Hamid Aruche, Thomas Steven, Bell Christopher, Gormley Mark
University of Bristol Dental Hospital and School, Lower Maudlin Street, Bristol BS1 2LY, UK.
University of Bristol Dental Hospital and School, Lower Maudlin Street, Bristol BS1 2LY, UK; MRC Integrative Epidemiology Unit, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol BS8 2BN, UK.
Br J Oral Maxillofac Surg. 2023 Apr;61(3):227-232. doi: 10.1016/j.bjoms.2023.02.003. Epub 2023 Mar 3.
The role of a drug holiday in the management of medication-related osteonecrosis of the jaw (MRONJ) remains controversial. Current UK guidance does not recommend this practice given the lack of conclusive evidence, and potential risk of skeletal-related events or cancer metastasis. This paper aims to describe a series of fifty patients with confirmed MRONJ who were prescribed a drug holiday as part of their management. Data were collected on exposures including: anti-resorptive and/or anti-angiogenic drug history, duration of drug, method of administration, concurrent therapy, MRONJ stage, management of MRONJ and duration of drug holiday. The primary outcome was complete healing as documented in the clinical notes. Multivariate Cox regression analysis was performed to evaluate the association between exposures and primary MRONJ outcome. Models were adjusted for age, sex, and index of multiple deprivation. Survival analysis was performed using a log-rank test, censoring any patients with no primary outcome recorded (p < 0.05). A total of 44% of patients stopped their medication for >36 months. Over half of all MRONJ cases presented in the posterior mandible and dental extraction was the most common precipitating factor (76%). Almost three-quarters (72%) of patients achieved complete healing. MRONJ recurrence (new site) was reported at 30%, mainly in those with incomplete healing of the initial area. There was a lack of evidence for an association between all recorded exposures and the primary MRONJ outcome using multivariate Cox regression. Similarly, we did not demonstrate evidence for an association between the duration of the drug holiday and MRONJ outcome. Our results support published guidelines, which do not recommend the discontinuation of bone modifying drugs for the prevention of MRONJ, or as part of treatment for established MRONJ.
药物假期在颌骨药物相关性骨坏死（MRONJ）管理中的作用仍存在争议。鉴于缺乏确凿证据以及存在骨相关事件或癌症转移的潜在风险，英国当前的指南不推荐这种做法。本文旨在描述一系列50例确诊为MRONJ的患者，他们在治疗过程中被安排了药物假期。收集了以下暴露数据：抗吸收和/或抗血管生成药物史、用药时长、给药方法、联合治疗、MRONJ分期、MRONJ的治疗以及药物假期时长。主要结局是临床记录中显示的完全愈合。进行多变量Cox回归分析以评估暴露因素与原发性MRONJ结局之间的关联。模型针对年龄、性别和多重剥夺指数进行了调整。使用对数秩检验进行生存分析，对任何未记录主要结局的患者进行截尾处理（p<0.05）。共有44%的患者停药超过36个月。所有MRONJ病例中，超过一半发生在下颌后部，拔牙是最常见的诱发因素（76%）。近四分之三（72%）的患者实现了完全愈合。报告的MRONJ复发（新部位）率为30%，主要发生在初始区域愈合不完全的患者中。使用多变量Cox回归分析时，没有证据表明所有记录的暴露因素与原发性MRONJ结局之间存在关联。同样，我们也没有证明药物假期时长与MRONJ结局之间存在关联的证据。我们的结果支持已发表的指南，该指南不建议为预防MRONJ而停用骨改良药物，也不建议将其作为已确诊MRONJ治疗的一部分。
