Division of Orbital and Ophthalmic Plastic Surgery, Jules Stein Eye Institute, University of California, Los Angeles, California, USA.
Orbit. 2024 Feb;43(1):58-63. doi: 10.1080/01676830.2023.2192787. Epub 2023 Mar 28.
To understand how thyroid eye disease (TED) impacts buccal fat pad (BFP) volume.
In this cohort study, computed tomography (CT) scans and charts of adult patients with and without TED were obtained from an institutional database. The primary outcome was BFP volume in cubic centimeters. Three independent, blinded observers analyzed scans using Horos, a free, open-source medical image viewing software. Bivariate and multivariable analyses were performed. We determined sample size using an effect size based on published reports of the minimum amount of fat excision needed to notice a clinical difference. Equivalence testing against upper and lower bounds set by the same effect size was conducted to assess practical significance of the results.
Our sample was sufficient to detect a difference as large as 1.5cc with 95% power. 72 scans were included in our study, 24 TED patients and 48 controls. Mean BFP volume was not statistically different between TED patients and controls (3.96 cc vs 4.06 cc, = .778). Analysis of covariance adjusting for relevant patient factors (age, sex, and BMI) also failed to find a significant difference between groups. Equivalence testing was significant ( < .001) and revealed the observed difference between groups was less than any clinically meaningful difference. For an effect size of 1.5cc, the data suggests there is a 5% risk of a false negative.
TED was not associated with a significant difference in BFP volume, suggesting that the BFP is spared from TED-related soft-tissue expansion.
了解甲状腺眼病（TED）如何影响颊脂垫（BFP）体积。
在这项队列研究中，从一个机构数据库中获取了患有和不患有 TED 的成年患者的计算机断层扫描（CT）扫描和图表。主要结果是 BFP 的体积（以立方厘米为单位）。三位独立的、盲目的观察者使用 Horos 分析扫描，这是一种免费的、开源的医学图像查看软件。进行了双变量和多变量分析。我们根据已发表的关于需要切除多少脂肪才能注意到临床差异的最小量的效应大小来确定样本量。对相同效应大小设定的上下限进行等效性检验，以评估结果的实际意义。
我们的样本足以检测到高达 1.5cc 的差异，具有 95%的功效。我们的研究包括 72 个扫描，24 个 TED 患者和 48 个对照。TED 患者和对照组之间的 BFP 体积平均值没有统计学差异（3.96 cc 与 4.06 cc，= 0.778）。调整了相关患者因素（年龄、性别和 BMI）的协方差分析也没有发现两组之间的显著差异。等效性检验具有统计学意义（ < 0.001），并表明观察到的两组之间的差异小于任何有临床意义的差异。对于 1.5cc 的效应大小，数据表明有 5%的假阴性风险。
TED 与 BFP 体积无显著差异相关，表明 BFP 免受 TED 相关软组织扩张的影响。
