| Title： | Chinese Expert Consensus on off-label Use of Sjogren's syndrome |
| Edition： | Original |
| Classification： | Experts consensus |
| Field： | Treatment |
| Countries and regions： | China |
| Guidelines users： | Clinical physicians at all levels (rheumatology, pharmacy, and other relevant fields) |
| Evidence classification method： | GRADE classification system |
| Development unit： | Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University |
| Registration time: | 2022-12-01 |
| Registration number： | PREPARE-2022CN789 |
| Purpose of the guideline: | In the clinic of Rheumatology and Immunology Department, primary Sj ö gren's syndrome (pSS) is the second common autoimmune connective tissue disease. The incidence rate of pSS in China is 0.06-0.12/1000, the prevalence rate is 0.16-3.39/1000, and the estimated number of patients is more than 4.5 million. The disease is mostly seen in middle-aged women, and is characterized by impaired exocrine gland function, lymphocytes infiltrating glands and positive autoantibodies such as anti SSA/Ro60 in serum. In addition to the impairment of salivary glands and lacrimal glands, multiple organs and systems may be involved. The commonly used drugs for treating pSS in clinic can be divided into three categories: One is symptomatic treatment for local glands. PSS can cause dry eye or corneal injury and other symptoms, so the use of ophthalmic preparations with indications of dry eye or corneal injury by patients with pSS to relieve symptoms belongs to the drug in the instructions. The indications of cyclosporine ophthalmic preparations include the indications of pSS, which is also included in the instructions. The other is to promote glandular secretion. Except for anetholtrithione with pSS indications, bromhexine, acetylcysteine and pilocarpine had no pSS indications, and they were off-label drug use. Third, the treatment of multi-system involvement outside the glands, such as glucocorticoids, immunosuppressants, belongs to the empirical treatment, or learn from the treatment of similar lesions, are off-label drug use. To sum up, it is very common to treat pSS on off-label Use in the clinic of Rheumatology and Immunology Department. Therefore, this consensus forms expert recommendations through evidence-based verification and systematic evaluation of the basis for the treatment of pSS on off-label use , aiming to further standardize the clinical application of pSS on off-label use. |
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