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. Retrospective study: The SLE patients admitted to Nanfang Hospital from 2018 to 2022 were retrieved. The patients enrolled from September 2018 to September 2021 applied for exemption from informed consent, and the patients enrolled from September 2021 to September 2022 voluntarily signed informed consent. Patients were selected according to inclusion and exclusion criteria, and clinical and laboratory data of all subjects were recorded. 2. Prospective study: Obtain the consent of the subjects, sign the informed consent, and record the clinical and laboratory examination data of all the subjects. (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.
Study Type
OBSERVATIONAL
Enrollment
180
Qin Huang
Guangzhou, Guangdong, China
RECRUITINGAssess 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, months 3, 6
Assess changes in cognitive function by auditory verbal learning test
-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)
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Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Baseline, months 3, 6
Changes in the intestinal flora
Intestinal microbiota detection using 16s rRNA technology
Time frame: Baseline, months 3, 6