基于FAERS数据库挖掘与分析第3代芳香化酶抑制剂的肌腱疾病风险

Risk of Tendon Disease with Third Generation Aromatase Inhibitors Based on FAERS Database Mining and Analysis

目的通过对FAERS数据库进行挖掘与分析,探讨第3代芳香化酶抑制剂(aromatase inhibitors,AIs)的肌腱疾病风险。方法基于2004年第1季度—2022年第3季度的FAERS数据,采用不成比例分析和贝叶斯分析来检测AIs与肌腱疾病信号,并分析第3代AIs相关肌腱炎、腱鞘炎和肌腱断裂的临床特征、发病时间和关联性。结果共提取26129份AIs不良事件报告,肌腱疾病报告148份。3种AIs药物均检测到肌腱炎、腱鞘炎和肌腱断裂的阳性信号,但依西美坦与肌腱断裂可能不相关[ROR 1.41(95%CI<1)、PRR 1.41(χ^(2)<4)],阿那曲唑与肌腱炎的统计学相关性最强,阳性信号值最高(ROR 7.72,PRR 7.67,IC 2.93,EBGM 7.64),依西美坦与腱鞘炎的相关性最强(ROR 10.4,PRR 10.35,IC 3.37,EBGM10.34)。阿那曲唑相关的肌腱炎、腱鞘炎和肌腱断裂中位发病时间分别为390、570、495 d;来曲唑相关肌腱炎和腱鞘炎的中位发病时间分别为30和45 d,肌腱断裂的中位发病为765 d;依西美坦的肌腱炎、腱鞘炎中位发病时间分别为360和150 d。结论通过分析FAERS数据确定了第3代AIs导致的肌腱疾病风险趋势,为临床识别AIs诱导的肌腱炎、腱鞘炎和肌腱断裂的不良事件提供参考。

OBJECTIVE To explore the risk of tendon disease with third-generation aromatase inhibitors(AIs)by mining and analyzing the FAERS database.METHODS Based on FAERS data from Q12004 to Q32022,disproportionality analysis and Bayesian analysis were used to detect AIs and tendon disease signals and to analyze the clinical characteristics,onset time,and association of tendinitis,tenosynovitis,and tendon rupture associated with third-generation AIs.RESULTS A total of 26129 adverse event reports of AIs and 148 reports of tendon disease were extracted.Positive signals for tendonitis,tenosynovitis and tendon rupture were detected for all three AIs drugs.In contrast to anastrozole and letrozole,exemestane might not correlate with tendon rupture[ROR 1.41(95%CI<1),PRR 1.41(χ^(2)<4)].Anastrozole had the strongest statistical correlation with tendonitis with the highest positive signal values(ROR 7.72,PRR 7.67,IC 2.93,EBGM 7.64)and exemestane had the strongest correlation with tenosynovitis(ROR 10.4,PRR 10.35,IC 3.37,EBGM 10.34).The median onset of anastrozole-associated tendonitis,tenosynovitis,and tendon rupture was 390,570 and 495 d,respectively;the median onset of letrozole-associated tendonitis and tenosynovitis was 30 and 45 d,respectively,and the median onset of tendon rupture was 765 d;and the median onset of exemestane's tendonitis and tenosynovitis was 360 and 150 d,respectively.CONCLUSION This study identifies trends in the risk of tendon disease due to third-generation AIs by analyzing FAERS data,providing reference for identifying adverse events in AIs-induced tendonitis,tenosynovitis,and tendon rupture.