嵌合抗原受体T细胞治疗与口腔颌面部不良事件的低绝对发生率相关，且与造血干细胞治疗相比显著更低。

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中文摘要

背景/目的： 嵌合抗原受体T细胞（CAR-T）治疗已被批准用于复发和难治性血液系统恶性肿瘤的管理，改变了肿瘤学格局，并在替代选择有限的患者群体中产生持久缓解。CAR-T的全身性不良事件已得到充分描述；然而，口腔颌面部不良事件尚未得到很好的描述。本研究的目的是利用一个大型、去标识化的真实世界数据集来（1）估计CAR-T后口腔颌面部不良事件的发生率，（2）将事件发生率与一般人群进行比较，以及（3）直接对比CAR-T与造血干细胞移植（HSCT）后观察到的口腔颌面部毒性负担。方法：我们使用TriNetX的去标识化电子健康记录数据进行了一项回顾性队列研究。CAR-T和HSCT队列通过RxNorm和操作代码识别；纳入了一个非暴露对照组。既往有口腔颌面部疾病或混杂治疗的患者被排除。一年内新发的口腔颌面部不良事件通过国际疾病分类第10版（ICD-10）代码识别。队列按年龄和性别进行1:1倾向性匹配；关联以比值比（OR）及双侧95%置信区间（CI）估计。结果：在1142名CAR-T接受者（平均年龄62岁）中，胃食管反流病（GERD）最常见（5.18%）。口腔黏膜事件包括口腔炎1.52%、黏膜炎1.31%和苔藓样反应1.03%。吞咽困难发生率为1.8%，口腔念珠菌病为1.6%。若干严重口腔疾病未出现。与一般人群相比（CAR-T vs. 一般人群）：黏膜炎-[12/995 vs. 0/1112]（OR 28.3）和口腔炎-[16/987 vs. 0/1119]（OR 38）风险显著增加，而在此分析中CAR-T患者黏膜并发症风险显著低于HSCT接受者（CAR-T vs. HSCT）：黏膜炎-[1.21% vs. 3.72%]（OR 0.316）和口腔炎-[1.42% vs. 3.91%]（OR 0.354）。结论：CAR-T治疗具有与HSCT不同且通常更低的口腔颌面部毒性负担，但针对性的牙科评估和前瞻性监测对于优化细胞治疗接受者的支持性护理仍然重要。

英文摘要

Background/Objectives: Chimeric antigen receptor T-cell (CAR-T) therapy has been approved for the management of relapsed and refractory hematologic malignancies, transforming the oncologic landscape and producing durable remissions in patient populations with limited alternatives. The systemic adverse events of CAR-T are well characterized; however, the orofacial adverse events have not been well described. The objective of this study is to leverage a large, de-identified, real-world dataset to (1) estimate the prevalence of orofacial adverse events following CAR-T, (2) compare event rates with the general population, and (3) directly contrast the orofacial toxicity burden of CAR-T with that observed after hemopoietic stem cell transplant (HSCT). Methods: We performed a retrospective cohort study using de-identified electronic health record data from TriNetX. CAR-T and HSCT cohorts were identified via RxNorm and procedure codes; a non-exposed control cohort was included. Patients with prior orofacial conditions or confounding therapies were excluded. New adverse orofacial events within one year were identified by International Classification of Diseases, 10th Revision (ICD-10) codes. Cohorts were 1:1 propensity-matched by age and sex; associations were estimated as odds ratios with two-sided 95% CIs. Results: In 1142 CAR-T recipients (mean age of 62), gastroesophageal reflux disease (GERD) was most frequent (5.18%). Oral mucosal events included stomatitis in 1.52%, mucositis in 1.31%, and lichenoid reactions in 1.03%. Dysphagia occurred in 1.8% and oral candidiasis in 1.6%. Several severe oral conditions were absent. Compared with the general population (CART vs. general population): mucositis-[12/995 vs. 0/1112] (OR 28.3)-and stomatitis-[16/987 vs. 0/1119] (OR 38)-risks were significantly increased, while CAR-T patients had significant lower risks of mucosal complications than HSCT recipients in this analysis (CART vs. HSCT): mucositis-[1.21% vs. 3.72%] (OR 0.316) and stomatitis-[1.42% vs. 3.91%] (OR 0.354). Conclusions: CAR-T therapy carries a distinct and generally lower orofacial toxicity burden than HSCT, but targeted dental assessment and prospective surveillance remain important to optimize supportive care for cellular therapy recipients.