基于FAERS数据库仑伐替尼相关结肠炎的真实世界研究

Real-world Study of Lenvatinib-related Colitis Based on FAERS Database

关键词:  仑伐替尼  FAERS数据库  结肠炎  真实世界研究

Key words:  lenvatinib  FAERS database  colitis  real-world research

摘要:

目的 基于FAERS数据库研究仑伐替尼与结肠炎之间的关系。方法 基于2015年1季度—2021年3季度的FAERS数据，检索使用仑伐替尼后报告结肠炎的病例，使用比例失衡法和贝叶斯法进行数据挖掘。同时评估结肠炎的发生时间、仑伐替尼的使用剂量和患者结局。结果 共检索到101例仑伐替尼相关结肠炎病例。仑伐替尼使用后结肠炎报告例数逐年增加，这些病例大多数由医师提交。住院或住院延长(77例，76.24%)是最常见的不良事件报告结局。4种算法均检测到仑伐替尼的结肠炎不良事件信号(ROR=3.66，95%CI=3.01~4.46；PRR=3.63，χ²=189.96；IC=1.86，IC025=1.53；EBGM=3.62，EBGM05=3.07)。仑伐替尼用量≥12 mg的有66例，占比82.50%。结肠炎发生时间大多数≤60 d，占比58.21%。结论 仑伐替尼与结肠炎存在相关性，在使用仑伐替尼时，应考虑其诱发结肠炎的可能性，并仔细监测结肠炎或腹部症状的迹象。

Abstract:

OBJECTIVE To investigate the relationship between lenvatinib and colitis based on the FAERS database. METHODS Based on FAERS data from 2015 q1 to 2021q3, the cases of colitis reported following lenvatinib were retrievaled and the disproportionality and Bayesian analysis were employed for data mining. The onset time to colitis, the dose of lenvatinib using and the patient outcomes were also evaluated. RESULTS A total of 101 cases of lenvatinib-associated colitis were retrieved. The number of reported cases of colitis following lenvatinib had increased year by year, and most of these cases were submitted by physicians. Hospitalization or prolonged hospitalization(77, 76.24%) was the most common adverse event reported outcome. All 4 methods found an association between lenvatinib and colitis(ROR=3.66, 95%CI=3.01-4.46; PRR=3.63, χ²=189.96; IC=1.86, IC025=1.53; EBGM=3.62, EBGM05=3.07). The 66 patients(82.50%) received lenvatinib dose more than 12 mg. Most of the colitis occurred within 60 d, accounting for 58.21%. CONCLUSION There is a correlation between lenvatinib and colitis. When lenvatinib is used, colitis should be considered and patients receiving lenvatinib should be carefully monitored for signs of colitis or abdominal symptoms.