背景:美沙拉嗪,制备5-氨基水杨酸,是一种在临床实践中广泛用作治疗轻中度炎症性肠病的一线疗法的药物。然而,美沙拉嗪在大样本人群中的长期安全性尚不清楚.目前的研究是通过美国食品和药物管理局不良事件报告系统(FAERS)的数据挖掘来评估真实世界中与美沙拉嗪相关的不良事件。方法:不相称性分析,包括报告赔率比(ROR),采用比例报告比、贝叶斯置信传播神经网络和多项目伽玛泊松收缩器(MGPS)算法来量化美沙拉嗪相关AE的信号。结果:从FDA不良事件报告系统数据库收集的14,149,980份报告中,发现24,284例美沙拉嗪相关不良事件报告。同时保留了符合四种算法的总共170个显著不成比例的首选项。最常见的AE包括溃疡性结肠炎,腹泻,病情加重,克罗恩病,疲劳,腹痛,恶心,便血,与说明书和临床试验中报道的相对应。意外的严重不良事件如头晕,药物无效,药物超敏反应,感染,标签外使用,体重下降,食欲下降,关节痛,皮疹也可能发生。美沙拉嗪相关不良事件的中位发病时间为1,127天(四分位距[IQR]1,127-1,674天),大多数病例发生在2年后(n=610,70.93%)和美沙拉嗪开始后的前1个月内(n=89,10.35%)。结论:我们的研究结果与临床观察结果一致。我们还发现了美沙拉嗪的潜在新的和意想不到的AE信号,提示需要前瞻性临床研究来证实这些结果并说明它们之间的关系.本研究结果可为进一步研究美沙拉嗪的安全性提供有价值的证据。
Background:
Mesalazine, a preparation of 5-aminosalicylic acid, is a medication widely used in clinical practice as a first-line therapy in the treatment of mild and moderate inflammatory bowel disease. However, the long-term safety of
mesalazine in large sample population was unknown. The current study was to assess
mesalazine -related adverse events of real-world through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: Disproportionality analyses, including the reporting odds ratio (ROR), the proportional reporting ratio the Bayesian confidence propagation neural network and the multi-item gamma Poisson shrinker (MGPS) algorithms were employed to quantify the signals of mesalazine -associated AEs. Results: Out of 14,149,980 reports collected from the FDA Adverse Event Reporting System database, 24,284 reports of mesalazine -associated AEs were identified. A total of 170 significant disproportionality preferred terms conforming to the four algorithms simultaneously were retained. The most common AEs included colitis ulcerative, diarrhoea, condition aggravated, crohn\'s disease, fatigue, abdominal pain, nausea, haematochezia, which were corresponding to those reported in the specification and clinical trials. Unexpected significant AEs as dizziness, drug ineffective, drug hypersensitivity, infection, off label use, weight decreased, decreased appetite, arthralgia, rash might also occur. The median onset time of
mesalazine -related AEs was 1,127 days (interquartile range [IQR] 1,127-1,674 days), and most of the cases occurred 2 years later (n = 610, 70.93%) and within the first 1 month (n = 89, 10.35%) after mesalazine initiation. Conclusion: Results of our study were consistent with clinical observations. We also found potential new and unexpected AEs signals for mesalazine, suggesting prospective clinical studies were needed to confirm these results and illustrate their relationship. Our results could provide valuable evidence for further safety studies of
mesalazine.