干燥综合征超药品说明书用药中国专家共识

标题: 干燥综合征超药品说明书用药中国专家共识
title: Chinese Expert Consensus on off-label Use of Sjogren's syndrome
版本: 原创版
version: Original
分类: 专家共识
classification: Experts consensus
领域: 治疗
field: Treatment
国家和地区: 中国
Country and region: China
指南使用者: 各级临床医生(风湿病、药学和其他相关领域)
Guide users: Clinical physicians at all levels (rheumatology, pharmacy, and other relevant fields)
证据分级方法: Clinical physicians at all levels (rheumatology, pharmacy, and other relevant fields)
Evidence grading method: GRADE classification system
制定单位: 中山大学孙逸仙纪念医院
Formulating unit: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
注册时间: 2022-12-01
Registration time:
注册编号: PREPARE-2022CN789
Registration number:
指南制订的目的: 在风湿免疫科临床中,原发性干燥综合征(primary Sjögren's syndrome, pSS)是第二常见的自身免疫性结缔组织病。我国pSS的发病率为0.06~0.12/1000,患病率0.16~3.39/1000,推算患病人数超过450万。该病多见于中年女性,主要特征是外分泌腺功能受损、淋巴细胞浸润腺体及血清抗SSA/Ro60等自身抗体阳性。除有涎腺、泪腺功能受损外,可出现多脏器多系统受累。 临床上治疗pSS的常用药物可分为三大类: 一是针对腺体局部对症治疗。pSS可引起干眼或者角膜损伤等症状,故pSS患者使用适应证有干眼或者角膜损伤的眼用制剂,用于缓解症状,属于说明书内用药。环孢素眼用制剂的适应证有pSS适应证,亦属于说明书内用药。 二是促进腺体分泌,除茴三硫有pSS适应证外,毛果芸香碱、溴己新、乙酰半胱氨酸等均无pSS适应证,属于超药品说明书用药。 三是治疗腺体外的多系统受累,如糖皮质激素、免疫抑制剂等,属于经验性治疗,或借鉴类似病变的治疗,均属于超药品说明书用药。 综上所述,在风湿免疫科临床中pSS超药品说明书用药十分常见。因此,本共识通过循证查证及系统评价超药品说明书用药治疗pSS的依据,形成专家推荐,旨在进一步规范pSS超说明书用药的临床应用。
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.