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Abstract：
Labial salivary gland biopsy (LSGB) is one of the specific diagnostic criteria for primary Sjögren\'s syndrome (pSS). In traditional LSGB, there is no lower lip fixation device, the field of view is unclear due to intraoperative bleeding, and the incision is large, which is unfavourable for healing. The use of auxiliary devices to improve the shortcomings of traditional LSGB technique would be meaningful. Therefore, this case-control study aimed to assess the value of modified LSGB using chalazion forceps as compared with traditional LSGB. After obtaining written informed consent from all participating parents and patients, we randomly assigned 217 eligible participants to undergo LSGB using chalazion forceps (n = 125) or traditional LSGB (n = 92). The outcome variables were surgical time, incision length, intraoperative bleeding, pain score at 24 h after surgery, incision healing status at 7 days after surgery, gland collection, and pathological results. The final diagnostic results of the two surgical methods were compared, and the match rates between the pathological results and the final clinical diagnoses were compared between the two groups. The data were analysed using parametric and nonparametric tests. Compared with the traditional group, the modified group had a smaller incision, shorter operative time, less blood loss, lower 24 h pain score, and better Grade A incision healing at 7 days after surgery (p < 0.01). There was no statistically significant difference between the patients in the two surgical-method groups in terms of the positive biopsy results and the final diagnosis based on expert opinions (p > 0.05). By multivariable regression analysis, only a focus score (FS) of ≥ 1 (p < 0.01), dry eye disease (p < 0.05) and anti-nuclear antibodies (ANA) titre ≥ 1:320 (p < 0.05) were correlated with the diagnosis of pSS. The positive biopsy results of patients in the different surgical-method groups had a biopsy accuracy of > 80.0% for the diagnosis of pSS. The positive biopsy results in the different surgical-method groups were consistent with the expert opinions and the 2016 ACR-EULAR primary SS classification criteria. The modified LSGB using an auxiliary chalazion forceps offers a good safety with a small incision, shorter operative time, less bleeding, reduced pain and a low incidence of postoperative complications.The match rate of LSGB pathological results of the proposed surgical procedure with the final diagnosis of pSS is high.
摘要：
唇腺活检（LSGB）是原发性干燥综合征（pSS）的具体诊断标准之一。在传统的LSGB中，没有下唇固定装置，由于术中出血，视野不清楚，切口很大，这对治疗是不利的。使用辅助设备来改善传统LSGB技术的缺点将是有意义的。因此,本病例-对照研究旨在评估改良LSGB与传统LSGB相比的价值.在获得所有参与的父母和患者的书面知情同意书后，我们随机分配了217名符合条件的参与者,他们使用chalazion镊子(n=125)或传统LSGB(n=92)进行LSGB.结果变量是手术时间，切口长度,术中出血,术后24h疼痛评分,术后7天切口愈合情况,腺体集合,和病理结果。比较两种手术方式的最终诊断结果,比较两组病理结果与最终临床诊断的符合率。使用参数和非参数检验对数据进行分析。与传统群体相比,改良组切口较小，手术时间更短，减少失血,较低的24小时疼痛评分，术后7天A级切口愈合较好(p<0.01)。两个手术组的患者在活检阳性结果和根据专家意见的最终诊断方面无统计学意义（p>0.05）。通过多元回归分析，只有焦点评分(FS)≥1(p<0.01)，干眼症（p<0.05）和抗核抗体（ANA）滴度≥1：320（p<0.05）与pSS的诊断相关。不同手术方式组患者的阳性活检结果诊断pSS的活检准确率>80.0%。不同手术方法组的阳性活检结果与专家意见和2016年ACR-EULAR主要SS分类标准一致。改良的LSGB使用辅助查尔兹根镊子提供了良好的安全性和小切口，手术时间更短，出血少,疼痛减轻，术后并发症发生率低。拟行手术的LSGB病理结果与最终诊断pSS的吻合率高。
