Wu Jing, Liang Yongying, Shi Fanjun, Tu Xianghong, Zhang Jingfa, Qiu Qinghua
Department of Ophthalmology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Department of Rheumatology, Shanghai University of Traditional Chinese Medicine Affiliated Guanghua Integrated Traditional Chinese and Western Medicine Hospital, Shanghai, China.
Ther Adv Musculoskelet Dis. 2024 Sep 2;16:1759720X241274726. doi: 10.1177/1759720X241274726. eCollection 2024.
Early diagnosis of primary Sjögren's syndrome (pSS) remains difficult due to its insidious onset.
To identify whether meibomian gland dropout (MGD) is a sensitive and noninvasive predictor of pSS by studying its association with histopathology in labial salivary gland biopsy in patients with clinically suspected pSS.
Prospective, randomized, multicenter, comparative effectiveness study.
The study was conducted from July 2022 to July 2023. In all, 56 eligible participants with clinically suspected pSS were recruited from three combined ophthalmology medicine/rheumatology SS clinics. All participants with suspected pSS were evaluated and diagnosed by ophthalmology and rheumatology consultants and underwent infrared imaging of the meibomian glands using Keratograph 5M and histopathological evaluation of labial salivary gland biopsies. The length, width, and tortuosity of the meibomian glands were measured; the dropout rate in the nasal, temporal, and total eyelids was analyzed; and the dropout score was calculated using meibography grading scales.
Among the 56 participants, 34 were identified with pSS, and 22 were diagnosed with non-SS dry eye (NSSDE) and served as the control group. We recorded significant differences in the temporal and total MGD rates of the upper eyelids between the pSS and NSSDE groups (all < 0.01). Improved prediction accuracy was achieved with the temporal and total MGD rates in the upper eyelids, with area under the curve values of 0.94 and 0.91, and optimal cutoff points of 0.78 and 0.75, respectively.
MGD in the upper eyelids, especially in the temporal portion, is strongly associated with the histopathological outcome of labial salivary gland biopsy in pSS and is proposed as a highly predictive and noninvasive biomarker for the early diagnosis of pSS.
ClinicalTrials.gov identifier: ChiCTR2000038911.
原发性干燥综合征（pSS）起病隐匿，早期诊断仍很困难。
通过研究睑板腺缺失（MGD）与临床疑似pSS患者唇腺活检组织病理学的相关性，确定MGD是否为pSS敏感且无创的预测指标。
前瞻性、随机、多中心、比较效果研究。
研究于2022年7月至2023年7月进行。共从3个眼科/风湿科联合的干燥综合征诊所招募了56名临床疑似pSS的合格参与者。所有疑似pSS的参与者均由眼科和风湿科顾问进行评估和诊断，并使用Keratograph 5M对睑板腺进行红外成像，对唇腺活检进行组织病理学评估。测量睑板腺的长度、宽度和迂曲度；分析鼻侧、颞侧和全眼睑的缺失率；使用睑板腺造影分级量表计算缺失评分。
56名参与者中，34名被确诊为pSS，22名被诊断为非干燥综合征干眼（NSSDE）并作为对照组。我们记录到pSS组和NSSDE组上睑颞侧和全睑MGD率存在显著差异（均<0.01）。上睑颞侧和全睑MGD率的预测准确性有所提高，曲线下面积值分别为0.94和0.91，最佳截断点分别为0.78和0.75。
上睑MGD，尤其是颞侧部分，与pSS唇腺活检的组织病理学结果密切相关，被提议作为pSS早期诊断的高度预测性无创生物标志物。
ClinicalTrials.gov标识符：ChiCTR2000038911。
