINGSchirmer's test
Dry eye syndrome (DES) and Sjögren's syndrome (SJS) take the Schirmer's test.
Time frame: 8 weeks
Ocular Surface Disease Index (OSDI)
Dry eye syndrome (DES) and Sjögren's syndrome (SJS) take the OSDI(Ocular Surface Disease Index).
Time frame: 8 weeks
TCM pattern
Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls (NHC) take the TCM pattern to differentiate the 9 types of TCM constitutions.
Time frame: 8 weeks
TCM tongue diagnosis
Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls (NHC) take the TCM tongue diagnosis with camera photo to differentiate the TCM tongue feature factors about Tongue body, Tongue Coating, Red spot, Tooth marks, and Ecchymosis. TCM tongue feature factors would present the status of inflammation, blood stasis, heat, dampness with TCM theory.
Time frame: 8 weeks
TCM pulse diagnosis
Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls (NHC) take the TCM pulse diagnosis with blood pressure monitors to differentiate the TCM pulse feature factors about Floating, Deep, Slow, Rapid, Deficient, Excessive, Slippery, Rough, String-like, Soggy, Fine, Weak. TCM tongue feature factors would present the status of inflammation, blood stasis, heat, dampness with TCM theory.
Time frame: 8 weeks
TCM heart rate variability
Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls (NHC) take the TCM heart rate variability.
Time frame: 8 weeks
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Whole-genome genotyping(TWBv2.0)
Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls (NHC) take the Whole-genome genotyping (TWBv2.0).
Time frame: 8 weeks
Cytokine markers
Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls, NHC) take the cytokine markers (IL-17, MMP-9, BAFF, BCMA) analysis.
Time frame: 8 weeks
Pittsburgh Sleep Quality Index
Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls, NHC) take the Pittsburgh Sleep Quality Index
Time frame: 8 weeks
Ford Insomnia Response to Stress Test
Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls, NHC) take the Ford Insomnia Response to Stress Test.
Time frame: 8 weeks
EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)
Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls, NHC) take the EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)
Time frame: 8 weeks
Tear breakup time (TBUT)
Tear breakup time (TBUT) is a clinical test used to assess for evaporative dry eye disease.
Time frame: 8 weeks
Exosome-miRNA, transcriptome
exosome-miRNA, transcriptome can be used to assess for Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls, NHC)
Time frame: 8 weeks
Proteomic, Exosome-proteomic
Proteomic, Exosome-proteomiccan be used to assess for Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls, NHC)
Time frame: 8 weeks