de Boissieu Paul, Gaboriau Louise, Morel Aurore, Trenque Thierry
Department for Pharmacovigilance and Pharmacoepidemiology, Reims University Hospital, Avenue du General Koenig, 51100, Reims, France.
Faculty of Medecine, University of Reims Champagne-Ardenne, EA 3797, Reims, France.
Fundam Clin Pharmacol. 2016 Oct;30(5):450-8. doi: 10.1111/fcp.12211. Epub 2016 Jul 13.
The aim of this study was to describe bisphosphonate-related osteonecrosis of the jaw (BRONJ) in the French national pharmacovigilance database. BRONJ was identified with the standardized MedDRA query (SMQ) 'osteonecrosis' among all data from 1985 to 31 December 2014. Because this SMQ was not specific to the jaw localization, selection of cases based on anatomy was performed after data extraction. For each case, demographic and medical information was analysed, as well as data about notification (year of notification, year of occurrence, outcome, seriousness). Known associated factors for BRONJ were also documented: dentoalveolar surgery, glucocorticoids, chemotherapy, anti-angiogenics, denosumab. Among 1404 SMQ notifications, 663 were located in the jaws and 629 were associated with bisphosphonate use. BRONJ reported in the database mainly affected women (n = 443, 71%) with an oncological indication (n = 440, 70%). BRONJ was considered as serious in 91%. Outcome was unfavourable for 92% of cases. Associated factors were identified for 70% of the patients. A peak of notification was noted in 2014 (13% of all cases), but on analysis by year of occurrence instead of by year of notification, this peak disappeared. SMQ 'osteonecrosis' appears to be an adequate tool to analyse BRONJ in a pharmacovigilance database.
本研究旨在描述法国国家药物警戒数据库中与双膦酸盐相关的颌骨坏死（BRONJ）情况。在1985年至2014年12月31日的所有数据中，通过标准化医学术语词典查询（SMQ）“骨坏死”来识别BRONJ。由于该SMQ并非特定针对颌骨部位，因此在数据提取后根据解剖结构进行病例选择。对于每个病例，分析了人口统计学和医学信息，以及关于报告的相关数据（报告年份、发生年份、结果、严重程度）。还记录了已知的BRONJ相关因素：牙槽外科手术、糖皮质激素、化疗、抗血管生成药物、地诺单抗。在1404份SMQ报告中，663例位于颌骨，629例与双膦酸盐使用相关。数据库中报告的BRONJ主要影响女性（n = 443，71%），且有肿瘤学指征（n = 440，70%）。91%的BRONJ被认为是严重的。92%的病例预后不佳。70%的患者识别出了相关因素。2014年出现报告高峰（占所有病例的13%），但按发生年份而非报告年份进行分析时，该高峰消失。SMQ“骨坏死”似乎是在药物警戒数据库中分析BRONJ的一个合适工具。
