Objectives of Study:
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To evaluate the efficacy of traditional Chinese medicine in the treatment of AS based on the real world, such as disease activity and function, imaging index, physicochemical index, patient report outcome, quality of life evaluation, mental state evaluation, health economics and other dimensions to evaluate the clinical efficacy of traditional Chinese medicine in the treatment of AS, so as to provide data support for the formation of standard treatment guidelines for patients with ankylosing spondylitis in China.
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Description for medicine or protocol of treatment in detail:
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Based on the AS patients registration database, a prospective cohort study was adopted. According to the classification of clinical treatments, the group treated only with Chinese medicine as the Chinese medicine group, the group treated with biological agents as the Western medicine group, and the group treated with Chinese medicine+ biological agents as the combined Chinese and Western medicine group.
ⅠGroups
1.The Chinese medicine group:
The treatment regimen included in this study was: According to TCM syndrome differentiation treated by Chinesse medicine decoction (200ml oral 2 / day) for 6 months, with 7 days as the grace period, the elution period was set to 3 months.
2.The Western medicine group
The treatment regimen included in this study was:
①TNF-alpha?antagonist: 40 mg, injected subcutaneously for once or twice a fortnight, for 6 consecutive months of treatment, with a set elution period of 3 months for those with a 30-day grace period;
or
②IL-17a antagonist: 150 mg, injected subcutaneously at weeks 0, 1, 2, 3, and 4, followed by injections every four weeks, for 6 consecutive months of treatment, with a set elution period of 3 months for those with a 30-day grace period.
3. the combined Chinese and Western medicine group:The treatment regimen included in this study was: Simultaneous treatment with Chinese medicine decoction and biological agents was used for 6 consecutive months of treatment, with an elution period of 3 months set for those with a grace period of 30 days.
Ⅱ Defining combined medications
In this study, for the patients in the western medicine group, those who use proprietary Chinese medicine will be included depends on the circumstances, and those who take conventional synthetic disease-modifying anti-rheumatic drugs will not be included; in view of good control of blood pressure, blood sugar and blood lipids, those who take antihypertensive drugs, hypoglycemic drugs and lipid-lowering drugs are assessed by the accusation team to determine whether they are included or not.
Ⅲ The matching principle
The tendency scoring method was used for matching, the covariates were set as age and course of disease, and the computer was used for non-playback pattern matching with a proportion of 1:1.
Ⅳ Therapeutic evaluation methods
1.Observation indicators
①Primary observation indicator:Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein(ASDAS-CRP)
②Secondary observation indicators
Bath Ankylosing Spondylitis Disease activity Index (BASDAI) ; Bath Ankylosing Spondylitis functional Index (BASFI) ; Bath Ankylosing Spondylitis Metrological Index (BASMI) ; Assessment of Spondyloarthritis International Society-Health Index (ASAS-HI) ; depression-anxiety-stress patients emotional self-rating scale (DASS-21) ; Work Efficiency and Activity Impact Questionnaire(WPAI-AS); Facit-fatigue Scale for treatment of Chronic Diseases(FACIT-fatigue);C reactive protein (CRP); Erythrocyte sedimentation rate (ESR)
2.Evaluation standard of curative effect
The rate of reaching ASDAS-CRP; ASAS20/40/60?response?rate; Clinical efficacy evaluation criteria of TCM syndromes.The evaluation time points were 0, 4, 12 and 24 weeks, and the time window was 7 days before and after the observation time point.
Ⅴ Imaging evaluation
Spinal magnetic resonance examination was performed before and after treatment, and imaging evaluation was carried out: ①bone marrow edema: SPARCC score; ②fat deposition: fat deposition vertebral body count score (evaluation time point was 0 and 24 weeks). The reading of the film was independently analyzed by two radiologists, the number of lesions was counted by the researchers, and the scoring results were checked correctly by the radiologist.
Ⅵ Data management and quality control
①Although the study involves different research units, the subject personnel are relatively fixed, and the information collectors are all rheumatic specialists and have received unified training and assessment to ensure that they master correct investigation methods and scientific working attitude; to collect and input information strictly in accordance with the requirements of the clinical information collection manual, and the data are accurate and comprehensive, so as to ensure the integrity, authenticity and accuracy of the data.
②The data of real world study accord with the clinical reality, but there are many confounding factors. On the basis of the existing data, we can draw lessons from the clinical epidemiological concepts and mathematical statistical methods, such as tendency scoring, Cox regression, etc., so as to avoid and eliminate confounding and biased factors as far as possible, and improve the objectivity of clinical evaluation.
③Clear staffing for each link in the clinical study, with a division of labor and responsibilities; problems that arise during the information collection process are reflected to the subject leader and clinical monitor in a timely manner for coordinated resolution.
④All the input information will not be valid until it is verified and confirmed by the main researchers of the research group. The server dedicated to data storage is equipped with passwords, access rights, and anti-virus software to prevent data loss; check the input data regularly to avoid omitting information, and contact researchers, clinicians and patients in time if in doubt.
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Exclusion criteria:
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①Those who underwent AS surgery/acupuncture treatment.
②Patients with other rheumatic immune diseases, such as rheumatoid Arthritis, sjogren syndrome et al.
③Patients with advanced disease spinal ankylosis, severe joint deformity.
④Patients with severe primary diseases such as combined tumor, severe cardiac, cerebrovascular, renal disease, liver and kidney insufficiency.
⑤Patients with poorly controlled blood pressure, blood glucose and blood lipids.
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