Objective: The aim of this study was to set up a large, longitudinal and prospective database to compare the clinical manifestations in human leucocyte antigen (HLA)-B(27) positive and negative patients with ankylosing spondylitis(AS) based on real-world evidence in Chinese population. Methods: A total of 897 outpatients with confirmed AS were recruited consecutively by smart management system for spondyloarthritis (SMSP) from April 13, 2016 to June 6, 2017 in Chinese PLA General Hospital from 30 provinces and autonomous regions. 801 patients with HLA-B(27) data were included in the analysis. Demographic and clinical parameters including Bath ankylosing spondylitis disease activity index (BASDAI), Bath ankylosing spondylitis functional index (BASFI), ankylosing spondylitis disease activity score (ASDAS), arthritis, enthesitis, Bath ankylosing spondylitis metrology index (BASMI), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were compared between HLA-B(27) positive and negative groups. Results: A total of 801 patients were included in the analysis with an average age of (30.7±8.8) years. There were 659 males and 142 females and HLA-B(27) was present in 88.0%(705/801). Males were significantly more in HLA-B(27) positive patients [83.3%(587/705) vs. 75.0%(72/96); P=0.047].The average age at disease onset was (22.3±7.6)years in HLA-B(27) positive patients and (24.4±8.7) years in HLA-B(2)7 negative ones (P=0.028).There was significant difference in diagnose delay between two groups [14.3(2.5,43.6)months in HLA-B(27) positive patients vs. 20.3(5.0,67.4) months in HLA-B(27) negative ones, P=0.041]. Anterior uveitis was found to be significantly more common in HLA-B(27) positive patients [18.9% (133/705)vs.7.3%(7/96),P=0.005], and knee involvement less common in HLA-B(27) positive patients [4.0%(27/682) vs.10.0%(9/90), P=0.010], conversely. CRP[6.5(3.0, 16.4)mg/L vs. 3.5(1.6, 12.3)mg/L] and ESR[11.0(4.0, 24.0)mm/1h vs. 7.0(3.0, 16.0)mm/1h] were significantly higher in HLA-B(27) positive patients(P=0.005,0.013, respectively).But no differences in BASDAI,ASDAS,BASFI and BASMI were obtained between two groups. Conclusions: HLA-B(27) positive patients had a higher proportion of males, a younger age of onset and a greater risk for occurrence of anterior uveitis, suggesting a poorer prognosis.
目的： 利用真实世界数据对比我国强直性脊柱炎（AS）患者人类白细胞抗原（HLA）-B(2)7不同携带状态的临床特点和预后转归，从而指导临床实践。 方法： 通过脊柱关节炎（SpA）智能移动管理系统（SMSP）连续收录2016年4月13日至2017年6月6日在解放军总医院风湿科门诊就诊并确诊的来自我国30个省、市、自治区的AS患者897例，本研究纳入HLA-B(27)资料完善的801例患者，分析HLA-B(27)阳性和阴性患者的人口学特征、患者自我病情评估[包括Bath强直性脊柱炎疾病活动度评分（BASDAI）、Bath强直性脊柱炎功能指数（BASFI）]、AS疾病活动度评分（ASDAS）、附着点炎、关节肿痛、Bath强直性脊柱炎测量指数（BASMI）等临床特点及实验室检查[包括红细胞沉降率（ESR）和C反应蛋白（CRP）]，并比较其异同。 结果： 801例HLA-B(27)资料完善的AS患者，男性659例，女性142例，年龄（30.7±8.8）岁，HLA-B(27)阳性705例（88.0%），阴性者96例（12.0%）。与HLA-B(27)阴性者比，HLA-B(2)7阳性者中男性明显增多（83.8%比75.0%，P=0.047），发病年龄偏低[（22.3±7.6）岁比（24.4±8.7）岁，P=0.028]，从发病至确诊所需时间较短[14.3（2.5，43.6）个月比20.3（5.0，67.4）个月，P=0.041]。HLA-B(27)阳性者合并葡萄膜炎的比例增加（18.9%），而阴性者膝关节炎的发生率升高（10.0%），差异有统计学意义（P值分别为0.010和0.005）。HLA-B(27)阳性和阴性AS患者BASDAI[阳性者2.0（1.1，3.4）比阴性者2.2（1.2，3.9）]、BASFI[阳性者1.1（0.3，2.4）比阴性者1.0（0.2，2.9）]、ASDAS（阳性者2.2±1.0比阴性者2.0±1.1）、BASMI[阳性者1.0（0.0，2.0）比阴性者0.5（0.0，1.0）]差异无统计学意义，但HLA-B(27)阳性者ESR[11.0（4.0，24.0）mm/1h]、CRP[6.5（3.0，16.4）mg/L]显著高于阴性者[ESR 7.0（3.0，16.0）mm/1h,CRP 3.5（1.6，12.3）mg/L;P值分别为0.013、0.005]。 结论： 与HLA-B(27)阴性者比，HLA-B(27)阳性者男性比例高，发病年龄较早，更易合并葡萄膜炎，且炎症程度更重，提示预后可能更差。.
Keywords: Cohort effect; HLA-B(27) antigen; Mobile health; Spondylitis, ankylosing.