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Based on clinical manifestations, laboratory data and intestinal microflora detection, the cognitive function characteristics of patients with systemic lupus erythematosus and cerebrovascular disease and its relationship with intestinal microflora were analyzed to explore the possible pathogenesis of lupus cerebrovascular disease.
This study was a retrospective and prospective cohort study. They were divided into three groups, namely SLE group, SLE cerebrovascular disease group and healthy control group. Each group included 60 patients [Anticipated].
(1) Cognitive function assessment; (2) Fresh stool and serum were collected, and 16s rRNA technology was used for intestinal flora detection, and QIIME2 platform was used for flora analysis; Serum inflammatory factors were detected and metabolomic analysis was performed.
The clinical data of all enrolled patients were statistically analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SLE group |
| ||
| NPSLE epilepsy group |
| ||
| Healthy control group |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Assess changes in cognitive function by Mini-mental State Examination | Score on a scale of 27-30: normal; Score<27 points: cognitive dysfunction; 21-26, mild; 10-20, moderate 0-9; Severe | Baseline, months 3, 6 |
| Assess changes in cognitive function by Montreal Cognitive Assessment | The total score of the scale is 30 points, and the test results show a normal value of ≥26 points. | Baseline, months 3, 6 |
| Assess changes in anxiety by Self-Rating Anxiety Assess changes in anxiety by Self-Rating Anxiety Scale | The cut-off value of the SAS standard score is 50 points, of which 50-59 is mild anxiety, 60-69 is moderate anxiety, and 70 points or more is severe anxiety. | Baseline, months 3, 6, |
| Assess depressive mood changes by Self-rating depression scale Assess depressive mood changes by Self-rating depression scale 8/5000 Assess depressive mood changes by Self-rating depression scale | The dividing value of the SDS standard score is 53 points, with 53-62 being mild depression, 63-72 being moderate depression, and 73 points or more being severe depression. | Baseline, months 3, 6 |
| Assess changes in memory and executive ability by memory and executive screening | Out of 100, the memory factor is 50, and the execution factor is 50. The 3 indicators of MES (memory score, execution score, and total score) correlated significantly with age, with older age scoring lower and no significant correlation with educational attainment. | Baseline, months 3, 6 |
| Assess changes in cognitive function by auditory verbal learning test |
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Inclusion Criteria:
Retrospective study
Prospective Research:
SLE group:
Healthy control group:
Exclusion Criteria:
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Diagnostic criteria: Patients diagnosed with systemic lupus erythematosus are classified as SLE by the European League against Rheumatism (EULAR)/American College of Rheumatology (ACR) 2019.
Brain imaging cerebrovascular changes were defined as: great vascular lesions including cerebral infarction, cerebral hemorrhage, venous sinus thrombosis; Microvascular lesions include leukodystrophy, cerebral atrophy, perivascular space enlargement, lacunar infarction, cerebral microhemorrhage focus, and recent subcortical infarction.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huang Qin, MD | Contact | 13632430850 | qinzihq@foxmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Qin Huang, MD | Southern Medical University, China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qin Huang | Recruiting | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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serum and stool specimens
-1.5SD (50-59 years: 4 points; 60-69 years old: 3 points; 70-89: 2 points); -1.0SD (50-59 years: 5 points; 60-69 years old: 4 points; 70-89:3 points)
| Baseline, months 3, 6 |
| Assess changes in cognitive function by Rey-Osterrieth complex figure | The total score is 36 points, and the lower the score, the worse it gets | Baseline, months 3, 6, |
| Assess changes in cognitive function by verbal fluency test | 1 point is awarded for each correct one, and the number of correctly enumerated within 1 minute is the total score. ≥11 points are normal. | Baseline, months 3, 6, |
| Assess changes in cognitive function by shape trails test | Record the total number of elapsed and first-minute arrivals as well as the number of prompts one | Baseline, months 3, 6 |
| Assess changes in cognitive function by StroopColor-WordTest | The amount of interference reflected includes: SIE time consumption = card C - card B time consumed: SIE correct number = card B - card C correct number, the larger the SIE indicates that the more severe the impairment of executive function. | Baseline, months 3, 6, |
| Assess changes in cognitive function by Clock Drawing Test | The total score is 30 points, CDT30-A is 4 out of 4, and ≤ 2 points are cognitive impairment; CDT30-B scored 26 out of 26, with ≤17 being rated as impaired cognitive function | Baseline, months 3, 6, |
| Assess changes in cognitive function by digit span test | Each correct answer is counted as 1 point for a string of numbers, and the total score = smooth back + reverse recitation. | Baseline, months 3, 6 |
| Assess changes in cognitive function by symbol digit modalities test | The number of correctly filled in within 90s is the final score. | Baseline, months 3, 6 |
| Assess changes in cognitive function by functional activities questionnaire | The total score is 30 points. A score of > 9 indicates social activity dysfunction. | Baseline, months 3, 6 |
| Assess quality of life changes by Activity of Daily Living Scale | The total score is 80 points, the higher the score, the more impaired the ability to live a daily life | Baseline, months 3, 6 |
| Assess changes in sleep quality by Pittsburgh sleep quality index | The total score ranges from 0~21, and the higher the score, the worse the sleep quality. | Baseline, months 3, 6 |
| Changes in the intestinal flora | Intestinal microbiota detection using 16s rRNA technology | Baseline, months 3, 6 |