梳理循证医学证据,规范与展望我国干燥综合征临床药物治疗实践

Summarize the evidence for evidence-based medicine and standardize clinical drug treatment practices for Sjögren syndrome in China

干燥综合征(Sjögren syndrome,SS)是风湿免疫领域三大常见的弥漫性结缔组织病之一。中国初级卫生保健基金会风湿免疫学专业委员会组织风湿病学专家,联合药学、眼科病学、口腔病学、产科学及指南方法学专家,制定了《干燥综合征超药品说明书用药中国临床实践指南(2023版)》,包括2条强推荐、14条弱推荐和5条基于共识的推荐。本文解读该指南制定的背景、难点、主要内容及特色,解析指南采用最新的SS疗效反应综合指标的单项分解条目作为疗效结局指标进行临床研究证据再评估,梳理出SS超说明书用药的循证分类,指导临床合理用药,同时结合操作要点,便于临床具体实施。该指南不仅有助于规范临床实践SS治疗用药,同时也揭示了SS治疗领域亟待解决的临床问题和未来研究方向。

Sjögren syndrome(SS)is one of the top three common diffuse connective tissue diseases in the field of rheumatological immunity.Recently,the Committee of Chinese Primary Health Care Foundation for Rheumatologists and Immunologists organized a multidisciplinary team of experts including rheumatology,pharmacy,ophthalmology,stomatology,obstetrics and methodology and formulated Clinical practice guidelines for the treatment of primary SS by off-label drug use in China(2023 edition).The guidelines included two strong recommendations,fourteen weak recommendations,and five consensus-based recommendations.This article interprets the background,difficulties,main content and characteristics of the guideline.The guidelines used the individual component of the latest comprehensive index for assessing the therapeutic response in patients with SS(STAR and CRESS)as the outcome for evidence re-evaluation.The results of evidence-based classifications will guide the rational off-label drug use for patients with SS.For convenient clinical implementation,the guidelines highlighted operational points.The guidelines not only promote the standardization of clinical practice of off-label drug use for patients with SS,but also reveal the urgent demand and future research direction on SS therapy.